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Radar On Market Access: MA Insurers Report Strong Performance, Predict Enrollment Growth

December 1, 2020

Select publicly traded insurers reporting third-quarter 2020 earnings this past month predicted big gains in Medicare Advantage enrollment during the current Annual Election Period (AEP), and noted that growth in government products helped offset the impact of commercial losses and COVID-19 costs in the recent quarter, AIS Health reported.

Reporting third-quarter 2020 earnings on Nov. 6, CVS Health Corp. said a 3.5% year-over-year increase in overall revenues was due in part to growth in its Health Care Benefits segment, which includes Aetna. Revenues in that segment rose 8.8% from the prior-year quarter to $18.7 billion, primarily driven by membership increases in Aetna’s government products and the favorable impact of the return of the Affordable Care Act health insurer fee for 2020.

Select publicly traded insurers reporting third-quarter 2020 earnings this past month predicted big gains in Medicare Advantage enrollment during the current Annual Election Period (AEP), and noted that growth in government products helped offset the impact of commercial losses and COVID-19 costs in the recent quarter, AIS Health reported.

Reporting third-quarter 2020 earnings on Nov. 6, CVS Health Corp. said a 3.5% year-over-year increase in overall revenues was due in part to growth in its Health Care Benefits segment, which includes Aetna. Revenues in that segment rose 8.8% from the prior-year quarter to $18.7 billion, primarily driven by membership increases in Aetna’s government products and the favorable impact of the return of the Affordable Care Act health insurer fee for 2020.

Although earnings for the quarter dropped slightly from adjusted earnings per share of $1.84 a year ago to $1.66 (mostly due to COVID-related expenses), CVS raised its full-year adjusted EPS guidance to a range of $7.35 to $7.45.

Aetna President Karen Lynch, who will take over for CVS Health President and CEO Larry Merlo when he retires in February, said the insurer believes it is poised for “above-market growth” in MA in 2021 and beyond.

For the quarter ending Sept. 30, Humana Inc. reported adjusted EPS of $3.08, down from $5.03 in the year-ago quarter as a result of COVID- related expenses, as the company experienced lower-than-usual utilization that was largely offset by higher COVID testing and treatment costs, said Chief Financial Officer Brian Kane. “Accordingly, in the fourth quarter, we expect to record a loss of approximately $2.40 on an adjusted EPS basis, and are tightening our full-year 2020 EPS guidance to a range of $18.50 to $18.75, still within our initial guidance expectations prior to COVID,” he stated, as per a transcript of the call from The Motley Fool.

Humana for the year expects its individual MA membership to grow by approximately 375,000 lives, representing year-over-year growth of approximately 10%.

Pointing to continued expansion of its MA business as a growth driver, Cigna Corp. President and CEO David Cordani during a Nov. 5 earnings call said the company is on track to achieve a strategic EPS goal of $20 to $21 next year. Cigna reported adjusted EPS of $4.41 for the third quarter and anticipates full-year consolidated adjusted EPS of $18.30 to $18.60.

MMIT Reality Check on Type 2 Diabetes (DPP4 and Combo) (Nov 2020)

November 27, 2020

According to our recent payer coverage analysis for type 2 Diabetes (DPP4 and Combo) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for type 2 Diabetes (DPP4 and Combo) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for type 2 Diabetes (DPP4 and Combo) treatments shows that under the pharmacy benefit, almost 40% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In December 2019, Lexicon Pharmaceuticals, Inc. reported topline data from their Phase III SOTA-EMPA study for Zynquista (sotagliflozin) in type 2 diabetes, according to the company.

Perspectives on CMS Insulin Demo

November 26, 2020

In 2021, about half of enhanced stand-alone Prescription Drug Plans (PDPs) and a little more than a third of Medicare Advantage-Prescription Drug (MA-PD) plans will participate in a new demonstration that aims to lower diabetic seniors’ out-of-pocket costs by capping copays at $35 for a broad set of insulin products, according to a new analysis by consulting firm Avalere Health.

Among the 310 enhanced PDPs that opted to participate in CMS’s Part D Senior Savings Model for 2021, the average enrollment-weighted premium is $57.53 — $23.46 higher than the average premium for non-participating plans, the analysis found. But in the MA-PD space, the average enrollment-weighted premium for the 1,287 participating plans is $10.36 less than the cost of non-participating plans ($22.74 versus $33.10).

In 2021, about half of enhanced stand-alone Prescription Drug Plans (PDPs) and a little more than a third of Medicare Advantage-Prescription Drug (MA-PD) plans will participate in a new demonstration that aims to lower diabetic seniors’ out-of-pocket costs by capping copays at $35 for a broad set of insulin products, according to a new analysis by consulting firm Avalere Health.

Among the 310 enhanced PDPs that opted to participate in CMS’s Part D Senior Savings Model for 2021, the average enrollment-weighted premium is $57.53 — $23.46 higher than the average premium for non-participating plans, the analysis found. But in the MA-PD space, the average enrollment-weighted premium for the 1,287 participating plans is $10.36 less than the cost of non-participating plans ($22.74 versus $33.10).

Tom Kornfield, one of the co-authors of the Avalere report and a senior consultant with the firm, tells AIS Health one reason why PDPs with higher premiums tended to participate in the demonstration may be that “the additional protections [for consumers] cost the plans more money, so they’re increasing their bids as a result of that.”

Regarding why the average premium for participating MA-PD plans is lower than non-participating plans, Kornfield notes that, unlike stand-alone PDPs, such plans can reap the benefits of any cost savings associated with the demonstration’s ability to improve medication adherence and diabetes management.

CMS unveiled the Part D Senior Savings Model in March, and in May it said that 1,750 PDPs and MA-PD plans applied to participate, as well as the three major insulin manufacturers: Eli Lilly and Co., Novo Nordisk Inc. and Sanofi SA.

For seniors who sign up for plans that participate in the new model, the main benefit is a maximum copay of $35 each for a month’s supply of insulin while in the deductible, initial coverage and coverage-gap phases of the Part D benefit, rather than cost-sharing amounts that vary by coverage phase.

Kornfield says he was somewhat surprised that so many plan sponsors opted into the demonstration for 2021. “I don’t know that I anticipated quite as much participation, but having said that, the major insulin manufacturers are all voluntarily participating in the demonstration, so I think that makes a big difference.”

Radar On Market Access: Teledermatology Program Reduces Patient Wait Time But Doesn’t Increase Utilization

November 26, 2020

A pilot telemedicine program dramatically reduced the amount of time it took for primary care physicians to consult with dermatologists on skin ailments but did not increase utilization or cost, according to a new study from Independence Blue Cross and the University of Pennsylvania, AIS Health reported.

“Dermatology is an ideal specialty for telemedicine due to the visual nature of the clinical assessment,” says study co-author Aaron Smith-McLallen, director of health informatics and advanced analytics at Independence Blue Cross. “Using telemedicine, patients can get quality care very quickly and reduce wait times for patients with more acute needs that are not suitable for telemedicine intervention.”

A pilot telemedicine program dramatically reduced the amount of time it took for primary care physicians to consult with dermatologists on skin ailments but did not increase utilization or cost, according to a new study from Independence Blue Cross and the University of Pennsylvania, AIS Health reported.

“Dermatology is an ideal specialty for telemedicine due to the visual nature of the clinical assessment,” says study co-author Aaron Smith-McLallen, director of health informatics and advanced analytics at Independence Blue Cross. “Using telemedicine, patients can get quality care very quickly and reduce wait times for patients with more acute needs that are not suitable for telemedicine intervention.”

The study provides a blueprint for teledermatology programs that plans could potentially implement as soon as 2021, and also could show a path forward for telemedicine in other specialties, says F. Randy Vogenberg, Ph.D., principal, Institute for Integrated Healthcare in Greenville, S.C.

“Carriers are assessing how to best manage new technology-enabled care delivery in a more systematic manner that addresses their need to control financial risk while providing appropriate access to care,” Vogenberg tells AIS Health. “A study result like this clearly establishes the value proposition of providing a win-win scenario by leveraging technology to aid broader, easier access to care without increasing total costs associated with such expanded care delivery.”

The study, published in the journal Telemedicine and e-Health, examined implementation of teledermatology at five University of Pennsylvania Health System primary care practices in 2016 and 2017.

In the teledermatology arm of the study, dermatologists’ average response time was five hours, while in the “usual care” control arm, it took 84 days for primary care physicians to consult with dermatologists.

Teledermatology patients who were recommended for in-person evaluation completed visits to the dermatologist in fewer than four weeks, compared with longer than 14 weeks for controls, according to the study. Meanwhile, there were no significant differences detected in average outpatient costs or total medical costs between the two groups.

The store-and-forward evaluation approach has been used in other specialties, such as radiology and pathology, and Independence is exploring ways to expand its use, Smith-McLallen says.

Radar On Market Access: Centene Expands ACA Footprint But Faces More Competition

November 24, 2020

Centene Corp., which has come to dominate the Affordable Care Act exchange market by continuing to expand even when other carriers pulled back, is facing more competition now that the market has stabilized and insurer participation has increased, AIS Health reported.

Given that dynamic, Citi analyst Ralph Giacobbe advised investors recently that he was placing a “negative catalyst watch” on Centene due to the new competitive pressures it’s facing. Centene, he observed, “was displaced as the lowest priced plan in a number of markets,” and so the insurer “will have to rely on retention and new market entry to offset competitive pressures, which could prove challenging and may stunt growth relative to expectations.”

Centene Corp., which has come to dominate the Affordable Care Act exchange market by continuing to expand even when other carriers pulled back, is facing more competition now that the market has stabilized and insurer participation has increased, AIS Health reported.

Given that dynamic, Citi analyst Ralph Giacobbe advised investors recently that he was placing a “negative catalyst watch” on Centene due to the new competitive pressures it’s facing. Centene, he observed, “was displaced as the lowest priced plan in a number of markets,” and so the insurer “will have to rely on retention and new market entry to offset competitive pressures, which could prove challenging and may stunt growth relative to expectations.”

SVB Leerink analyst Stephen Tanal, however, takes a more optimistic view. “I’m pretty comfortable saying Centene’s likely to grow their overall HIX [health insurance exchange] earnings, because they’re going to be in so many more places with higher premiums,” he tells AIS Health.

According to Tanal’s analysis, Centene is increasing its county-level, member-weighted bronze plan premium by about 4% and raising premiums across all metal levels by 4% to 6%. Centene is also expanding its geographic footprint next year, a move that Tanal estimates will put the insurer in 61% more counties than it covered in 2020.

But Tanal did notes that the exchanges next year will feature “more competition in the form of fewer monopoly markets and a larger number of local market competitors.”

“It is definitely more competitive,” Kathy Hempstead, senior policy adviser at the Robert Wood Johnson Foundation, says of the 2021 ACA exchange market. “There’s more participants and it’s not just the Medicaid MCOs spreading out into more places.”

In fact, a new Kaiser Family Foundation analysis found that 30 insurers are entering the individual market next year across 20 states, and 61 insurers are expanding in states where they already operated.

However, “even though there’s a lot of new competition in the marketplace this year, I think that it’s definitely pretty fragmented so far,” Hempstead says. “UnitedHealth came back into a handful of states, Bright Health went into a handful of states, but it’s nothing like the scale that Centene has.”

MMIT Reality Check on Multiple Myeloma (Nov 2020)

November 20, 2020

According to our recent payer coverage analysis for multiple myeloma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for multiple myeloma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for multiple myeloma treatments shows that under the pharmacy benefit, about 51% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In August 2020, the FDA gave accelerated approval to GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf) for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunotherapy agent.

Trends That Matter for Employer Health Benefits

November 19, 2020

Several recent surveys on employer-sponsored health insurance have found that plan sponsors are following three major trends: expanding virtual care and telehealth benefits, narrowing provider networks and emphasizing centers of excellence in their benefit designs, AIS Health reported.

According to the 2020 edition of the Kaiser Family Foundation’s (KFF) Employer Health Benefits Survey, this year’s annual premium growth (4% for individuals and families) outstripped both wage growth (3.4%) and inflation (2.1%).

Several recent surveys on employer-sponsored health insurance have found that plan sponsors are following three major trends: expanding virtual care and telehealth benefits, narrowing provider networks and emphasizing centers of excellence in their benefit designs, AIS Health reported.

According to the 2020 edition of the Kaiser Family Foundation’s (KFF) Employer Health Benefits Survey, this year’s annual premium growth (4% for individuals and families) outstripped both wage growth (3.4%) and inflation (2.1%).

Other surveys project similar results in 2021, but caution that the pandemic saddles employers with unprecedented risk and uncertainty when setting premiums. The main cause of that uncertainty is utilization. Health insurers reported a dramatic fall in claims during the second quarter of 2020, but indications are that utilization begun to return to somewhat normal levels in the third quarter.

“There’s a lot of chatter specifically about [Affordable Care Act] marketplace insurers and about how they are experiencing fewer claims than expected,” says James Gelfand, senior vice president for the ERISA Industry Committee. “That’s not what I’m hearing from member companies. They feel like they’re under the same dynamic that they’ve been under for a decade: costs are going up, and the things they’re doing to try and save money have had a very mediocre effect.”

That tension has led to the emerging trend of narrower networks. Lowering costs and reducing unnecessary utilization is a key goal of narrowing provider networks, along with emphasizing quality and return on investment.

Concerns about COVID-19 exposure have caused a boom in virtual care and telehealth utilization, as patients have avoided in-person clinical visits. Hodgson says that plan sponsors and insurers need to determine how virtual visits will fit into benefit designs going forward.

Radar On Market Access: Insurer-Affiliated PBMs Propel Parent Firms’ Revenues in Third Quarter

November 19, 2020

Large insurer-affiliated PBMs saw strong results for the third quarter of 2020, in several cases driving revenues for parent companies that are grappling with various disruptive effects of the coronavirus pandemic, AIS Health reported.

At CVS Health Corp., which reported earnings on Nov. 6, total revenues increased 3.5% year over year to $67 billion, and the company posted earnings per share (EPS) of $1.66, beating analysts’ estimates.

Large insurer-affiliated PBMs saw strong results for the third quarter of 2020, in several cases driving revenues for parent companies that are grappling with various disruptive effects of the coronavirus pandemic, AIS Health reported.

At CVS Health Corp., which reported earnings on Nov. 6, total revenues increased 3.5% year over year to $67 billion, and the company posted earnings per share (EPS) of $1.66, beating analysts’ estimates.

“Our pharmacy services segment delivered double-digit operating income growth versus [the] prior year, reflecting strength in specialty along with favorable purchasing economics, and our 2021 [PBM] selling season is wrapping up quite nicely, with $3.3 billion of net new business,” President and CEO Larry Merlo said.

Still, SVB Leerink equities analyst Stephen Tanal said in a Nov. 6 investor note that CVS’s Caremark business remains at risk from state-level initiatives involving Medicaid pharmacy benefits.

Cigna Corp.’s new Evernorth segment, which includes the company’s Express Scripts PBM business, its Accredo specialty pharmacy division and its eviCore utilization management business, drove strong third-quarter earnings that beat analysts’ expectations.

Evernorth helped to boost Cigna’s overall revenues to $40.8 billion, said Citi analyst Ralph Giacobbe in a Nov. 5 investor note. Revenues for the Evernorth segment were $29.83 billion, a 20% increase year over year.

Evercore ISI analyst Michael Newshel said in a Nov. 5 investor note that Evernorth showed higher script volume and a slightly better margin than anticipated in the quarter, along with lower corporate expenses than expected.

UnitedHealth, which also handily beat analyst expectations with earnings of $3.51 per share, brought in $65.1 billion in the third quarter, representing an 8% increase year over year. However, the $3.51 adjusted EPS is a 10% drop from last year’s third-quarter earnings.

Health insurer Anthem, which has launched its own in-house PBM, IngenioRx, reported third-quarter adjusted EPS of $4.20, a decline of 14% year over year that reflected the company’s obligations to pay out its $594 million share of a recently settled lawsuit against Blue Cross and Blue Shield plans.

Anthem’s revenues increased by 15.9% year over year to $30.6 billion, which Chief Financial Officer John Gallina attributed largely to growth in the firm’s Medicare and Medicaid businesses, although he also gave a nod to “pharmacy revenue related to the launch of IngenioRx.”

Radar On Market Access: Biden Administration’s Drug-Pricing Moves May Be Limited

November 17, 2020

As is the case for other flavors of health care reform, President-elect Joe Biden’s chance of passing substantial, transformative drug-pricing legislation is now highly dependent upon whether Democrats can eke out a majority in the Senate. While that question won’t be resolved until Georgia completes runoff elections in January, industry observers point out that there are still ways that a Biden administration can address drug pricing, AIS Health reported.

“A president can do a lot even with a divided Congress,” says Stephanie Kennan, a member of McGuireWoods Consulting’s federal public affairs group. “Part of how well something gets done…depends upon the skills of the president or those negotiating for him. With Biden perhaps having a better understanding of the Senate, having come from the Senate, [that] might help him.”

As is the case for other flavors of health care reform, President-elect Joe Biden’s chance of passing substantial, transformative drug-pricing legislation is now highly dependent upon whether Democrats can eke out a majority in the Senate. While that question won’t be resolved until Georgia completes runoff elections in January, industry observers point out that there are still ways that a Biden administration can address drug pricing, AIS Health reported.

“A president can do a lot even with a divided Congress,” says Stephanie Kennan, a member of McGuireWoods Consulting’s federal public affairs group. “Part of how well something gets done…depends upon the skills of the president or those negotiating for him. With Biden perhaps having a better understanding of the Senate, having come from the Senate, [that] might help him.”

During a webinar held on Nov. 5, Avalere Health experts highlighted restructuring the Medicare Part D benefit as an area of potential bipartisan compromise. “I see something like that packaged with the health care extenders that’ll need to move in 2021,” said Chris Sloan, an associate principal at the consulting firm.

Yet Kathryn Bakich, the National Health Compliance Practice Leader at Segal, says that adding an out-of-pocket cost cap in Part D could raise some concerns from employers. “The problem with that is for employer-sponsored plans that have a Part D program, that could make the value of that program less to them,” she says.

In a Nov. 3 note to investors, Leerink SVB analyst Geoffrey Porges pointed out that using regulatory authority to rein in drug prices won’t have as large of an impact as legislation would. “Drug pricing mechanisms implemented via executive order are likely to be limited to a small class of higher-priced drugs within Medicare and Medicaid, with expansion to the commercial side requiring congressional action,” he wrote.

Porges also argued that regardless of who is in charge of the federal government, “the PBM system is likely to remain a target of future reforms.”

Going forward, it’s likely that “lawmakers will focus on the incentives governing formulary decisions and rebates in considering drug pricing reform, although the vehicle for this change is highly uncertain,” he wrote.

MMIT Reality Check on Cystic Fibrosis (Nov 2020)

November 13, 2020

According to our recent payer coverage analysis for cystic fibrosis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for cystic fibrosis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for cystic fibrosis treatments shows that under the pharmacy benefit, almost 62% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In September 2020, the FDA expanded the label of Vertex Pharmaceuticals Inc.’s Kalydeco (ivacaftor) for use in children ages 4 months to less than 6 months old with cystic fibrosis who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to Kalydeco based on clinical and/or in vitro assay data.

Perspectives on MA Star Ratings

November 12, 2020

Although more than three-quarters of Medicare Advantage beneficiaries remain in highly rated plans, roughly 77% of MA Prescription Drug (MA-PD) members are currently in contracts that will have 4 or more stars in 2021, down from about 81% in 2020, estimated CMS.

Approximately 49% of MA-PD plans (194 contracts) that will be offered in 2021 earned overall star ratings of 4 or higher, compared with 52% of MA-PDs (210 contracts) offered in 2020, according to CMS.

Although more than three-quarters of Medicare Advantage beneficiaries remain in highly rated plans, roughly 77% of MA Prescription Drug (MA-PD) members are currently in contracts that will have 4 or more stars in 2021, down from about 81% in 2020, estimated CMS.

Approximately 49% of MA-PD plans (194 contracts) that will be offered in 2021 earned overall star ratings of 4 or higher, compared with 52% of MA-PDs (210 contracts) offered in 2020, according to CMS.

Those declines are at least partly due to the increased weight of member experience measures based on Consumer Assessment of Healthcare Providers and Systems (CAHPS) and CMS administrative data, Melissa Newton Smith at HealthMine, Inc. tells AIS Health. For the 2021 star ratings, CMS increased the weighting value of the Part C Patients’ Experience and Complaints measures from 1.5 to 2.

That combined with the “continued improved performance on the Part D measures” created a downward shift in overall performance, she suggests.

MA-PDs performed worse on nine out of 14 Part D measures, including on all three medication adherence measures and in Statin Use in Persons with Diabetes (SUPD), which contribute about 15% to the overall rating. And 15 out of the 16 cut points for those measures increased, observes Smith.

“When you look at the number of plans that improved, there were 65 contracts that improved and only 19 picked up the fourth star, which is a pretty low number,” observes Smith. “And if you compare that to the plans that dropped this year…you can [observe that] CMS is seeing more plans dip below the 4-star level and losing quality bonus payments, which obviously trickles down into the market and changes the competitiveness of those contracts, which really jumped out.”

Tom Kornfield, senior consultant with Avalere Health, estimates that the 31 contracts that lost their fourth star collectively cover about 2 million enrollees, which is “not insignificant.” And even though three-quarters of the MA population are still in contracts with 4 or more stars, “when we look at the fact sheets from the last several years, there’s been an increase — or if it went down it was maybe by a percentage point,” says Kornfield.

Radar On Market Access: What’s Next for Health Insurers in a Likely Split Congress?

November 12, 2020

Though the new makeup of Congress may not be cemented until runoff elections take place in Georgia, perhaps the most consequential outcome of the 2020 general elections for the health insurance industry is that no one political party is likely to control the White House and both chambers of Congress, AIS Health reported.

“[I]t is evident there is no ‘blue wave’ as Republicans appear to have held the Senate,” Citi analyst Ralph Giacobbe advised investors on Nov. 5. “The news drove significant outperformance within the managed care space,” he observed. On Nov. 7, the presidential election was called in favor of former Vice President Joe Biden.

Though the new makeup of Congress may not be cemented until runoff elections take place in Georgia, perhaps the most consequential outcome of the 2020 general elections for the health insurance industry is that no one political party is likely to control the White House and both chambers of Congress, AIS Health reported.

“[I]t is evident there is no ‘blue wave’ as Republicans appear to have held the Senate,” Citi analyst Ralph Giacobbe advised investors on Nov. 5. “The news drove significant outperformance within the managed care space,” he observed. On Nov. 7, the presidential election was called in favor of former Vice President Joe Biden.

Jefferies analyst Brian Tanquilut, in his note to investors on Nov. 5, pointed out that a split Congress helps health insurers because it “essentially eliminates” the risk associated with Medicare for All gaining traction and generally limits legislators’ ability to advance progressives’ health care priorities.

In addition to implementing a public insurance option and lowering the Medicare eligibility age, other Democratic health care priorities that likely won’t happen with a GOP-controlled Senate include expanding Affordable Care Act (ACA) subsidies to middle-income individuals and allowing the federal government to negotiate Medicare Part D drug prices, Larry Levitt at the Kaiser Family Foundation, wrote in a Nov. 5 post on Twitter.

Kathryn Bakich, National Health Compliance Practice Leader at Segal, points out that a split Congress is also less likely to pass legislation that rescues the ACA if all or part of the law is struck down by the Supreme Court, which on Nov. 10 heard oral arguments in a case challenging the law’s constitutionality.

One area where the Biden administration and Congress will likely train their sights is on surprise medical billing.

Yet bipartisan support for a surprise-billing fix existed long before the election — including an executive order from Trump directing Congress to pass such legislation — and still a solution failed to materialize.

“Presumably if you had an administration that had really great negotiating skills, they could get everybody in the same room and say, ‘We’ve got to figure this out; we’re not leaving until we do,'” says Stephanie Kennan, a member of McGuireWoods Consulting’s federal public affairs group. “But I think people have tried that.”

Radar On Market Access: Humana Reports Strong Earnings, But Expects Fourth-Quarter Loss

November 10, 2020

While Humana Inc. has seen its profits swell as members avoided non-coronavirus-related care during the pandemic, the company is making it crystal clear that those financial gains will be erased before the year is over, AIS Health reported.

“We continue to expect our results for the second half of 2020, including an anticipated loss in the fourth quarter, to entirely offset the significant outperformance experienced in the first half of the year that resulted from historically low medical utilization levels,” Chief Financial Officer Brian Kane said during Humana’s third-quarter earnings call, according to a transcript from The Motley Fool.

While Humana Inc. has seen its profits swell as members avoided non-coronavirus-related care during the pandemic, the company is making it crystal clear that those financial gains will be erased before the year is over, AIS Health reported.

“We continue to expect our results for the second half of 2020, including an anticipated loss in the fourth quarter, to entirely offset the significant outperformance experienced in the first half of the year that resulted from historically low medical utilization levels,” Chief Financial Officer Brian Kane said during Humana’s third-quarter earnings call, according to a transcript from The Motley Fool.

That’s despite the fact that medical utilization has not yet returned to normal among Humana’s members, as it was tracking at 95% in September and October. And with COVID-19 cases once again rising throughout the country, the insurer anticipates the use of non-COVID care “to remain modestly below pre-COVID expectations through the end of 2020.”

Humana is also expecting to spend more on COVID-19 patients’ care than it originally anticipated. “[W]e now expect COVID testing and treatment costs to approach $1 billion in 2020,” Kane said.

For the third quarter of 2020, Humana reported earnings per share (EPS) of $10.05, or $3.08 on an adjusted basis. The large discrepancy is because the latter figure saw an impact from two major items: the receipt of unpaid Affordable Care Act risk corridor payments following a favorable Supreme Court ruling, and “a market gain from publicly traded investments,” chiefly primary care startup Oak Street Health, Inc., which raised more than expected in its initial public offering in August.

Humana’s adjusted EPS for the third quarter — which excluded the Oak Street and risk corridors impact — came in 27 cents above the Wall Street consensus, Evercore ISI analyst Michael Newshel advised investors. The insurer’s consolidated medical loss ratio of 85.3% was 60 basis points below consensus, Newshel added, “but operating costs were higher.”

Wall Street analysts took an optimistic view of Humana’s financial results. “Core utilization is still running below the baseline, which affords [management] flexibility to absorb COVID costs while pulling forward investments,” Jefferies analyst David Windley observed.

MMIT Reality Check on Chronic Lymphocytic Leukemia (Nov 2020)

November 6, 2020

According to our recent payer coverage analysis for chronic lymphocytic leukemia (CLL) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for chronic lymphocytic leukemia (CLL) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for CLL treatments shows that under the pharmacy benefit, almost 51% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, the FDA expanded the label for Pharmacyclics LLC, an AbbVie Inc. company, and Janssen Biotech, Inc.’s Imbruvica (ibrutinib) in combination with rituximab for the treatment of adults newly diagnosed with chronic lymphocytic leukemia or small lymphocytic leukemia.

Trends That Matter for Major PBMs’ 2021 Formulary

November 5, 2020

CVS Health Corp.’s Caremark will exclude 57 medications from its 2021 formulary and add six back. Meanwhile, UnitedHealth Group’s OptumRx subsidiary will exclude 19 medications and products while adding back five and implementing restrictions on others, AIS Health reported.

Still, only a handful of products excluded by either PBM are likely to impact many members adversely, says Marc Guieb, a pharmacist and consultant with Milliman Inc. That also applies to the exclusions announced earlier by Cigna Corp.-owned PBM Express Scripts, he adds.

Guieb observes that brand-name albuterol inhalers are seeing exclusions in 2021 from multiple PBMs, and that’s the change that will affect the most members. “That’s a big one this year,” he says. “One of the PBMs’ new strategies is, they’re completely excluding all the brands of albuterol inhalers, and they’re just going with the generic.”

CVS Health Corp.’s Caremark will exclude 57 medications from its 2021 formulary and add six back. Meanwhile, UnitedHealth Group’s OptumRx subsidiary will exclude 19 medications and products while adding back five and implementing restrictions on others, AIS Health reported.

Still, only a handful of products excluded by either PBM are likely to impact many members adversely, says Marc Guieb, a pharmacist and consultant with Milliman Inc. That also applies to the exclusions announced earlier by Cigna Corp.-owned PBM Express Scripts, he adds.

Guieb observes that brand-name albuterol inhalers are seeing exclusions in 2021 from multiple PBMs, and that’s the change that will affect the most members. “That’s a big one this year,” he says. “One of the PBMs’ new strategies is, they’re completely excluding all the brands of albuterol inhalers, and they’re just going with the generic.”

Meanwhile, “the change that will actually cause the most widespread disruption and confusion will be diabetics switching to entirely new blood glucose monitoring systems, which is a hassle,” Guieb says.

PBMs that decide to prefer one specialty drug over another also can cause significant member disruption, Guieb adds, pointing to potential issues involving Novartis Pharmaceuticals Corp.’s biologic Cosentyx (secukinumab), which was excluded from Express Scripts’ 2021 formulary in favor of Eli Lilly and Co.’s Taltz (ixekizumab).

Overall, “I will say that for a lot of these annual formulary changes, they’re definitely a step in the right direction, although it may not be a big enough step in the right direction,” Guieb adds.

For 2021, OptumRx is changing up its multiple sclerosis coverage, adding Biogen’s Tecfidera (dimethyl fumarate) to its excluded list and preferring bioequivalent Bafiertam, made by Banner Life Sciences. Biogen’s Vumerity (diroximel fumarate) remains excluded.

Graphics below list medications that will be excluded by two or three major PBMs and their current market access among commercial formularies under the pharmacy benefit.

Radar On Market Access: FDA’s Approval of Sogroya May Change GH Class Management

November 5, 2020

When the FDA approved Novo Nordisk, Inc.’s Sogroya (somapacitan-beco) for the replacement of growth hormone in adults with growth hormone deficiency on Aug. 28, it became the only long-acting agent on the market, AIS Health reported.

There are seven short-acting growth hormones currently available to treat adults with growth hormone deficiency, all of them branded forms of somatropin. Differences among the products, all of which are self-administered, include the strengths available and the type of device to deliver the treatment. But all of them must be administered daily. Sogroya, which also is self-administered, is the only FDA-approved product with weekly dosing.

When the FDA approved Novo Nordisk, Inc.’s Sogroya (somapacitan-beco) for the replacement of growth hormone in adults with growth hormone deficiency on Aug. 28, it became the only long-acting agent on the market, AIS Health reported.

There are seven short-acting growth hormones currently available to treat adults with growth hormone deficiency, all of them branded forms of somatropin. Differences among the products, all of which are self-administered, include the strengths available and the type of device to deliver the treatment. But all of them must be administered daily. Sogroya, which also is self-administered, is the only FDA-approved product with weekly dosing.

Mesfin Tegenu, R.Ph., president of PerformRx, LLC, points out that Sogroya “is a human growth hormone (hGH) analog — an hGH with an added albumin-binding moiety. Up until this point, all hGH products have been a recombinant product, identical copies of hGH (rhGH). The half-life of somapacitan is measured in days (two to three days) while the half-life of rhGH (somatropin) is measured in hours (approximately two-and-a-half hours). The extended half-life of somapacitan allows less frequent (weekly) dosing.”

He says that payers typically have prior authorization on somatropin, with “controls including diagnostic and lab values as prerequisites.” A prescription from an endocrinologist is also a “common practice.”
“Somapacitan is likely to be managed similar to all the other rhGH class of drugs,” Tegenu says, adding that “it is reasonable to classify it as a second-line or nonpreferred agent whose use is allowed only after a trial and failure of or other medical reason for not using a preferred daily rhGH.”

For the Managed Care Biologics and Injectables Index: Q1 2020, Zitter Insights surveyed between Feb. 25 and April 1 51 commercial payers with 138.1 million covered lives, and respondents with 55% of the lives said they expect to cover at least one long-acting therapy at parity with a preferred short-acting one. Payers with 11% of the covered lives said they expected to prefer a long-acting agent over all other products.

Zitter also polled 25 endocrinologists about their anticipated reaction to the availability of a long-acting growth hormone. Three-fourths of them said they were somewhat likely and highly likely to prescribe it to patients new to therapy, and 68% said they were somewhat likely and highly likely to shift current patients to it.

Radar On Market Access: Centene Talks ACA’s Future, Medicaid Rates in 3Q Earnings Call

November 3, 2020

During their third-quarter 2020 earnings conference call, Centene Corp. executives made the case that despite all the challenges related to the pandemic and politics, there are plenty of reasons to believe the company is well-equipped to weather the storm, AIS Health reported.

As has come to be a habit for Neidorff during earnings calls, Centene’s leader directly addressed the latest threat to the viability of the Affordable Care Act — a case challenging the law’s constitutionality that the Supreme Court is scheduled to hear just one week after the Nov. 3 general election. “I don’t believe when push comes to shove, they really want to put all these people during the height of a pandemic on the street with no insurance,” Neidorff said. Thus, he says he expects the court will uphold the ACA even though it has just become more conservative with the addition of Justice Amy Coney Barrett.

During their third-quarter 2020 earnings conference call, Centene Corp. executives made the case that despite all the challenges related to the pandemic and politics, there are plenty of reasons to believe the company is well-equipped to weather the storm, AIS Health reported.

As has come to be a habit for Neidorff during earnings calls, Centene’s leader directly addressed the latest threat to the viability of the Affordable Care Act — a case challenging the law’s constitutionality that the Supreme Court is scheduled to hear just one week after the Nov. 3 general election. “I don’t believe when push comes to shove, they really want to put all these people during the height of a pandemic on the street with no insurance,” Neidorff said. Thus, he says he expects the court will uphold the ACA even though it has just become more conservative with the addition of Justice Amy Coney Barrett.

Centene also offered reasons for optimism regarding a challenge that it and other Medicaid managed care organizations are facing: cash-strapped states that are moving to claw back funds from MCOs that have benefitted from reduced care utilization amid the COVID-19 pandemic.

“Centene expects a smaller headwind in 2021 from Medicaid rate actions and risk corridors than it will absorb in 2020,” Leerink analyst Stephen Tanal pointed out in an Oct. 27 note to investors. While the insurer is on track to absorb a $500 million headwind related to Medicaid rate cuts this year, “some of the programs driving the impact in 2020 will expire” next year, Tanal noted.

Meanwhile, Centene’s Medicaid and health insurance exchange membership has increased by 1.3 million from the first through third quarters of 2020, Jefferies analyst David Windley wrote in an Oct. 27 note. And Centene executives confirmed during the earnings call that the insurer remains on track to reach a peak of 1.4 million new members in November.

For the quarter ending on Sept. 30, Centene reported that its adjusted diluted earnings per share (EPS) was $1.26, up from $0.96 last year. But that number drops down to $0.97 when excluding Centene’s share of the settlement from the recent Supreme Court risk corridors decision, a charitable contribution to its foundation, and an unrelated tax benefit.

MMIT Reality Check on Hepatocellular Carcinoma (Oct 2020)

October 30, 2020

According to our recent payer coverage analysis for hepatocellular carcinoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for hepatocellular carcinoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for hepatocellular carcinoma treatments shows that under the pharmacy benefit, about 59% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In May 2020, the FDA expanded the indication for Roche’s Tecentriq (atezolizumab) in combination with bevacizumab for the treatment of people with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.

Perspectives on the Future of ACA

October 29, 2020

The Sept. 18 death of Justice Ruth Bader Ginsburg — which could tip the scales in favor of striking down the Affordable Care Act (ACA) — was hardly welcome news for health insurers during a year when a pandemic and a presidential election are already fueling high levels of uncertainty. However, industry analysts and legal experts say there are plenty of reasons not to hit the panic button just yet, AIS Health reported.

“This definitely increases the chance of the Supreme Court striking down the full ACA. But we’re going from a pretty low likelihood base,” says Chris Sloan at Avalere Health. “The odds are still really stacked against anything materially changing for the ACA.”

At issue is a case now known as California v. Texas, which Republican state officials filed in 2018 to challenge the constitutionality of the ACA. Because Congress changed the tax penalty for the law’s individual mandate to $0 via the 2017 Tax Cuts and Jobs Act, they argued, the mandate is unlawful, and if that part is unconstitutional, the whole law must go.

The Sept. 18 death of Justice Ruth Bader Ginsburg — which could tip the scales in favor of striking down the Affordable Care Act (ACA) — was hardly welcome news for health insurers during a year when a pandemic and a presidential election are already fueling high levels of uncertainty. However, industry analysts and legal experts say there are plenty of reasons not to hit the panic button just yet, AIS Health reported.

“This definitely increases the chance of the Supreme Court striking down the full ACA. But we’re going from a pretty low likelihood base,” says Chris Sloan at Avalere Health. “The odds are still really stacked against anything materially changing for the ACA.”

At issue is a case now known as California v. Texas, which Republican state officials filed in 2018 to challenge the constitutionality of the ACA. Because Congress changed the tax penalty for the law’s individual mandate to $0 via the 2017 Tax Cuts and Jobs Act, they argued, the mandate is unlawful, and if that part is unconstitutional, the whole law must go.

Until Ginsburg’s death from cancer complications, many legal observers expected that the ACA had a good shot at surviving this latest Supreme Court challenge. But if Senate Republicans are able to confirm a replacement for Ginsburg before Nov. 10 oral arguments, not one but two conservative justices would have to side with their liberal colleagues to produce a pro-ACA ruling, explains health care attorney Katie Keith.

Ultimately, “I’m still skeptical that the entire law would be invalidated; I think that would be a step too far and does go against some of the recent decisions we’ve seen on severability from this court,” Keith says. However, she adds that the loss of Ginsburg “makes it more likely that parts of the ACA will be struck down” — in particular, the so-called preexisting condition protections.

Wall Street analysts, meanwhile, appeared unconvinced that the law will be unraveled — but noted that Centene Corp. has the most exposure if that happens, given its strong concentration in Medicaid and the individual market. Credit Suisse’s A.J. Rice estimated that those two business lines make up roughly 26% of Centene’s earnings, but only 4% for Anthem, Inc., and less than 1% each for Cigna Corp., CVS Health Corp., Humana Inc. and UnitedHealth Group.

Radar On Market Access: Employers Aim to Narrow Networks, Emphasize COEs, Expand Virtual Care Benefits

October 29, 2020

Several recent surveys on employer-sponsored health insurance have found that plan sponsors are following three major trends: expanding virtual care and telehealth benefits, narrowing provider networks and emphasizing centers of excellence in their benefit designs, AIS Health reported.

According to the 2020 edition of the Kaiser Family Foundation’s (KFF) Employer Health Benefits Survey, this year’s annual premium growth (4% for individuals and families) outstripped both wage growth (3.4%) and inflation (2.1%).

Other surveys project similar results in 2021, but caution that the pandemic saddles employers with unprecedented risk and uncertainty when setting premiums. The main cause of that uncertainty is utilization. Health insurers reported a dramatic fall in claims during the second quarter of 2020, but indications are that utilization begun to return to somewhat normal levels in the third quarter.

Several recent surveys on employer-sponsored health insurance have found that plan sponsors are following three major trends: expanding virtual care and telehealth benefits, narrowing provider networks and emphasizing centers of excellence in their benefit designs, AIS Health reported.

According to the 2020 edition of the Kaiser Family Foundation’s (KFF) Employer Health Benefits Survey, this year’s annual premium growth (4% for individuals and families) outstripped both wage growth (3.4%) and inflation (2.1%).

Other surveys project similar results in 2021, but caution that the pandemic saddles employers with unprecedented risk and uncertainty when setting premiums. The main cause of that uncertainty is utilization. Health insurers reported a dramatic fall in claims during the second quarter of 2020, but indications are that utilization begun to return to somewhat normal levels in the third quarter.

“There’s a lot of chatter specifically about [Affordable Care Act] marketplace insurers and about how they are experiencing fewer claims than expected,” says James Gelfand, senior vice president for the ERISA Industry Committee. “That’s not what I’m hearing from member companies. They feel like they’re under the same dynamic that they’ve been under for a decade: costs are going up, and the things they’re doing to try and save money have had a very mediocre effect.”

That tension has led to the emerging trend of narrower networks. Lowering costs and reducing unnecessary utilization is a key goal of narrowing provider networks, along with emphasizing quality and return on investment.

“This is something that a lot of providers out here are realizing: the ones that did not embrace value-based care before the pandemic and continued on fee-for-service — they’re the ones that are really struggling….I think this potentially could push more [providers] into that avenue,” says Drew Hodgson, the national practice leader for health care delivery at Willis Towers Watson.

Hodgson adds that “a lot of employers are looking at [centers of excellence] more than they ever did. Mainly because of the fear of the rising costs right now, and they think they can control costs.”

Concerns about COVID-19 exposure have caused a boom in virtual care and telehealth utilization, as patients have avoided in-person clinical visits. Hodgson says that plan sponsors and insurers need to determine how virtual visits will fit into benefit designs going forward.

Radar On Market Access: Costlier PDPs, Cheaper MA-PDs Participate in CMS Insulin Demo

October 27, 2020

In 2021, about half of enhanced stand-alone Prescription Drug Plans (PDPs) and a little more than a third of Medicare Advantage-Prescription Drug (MA-PD) plans will participate in a new demonstration that aims to lower diabetic seniors’ out-of-pocket costs by capping copays at $35 for a broad set of insulin products, according to a new analysis by consulting firm Avalere Health.

Among the 310 enhanced PDPs that opted to participate in CMS’s Part D Senior Savings Model for 2021, the average enrollment-weighted premium is $57.53 — $23.46 higher than the average premium for non-participating plans, the analysis found. But in the MA-PD space, the average enrollment-weighted premium for the 1,287 participating plans is $10.36 less than the cost of non-participating plans ($22.74 versus $33.10).

In 2021, about half of enhanced stand-alone Prescription Drug Plans (PDPs) and a little more than a third of Medicare Advantage-Prescription Drug (MA-PD) plans will participate in a new demonstration that aims to lower diabetic seniors’ out-of-pocket costs by capping copays at $35 for a broad set of insulin products, according to a new analysis by consulting firm Avalere Health.

Among the 310 enhanced PDPs that opted to participate in CMS’s Part D Senior Savings Model for 2021, the average enrollment-weighted premium is $57.53 — $23.46 higher than the average premium for non-participating plans, the analysis found. But in the MA-PD space, the average enrollment-weighted premium for the 1,287 participating plans is $10.36 less than the cost of non-participating plans ($22.74 versus $33.10).

Tom Kornfield, one of the co-authors of the Avalere report and a senior consultant with the firm, tells AIS Health one reason why PDPs with higher premiums tended to participate in the demonstration may be that “the additional protections [for consumers] cost the plans more money, so they’re increasing their bids as a result of that.”

Regarding why the average premium for participating MA-PD plans is lower than non-participating plans, Kornfield notes that, unlike stand-alone PDPs, such plans can reap the benefits of any cost savings associated with the demonstration’s ability to improve medication adherence and diabetes management.

CMS unveiled the Part D Senior Savings Model in March, and in May it said that 1,750 PDPs and MA-PD plans applied to participate, as well as the three major insulin manufacturers: Eli Lilly and Co., Novo Nordisk Inc. and Sanofi SA.

For seniors who sign up for plans that participate in the new model, the main benefit is a maximum copay of $35 each for a month’s supply of insulin while in the deductible, initial coverage and coverage-gap phases of the Part D benefit, rather than cost-sharing amounts that vary by coverage phase.

Kornfield says he was somewhat surprised that so many plan sponsors opted into the demonstration for 2021. “I don’t know that I anticipated quite as much participation, but having said that, the major insulin manufacturers are all voluntarily participating in the demonstration, so I think that makes a big difference.”

MMIT Reality Check on Psoriasis (Oct 2020)

October 23, 2020

According to our recent payer coverage analysis for psoriasis (PsO) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for psoriasis (PsO) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for psoriasis treatments shows that under the pharmacy benefit, about 75% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In July 2020, the FDA approved Mylan N.V. and Fujifilm Kyowa Kirin Biologics Co., Ltd.’s Hulio (adalimumab-fkjp) for the treatment of plaque psoriasis, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease and ulcerative colitis.

Trends That Matter for CAR-T Therapies

October 22, 2020

This summer, a drug called Tecartus (brexucabtagene autoleucel) became the third chimeric antigen receptor T-cell (CAR-T) therapy approved by the FDA. CAR-T therapies, which use a patient’s genetically modified immune cells to target and fight cancer cells, are a cutting-edge type of treatment that comes with eye-popping price tags, ranging from $373,000 to $475,000. However, a new report from OptumRx highlights an “industry trend to watch” that could eventually provide some relief to payers worried about how to finance CAR-T treatments, AIS Health reported.

Currently, CAR-T therapies’ high cost is at least in part attributable to the “labor-intensive and time-consuming” manufacturing process for such drugs, stated the UnitedHealth Group-owned PBM’s Drug Pipeline Insights Report for the third quarter of 2020. Essentially, T-cells are taken from a patient, treated and multiplied in a lab, and reinfused into the same patient — a completely personalized process known as autologous therapy.

This summer, a drug called Tecartus (brexucabtagene autoleucel) became the third chimeric antigen receptor T-cell (CAR-T) therapy approved by the FDA. CAR-T therapies, which use a patient’s genetically modified immune cells to target and fight cancer cells, are a cutting-edge type of treatment that comes with eye-popping price tags, ranging from $373,000 to $475,000. However, a new report from OptumRx highlights an “industry trend to watch” that could eventually provide some relief to payers worried about how to finance CAR-T treatments, AIS Health reported.

Currently, CAR-T therapies’ high cost is at least in part attributable to the “labor-intensive and time-consuming” manufacturing process for such drugs, stated the UnitedHealth Group-owned PBM’s Drug Pipeline Insights Report for the third quarter of 2020. Essentially, T-cells are taken from a patient, treated and multiplied in a lab, and reinfused into the same patient — a completely personalized process known as autologous therapy.

As the industry searches for a cheaper and more scalable way of manufacturing CAR-T treatments, a new approach known as an allogeneic process “is currently under study as one possible solution,” according to OptumRx. In this process, previously extracted and banked healthy donor T-cells are multiplied “many times over for use in many patients,” effectively spreading out the high initial manufacturing cost over multiple doses.

When asked how much the allogeneic process could reduce the manufacturing cost of CAR-T therapies, Bill Dreitlein, senior director of pipeline and drug surveillance at OptumRx, cited a 2019 study.

“Per the International Society for Cell and Gene Therapy, the cost to manufacture CAR-T using current methods is at $95,780 per dose,” he says via email. “That study also calculates the production cost using the new process would be only $4,460 per dose — over 95% lower.”

Tecartus’ list price is $373,000, and the wholesale acquisition costs of the other CAR-T therapies, Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), are $373,000 and $475,000 respectively, per the OptumRx report.

The graphic below show how Tecartus, Kymriah and Yescarta are covered among commercial health plans, health exchange programs, Medicare and Medicaid programs under the pharmacy benefit.

Radar On Market Access: Racial Disparities Are Highlighted by Pandemic

October 22, 2020

The COVID-19 pandemic has been especially harmful to people of color in the U.S., as they are more likely to suffer financial hardship, extreme cases of the disease or death than the white population. Experts say the devastation to communities of color is the product of systemic racism — particularly a lack of access to insurance coverage and quality care — and the pandemic’s economic consequences will make all of those problems worse, AIS Health reported.

According to a Sept. 15 report released by the Kaiser Family Foundation (KFF) and the Epic Health Research Network, people of color were more likely to test positive for COVID-19 and to require a higher level of care at the time of diagnosis compared to white patients, and they also were more likely to be hospitalized and die from the novel coronavirus than white patients were.

The COVID-19 pandemic has been especially harmful to people of color in the U.S., as they are more likely to suffer financial hardship, extreme cases of the disease or death than the white population. Experts say the devastation to communities of color is the product of systemic racism — particularly a lack of access to insurance coverage and quality care — and the pandemic’s economic consequences will make all of those problems worse, AIS Health reported.

According to a Sept. 15 report released by the Kaiser Family Foundation (KFF) and the Epic Health Research Network, people of color were more likely to test positive for COVID-19 and to require a higher level of care at the time of diagnosis compared to white patients, and they also were more likely to be hospitalized and die from the novel coronavirus than white patients were.

The economic impact of the pandemic has been similarly dire for households of color. According to a Sept. 16 survey prepared by NPR, the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health, majorities of Latino (72%), Black (60%) and Native American (55%) households all “report facing serious financial problems during the coronavirus outbreak.”

The survey also found that 25% of Latino households, 18% of Black households and 12% of Native American households “report serious problems affording medical care during the coronavirus outbreak.”

Policymakers say that COVID-19’s poor outcomes within communities of color are sadly predictable. During an Oct. 7 webinar organized by Axios, Rep. Markwayne Mullin (R-Okla.), a member of the Cherokee Nation, said that the problems in Indian Country are a direct product of underfunding the federal Indian Health Service (IHS), which is the primary insurer and provider for Native Americans. According to Mullin, the IHS receives about one-third of the funding per patient as Medicare, Medicaid and the Veterans Administration.

Leading public health figures have argued that racial disparities must be accounted for in plans to distribute COVID-19 vaccines. On Oct. 6, a panel convened by the National Academies of Sciences, Engineering and Medicine released a draft of a report titled Framework for Equitable Allocation of COVID-19 Vaccine. The framework emphasizes the importance of accounting for existing racial disparities in vaccine distribution, and noted the skepticism that communities of color have toward vaccines and the medical profession in general.

Radar On Market Access: Average MA Star Ratings Fall Due to Increased Weights, Cut Points

October 20, 2020

Although more than three-quarters of Medicare Advantage beneficiaries remain in highly rated plans, roughly 77% of MA Prescription Drug (MA-PD) members are currently in contracts that will have 4 or more stars in 2021, down from about 81% in 2020, estimated CMS.

Approximately 49% of MA-PD plans (194 contracts) that will be offered in 2021 earned overall star ratings of 4 or higher, compared with 52% of MA-PDs (210 contracts) offered in 2020, according to CMS.

Those declines are at least partly due to the increased weight of member experience measures based on Consumer Assessment of Healthcare Providers and Systems (CAHPS) and CMS administrative data, Melissa Newton Smith at HealthMine, Inc. tells AIS Health. For the 2021 star ratings, CMS increased the weighting value of the Part C Patients’ Experience and Complaints measures from 1.5 to 2.

Although more than three-quarters of Medicare Advantage beneficiaries remain in highly rated plans, roughly 77% of MA Prescription Drug (MA-PD) members are currently in contracts that will have 4 or more stars in 2021, down from about 81% in 2020, estimated CMS.

Approximately 49% of MA-PD plans (194 contracts) that will be offered in 2021 earned overall star ratings of 4 or higher, compared with 52% of MA-PDs (210 contracts) offered in 2020, according to CMS.

Those declines are at least partly due to the increased weight of member experience measures based on Consumer Assessment of Healthcare Providers and Systems (CAHPS) and CMS administrative data, Melissa Newton Smith at HealthMine, Inc. tells AIS Health. For the 2021 star ratings, CMS increased the weighting value of the Part C Patients’ Experience and Complaints measures from 1.5 to 2.

That combined with the “continued improved performance on the Part D measures” created a downward shift in overall performance, she suggests.

MA-PDs performed worse on nine out of 14 Part D measures, including on all three medication adherence measures and in Statin Use in Persons with Diabetes (SUPD), which contribute about 15% to the overall rating. And 15 out of the 16 cut points for those measures increased, observes Smith.

“When you look at the number of plans that improved, there were 65 contracts that improved and only 19 picked up the fourth star, which is a pretty low number,” observes Smith. “And if you compare that to the plans that dropped this year…you can [observe that] CMS is seeing more plans dip below the 4-star level and losing quality bonus payments, which obviously trickles down into the market and changes the competitiveness of those contracts, which really jumped out.”

Tom Kornfield, senior consultant with Avalere Health, estimates that the 31 contracts that lost their fourth star collectively cover about 2 million enrollees, which is “not insignificant.” And even though three-quarters of the MA population are still in contracts with 4 or more stars, “when we look at the fact sheets from the last several years, there’s been an increase — or if it went down it was maybe by a percentage point,” says Kornfield.

In an Oct. 8 analysis from SVB Leerink, securities analyst Stephan Tanal observed that Cigna Corp. demonstrated the greatest improvement from the prior year. Anthem, Inc., and UnitedHealthcare both showed downward movement.

MMIT Reality Check on Hemophilia A (Factor VIII) (Oct 2020)

October 16, 2020

According to our recent payer coverage analysis for hemophilia A (factor VIII) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for hemophilia A (factor VIII) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for hemophilia A (factor VIII) treatments shows that under the pharmacy benefit, about 42% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: The market is trending toward longer half-life recombinant products. Anticipated product approvals may develop improved product placement based on potential costs, adherence and efficacy advantages. The market will be managed more tightly as we start seeing an increase in longer acting products and gene therapy products in the pipeline.

Perspectives on Provider Consolidation

October 15, 2020

The climate for payer mergers and acquisitions (M&A) has cooled substantially at a national level ever since the collapse of the proposed deals between Anthem, Inc. and Cigna Corp. and between Aetna Inc. and Humana Inc. However, consolidation in the provider sector has increased since the start of the COVID-19 pandemic as such firms grapple with the rapid collapse of fee-for-service revenue, AIS Health reported.

The breakdown of Anthem’s bid to acquire Cigna resulted in a public spat and dueling lawsuits over Cigna’s attempt to exit their agreement before exhausting the firms’ option to appeal a federal ruling against the transaction. On Aug. 31, the Delaware Court of Chancery ruled that neither firm had to pay damages to the other over the failed deal.

The climate for payer mergers and acquisitions (M&A) has cooled substantially at a national level ever since the collapse of the proposed deals between Anthem, Inc. and Cigna Corp. and between Aetna Inc. and Humana Inc. However, consolidation in the provider sector has increased since the start of the COVID-19 pandemic as such firms grapple with the rapid collapse of fee-for-service revenue, AIS Health reported.

The breakdown of Anthem’s bid to acquire Cigna resulted in a public spat and dueling lawsuits over Cigna’s attempt to exit their agreement before exhausting the firms’ option to appeal a federal ruling against the transaction. On Aug. 31, the Delaware Court of Chancery ruled that neither firm had to pay damages to the other over the failed deal.

This failed deal was a catalyst for the slowing pace of health insurance consolidation at the national scale, according to antitrust lawyer and former Federal Trade Commission official David Balto.

Ashraf Shehata, KPMG national sector leader for health care and life sciences, says that Cigna’s acquisition of Express Scripts, a transaction that the firm pursued partly because of the failed Anthem merger, set a precedent of its own.

“I would say what that has spawned instead of the health plan integration, it’s spawned…the PBM integration. Rather than health plan to health plan, it was health plan plus PBM. And we saw that across the board with all the commercial entities,” he says.

Shehata says he sees three likely types of payer transactions and reorganizations going forward. The first is the PBM-payer integration. Second, Shehata says that horizontal coordination between regional payers, if not outright mergers, is likely to accelerate. Finally, he’s tracking the emerging model of “health plan plus retail plus PBM.”

Michael Abrams, co-founder and managing partner of consultancy Numerof & Associates, says that large regional hospital systems with healthy balance sheets are likely to speed up their vertical acquisition of independent hospitals or horizontal consolidation with local peers.

Abrams also points out that this wave of consolidation will compound or accelerate the rising cost of health care. He adds this continual rise in prices will eventually drain the generous margins that payers have enjoyed over the course of the pandemic.

Radar On Market Access: Trump’s $200 Medicare Drug Card Proposal Prompts Criticism

October 15, 2020

Experts say a last-minute proposal by President Donald Trump to distribute $200 prescription drug credits to Medicare Part D enrollees on preloaded debit cards faces many unanswered questions and will be difficult to implement, especially in the short time before the Nov. 3 election, AIS Health reported.

Little is known about the drug credit plan other than what can be gleaned from public statements by the president and an unnamed HHS source cited by the Washington Post. The president announced the plan during a Sept. 24 campaign speech in North Carolina.

“This is just another of the president’s many off-the-cuff promises, one it appears none of his staff knew about before he made it in a campaign speech,” says Joe Paduda, principal of Health Strategy Associates.

Experts say a last-minute proposal by President Donald Trump to distribute $200 prescription drug credits to Medicare Part D enrollees on preloaded debit cards faces many unanswered questions and will be difficult to implement, especially in the short time before the Nov. 3 election, AIS Health reported.

Little is known about the drug credit plan other than what can be gleaned from public statements by the president and an unnamed HHS source cited by the Washington Post. The president announced the plan during a Sept. 24 campaign speech in North Carolina.

“This is just another of the president’s many off-the-cuff promises, one it appears none of his staff knew about before he made it in a campaign speech,” says Joe Paduda, principal of Health Strategy Associates.

“This is definitely shameless electoral politics,” says Avalere Health founder Dan Mendelson. “Once the $200 is gone, beneficiaries still have to pay out of pocket for expensive medications. I don’t think anybody looks at this and says that this is a solution to the consumer problem [of high drug prices].”

In the absence of a written plan, health care experts have begun to speculate about what legal authority the administration could use to implement the program — which would likely cost about $7 billion — and whether the president has the ability to implement the program at all.

Matt Kazan, a principal at Avalere, says that there seem to be two possible legal avenues for the administration to pay for the debit card program. The first is a demonstration program through the Center for Medicare and Medicaid Innovation (CMMI), and the second via Section 402 of Public Law 92-603, which “grants CMS the authority to waive Medicare payment and benefit statutes to conduct these demonstrations,” according to a CMS document.

“Which authority they use probably determines some of the policy specifics,” Kazan says. “I think linked to that is a financing question. If you’re sending this to all Part D enrollees, the cost of that does become significant.”

Leaving all the legal wrangling aside, Raja Sekaran, a partner at Nossaman LLP, says that the short time until the election, and the speed that would be needed to get the drug card program off the ground, will likely doom the proposal.

Radar On Market Access: CVS, OptumRx Exclude Brand-Name Inhalers From 2021 Formularies, Switch Up Diabetes Supplies

October 13, 2020

CVS Health Corp.’s Caremark will exclude 57 medications from its 2021 formulary and add six back. Meanwhile, UnitedHealth Group’s OptumRx subsidiary will exclude 19 medications and products while adding back five and implementing restrictions on others, AIS Health reported.

Still, only a handful of products excluded by either PBM are likely to impact many members adversely, says Marc Guieb, a pharmacist and consultant with Milliman Inc. That also applies to the exclusions announced earlier by Cigna Corp.-owned PBM Express Scripts, he adds.

CVS Health Corp.’s Caremark will exclude 57 medications from its 2021 formulary and add six back. Meanwhile, UnitedHealth Group’s OptumRx subsidiary will exclude 19 medications and products while adding back five and implementing restrictions on others, AIS Health reported.

Still, only a handful of products excluded by either PBM are likely to impact many members adversely, says Marc Guieb, a pharmacist and consultant with Milliman Inc. That also applies to the exclusions announced earlier by Cigna Corp.-owned PBM Express Scripts, he adds.

Guieb observes that brand-name albuterol inhalers are seeing exclusions in 2021 from multiple PBMs, and that’s the change that will affect the most members. “That’s a big one this year,” he says. “One of the PBMs’ new strategies is, they’re completely excluding all the brands of albuterol inhalers, and they’re just going with the generic.”

Meanwhile, “the change that will actually cause the most widespread disruption and confusion will be diabetics switching to entirely new blood glucose monitoring systems, which is a hassle,” Guieb says.

PBMs that decide to prefer one specialty drug over another also can cause significant member disruption, Guieb adds, pointing to potential issues involving Novartis Pharmaceuticals Corp.’s biologic Cosentyx (secukinumab), which was excluded from Express Scripts’ 2021 formulary in favor of Eli Lilly and Co.’s Taltz (ixekizumab).

Overall, “I will say that for a lot of these annual formulary changes, they’re definitely a step in the right direction, although it may not be a big enough step in the right direction,” Guieb adds.

For 2021, OptumRx is changing up its multiple sclerosis coverage, adding Biogen’s Tecfidera (dimethyl fumarate) to its excluded list and preferring bioequivalent Bafiertam, made by Banner Life Sciences. Biogen’s Vumerity (diroximel fumarate) remains excluded.

Brian Anderson, a principal at Milliman, tells AIS Health that the products added back by PBMs can be “just as interesting” as those excluded.

Caremark is adding back seven products, six of which are preferred. OptumRx is adding back the Accu-Chek glucose meters, along with Teva Pharmaceuticals USA Inc.’s ProAir inhalers, Anderson says.

Add-backs can confuse plan members, Anderson points out. “It’s really hard for a plan or employer to explain to their membership why a drug that was excluded last year is now covered again,” he says.

MMIT Reality Check on IBS-C (Oct 2020)

October 9, 2020

According to our recent payer coverage analysis for the treatment of irritable bowel syndrome with constipation (IBS-C), combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for the treatment of irritable bowel syndrome with constipation (IBS-C), combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for IBS-C treatments shows that under the pharmacy benefit, about 40% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In September 2020, the FDA authorized an investigational new drug (IND) application from Seed Health to evaluate the impact of its DS-01, a broad spectrum probiotic, on gut microbiota of patients with irritable bowel syndrome.

Trends That Matter on Trump Administration’s Rebate Order

October 8, 2020

A promised executive order that would tie drug prices to their costs in other countries has yet to emerge, although President Donald Trump has promoted the order as part of his re-election campaign. Meanwhile, payers and PBMs are continuing to push back against three executive orders the Trump administration issued in July with the intention of lowering drug prices, one of which would overhaul the Medicare Part D prescription drug rebate system, AIS Health reported.

“I think the purpose of these executive orders is to give the president some talking points going into the debates,” says Avalere Health founder Dan Mendelson. He adds that, regardless of their purpose, the orders will not make a difference in the real world any time soon.

A promised executive order that would tie drug prices to their costs in other countries has yet to emerge, although President Donald Trump has promoted the order as part of his re-election campaign. Meanwhile, payers and PBMs are continuing to push back against three executive orders the Trump administration issued in July with the intention of lowering drug prices, one of which would overhaul the Medicare Part D prescription drug rebate system, AIS Health reported.

“I think the purpose of these executive orders is to give the president some talking points going into the debates,” says Avalere Health founder Dan Mendelson. He adds that, regardless of their purpose, the orders will not make a difference in the real world any time soon.

Meanwhile, the executive orders that actually have been released are being criticized from stakeholders across health care. The order that would remove safe harbor protections from the Anti-Kickback Statute for prescription drug rebates in Medicare Part D has been panned even by conservatives.

Alex Brill, a resident fellow at the American Enterprise Institute (AEI), penned a white paper sponsored by PBM trade group Pharmaceutical Care Management Association (PCMA) that concluded the executive order would “restrict an important tool for providing savings to the federal government and Medicare Part D beneficiaries. Moreover, net drug costs and drug company revenues would rise significantly if the Medicare Part D safe harbor for rebates is eliminated.”

Radar On Market Access: COVID-19 Pandemic May Lower Health Care Costs, But Deferral Impact Exists

October 8, 2020

Health insurers will probably have lower health care expenditures in 2020 and 2021 than before the COVID-19 pandemic, according to a new analysis from Willis Towers Watson. However, the white paper emphasizes that substantial risk is still possible and says plan sponsors need to take proactive steps to blunt the future impact of deferred care, AIS Health reported.

The policy environment could change suddenly and dramatically depending on the outcome of California v. Texas, a suit that could lead the Supreme Court to overturn the Affordable Care Act, and the presidential election.

Health insurers will probably have lower health care expenditures in 2020 and 2021 than before the COVID-19 pandemic, according to a new analysis from Willis Towers Watson. However, the white paper emphasizes that substantial risk is still possible and says plan sponsors need to take proactive steps to blunt the future impact of deferred care, AIS Health reported.

The policy environment could change suddenly and dramatically depending on the outcome of California v. Texas, a suit that could lead the Supreme Court to overturn the Affordable Care Act, and the presidential election.

“Pursuant to the upcoming case on the ACA, and obviously the current Supreme Court nomination and whether or not it gets through — so many major factors really put a lot of these pieces into an unknown place,” says Trevis Parson, Willis Towers Watson’s managing director and chief actuary for health and benefits, who coauthored the analysis.

According to the paper, “the likelihood of deferred care returning to the system will vary based on the type of care. In fact, we expect that a significant portion of deferred care will be completely forgone and never return. Further, the return time will depend on status of the pandemic, system capacity, public policy, patient willingness to visit care settings and the urgency of the need for care.”

Worryingly, the paper found that “the largest decreases in utilization have been in preventive care and other office-based services.” Parson says plan sponsors were not doing a very good job emphasizing preventive care and holistic health before the pandemic, and the care deferrals could make that problem worse.

The paper also attempts to project the short- and middle-term impact of the pandemic on utilization. Parson and coauthor Jeff Levin-Scherz, M.D., the North America co-leader of the health management practice at Willis Towers Watson, modeled four scenarios, and found that any of the four scenarios would result in a 2.7% to 3.8% net decrease in medical costs per member over the course of the combined two years.

These findings are welcome news to health insurance stakeholders, as previous projections of the pandemic’s costs were much more catastrophic. However, Parson urges plan sponsors to resist complacency — a point he regards as the “key message” of the paper.

Radar On Market Access: If Preexisting Condition Protections Vanish, Health Insurers Probably Won’t Cheer

October 6, 2020

Since at least the 2017 saga when Republicans tried to repeal and replace the Affordable Care Act (ACA), one of the law’s most visible — and politically charged — components has become its protections for people with preexisting conditions. Now, with the makeup of the Supreme Court slated to shift, some experts believe those same provisions are the most at risk from being struck down alongside the law’s now-defunct individual mandate, AIS Health reported.

But that begs the question: Would health insurers actually want to go back to a pre-ACA world?

“No, they so do not want that to happen,” says Chris Sloan, an associate principal at Avalere Health. Before the ACA was enacted, “it wasn’t that they [insurers] liked medically underwriting…it’s just that anybody who didn’t would get all the bad risk and their health plan would collapse,” Sloan explains.

Since at least the 2017 saga when Republicans tried to repeal and replace the Affordable Care Act (ACA), one of the law’s most visible — and politically charged — components has become its protections for people with preexisting conditions. Now, with the makeup of the Supreme Court slated to shift, some experts believe those same provisions are the most at risk from being struck down alongside the law’s now-defunct individual mandate, AIS Health reported.

But that begs the question: Would health insurers actually want to go back to a pre-ACA world?

“No, they so do not want that to happen,” says Chris Sloan, an associate principal at Avalere Health. Before the ACA was enacted, “it wasn’t that they [insurers] liked medically underwriting…it’s just that anybody who didn’t would get all the bad risk and their health plan would collapse,” Sloan explains.

Katie Keith, a health care attorney and faculty member at Georgetown University’s Center on Health Insurance Reforms, says that companies that are already underwriting short-term, limited-duration plans “could jump right in” and underwrite more plans if parts of the ACA are struck down. But other insurers might not even have the infrastructure to do so anymore, having given up their underwriting divisions after the ACA was enacted, she observes.

About 54 million people currently have a preexisting condition that could have resulted in them being denied coverage in the pre-ACA individual market, according to a new analysis from the Kaiser Family Foundation. The ACA required insurers in the non-group, small-group and large-group markets to issue coverage regardless of health status and prohibited non-group and small-group plans from varying premiums based on health status or gender, among other protections for preexisting conditions.

In Sloan’s view, insurers would prefer to keep operating in a post-underwriting world mainly because “they like that everybody plays by the same rules across the markets” so that they can compete more fairly.

Sloan also points out that “disruption is challenging — I mean, just think about how long it took to get the ACA and the individual markets to a sort of stable place.” Therefore, insurers “above all else value stability in markets, and in particular, stability when it comes to rules and regulations,” he adds.

MMIT Reality Check on Merkel Cell Carcinoma (Oct 2020)

October 2, 2020

According to our recent payer coverage analysis for Merkel cell carcinoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for Merkel cell carcinoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for Merkel cell carcinoma treatments shows that under the pharmacy benefit, about 53% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, the FDA approved the supplemental biologics license application (sBLA) for Merck & Co., Inc.’s Keytruda (pembrolizumab) to include an additional recommended dosage of 400 mg every six weeks across all adult indications. The new dosing option is in addition to the approved dosage of 200 mg every three weeks.

Perspectives on Amazon-Sharp HealthCare Deal

October 1, 2020

Health care industry insiders say that Amazon.com Inc.’s Aug. 27 deal to provide Halo fitness trackers to Sharp HealthCare indicates the retail and tech giant will make big bets on clinical and actuarial data analytics, AIS Health reported.

Sharp Chief Information and Innovation Officer Michael Reagin says that Amazon will provide the San Diego-based integrated plan and provider with about 500 of the wearable fitness trackers.

Sharp will use the devices in two pilot programs, Reagin says. The company will give “about 100” Halos to clinicians, who will wear them in order to track staff performance and prevent burnout. Reagin says the Halo’s much-discussed voice monitoring technology is an essential element of the clinician-focused effort.

Health care industry insiders say that Amazon.com Inc.’s Aug. 27 deal to provide Halo fitness trackers to Sharp HealthCare indicates the retail and tech giant will make big bets on clinical and actuarial data analytics, AIS Health reported.

Sharp Chief Information and Innovation Officer Michael Reagin says that Amazon will provide the San Diego-based integrated plan and provider with about 500 of the wearable fitness trackers.

Sharp will use the devices in two pilot programs, Reagin says. The company will give “about 100” Halos to clinicians, who will wear them in order to track staff performance and prevent burnout. Reagin says the Halo’s much-discussed voice monitoring technology is an essential element of the clinician-focused effort.

Michael Abrams, co-founder and managing partner of health care consultancy Numerof & Associates, says that member engagement will be essential to the pilot program’s success. He says that remote monitoring can be stifled if patients don’t fully buy in.

Since the Halo will continually monitor members without any action in their part, Abrams is optimistic that the program will enjoy better adherence than other remote monitoring efforts.

“If plans can get member adoption and perseverance, this could be a great tool for seeing high-level, aggregated community trends and identifying specific interventions,” says Rajshri Ravi, the head of product and technology at ConsejoSano. “Population health management is all about data: the more, the better. It depends on how they use the data. Propensity modeling could predict member behavior and offer insights to increase retention.”

Friso van Reesema, a senior account executive for Eliza, Elli and Essette Solutions, says that Amazon is uniquely well-positioned to offer health plans technology and services that will process that data.

“In the next three years, we’re going to see some really exciting artificial intelligence and improvement of these platforms that are leveraging these devices to power the platform and be able to roll out exciting algorithms, whether they’re retrospective, prospective, prescriptive,” van Reesema says.

Radar On Market Access: New Manufacturing Approach May Drive Down CAR-T Therapies’ Prices

October 1, 2020

This summer, a drug called Tecartus (brexucabtagene autoleucel) became the third chimeric antigen receptor T-cell (CAR-T) therapy approved by the FDA. CAR-T therapies, which use a patient’s genetically modified immune cells to target and fight cancer cells, are a cutting-edge type of treatment that comes with eye-popping price tags, ranging from $373,000 to $475,000. However, a new report from OptumRx highlights an “industry trend to watch” that could eventually provide some relief to payers worried about how to finance CAR-T treatments, AIS Health reported.

Currently, CAR-T therapies’ high cost is at least in part attributable to the “labor-intensive and time-consuming” manufacturing process for such drugs, stated the UnitedHealth Group-owned PBM’s Drug Pipeline Insights Report for the third quarter of 2020. Essentially, T-cells are taken from a patient, treated and multiplied in a lab, and reinfused into the same patient — a completely personalized process known as autologous therapy.

This summer, a drug called Tecartus (brexucabtagene autoleucel) became the third chimeric antigen receptor T-cell (CAR-T) therapy approved by the FDA. CAR-T therapies, which use a patient’s genetically modified immune cells to target and fight cancer cells, are a cutting-edge type of treatment that comes with eye-popping price tags, ranging from $373,000 to $475,000. However, a new report from OptumRx highlights an “industry trend to watch” that could eventually provide some relief to payers worried about how to finance CAR-T treatments, AIS Health reported.

Currently, CAR-T therapies’ high cost is at least in part attributable to the “labor-intensive and time-consuming” manufacturing process for such drugs, stated the UnitedHealth Group-owned PBM’s Drug Pipeline Insights Report for the third quarter of 2020. Essentially, T-cells are taken from a patient, treated and multiplied in a lab, and reinfused into the same patient — a completely personalized process known as autologous therapy.

As the industry searches for a cheaper and more scalable way of manufacturing CAR-T treatments, a new approach known as an allogeneic process “is currently under study as one possible solution,” according to OptumRx. In this process, previously extracted and banked healthy donor T-cells are multiplied “many times over for use in many patients,” effectively spreading out the high initial manufacturing cost over multiple doses.

When asked how much the allogeneic process could reduce the manufacturing cost of CAR-T therapies, Bill Dreitlein, senior director of pipeline and drug surveillance at OptumRx, cited a 2019 study.

“Per the International Society for Cell and Gene Therapy, the cost to manufacture CAR-T using current methods is at $95,780 per dose,” he says via email. “That study also calculates the production cost using the new process would be only $4,460 per dose — over 95% lower.”

However, because manufacturing costs are only one part of the drug-pricing equation, the new allogeneic process may not actually lower CAR-T prices that dramatically, the report noted.

Tecartus’ list price is $373,000, and the wholesale acquisition costs of the other CAR-T therapies, Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), are $373,000 and $475,000 respectively, per the OptumRx report. As of Oct. 1, 2019, CMS agreed to cover CAR-T therapies for qualifying Medicare beneficiaries, but private payers generally reimburse providers for CAR-T treatment on a case-by-case basis, industry experts previously told AIS Health.

Radar On Market Access: Experts Remain Skeptical That SCOTUS Will Scuttle Entire ACA

September 29, 2020

The Sept. 18 death of Justice Ruth Bader Ginsburg — which could tip the scales in favor of striking down the Affordable Care Act (ACA) — was hardly welcome news for health insurers during a year when a pandemic and a presidential election are already fueling high levels of uncertainty. However, industry analysts and legal experts say there are plenty of reasons not to hit the panic button just yet, AIS Health reported.

“This definitely increases the chance of the Supreme Court striking down the full ACA. But we’re going from a pretty low likelihood base,” says Chris Sloan at Avalere Health. “The odds are still really stacked against anything materially changing for the ACA.”

The Sept. 18 death of Justice Ruth Bader Ginsburg — which could tip the scales in favor of striking down the Affordable Care Act (ACA) — was hardly welcome news for health insurers during a year when a pandemic and a presidential election are already fueling high levels of uncertainty. However, industry analysts and legal experts say there are plenty of reasons not to hit the panic button just yet, AIS Health reported.

“This definitely increases the chance of the Supreme Court striking down the full ACA. But we’re going from a pretty low likelihood base,” says Chris Sloan at Avalere Health. “The odds are still really stacked against anything materially changing for the ACA.”

At issue is a case now known as California v. Texas, which Republican state officials filed in 2018 to challenge the constitutionality of the ACA. Because Congress changed the tax penalty for the law’s individual mandate to $0 via the 2017 Tax Cuts and Jobs Act, they argued, the mandate is unlawful, and if that part is unconstitutional, the whole law must go.

Until Ginsburg’s death from cancer complications, many legal observers expected that the ACA had a good shot at surviving this latest Supreme Court challenge. But if Senate Republicans are able to confirm a replacement for Ginsburg before Nov. 10 oral arguments, not one but two conservative justices would have to side with their liberal colleagues to produce a pro-ACA ruling, explains health care attorney Katie Keith.

Ultimately, “I’m still skeptical that the entire law would be invalidated; I think that would be a step too far and does go against some of the recent decisions we’ve seen on severability from this court,” Keith says. However, she adds that the loss of Ginsburg “makes it more likely that parts of the ACA will be struck down” — in particular, the so-called preexisting condition protections.

Wall Street analysts, meanwhile, appeared unconvinced that the law will be unraveled — but noted that Centene Corp. has the most exposure if that happens, given its strong concentration in Medicaid and the individual market. Credit Suisse’s A.J. Rice estimated that those two business lines make up roughly 26% of Centene’s earnings, but only 4% for Anthem, Inc., and less than 1% each for Cigna Corp., CVS Health Corp., Humana Inc. and UnitedHealth Group.

MMIT Reality Check on Sickle Cell Disease (Sep 2020)

September 25, 2020

According to our recent payer coverage analysis for sickle cell disease treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for sickle cell disease treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for sickle cell disease treatments shows that under the pharmacy benefit, about 22% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In November 2019, the FDA gave accelerated approval to Global Blood Therapeutics, Inc.’s Oxbryta (voxelotor) for the treatment of sickle cell disease in people at least 12 years old. The company says it’s the first FDA-approved treatment that targets the root cause of the disease.

Trends That Matter for COVID Cost-Sharing Waivers

September 24, 2020

Although federal relief legislation tied to the pandemic required health insurers to waive cost sharing for COVID-19 testing, not treatment, many plans opted to do both anyway. In fact, a recent analysis from the Kaiser Family Foundation (KFF) found that 80% of enrollees in the individual and fully insured group insurance markets were in plans that voluntarily waived out-of-pocket costs for COVID-19 at some point during the pandemic, AIS Health reported.

Yet according to the Peterson-KFF Health System Tracker analysis, published Aug. 20, 20% of individual and fully insured group plan enrollees are in plans where a cost-sharing waiver for COVID-19 treatment has already expired, and another 16% are in plans where the waiver is scheduled to expire by the end of September.

Although federal relief legislation tied to the pandemic required health insurers to waive cost sharing for COVID-19 testing, not treatment, many plans opted to do both anyway. In fact, a recent analysis from the Kaiser Family Foundation (KFF) found that 80% of enrollees in the individual and fully insured group insurance markets were in plans that voluntarily waived out-of-pocket costs for COVID-19 at some point during the pandemic, AIS Health reported.

Yet according to the Peterson-KFF Health System Tracker analysis, published Aug. 20, 20% of individual and fully insured group plan enrollees are in plans where a cost-sharing waiver for COVID-19 treatment has already expired, and another 16% are in plans where the waiver is scheduled to expire by the end of September.

Daniel McDermott, a KFF research associate and co-author of the analysis, says that the calculus could change for some insurers as the pandemic wears on.

“Among the insurers who have pushed back their expiration date or extended it, a lot of them had initially set expiration deadlines in early spring — so around May — only to push those back as that date approached,” he says. “So I think it would be reasonable to expect that as some of these fall expiration dates approach, some insurers might take the opportunity to re-evaluate…and make a decision about whether to push back that expiration date again.”

Among enrollees in individual and fully insured group health insurance, 15% were in plans where the expiration date of the COVID-19 treatment cost-sharing waiver was either unspecified or set to end when the public health emergency does, observed the KFF analysis.

Radar On Market Access: Pandemic, Market Stability Encourage Major Insurers to Expand ACA Footprints

September 24, 2020

Given that enrollment in the Affordable Care Act (ACA) exchanges has basically flatlined, one might not expect insurers to view the exchanges as a growth opportunity. But recent moves by some of the country’s largest payers suggest otherwise.

Centene Corp. said on Sept. 11 that it will widen its ACA marketplace footprint by selling plans in “nearly 400 new counties” next year. The company will increase its presence in 13 of the states where it already sells plans, plus enter two new states: Michigan and New Mexico.

Given that enrollment in the Affordable Care Act (ACA) exchanges has basically flatlined, one might not expect insurers to view the exchanges as a growth opportunity. But recent moves by some of the country’s largest payers suggest otherwise.

Centene Corp. said on Sept. 11 that it will widen its ACA marketplace footprint by selling plans in “nearly 400 new counties” next year. The company will increase its presence in 13 of the states where it already sells plans, plus enter two new states: Michigan and New Mexico.

On Sept. 10, Cigna Corp. announced that it will be increasing its ACA exchange presence by “nearly 80 counties” next year, expanding its customer reach in that market by more than 50%. All told, Cigna will offer marketplace plans in 220 counties spanning 10 states.

In addition, UnitedHealth Group has so far announced it will expand to three new states in 2021: Maryland, Tennessee and Virginia. And startup insurer Oscar said on July 30 that it will increase its ACA marketplace presence for the fourth consecutive year in 2021, entering four new states.

As for what may be driving those moves, Katherine Hempstead, a senior policy adviser at the Robert Wood Johnson Foundation, observes that “there’s been this kind of secular trend away from employer-sponsored insurance vs. various other government or quasi-government products — Medicaid, Medicare Advantage and the marketplace — and I think that carriers are seeing synergies between all those government markets and want to be in all of them.”

The COVID-19 pandemic and its economic repercussions comprise another, more recent, catalyst for insurers’ ACA exchange expansions, according to S&P Global Ratings analyst Deep Banerjee.

“This market has not been growing in terms of the number of people signing up each year — it’s not drastically declining either, but you wouldn’t look at this market and say all of a sudden it’s a growth market,” Banerjee says. “But because of unemployment, because of [commercial group enrollment] shrinking, this could become a growth option in the future.”

While the economy is expected to eventually rebound, it makes sense for firms that stand to lose group-market members in the short term to follow those enrollees by investing in other market segments, Hempstead adds.

Radar On Market Access: As Payer M&A Slows Down, What’s Next?

September 22, 2020

The climate for payer mergers and acquisitions (M&A) has cooled substantially at a national level ever since the collapse of the proposed deals between Anthem, Inc. and Cigna Corp. and between Aetna Inc. and Humana Inc. However, consolidation in the provider sector has increased since the start of the COVID-19 pandemic as such firms grapple with the rapid collapse of fee-for-service revenue, AIS Health reported.

The breakdown of Anthem’s bid to acquire Cigna resulted in a public spat and dueling lawsuits over Cigna’s attempt to exit their agreement before exhausting the firms’ option to appeal a federal ruling against the transaction. On Aug. 31, the Delaware Court of Chancery ruled that neither firm had to pay damages to the other over the failed deal.

The climate for payer mergers and acquisitions (M&A) has cooled substantially at a national level ever since the collapse of the proposed deals between Anthem, Inc. and Cigna Corp. and between Aetna Inc. and Humana Inc. However, consolidation in the provider sector has increased since the start of the COVID-19 pandemic as such firms grapple with the rapid collapse of fee-for-service revenue, AIS Health reported.

The breakdown of Anthem’s bid to acquire Cigna resulted in a public spat and dueling lawsuits over Cigna’s attempt to exit their agreement before exhausting the firms’ option to appeal a federal ruling against the transaction. On Aug. 31, the Delaware Court of Chancery ruled that neither firm had to pay damages to the other over the failed deal.

This failed deal was a catalyst for the slowing pace of health insurance consolidation at the national scale, according to antitrust lawyer and former Federal Trade Commission official David Balto.

Ashraf Shehata, KPMG national sector leader for health care and life sciences, says that Cigna’s acquisition of Express Scripts, a transaction that the firm pursued partly because of the failed Anthem merger, set a precedent of its own.

“I would say what that has spawned instead of the health plan integration, it’s spawned…the PBM integration. Rather than health plan to health plan, it was health plan plus PBM. And we saw that across the board with all the commercial entities,” he says.

Shehata says he sees three likely types of payer transactions and reorganizations going forward. The first is the PBM-payer integration. Second, Shehata says that horizontal coordination between regional payers, if not outright mergers, is likely to accelerate. Finally, he’s tracking the emerging model of “health plan plus retail plus PBM.”

Michael Abrams, co-founder and managing partner of consultancy Numerof & Associates, says that large regional hospital systems with healthy balance sheets are likely to speed up their vertical acquisition of independent hospitals or horizontal consolidation with local peers.

Abrams also points out that this wave of consolidation will compound or accelerate the rising cost of health care. He adds this continual rise in prices will eventually drain the generous margins that payers have enjoyed over the course of the pandemic.

MMIT Reality Check on Schizophrenia (Sep 2020)

September 18, 2020

According to our recent payer coverage analysis for schizophrenia treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for schizophrenia treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for schizophrenia treatments shows that under the pharmacy benefit, about 26% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In December 2019, the FDA approved Intra-Cellular Therapies, Inc.’s Caplyta (lumateperone) for the treatment of schizophrenia in adults. The drug is an oral, once-daily medicine and is being developed for the treatment of bipolar depression; behavioral disturbances in patients with dementia, including Alzheimer’s disease; depression; and other neuropsychiatric and neurological disorders.

Perspectives on PBM Performance Amid COVID-19

September 17, 2020

For PBMs, 2020 has been far from business as usual, given the myriad ways the COVID-19 pandemic has changed how people interact with the health care system. However, during their second-quarter earnings conference calls, companies that own some of the largest PBMs emphasized that they are largely satisfied with how the PBM segments of their businesses are performing, AIS Health reported.

Anthem, Inc. Chief Financial Officer John Gallina said during the insurer’s earnings call that “IngenioRx is actually doing quite well, and has really done a nice job of meeting our expectations.”

For PBMs, 2020 has been far from business as usual, given the myriad ways the COVID-19 pandemic has changed how people interact with the health care system. However, during their second-quarter earnings conference calls, companies that own some of the largest PBMs emphasized that they are largely satisfied with how the PBM segments of their businesses are performing, AIS Health reported.

Anthem, Inc. Chief Financial Officer John Gallina said during the insurer’s earnings call that “IngenioRx is actually doing quite well, and has really done a nice job of meeting our expectations.”

Anthem is on track this year to realize $900 million in operating profit contributed from its relatively new PBM, which exceeds its prior expectation of $800 million, Credit Suisse analyst A.J. Rice pointed out in a July 29 note to investors. But he also noted that while maintenance prescription volume was steady compared with the prior-year quarter, “new scripts saw a 10-15% drop in April versus normal utilization. Thus, IngenioRx captured less profit in Q2.”

CVS Health Corp., which owns the PBM Caremark, reported that operating income and adjusted operating income for its pharmacy services segment increased 6.2% and 2.4%, respectively, from the prior-year quarter. Those results were “primarily driven by growth in specialty pharmacy and improved purchasing economics,” but they were offset by “continued price compression and previously disclosed client losses,” the company said in its earnings release.

Cigna Corp. reported on July 30 that for its health services segment — which houses the PBM Express Scripts — pretax adjusted income from operations increased 7% relative to the second quarter of 2019.

Executives from Anthem, Cigna and CVS all acknowledged that the PBM selling season for 2021 was affected by the shutdowns and economic uncertainty ushered in by the COVID-19 pandemic.

Anthem President and CEO Gail Boudreaux described the selling season as “an interesting operating environment, given all the change.” As the insurer mentioned in its first-quarter earnings call, “things are, I would say, at least slightly delayed, as customers try to work through their own stability across their business,” Boudreaux said.

Alan Lotvin, M.D., the executive vice president and president of Caremark, offered: “I’d say the season itself has been interesting in the lumpiness with COVID, but overall ending up about where we thought.”

Radar On Market Access: Prime Therapeutics Introduces Real Time Benefit Tool

September 17, 2020

With the deadline approaching for Medicare Part D plans to implement a Real Time Benefit Tool (RTBT) — which informs prescribers when lower-cost alternative therapies are available under a beneficiary’s drug benefit — Prime Therapeutics, LLC said on Sept. 2 that it is rolling out a tool that will meet the new requirements, AIS Health reported.

In addition to showing a drug’s price, the Real Time Benefit Check tool displays lower-cost and therapeutically equivalent alternatives to any given drug, breaks down costs based on a member’s health plan formulary, and alerts a prescriber if a drug requires prior authorization.

With the deadline approaching for Medicare Part D plans to implement a Real Time Benefit Tool (RTBT) — which informs prescribers when lower-cost alternative therapies are available under a beneficiary’s drug benefit — Prime Therapeutics, LLC said on Sept. 2 that it is rolling out a tool that will meet the new requirements, AIS Health reported.

In addition to showing a drug’s price, the Real Time Benefit Check tool displays lower-cost and therapeutically equivalent alternatives to any given drug, breaks down costs based on a member’s health plan formulary, and alerts a prescriber if a drug requires prior authorization.

To develop its new tool, Prime conducted a 14-month pilot with multiple vendors, including DrFirst, which created the myBenefitCheck tool that the PBM decided to release first.

After processing 700,000 transactions among 25,000 prescribers, Prime calculated an average annual savings of $692 for each prescription that was changed as a result of using the tool. One Blues plan involved in the pilot “realized a total estimated savings due to alternate drug choices of $348,000 from April 2019 to March 2020,” stated a news release from the PBM.

Prime’s new Real Time Benefit Check tool will fulfill its obligations under the Medicare Advantage and Part D Drug Pricing Final Rule, which was issued in May 2019 and requires each Part D health plan to adopt one or more RTBTs that can integrate with at least one prescriber’s ePrescribing system or electronic health record system starting Jan. 1, 2021. In addition to Prime’s Part D members, the Real Time Benefit Check tool will also be available to the PBM’s commercial members.

Matt Kazan, a principal at Avalere Health, says that initially the new RTBT requirement was slated to go into effect in 2020, but CMS pushed back the deadline one year in response to some industry stakeholders’ concerns over readiness.

“Generally speaking, larger organizations had a system in place…and CMS is allowing them to utilize that,” says Kazan. “I think more of the concern was from maybe smaller, midsized organizations that didn’t have their own system ready to go.”

However, “time has lapsed since that final rule, so I’ve heard less about major concerns about the upcoming deadline,” he adds.

Radar On Market Access: Trump’s International Drug Pricing Order Is Still Missing; Rebate Order Draws Fire

September 16, 2020

A promised executive order that would tie drug prices to their costs in other countries has yet to emerge, although President Donald Trump has promoted the order as part of his re-election campaign. Meanwhile, payers and PBMs are continuing to push back against three executive orders the Trump administration issued in July with the intention of lowering drug prices, one of which would overhaul the Medicare Part D prescription drug rebate system, AIS Health reported.

“I think the purpose of these executive orders is to give the president some talking points going into the debates,” says Avalere Health founder Dan Mendelson. He adds that, regardless of their purpose, the orders will not make a difference in the real world any time soon.

A promised executive order that would tie drug prices to their costs in other countries has yet to emerge, although President Donald Trump has promoted the order as part of his re-election campaign. Meanwhile, payers and PBMs are continuing to push back against three executive orders the Trump administration issued in July with the intention of lowering drug prices, one of which would overhaul the Medicare Part D prescription drug rebate system, AIS Health reported.

“I think the purpose of these executive orders is to give the president some talking points going into the debates,” says Avalere Health founder Dan Mendelson. He adds that, regardless of their purpose, the orders will not make a difference in the real world any time soon.

Administration officials indicated during the rollout of the executive orders on July 24 that the international pricing order would be released within 30 days of the debut of the other three drug pricing orders. Yet the deadline passed and the administration at press time had not released the promised order.

Meanwhile, the executive orders that actually have been released are being criticized from stakeholders across health care. The order that would remove safe harbor protections from the Anti-Kickback Statute for prescription drug rebates in Medicare Part D has been panned even by conservatives.

Alex Brill, a resident fellow at the American Enterprise Institute (AEI), penned a white paper sponsored by PBM trade group Pharmaceutical Care Management Association (PCMA) that concluded the executive order would “restrict an important tool for providing savings to the federal government and Medicare Part D beneficiaries. Moreover, net drug costs and drug company revenues would rise significantly if the Medicare Part D safe harbor for rebates is eliminated.”

Mendelson says that the pharmaceutical industry is beginning to realize that it will have to change its business model one way or another.

“The pharmaceutical industry is facing a real pivot point where there are going to have to be more innovative ways to price for these products,” Mendelson observes. “…it’s really important that the industry start to figure out ways to engage positively with payers. And the government is the biggest payer.”

MMIT Reality Check on Acute Migraine (Sep 2020)

September 11, 2020

According to our recent payer coverage analysis for acute migraine treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for acute migraine treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for acute migraine treatments shows that under the pharmacy benefit, about 55% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In February 2020, the FDA approved Biohaven Pharmaceuticals’ Nurtec ODT (rimegepant) for the acute treatment of migraine in adults. The medication is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet, according to the company’s news release.

Trends That Matter for Large Employers in 2021

September 10, 2020

While the COVID-19 pandemic has not caused employers to significantly alter their health care cost estimates for the coming year, it has unquestionably intensified their interest in embracing virtual care. Those are just a couple of the major findings from the Business Group on Health’s 2021 Large Employers’ Health Care Strategy and Plan Design Survey, AIS Health reported.

Notably, 80% of respondents said they believe virtual health will play a significant role in how care is delivered in the future, up considerably from 64% last year. Further, when asked about actions they were taking to ease the burdens of COVID-19 for employees, the largest share of respondents — 76% — said they “made changes to allow for better access to virtual care solutions.”

While the COVID-19 pandemic has not caused employers to significantly alter their health care cost estimates for the coming year, it has unquestionably intensified their interest in embracing virtual care. Those are just a couple of the major findings from the Business Group on Health’s 2021 Large Employers’ Health Care Strategy and Plan Design Survey, AIS Health reported.

Notably, 80% of respondents said they believe virtual health will play a significant role in how care is delivered in the future, up considerably from 64% last year. Further, when asked about actions they were taking to ease the burdens of COVID-19 for employees, the largest share of respondents — 76% — said they “made changes to allow for better access to virtual care solutions.”

During an Aug. 18 press briefing, Business Group on Health President and CEO Ellen Kelsay attributed such findings to not only telehealth’s ability to offer more convenience and greater access for consumers, but also to the sheer necessity of pivoting to a different care modality amid widespread stay-at-home orders.

Regarding the controversial issue of telehealth reimbursement, which payers generally want to be lower than in-person visits but providers want to be equal, Kelsay said her organization supports payment flexibility over parity. In some cases, that “might mean less reimbursement for telehealth, and in other instances maybe increased reimbursement for telehealth if it’s a better modality for delivery, depending on the situation,” she added.

Kelsay also emphasized that there are still more questions than answers about how the pandemic will affect health care costs for companies and their workers. For 2021, the Business Group on Health is projecting the total cost of health benefits will rise by 5.3% — slightly higher than the 5% trend it predicted in the past few years.

Radar On Market Access: Amazon Moves Further Into Health Care Data, Sharp Deal Shows

September 10, 2020

Health care industry insiders say that Amazon.com Inc.’s Aug. 27 deal to provide Halo fitness trackers to Sharp HealthCare indicates the retail and tech giant will make big bets on clinical and actuarial data analytics, AIS Health reported.

Sharp Chief Information and Innovation Officer Michael Reagin says that Amazon will provide the San Diego-based integrated plan and provider with about 500 of the wearable fitness trackers.

Health care industry insiders say that Amazon.com Inc.’s Aug. 27 deal to provide Halo fitness trackers to Sharp HealthCare indicates the retail and tech giant will make big bets on clinical and actuarial data analytics, AIS Health reported.

Sharp Chief Information and Innovation Officer Michael Reagin says that Amazon will provide the San Diego-based integrated plan and provider with about 500 of the wearable fitness trackers.

Sharp will use the devices in two pilot programs, Reagin says. The company will give “about 100” Halos to clinicians, who will wear them in order to track staff performance and prevent burnout. Reagin says the Halo’s much-discussed voice monitoring technology is an essential element of the clinician-focused effort.

The rest of the devices will go to Sharp Health Plan members for remote monitoring purposes.

Michael Abrams, co-founder and managing partner of health care consultancy Numerof & Associates, says that member engagement will be essential to the pilot program’s success. He says that remote monitoring can be stifled if patients don’t fully buy in.

Since the Halo will continually monitor members without any action in their part, Abrams is optimistic that the program will enjoy better adherence than other remote monitoring efforts.

“If plans can get member adoption and perseverance, this could be a great tool for seeing high-level, aggregated community trends and identifying specific interventions,” says Rajshri Ravi, the head of product and technology at ConsejoSano. “Population health management is all about data: the more, the better. It depends on how they use the data. Propensity modeling could predict member behavior and offer insights to increase retention.”

Friso van Reesema, a senior account executive for Eliza, Elli and Essette Solutions, says that Amazon is uniquely well-positioned to offer health plans technology and services that will process that data.

“In the next three years, we’’re going to see some really exciting artificial intelligence and improvement of these platforms that are leveraging these devices to power the platform and be able to roll out exciting algorithms, whether they’re retrospective, prospective, prescriptive,” van Reesema says.

He adds that the deal is likely an attempt by the tech giant to start training its AIs on population health models using data gathered from the Halo pilot.

Radar On Market Access: Some COVID Cost-Sharing Waivers Would Expire Soon

September 8, 2020

Although federal relief legislation tied to the pandemic required health insurers to waive cost sharing for COVID-19 testing, not treatment, many plans opted to do both anyway. In fact, a recent analysis from the Kaiser Family Foundation (KFF) found that 80% of enrollees in the individual and fully insured group insurance markets were in plans that voluntarily waived out-of-pocket costs for COVID-19 at some point during the pandemic, AIS Health reported.

Yet according to the Peterson-KFF Health System Tracker analysis, published Aug. 20, 20% of individual and fully insured group plan enrollees are in plans where a cost-sharing waiver for COVID-19 treatment has already expired, and another 16% are in plans where the waiver is scheduled to expire by the end of September.

Although federal relief legislation tied to the pandemic required health insurers to waive cost sharing for COVID-19 testing, not treatment, many plans opted to do both anyway. In fact, a recent analysis from the Kaiser Family Foundation (KFF) found that 80% of enrollees in the individual and fully insured group insurance markets were in plans that voluntarily waived out-of-pocket costs for COVID-19 at some point during the pandemic, AIS Health reported.

Yet according to the Peterson-KFF Health System Tracker analysis, published Aug. 20, 20% of individual and fully insured group plan enrollees are in plans where a cost-sharing waiver for COVID-19 treatment has already expired, and another 16% are in plans where the waiver is scheduled to expire by the end of September.

Daniel McDermott, a KFF research associate and co-author of the analysis, says that the calculus could change for some insurers as the pandemic wears on.

“Among the insurers who have pushed back their expiration date or extended it, a lot of them had initially set expiration deadlines in early spring — so around May — only to push those back as that date approached,” he says. “So I think it would be reasonable to expect that as some of these fall expiration dates approach, some insurers might take the opportunity to re-evaluate…and make a decision about whether to push back that expiration date again.”

Among enrollees in individual and fully insured group health insurance, 15% were in plans where the expiration date of the COVID-19 treatment cost-sharing waiver was either unspecified or set to end when the public health emergency does, observed the KFF analysis.

Meanwhile, KFF’s more recent report also found that 11% of individual market enrollees and 27% of fully insured group market enrollees are in plans that have offered some form of premium credit or reduction during the pandemic.

For the individual and fully insured group markets combined, just 7% of enrollees were in a plan that offered a premium grace period — in which insurers don’t immediately cancel policies for people who fail to pay their premiums on time, while just 2% were in a plan that offered fast-tracked medical loss ratio rebates.

MMIT Reality Check on Breast Cancer HR+/HER2- (Sep 2020)

September 4, 2020

According to our recent payer coverage analysis for hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for breast cancer (HR+/HER2-) treatments shows that under the pharmacy benefit, about 52% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In December 2019, the FDA approved Teva Pharmaceuticals USA, Inc.’s and Endo International plc unit Par Pharmaceuticals’ everolimus for the treatment of advanced hormone receptor-positive, HER2- negative breast cancer in postmenopausal women, among other indications. The tablets are the first generics of Novartis International AG’s Afinitor (everolimus).

Perspectives on Telehealth Executive Order

September 3, 2020

Recent events indicate the telehealth boom caused by the COVID-19 pandemic will result in a permanent expansion of virtual care. On Aug. 3, the Trump administration issued an executive order directing HHS to make permanent some of the telehealth regulations it relaxed for Medicare beneficiaries during the public health emergency, AIS Health reported.

The executive order directs officials to issue proposed regulations that will lock in some of the changes in telehealth policy that the Trump administration included as part of pandemic relief. In response to the order, CMS on Aug. 3 proposed a rule that would permanently allow Medicare to reimburse for certain services that are furnished virtually, “including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments.”

Recent events indicate the telehealth boom caused by the COVID-19 pandemic will result in a permanent expansion of virtual care. On Aug. 3, the Trump administration issued an executive order directing HHS to make permanent some of the telehealth regulations it relaxed for Medicare beneficiaries during the public health emergency, AIS Health reported.

The executive order directs officials to issue proposed regulations that will lock in some of the changes in telehealth policy that the Trump administration included as part of pandemic relief. In response to the order, CMS on Aug. 3 proposed a rule that would permanently allow Medicare to reimburse for certain services that are furnished virtually, “including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments.”

Avalere Health founder Dan Mendelson says that the order will have limited impact in the near term, but it speaks to the rapid entrenchment of telehealth.

“The administration is doing what they can with their existing authority. Notionally, it’s in the right direction,” says Mendelson. “It’s thoughtful and positive, but it’s also limited in terms of the practical effect because it’s focused on these rural geographies.”

Meanwhile, telehealth provider Teladoc Health Inc. reached a deal to acquire remote monitoring firm Livongo Health Inc. in a transaction announced Aug. 5, which the firms expect to close by the end of the year. In a July white paper prepared by members of its health care practice, KPMG predicted ample transactions in the telehealth space going forward.

James Gelfand, ERISA Industry Committee (ERIC) senior vice president for health policy, tells AIS Health via email that Congress needs to take telehealth reform further.

“ERIC urges Congress to follow the President’s lead and remove restrictions that ban employers from offering telehealth to all employees, opening up access to health care for millions of Americans nationwide permanently,” he wrote.

Mendelson makes a similar point. He says that Congress needs to set rules for complex, controversial issues like reimbursement. He adds that he expects action on telehealth after the election, if only for Medicare and Medicaid.

Radar On Market Access: Insurers Expand Flu Vaccination Outreach to Blunt COVID-19 Effects

September 3, 2020

Even as the COVID-19 crisis continues, public health officials are warning that an influenza pandemic might emerge this fall or winter. A double pandemic would kill even more people than COVID-19 on its own and strain the already overworked health care system. To prevent that deadly combination, plans have stepped up their usual flu-season member outreach programs, particularly for seniors, AIS Health reported.

In the Aug. 21 edition of its Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention tied improved flu vaccination rates to reducing the strain that COVID-19 has put on the health care system.

Even as the COVID-19 crisis continues, public health officials are warning that an influenza pandemic might emerge this fall or winter. A double pandemic would kill even more people than COVID-19 on its own and strain the already overworked health care system. To prevent that deadly combination, plans have stepped up their usual flu-season member outreach programs, particularly for seniors, AIS Health reported.

In the Aug. 21 edition of its Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention tied improved flu vaccination rates to reducing the strain that COVID-19 has put on the health care system.

Flu vaccines are fairly easy to access. However, Richard Hughes IV, managing director of Avalere Health’s vaccine team, says that payers need to consider how to make special accommodations for patients who are immunocompromised or have other viral infection comorbidities. He points out that those patients have the most need for the flu vaccine — but that they paradoxically have the highest risk from COVID-19 exposure.

“A lot of employers have workplace flu clinics,” Hughes adds. But now, he observes, “we have a lot of people working remotely in our economy. So I think you’re going to see some additional challenges to getting people vaccinated.”

UnitedHealth Group is taking a proactive approach to flu vaccination, according to Jennifer Brueckner, Pharm.D., head of the company’s Enterprise Flu Committee. She says the company will email all members who have an address on file and UnitedHealth will target certain at-risk members for extra communication.

Meanwhile, Cigna Corp. is also expanding its annual vaccine outreach. Cigna members do not pay any cost sharing for flu vaccinations if they get their shots at an in-network provider or pharmacy, according to a company statement.

Humana Corporate Medical Director Todd Prewitt, M.D., tells AIS Health via email that the insurer has expanded flu vaccination outreach beyond its usual scope.

“Humana has initiated our ‘Safer Sooner’ campaign theme to encourage all members to obtain the vaccination as soon as it is available through their local providers,” Prewitt explains. “As part of the campaign, we’ve distributed personal safety kits to over seven million members and associates including two cloth masks for personal protection,” he says.

Radar On Market Access: USPS Delivery Slowdown Is Unlikely to Cause Major Rx Fill Disruption

September 1, 2020

The recent, sudden disruption of U.S. Postal Service (USPS) deliveries has caused concern about people receiving their medications later than they normally would. While news reports and statements by lawmakers indicate that many Americans have lost prescriptions in the mail or received them late, drug benefit and supply chain experts tell AIS Health the disruption to the most vulnerable patients served by specialty and mail order pharmacies should be minimal.

An Aug. 24 Axios-Ipsos poll shows that one in five Americans received medication through the mail during the preceding week. One in four of that group, or 5% of Americans overall, didn’t receive their medication or got it late.

The recent, sudden disruption of U.S. Postal Service (USPS) deliveries has caused concern about people receiving their medications later than they normally would. While news reports and statements by lawmakers indicate that many Americans have lost prescriptions in the mail or received them late, drug benefit and supply chain experts tell AIS Health the disruption to the most vulnerable patients served by specialty and mail order pharmacies should be minimal.

An Aug. 24 Axios-Ipsos poll shows that one in five Americans received medication through the mail during the preceding week. One in four of that group, or 5% of Americans overall, didn’t receive their medication or got it late.

In addition, PBMs have not reported significant disruption to their supply chains.

“Most of the drugs shipped from a mail order pharmacy — a non-specialty pharmacy — you worry about them being perishable, but they tend to be pretty stable. They’re oral pills, things like that,” says Mike Schneider, a principal at Avalere Health.

Schneider also suggests that mail order pharmacies’ longer fills, which typically keep shipping costs down by filling for 90 days or more, should insulate patients from major disruptions. He adds that most mail order medication businesses also build logistical complications into their shipping schedules.

Omar Hafez, a principal at Avalere and a former supply chain executive at specialty pharmacy McKesson Specialty Health, says that time- and temperature-sensitive therapies have very specific delivery windows that are mandated by law. He says the strict requirements mean that the bulk of the supply chain for temperature-sensitive specialty drugs is managed by specialized logistics firms, not the USPS.

Schneider says the pharmacy supply chain as a whole has proved remarkably resilient over the course of 2020 — despite the tumult caused by the pandemic and the USPS brouhaha.

“I think a lot of supply chain issues never really materialized, at least not to my knowledge,” Schneider says. “There are a certain drugs that have shortages, but nothing that seemed like it was a national emergency. I think part of the reduced supply might have been everybody was going and filling their prescriptions as the virus was hitting, and everybody was getting some longer-term fills.”

MMIT Reality Check on Non-Small Cell Lung Cancer Systemic Therapy (Aug 2020)

August 28, 2020

According to our recent payer coverage analysis for non-small cell lung cancer systemic therapy treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for non-small cell lung cancer systemic therapy treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for non-small cell lung cancer systemic therapy treatments shows that under the pharmacy benefit, about 46% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: When the FDA approved Novartis Pharmaceuticals Corp.’s Tabrecta (capmatinib) on May 6, 2020, it was the first of seven approvals in non-small cell lung cancer (NSCLC) through May 29.

Trends That Matter for Prostate Cancer Treatments

August 27, 2020

Although poly ADP-ribose polymerase (PARP) inhibitors are not new to the market, two of them recently gained approval for use in prostate cancer for the first time. The therapies will bring a new option for the treatment of certain subpopulations of patients, AIS Health reported.

On May 19, the FDA expanded the label of AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) to include the treatment of people with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following treatment with Xtandi (enzalutamide) or Zytiga/Yonsa (abiraterone acetate).

Although poly ADP-ribose polymerase (PARP) inhibitors are not new to the market, two of them recently gained approval for use in prostate cancer for the first time. The therapies will bring a new option for the treatment of certain subpopulations of patients, AIS Health reported.

On May 19, the FDA expanded the label of AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) to include the treatment of people with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following treatment with Xtandi (enzalutamide) or Zytiga/Yonsa (abiraterone acetate).

On May 15, the FDA gave accelerated approval to Clovis Oncology, Inc.’s Rubraca (rucaparib) for the treatment of adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

Two other PARP inhibitors — GSK’s Tesaro, Inc.’s Zejula (niraparib) and Pfizer Inc.’s Talzenna (talazoparib) — are on the market, and both are in clinical trials for prostate cancer.

The graphic below show how prostate cancer medications are covered among commercial health plans, health exchange programs, Medicare and Medicaid programs under the pharmacy benefit.

Radar On Market Access: Payers Face Challenges to Enroll Newly Uninsured

August 27, 2020

Health insurers are conducting outreach to people who may have been left without coverage as a result of the COVID-19 crisis, but experts say they may be partially stymied in their efforts to get people enrolled in new plans by the difficulties of operating within a pandemic environment, AIS Health reported.

AmeriHealth Caritas, which is run by Independence Blue Cross in partnership with Blue Cross Blue Shield of Michigan, says it has launched a series of videos designed to help potential Medicaid enrollees learn how they can apply.

Health insurers are conducting outreach to people who may have been left without coverage as a result of the COVID-19 crisis, but experts say they may be partially stymied in their efforts to get people enrolled in new plans by the difficulties of operating within a pandemic environment, AIS Health reported.

AmeriHealth Caritas, which is run by Independence Blue Cross in partnership with Blue Cross Blue Shield of Michigan, says it has launched a series of videos designed to help potential Medicaid enrollees learn how they can apply.

Meanwhile, Fort Worth, Texas-based Care N’ Care Health Plan, which offers Medicare Advantage (MA) plans, is urging newly unemployed seniors — who already were Medicare-eligible but delayed signing up because they still had health insurance through a job — to get coverage now. So it’s deploying a public relations campaign stressing that those people don’t need to wait until open enrollment begins later this year to choose an MA plan.

In addition, most state Medicaid agencies have tried to make it easier for people to apply for coverage during the pandemic by offering a dedicated phone line for enrollment assistance, providing real-­time eligibility decisions, and waiving interviews and other documentation requirements, according to a Health Affairs blog post.

Medicaid managed care organizations are conducting their own outreach, and “they’re really great at consumer engagement with the Medicaid population,” Jerry Vitti, founder and CEO of Healthcare Financial, Inc., tells AIS Health. “But the folks who are newly uninsured are not a typical Medicaid population,” and states and plans may need different types of communications to reach people and enroll them, he says.

So far, Medicaid plans are not seeing as big an influx of enrollees as they might have expected in the pandemic.

“People are forgoing health care, mostly preventive non-emergency visits, in favor of more pressing needs like eating and paying rent — addressing these underlying social determinants of health is primary, so health coverage kind of falls between the cracks,” Vitti says. “Another reason may be that people are expecting to return to work when this is all over and are just waiting to get their old employer coverage back.”

Since “at the very least I think we’re looking at a protracted COVID-related recession,” he says, “we should eventually see the enrollment increase they were expecting.”

Radar On Market Access: Large Employers Expect Cost Uncertainty, More Virtual Care in 2021

August 25, 2020

While the COVID-19 pandemic has not caused employers to significantly alter their health care cost estimates for the coming year, it has unquestionably intensified their interest in embracing virtual care. Those are just a couple of the major findings from the Business Group on Health’s 2021 Large Employers’ Health Care Strategy and Plan Design Survey, AIS Health reported.

Notably, 80% of respondents said they believe virtual health will play a significant role in how care is delivered in the future, up considerably from 64% last year. Further, when asked about actions they were taking to ease the burdens of COVID-19 for employees, the largest share of respondents — 76% — said they “made changes to allow for better access to virtual care solutions.”

While the COVID-19 pandemic has not caused employers to significantly alter their health care cost estimates for the coming year, it has unquestionably intensified their interest in embracing virtual care. Those are just a couple of the major findings from the Business Group on Health’s 2021 Large Employers’ Health Care Strategy and Plan Design Survey, AIS Health reported.

Notably, 80% of respondents said they believe virtual health will play a significant role in how care is delivered in the future, up considerably from 64% last year. Further, when asked about actions they were taking to ease the burdens of COVID-19 for employees, the largest share of respondents — 76% — said they “made changes to allow for better access to virtual care solutions.”

During an Aug. 18 press briefing, Business Group on Health President and CEO Ellen Kelsay attributed such findings to not only telehealth’s ability to offer more convenience and greater access for consumers, but also to the sheer necessity of pivoting to a different care modality amid widespread stay-at-home orders.

Regarding the controversial issue of telehealth reimbursement, which payers generally want to be lower than in-person visits but providers want to be equal, Kelsay said her organization supports payment flexibility over parity. In some cases, that “might mean less reimbursement for telehealth, and in other instances maybe increased reimbursement for telehealth if it’s a better modality for delivery, depending on the situation,” she added.

Kelsay also emphasized that there are still more questions than answers about how the pandemic will affect health care costs for companies and their workers. For 2021, the Business Group on Health is projecting the total cost of health benefits will rise by 5.3% — slightly higher than the 5% trend it predicted in the past few years.

“There is a lot of uncertainty around what is actually going to manifest itself in terms of costs, both this year and next year,” Kelsay said. “Many employers are having a really hard time from a budgeting and actuarial perspective working with their health plan and consulting partners, to really get a good handle of what that means.”

MMIT Reality Check on Ulcerative Colitis (Aug 2020)

August 21, 2020

According to our recent payer coverage analysis for ulcerative colitis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for ulcerative colitis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for ulcerative colitis treatments shows that under the pharmacy benefit, about 69% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In July 2020, the FDA approved Mylan N.V. and Fujifilm Kyowa Kirin Biologics Co., Ltd.’s Hulio (adalimumab-fkjp) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. The agency approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) — the sixth one that the agency approved — in both prefilled syringe and auto-injector presentations.

Perspectives on UnitedHealth, Humana’s Chronic Conditions Programs

August 20, 2020

Both UnitedHealthcare and Humana Inc. are rolling out new disease-specific care management programs aimed at providing patients with the tools they need to help control their chronic conditions, AIS Health reported.

The new initiatives highlight new digital and time-tested interpersonal ways of managing chronic conditions, observers say.

UnitedHealth said it has launched its new digital therapy for people with type 2 diabetes that combines wearable technology and customized personal support. The therapy, called Level2, helps participants gain real-time insights about their condition, using a mobile continuous glucose monitor, activity tracker, app-based alerts and one-on-one clinical coaching.

Both UnitedHealthcare and Humana Inc. are rolling out new disease-specific care management programs aimed at providing patients with the tools they need to help control their chronic conditions, AIS Health reported.

The new initiatives highlight new digital and time-tested interpersonal ways of managing chronic conditions, observers say.

UnitedHealth said it has launched its new digital therapy for people with type 2 diabetes that combines wearable technology and customized personal support. The therapy, called Level2, helps participants gain real-time insights about their condition, using a mobile continuous glucose monitor, activity tracker, app-based alerts and one-on-one clinical coaching.

Meanwhile, Humana says it has contracted with REACH Kidney Care, an educational nonprofit affiliated with Dialysis Clinic, Inc., to provide kidney disease care coordination services to eligible Medicare Advantage and commercial members in Georgia, North Carolina, South Carolina and Tennessee. The collaboration is focused on early detection of chronic kidney disease, slowing disease progression and improving the patient experience.

Joseph Paduda, principal at Health Strategy Associates, LLC, notes that both programs are designed to reduce severity and therefore the cost of treating patients, identifying patients who are “heading in the wrong direction and likely intervening.” Still, Paduda says, “what’s notable is that both are focused on individual disease states, especially knowing more than a third of adults — and more than half of older adults — have multiple chronic conditions.”

William DeMarco, president of Pendulum HealthCare Development Corp., says that UnitedHealth has an in-house advantage with its Optum subsidiary, which connects the insurer’s data platforms for claims and clinical data. Therefore, more information and measures can be tracked electronically, reducing the need for physician or even nurse intervention except when needed, DeMarco says.

DeMarco says the applicability of digital care management solutions, versus more traditional solutions, depends on the condition — although technology always has a place.

“Diabetes is a data-driven disease,” and therefore particularly well-suited to digital therapy, observes Dan Mendelson, founder of Avalere Health. Other chronic conditions that are particularly data-driven include cardiovascular disease and Crohn’s disease, he says, and “any conditions that require regular medication management are likely to benefit from some kind of digital tools.”

Radar On Market Access: COVID-19 Pandemic Amps Up Interest in Home Care

August 20, 2020

As visits to hospitals and outpatient clinics have become sources of anxiety for patients worried about exposure to the novel coronavirus, plans and providers alike have begun to make major investments in home care, AIS Health reported.

Humana Inc., for example, recently announced a $100 million investment in home primary care startup Heal Inc. Heal CEO Nick Desai says his company will aid Humana’s long-term strategy to reduce the cost of care and improve quality.

As visits to hospitals and outpatient clinics have become sources of anxiety for patients worried about exposure to the novel coronavirus, plans and providers alike have begun to make major investments in home care, AIS Health reported.

Humana Inc., for example, recently announced a $100 million investment in home primary care startup Heal Inc. Heal CEO Nick Desai says his company will aid Humana’s long-term strategy to reduce the cost of care and improve quality.

Heal’s model places patients with a consistent primary care physician who makes house calls. The doctors are dispatched and routed using an app and driven to visits with a medical assistant, and they input notes and update care plans into an electronic health record between visits.

“Our doctors are paid on a salary basis, so they don’t worry about the billing,” Desai explains. “They have incentives and bonuses for delivering quality, but never for seeing more patients. We’re fundamentally economically aligned around the delivery of value, not volume.”

Where payers will find significant appeal in home care is in reducing the duration and number of inpatient visits, says Ashraf Shehata, KPMG national sector leader for health care and life sciences.

Shehata says that building home care capacity will give plans more flexibility to meet patients on their own terms and could improve outcomes in a post-acute context. Still, he suggests that there are substantial barriers to scaling up home care to that level. Those include regulatory standards, including special certifications that are required for licensed home care providers. He also notes lagging EHR interoperability impedes the flow of information between home care providers and other parts of the health care system.

COVID-19 has thrown a bright light on existing incentives for hospital systems to reduce inpatient stays. In the spring, Utah-based integrated health system Intermountain Healthcare launched a pilot program to move post-acute patients and low-acuity emergency patients to home care.

Nick Bassett, vice president for population health services at Intermountain subsidiary Castell, says the pilot is tied to health system’s longer-term value-based care strategy. He adds that the pilot has shown promising savings — mainly from reducing the physical plant and staffing costs of a hospital stay.

Radar On Market Access: Anthem, Cigna, CVS Report Strong PBM Performance Amid COVID-19

August 18, 2020

For PBMs, 2020 has been far from business as usual, given the myriad ways the COVID-19 pandemic has changed how people interact with the health care system. However, during their second-quarter earnings conference calls, companies that own some of the largest PBMs emphasized that they are largely satisfied with how the PBM segments of their businesses are performing, AIS Health reported.

Anthem, Inc. Chief Financial Officer John Gallina said during the insurer’s earnings call that “IngenioRx is actually doing quite well, and has really done a nice job of meeting our expectations.”

For PBMs, 2020 has been far from business as usual, given the myriad ways the COVID-19 pandemic has changed how people interact with the health care system. However, during their second-quarter earnings conference calls, companies that own some of the largest PBMs emphasized that they are largely satisfied with how the PBM segments of their businesses are performing, AIS Health reported.

Anthem, Inc. Chief Financial Officer John Gallina said during the insurer’s earnings call that “IngenioRx is actually doing quite well, and has really done a nice job of meeting our expectations.”

Anthem is on track this year to realize $900 million in operating profit contributed from its relatively new PBM, which exceeds its prior expectation of $800 million, Credit Suisse analyst A.J. Rice pointed out in a July 29 note to investors. But he also noted that while maintenance prescription volume was steady compared with the prior-year quarter, “new scripts saw a 10-15% drop in April versus normal utilization. Thus, IngenioRx captured less profit in Q2.”

CVS Health Corp., which owns the PBM Caremark, reported that operating income and adjusted operating income for its pharmacy services segment increased 6.2% and 2.4%, respectively, from the prior-year quarter. Those results were “primarily driven by growth in specialty pharmacy and improved purchasing economics,” but they were offset by “continued price compression and previously disclosed client losses,” the company said in its earnings release.

Cigna Corp. reported on July 30 that for its health services segment — which houses the PBM Express Scripts — pretax adjusted income from operations increased 7% relative to the second quarter of 2019.

Executives from Anthem, Cigna and CVS all acknowledged that the PBM selling season for 2021 was affected by the shutdowns and economic uncertainty ushered in by the COVID-19 pandemic.

Anthem President and CEO Gail Boudreaux described the selling season as “an interesting operating environment, given all the change.” As the insurer mentioned in its first-quarter earnings call, “things are, I would say, at least slightly delayed, as customers try to work through their own stability across their business,” Boudreaux said.

Alan Lotvin, M.D., the executive vice president and president of Caremark, offered: “I’d say the season itself has been interesting in the lumpiness with COVID, but overall ending up about where we thought.”

MMIT Reality Check on Duchenne Muscular Dystrophy (Aug 2020)

August 14, 2020

According to our recent payer coverage analysis for Duchenne muscular dystrophy treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for Duchenne muscular dystrophy treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for Duchenne muscular dystrophy treatments shows that under the pharmacy benefit, about 49% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: More recently, in August 2020, the agency gave accelerated approval to NS Pharma, Inc.’s Viltepso (viltolarsen) for people amenable to exon 53 skipping therapy.

Trends That Matter for Major Insurers’ Performance Amid COVID-19

August 13, 2020

With COVID-19 cases and deaths surging in some U.S. states, it has become clear that the nation won’t be back to normal anytime soon. Still, the country’s largest health insurer is betting that health care utilization, and the costs associated with it, will return to something close to typical levels in the second half of the year, AIS Health reported.

With COVID-19 cases and deaths surging in some U.S. states, it has become clear that the nation won’t be back to normal anytime soon. Still, the country’s largest health insurer is betting that health care utilization, and the costs associated with it, will return to something close to typical levels in the second half of the year, AIS Health reported.

At its lowest point in April, inpatient care volume — including care for COVID-19 patients — was about three quarters less than normal, UnitedHealth Group Chief Financial Officer John Rex said during a July 15 conference call to discuss the company’s second-quarter earnings. At that same low point, utilization of outpatient and physician services fell to roughly 60% of normal levels. But in June, UnitedHealth saw inpatient volume recover to nearly 95% of baseline, and as June turned to July, outpatient and physician services were “tracking above 90%,” Rex said. “These national trends have continued thus far in July, even as certain states are seeing short-term deferral of services where there are elevated levels of infection and hospitalization,” he added.

Indeed, the company predicts that overall, “utilization’s going to come back during the second half of the year,” UnitedHealthcare CEO Dirk McMahon said.

In a note to investors, Citi analyst Ralph Giacobbe observed that the executives’ comments about health care utilization returning to normal were “surprising to us.”

“Ultimately we believe healthcare cost trends will remain muted, and as we look out over the next 12+ months we see those trends driving upside, and lower headline risk post-election driving multiples higher,” Giacobbe added.

Below shows the key financial data for leading health plans in the second quarter of 2020 and 2019.

Radar On Market Access: Trump Administration Issues Telehealth Executive Order, More Acts Are Needed

August 13, 2020

Recent events indicate the telehealth boom caused by the COVID-19 pandemic will result in a permanent expansion of virtual care. On Aug. 3, the Trump administration issued an executive order directing HHS to make permanent some of the telehealth regulations it relaxed for Medicare beneficiaries during the public health emergency, AIS Health reported.

Recent events indicate the telehealth boom caused by the COVID-19 pandemic will result in a permanent expansion of virtual care. On Aug. 3, the Trump administration issued an executive order directing HHS to make permanent some of the telehealth regulations it relaxed for Medicare beneficiaries during the public health emergency, AIS Health reported.

The executive order directs officials to issue proposed regulations that will lock in some of the changes in telehealth policy that the Trump administration included as part of pandemic relief. In response to the order, CMS on Aug. 3 proposed a rule that would permanently allow Medicare to reimburse for certain services that are furnished virtually, “including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments.”

Avalere Health founder Dan Mendelson says that the order will have limited impact in the near term, but it speaks to the rapid entrenchment of telehealth.

“The administration is doing what they can with their existing authority. Notionally, it’s in the right direction,” says Mendelson. “It’s thoughtful and positive, but it’s also limited in terms of the practical effect because it’s focused on these rural geographies.”

Meanwhile, telehealth provider Teladoc Health Inc. reached a deal to acquire remote monitoring firm Livongo Health Inc. in a transaction announced Aug. 5, which the firms expect to close by the end of the year. In a July white paper prepared by members of its health care practice, KPMG predicted ample transactions in the telehealth space going forward.

James Gelfand, ERISA Industry Committee (ERIC) senior vice president for health policy, tells AIS Health via email that Congress needs to take telehealth reform further.

“ERIC urges Congress to follow the President’s lead and remove restrictions that ban employers from offering telehealth to all employees, opening up access to health care for millions of Americans nationwide permanently,” he wrote.

Mendelson makes a similar point. He says that Congress needs to set rules for complex, controversial issues like reimbursement. He adds that he expects action on telehealth after the election, if only for Medicare and Medicaid.

Radar On Market Access: FDA Approved Two PARP Inhibitors for Prostate Cancer

August 11, 2020

Although poly ADP-ribose polymerase (PARP) inhibitors are not new to the market, two of them recently gained approval for use in prostate cancer for the first time. The therapies will bring a new option for the treatment of certain subpopulations of patients, AIS Health reported.

On May 19, the FDA expanded the label of AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) to include the treatment of people with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following treatment with Xtandi (enzalutamide) or Zytiga/Yonsa (abiraterone acetate).

Although poly ADP-ribose polymerase (PARP) inhibitors are not new to the market, two of them recently gained approval for use in prostate cancer for the first time. The therapies will bring a new option for the treatment of certain subpopulations of patients, AIS Health reported.

On May 19, the FDA expanded the label of AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) to include the treatment of people with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following treatment with Xtandi (enzalutamide) or Zytiga/Yonsa (abiraterone acetate).

On May 15, the FDA gave accelerated approval to Clovis Oncology, Inc.’s Rubraca (rucaparib) for the treatment of adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

Two other PARP inhibitors — GSK’s Tesaro, Inc.’s Zejula (niraparib) and Pfizer Inc.’s Talzenna (talazoparib) — are on the market, and both are in clinical trials for prostate cancer.

Lynparza’s and Rubraca’s approvals are “indicative of the growing knowledge we are gaining with respect to the intermediary pathways within the cells regulating DNA repair as it relates to tumor growth,” says Winston Wong, Pharm.D., president of W-Squared Group.

The PARP inhibitors will impact “refractory patients who have failed standard-of-care therapies,” notes Mesfin Tegenu, R.Ph., president of PerformRx, LLC. First-line treatment will be with antiandrogens or taxanes, he explains: Zytiga, Yonsa, Jevtana (cabazitaxel), Taxotere (docetaxel) or Xtandi. Then the top competitors in the second-line setting will be Lynparza, Rubraca and Keytruda (pembrolizumab), he says.

Asked how the two PARP inhibitors compare with other therapies in the class, Tegenu points out that “Lynparza had higher objective response rates and better radiographic progression-free survival compared to enzalutamide and abiraterone. It also showed benefit compared to docetaxel. Men with specific mutations may benefit more with PARP inhibitors.”

“Rubraca after receiving taxane therapy showed benefit,” he continues. “It is currently being compared to abiraterone, enzalutamide or docetaxel in an ongoing clinical trial. It has accelerated approval contingent upon verification of success in this trial.”

MMIT Reality Check on Parkinson’s Disease (Aug 2020)

August 7, 2020

According to our recent payer coverage analysis for Parkinson’s disease treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for Parkinson’s disease treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for Parkinson’s disease treatments shows that under the pharmacy benefit, about 36% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In May 2020, the FDA approved Sunovion Pharmaceuticals Inc.’s Kynmobi (apomorphine) for the acute, intermittent treatment of “off” episodes in people with Parkinson’s disease.

Perspectives on Remdesivir’s $3,120 Price Tag

August 6, 2020

Gilead Sciences, Inc. revealed that for promising COVID-19 treatment remdesivir, it will charge $2,340 for a typical five-day, six-vial treatment course for people covered by U.S. government health programs and $3,120 for those covered by private insurance, AIS Health reported.

In an open letter, Gilead CEO Daniel O’Day argued that Gilead priced remdesivir “well below” its estimated value, considering it can save the U.S. health care system approximately $12,000 per patient by reducing the length of COVID-19 patients’ hospital stays.

But not everyone is convinced by that argument.

Gilead Sciences, Inc. revealed that for promising COVID-19 treatment remdesivir, it will charge $2,340 for a typical five-day, six-vial treatment course for people covered by U.S. government health programs and $3,120 for those covered by private insurance, AIS Health reported.

In an open letter, Gilead CEO Daniel O’Day argued that Gilead priced remdesivir “well below” its estimated value, considering it can save the U.S. health care system approximately $12,000 per patient by reducing the length of COVID-19 patients’ hospital stays.

But not everyone is convinced by that argument.

“So they’re saying by shortening hospital stays, the system is going to save all these monies, but I always ask the question, ‘Why is it that the drug company should get to pocket all or some substantial portion of that savings?'” says Jack Hoadley, Ph.D., a research professor emeritus at Georgetown University’s Health Policy Institute. “That’s a savings we should accumulate for consumers, for payers [and] everybody else.”

Hoadley is not alone in those views. The advocacy group Patients for Affordable Drugs, in a June 29 statement, wrote that “Gilead’s price for remdesivir shows once again that we can’t trust Big Pharma to act responsibly — even in the face of a global pandemic.”

The U.S. government helped fund the development of remdesivir, and dexamethasone — a generic steroid — is priced at less than $1 per day even though it ‘showed promise for combating severe COVID-19 cases and reducing potential mortality rates,” the organization said.

The Institute for Clinical and Economic Review (ICER) also brought up dexamethasone in its statement. The U.S. price range of $2,340 to $3,120 is “is largely in line with ICER’s independent assessment suggesting that a price of approximately $2,800 would be reasonable in proportion to the added benefits for patients and the cost offsets in the health system now that dexamethasone is rapidly becoming standard of care,” wrote ICER President Steven D. Pearson, M.D.

Leerink analyst Geoffrey Porges, in a June 29 note to investors, pointed out that the U.S. commercial price set for remdesivir was below his firm’s expectations. Still, “we believe the disclosed [remdesivir] pricing is reasonable, and should provide significant value to the Gilead shareholders and still deflect much of the criticism the company might face in this emergency,” Porges wrote.

Radar On Market Access: Anthem Warns of Greater Commercial Enrollment Drop in Second Half

August 6, 2020

While Anthem, Inc. has seen less of an enrollment dip in its commercial business than it originally feared when the COVID-19 pandemic and economic recession first took hold, the insurer’s executives said during a July 29 earnings conference call that they expect that attrition to accelerate in the coming months as some furloughs become permanent job losses, AIS Health reported.

From March 31 to June 30, Anthem saw enrollment in its commercial and specialty business lines drop by 290,000. “But as you think about unemployment, that was fairly muted,” especially when it comes to Anthem’s risk-based business, President and CEO Gail Boudreaux said during the earnings call. She and other Anthem executives attributed that effect to the fact that many companies have thus far furloughed rather than laid off workers, thanks in part to federal stimulus funding.

While Anthem, Inc. has seen less of an enrollment dip in its commercial business than it originally feared when the COVID-19 pandemic and economic recession first took hold, the insurer’s executives said during a July 29 earnings conference call that they expect that attrition to accelerate in the coming months as some furloughs become permanent job losses, AIS Health reported.

From March 31 to June 30, Anthem saw enrollment in its commercial and specialty business lines drop by 290,000. “But as you think about unemployment, that was fairly muted,” especially when it comes to Anthem’s risk-based business, President and CEO Gail Boudreaux said during the earnings call. She and other Anthem executives attributed that effect to the fact that many companies have thus far furloughed rather than laid off workers, thanks in part to federal stimulus funding.

“We can’t predict exactly what’s going to happen when they come off [furlough]; it will depend on the strengthening of the economy and what happens there and what employers decide to do,” Boudreaux said.

Ultimately, “we do expect further declines, assuming the economy continues to operate at less than full capacity,” Boudreaux said of Anthem’s commercial business. Meanwhile, Anthem’s Medicaid and Medicare enrollment grew by 599,000 from the first quarter of 2020 to the second quarter. Overall medical enrollment rose by 0.7% between the first and second quarters of this year, and it increased 3.9% in the second quarter of 2020 compared with the prior-year quarter.

Anthem reported adjusted earnings per share of $8.91 per share in the quarter, compared with $4.36 during the prior-year period. The insurer’s quarterly operating revenue was $29.2 billion — an increase of $4 billion, or 15.9% compared with the prior-year quarter — which Anthem attributed to “pharmacy product revenue related to the launch of IngenioRx,” the company’s PBM.

Radar On Market Access: Experts Are Skeptical of Trump Administration’s Drug Pricing Executive Orders

August 4, 2020

In executive orders released July 24, the Trump administration renewed its push toward a signature campaign issue: lowering drug prices. The three executive orders call for regulations allowing drugs to be imported from other countries, requiring Federally Qualified Health Centers to make insulin and epinephrine available to low-income members of the public at the discounted prices set by the 340B Drug Pricing Program, and removing safe harbor protections under the Anti-Kickback Statue for prescription drug rebates in Medicare Part D, AIS Health reported.

“I think that what you have here is a collection of policies that are intended to make noise, but will have little to no practical effect on drug prices before the election,” Avalere founder Dan Mendelson says.

In executive orders released July 24, the Trump administration renewed its push toward a signature campaign issue: lowering drug prices. The three executive orders call for regulations allowing drugs to be imported from other countries, requiring Federally Qualified Health Centers to make insulin and epinephrine available to low-income members of the public at the discounted prices set by the 340B Drug Pricing Program, and removing safe harbor protections under the Anti-Kickback Statue for prescription drug rebates in Medicare Part D, AIS Health reported.

“I think that what you have here is a collection of policies that are intended to make noise, but will have little to no practical effect on drug prices before the election,” Avalere founder Dan Mendelson says.

Marc Samuels, CEO of ADVI, says that the proposals seem half-baked, and will likely draw strong opposition. “These executive orders are consistent with the previous [drug pricing] blueprint adopted by the Administration and debated in part in Congress. But having the authority to make quick changes doesn’t mean doing so is a good idea, especially so close to an election,” he says.

The idea of importing drugs from other developed countries, and relying on their drug safety inspection regimes, has popped up in the past. Mendelson, who ran the health division of the Office of Management and Budget between 1998 and 2000, says that although the Clinton administration considered the idea seriously, it found that it wasn’t feasible.

“We looked at it and rejected the policy because we were concerned that it wouldn’t work, and that in fact it would not only compromise the pharmaceutical supply chain but also likely be rejected by the very countries we would want to import the drugs from,” Mendelson explains.

The rebate order addresses a persistent challenge for the administration. And Citi analyst Ralph Giacobbe is skeptical that the proposal will actually manifest substantial changes in the way PBMs do business.

“While this will resurrect some debate on the PBM business model, we see the likelihood as either low or limited in scope,” Giacobbe wrote in a note. “Additionally, [with] the language of HHS having to confirm that this action does not increase federal spending, Medicare beneficiary premiums or out-of-pocket cost may make it a moot point since premiums will definitively rise, in our opinion.”

A fourth executive order would tie drug prices to their list prices in countries with Most Favored Nation status. That order has not yet been released, but could be in the coming weeks.

MMIT Reality Check on Kidney Cancer (July 2020)

July 31, 2020

According to our recent payer coverage analysis for kidney cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for kidney cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for kidney cancer treatments shows that under the pharmacy benefit, about 62% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In December 2019, the FDA approved Teva Pharmaceuticals USA, Inc.’s and Endo International plc unit Par Pharmaceuticals’ everolimus for the treatment of advanced hormone receptor-positive, HER2-negative breast cancer in postmenopausal women; advanced renal cell carcinoma; renal angiomyolipoma and tuberous sclerosis complex; progressive neuroendocrine tumors of pancreatic origin; and progressive, well-differentiated, non-functional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable.

Trends That Matter for Medicaid MCOs

July 30, 2020

Two recent reports found that Medicaid managed care plans now enroll most Medicaid members, help keep costs and premiums low in the markets where they participate, and are competitive with commercial plans at the low end of the individual market in areas including network quality and benefit design, AIS Health reported.

One white paper was prepared by consultancy The Menges Group for America’s Health Insurance Plans (AHIP), and the other was authored by researchers at the Robert Wood Johnson Foundation (RWJF) and Urban Institute.

Two recent reports found that Medicaid managed care plans now enroll most Medicaid members, help keep costs and premiums low in the markets where they participate, and are competitive with commercial plans at the low end of the individual market in areas including network quality and benefit design, AIS Health reported.

One white paper was prepared by consultancy The Menges Group for America’s Health Insurance Plans (AHIP), and the other was authored by researchers at the Robert Wood Johnson Foundation (RWJF) and Urban Institute.

The Menges Group-AHIP white paper, which had a national scope, found that Medicaid MCO enrollment increased by 121% between fiscal years 2010 and 2018, from 26 million to over 56 million members, and that as of 2018, more than 75% of all Medicaid enrollees are members of an MCO, up from 50% in 2010. The report also found that, since 2017, capitated payments to MCOs have exceeded fee-for-service expenditures.

The RWJF-Urban Institute paper, which relied on case study surveys in Arkansas, California, Florida, New York, Ohio, and Washington state, concluded that MCOs offer coverage that is at least as good as commercial plans in the low end of the Affordable Care Act individual market.

“Many [stakeholders] feel there are no longer major distinctions between Medicaid and commercial insurers in the marketplaces. Most interviewees have positive perceptions of Medicaid insurers, crediting their ability to increase choice and affordability in the individual health insurance market,” wrote the paper’s authors.

Radar On Market Access: UnitedHealth, Humana Launch Programs for Chronic Conditions

July 30, 2020

Both UnitedHealthcare and Humana Inc. are rolling out new disease-specific care management programs aimed at providing patients with the tools they need to help control their chronic conditions, AIS Health reported.

The new initiatives highlight new digital and time-tested interpersonal ways of managing chronic conditions, observers say.

UnitedHealth said it has launched its new digital therapy for people with type 2 diabetes that combines wearable technology and customized personal support. The therapy, called Level2, helps participants gain real-time insights about their condition, using a mobile continuous glucose monitor, activity tracker, app-based alerts and one-on-one clinical coaching.

Both UnitedHealthcare and Humana Inc. are rolling out new disease-specific care management programs aimed at providing patients with the tools they need to help control their chronic conditions, AIS Health reported.

The new initiatives highlight new digital and time-tested interpersonal ways of managing chronic conditions, observers say.

UnitedHealth said it has launched its new digital therapy for people with type 2 diabetes that combines wearable technology and customized personal support. The therapy, called Level2, helps participants gain real-time insights about their condition, using a mobile continuous glucose monitor, activity tracker, app-based alerts and one-on-one clinical coaching.

Meanwhile, Humana says it has contracted with REACH Kidney Care, an educational nonprofit affiliated with Dialysis Clinic, Inc., to provide kidney disease care coordination services to eligible Medicare Advantage and commercial members in Georgia, North Carolina, South Carolina and Tennessee. The collaboration is focused on early detection of chronic kidney disease, slowing disease progression and improving the patient experience.

Joseph Paduda, principal at Health Strategy Associates, LLC, notes that both programs are designed to reduce severity and therefore the cost of treating patients, identifying patients who are “heading in the wrong direction and likely intervening.” Still, Paduda says, “what’s notable is that both are focused on individual disease states, especially knowing more than a third of adults — and more than half of older adults — have multiple chronic conditions.”

William DeMarco, president of Pendulum HealthCare Development Corp., says that UnitedHealth has an in-house advantage with its Optum subsidiary, which connects the insurer’s data platforms for claims and clinical data. Therefore, more information and measures can be tracked electronically, reducing the need for physician or even nurse intervention except when needed, DeMarco says.

DeMarco says the applicability of digital care management solutions, versus more traditional solutions, depends on the condition — although technology always has a place.

“Diabetes is a data-driven disease,” and therefore particularly well-suited to digital therapy, observes Dan Mendelson, founder of Avalere Health. Other chronic conditions that are particularly data-driven include cardiovascular disease and Crohn’s disease, he says, and “any conditions that require regular medication management are likely to benefit from some kind of digital tools.”

Radar On Market Access: Manufacturers, Payers Wait on Federal COVID-19 Vaccine Distribution Plan

July 28, 2020

As the many COVID-19 vaccines under development barrel toward clinical trials for safety and efficacy, questions remain about how they will be distributed when they become available, AIS Health reported.

In a hearing held by a subcommittee of the House Energy & Commerce committee, pharmaceutical executives said they would rely on guidance from the Trump administration and the Centers for Disease Control and Prevention (CDC) to distribute vaccine doses.

As the many COVID-19 vaccines under development barrel toward clinical trials for safety and efficacy, questions remain about how they will be distributed when they become available, AIS Health reported.

In a hearing held by a subcommittee of the House Energy & Commerce committee, pharmaceutical executives said they would rely on guidance from the Trump administration and the Centers for Disease Control and Prevention (CDC) to distribute vaccine doses.

Those guidelines will be important to insurers, as vaccine doses aren’t likely to be available to everyone immediately, according to Mike Schneider, a principal at Avalere Health. Though some firms have already begun manufacturing doses of their vaccine in parallel to testing, the immediate availability of hundreds of millions of doses at the time of FDA approval would be unprecedented.

Schneider notes that multiple vaccines may be available at the same time, and one may offer greater protection from COVID-19 than others. Protocols will need to be developed to determine which patients will be first in line for the most effective vaccine. Schneider says that plans need to start thinking about their internal guidelines now.

He adds that PBMs, which often have the most robust data about a patient’s drug regimen and immunization status, will be essential to tracking who has been vaccinated and screened.

Schneider says that plans are unlikely to favor one vaccine over another in their formularies. For example, Prime Therapeutics, a PBM owned by Blue Cross and Blue Shield affiliates, says it is committed to obtaining a supply of COVID-19 vaccine as soon as possible, seemingly regardless of who manufactures it.

A July 20 analysis prepared by health care investment bank SVB Leerink LLC takes a different view of the shape of the initial vaccine market than Schneider’s prediction of scarcity, arguing that the sheer volume of development efforts makes more than one breakout product likely.

In any case, Schneider predicts that the initial rollout will be unusual when compared with other vaccine distribution.

“This won’t just be going to your pharmacy and your pharmacist gives you a vaccine, like the flu vaccine,” Schneider says. He suspects that rollout will involve specialized facilities that combine rapid screening with inoculations at the same site.

MMIT Reality Check on Bipolar Disorder (July 2020)

July 24, 2020

According to our recent payer coverage analysis for bipolar disorder treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for bipolar disorder treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for bipolar disorder treatments shows that under the pharmacy benefit, about 23% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: A new brand drug, Allergan plc’s Vraylar (cariprazine), for bipolar disorder will have little impact on how health plans cover these medications, experts say. Health plans will continue to encourage the use of less expensive generic bipolar drugs.

Perspectives on Trump Admin’s COVID-19 Testing Payment Guidance

July 23, 2020

As more employers turn to COVID-19 testing to see if employees are safe to return to the workplace, the Trump administration has clarified that insurers must cover only physician-ordered “medically necessary” diagnostic and antibody tests, AIS Health reported.

The guidance, released jointly on June 23 by HHS, the Dept. of Labor and the Dept. of the Treasury, also says self-funded employer plans must pay for COVID-19 testing that’s medically appropriate.

As more employers turn to COVID-19 testing to see if employees are safe to return to the workplace, the Trump administration has clarified that insurers must cover only physician-ordered “medically necessary” diagnostic and antibody tests, AIS Health reported.

The guidance, released jointly on June 23 by HHS, the Dept. of Labor and the Dept. of the Treasury, also says self-funded employer plans must pay for COVID-19 testing that’s medically appropriate.

“Testing conducted to screen for general workplace health and safety (such as employee ‘return to work’ programs), for public health surveillance for SARS-CoV-2, or for any other purpose not primarily intended for individualized diagnosis or treatment of COVID-19 or another health condition is beyond the scope” of the requirements embedded in the legislation approved by Congress earlier this year that requires insurers to pay for COVID-19 testing, the FAQ document said.

“I think now that [the insurers] have had this clarification, they’re going to use that as part of their determination of coverage,” Ashraf Shehata, KPMG national sector leader for health care and life sciences, tells AIS Health.

Richard Hughes IV, managing director at Avalere Health, says that it’s possible to argue that Congress intended insurers to cover all tests for their members, regardless of whether a physician ordered them, whether the person was symptomatic, or whether the test was needed to return to work.

However, Hughes says it’s also possible to argue that Congress gave CMS the authority to implement these testing requirements with some restrictions. “There could be tremendous variability across payers’ approaches to coverage policy and how they process claims,” he says.

In fact, many insurers already have moved to limit testing coverage in some ways, although their policies are fluid and have been updated frequently, says Danielle Showalter, principal at Avalere.

Individuals whose plans will not cover a test can turn to what Shehata calls the “retail model,” which is direct-to-consumer COVID-19 testing sites that don’t require a health care provider’s permission. Costs vary for this type of testing, which generally wouldn’t be covered by insurance unless the person is symptomatic.

Radar On Market Access: Despite Coronavirus Surge, UnitedHealth Expects Care Utilization to Rebound This Year

July 23, 2020

With COVID-19 cases and deaths surging in some U.S. states, it has become clear that the nation won’t be back to normal anytime soon. Still, the country’s largest health insurer is betting that health care utilization, and the costs associated with it, will return to something close to typical levels in the second half of the year, AIS Health reported.

With COVID-19 cases and deaths surging in some U.S. states, it has become clear that the nation won’t be back to normal anytime soon. Still, the country’s largest health insurer is betting that health care utilization, and the costs associated with it, will return to something close to typical levels in the second half of the year, AIS Health reported.

At its lowest point in April, inpatient care volume — including care for COVID-19 patients — was about three quarters less than normal, UnitedHealth Group Chief Financial Officer John Rex said during a July 15 conference call to discuss the company’s second-quarter earnings. At that same low point, utilization of outpatient and physician services fell to roughly 60% of normal levels. But in June, UnitedHealth saw inpatient volume recover to nearly 95% of baseline, and as June turned to July, outpatient and physician services were “tracking above 90%,” Rex said. “These national trends have continued thus far in July, even as certain states are seeing short-term deferral of services where there are elevated levels of infection and hospitalization,” he added.

Indeed, the company predicts that overall, “utilization’s going to come back during the second half of the year,” UnitedHealthcare CEO Dirk McMahon said.

In a note to investors, Citi analyst Ralph Giacobbe observed that the executives’ comments about health care utilization returning to normal were “surprising to us.”

“Ultimately we believe healthcare cost trends will remain muted, and as we look out over the next 12+ months we see those trends driving upside, and lower headline risk post-election driving multiples higher,” Giacobbe added.

In the second quarter, UnitedHealth’s adjusted earnings per share of $7.12 easily beat the consensus estimate of $5.28, and the firm nearly doubled its adjusted EPS compared with the second quarter of 2019. UnitedHealth also maintained its 2020 EPS outlook of $15.45 to $15.75 ($16.25 to $16.55 on an adjusted basis).

Meanwhile, job losses tied to the COVID-19 pandemic and ensuing recession led to a decline in revenue and enrollment for UnitedHealth’s commercial insurance business. But revenue rose on the government business side as Medicare and Medicaid enrollment grew “by nearly 600,000 additional people served year to date,” per the company’s earnings release.

Radar On Market Access: Trump Admin’s COVID-19 Testing Payment Guidance Stirs Debate

July 21, 2020

Weeks after the Trump administration released guidance saying private health insurers don’t have to pay for COVID-19 testing conducted for the purposes of workplace safety or public health surveillance, questions and controversy are still simmering about the implications of that edict, AIS Health reported.

“With COVID-19 cases skyrocketing and our testing capacity nowhere near where it needs to be, it is unacceptable that this Administration’s priority seems to be giving insurance companies loopholes instead of getting people the free testing they need,” wrote Frank Pallone Jr. (D-N.Y.), Bobby Scott (D-Va.), Richard Neal (D-Mass.), Patty Murray (D-Wash.) and Ron Wyden (D-Ore.) in a recent letter to HHS, the Dept. of Labor and the Treasury Dept.

Weeks after the Trump administration released guidance saying private health insurers don’t have to pay for COVID-19 testing conducted for the purposes of workplace safety or public health surveillance, questions and controversy are still simmering about the implications of that edict, AIS Health reported.

“With COVID-19 cases skyrocketing and our testing capacity nowhere near where it needs to be, it is unacceptable that this Administration’s priority seems to be giving insurance companies loopholes instead of getting people the free testing they need,” wrote Frank Pallone Jr. (D-N.Y.), Bobby Scott (D-Va.), Richard Neal (D-Mass.), Patty Murray (D-Wash.) and Ron Wyden (D-Ore.) in a recent letter to HHS, the Dept. of Labor and the Treasury Dept.

James Gelfand, senior vice president of health policy at the ERISA Industry Committee (ERIC), tells AIS Health that he’s fielded concerns that since insurers aren’t paying for back-to-work testing, workers might have to. But in reality, many of the large, self-insured businesses that ERIC represents “are starting to reopen and relaunch back up to full capacity, but most of them are not using a robust testing regime to do so.” The reason, he says, is that diagnostic tests “are essentially taking a snapshot of a moment in time with sometimes a 10-day lag time,” so they’re not very helpful to employees who need to know right away if they’re safe to go back to work.

Steve Wojcik, vice president of public policy at the Business Group on Health, says he sees the logic behind not forcing health insurers to pay for back-to-work testing.

“If there is a medical reason…to get tested, and a doctor is recommending it, then the health plan would cover it, but if testing is part of return to work, some employers may be incorporating testing [costs] into their return-to-work plans,” he points out.

According to Christen Linke Young, a fellow at the USC-Brookings Schaeffer Initiative for Health Policy, a separate problem is the fact that private insurers are required to pay for out-of-network COVID-19 testing at whatever cash price that a lab or provider lists on a public website. Because those prices aren’t necessarily constrained by prevailing market rates, that can “put a lot of upward pressure on insurance reimbursement for tests,” she says.

MMIT Reality Check on Psoriatic Arthritis (July 2020)

July 17, 2020

According to our recent payer coverage analysis for psoriatic arthritis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for psoriatic arthritis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for psoriatic arthritis treatments shows that under the pharmacy benefit, about 77% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In December 2019, the FDA approved Amgen Inc.’s Avsola (infliximabaxxq) for the treatment of psoriatic arthritis, moderate-to-severe rheumatoid arthritis, moderate-to-severe Crohn’s disease in adult and pediatric populations, moderate-to-severe ulcerative colitis in adult and pediatric populations, chronic severe plaque psoriasis and ankylosing spondylitis. It is the fourth biosimilar of Remicade (infliximab) from Janssen Biotech, Inc., a Johnson & Johnson company, that the agency has approved.

Radar On Market Access: IngenioRx Acquires ZipDrug to Improve Medication Adherence, Affordability

July 16, 2020

In what one expert calls a “logical” move for a PBM vying for business from cost-conscious payers, Anthem, Inc.’s IngenioRx said on July 6 that it acquired ZipDrug, a company that focuses on improving patients’ medication adherence and affordability, AIS Health reported.

“As plan sponsors and members opt in for the service, ZipDrug ensures members are matched with the best high-quality pharmacy to fulfill their needs,” Justin Petronzi, IngenioRx’s vice president of strategic growth, explains to AIS Health via email. Services offered by ZipDrug include “guaranteed prescription delivery, multi-dose compliance packaging that provides specific instructions to empower patients to manage their medications at home safely on a daily basis, along with other targeted clinical programs,” he says.

In what one expert calls a “logical” move for a PBM vying for business from cost-conscious payers, Anthem, Inc.’s IngenioRx said on July 6 that it acquired ZipDrug, a company that focuses on improving patients’ medication adherence and affordability, AIS Health reported.

“As plan sponsors and members opt in for the service, ZipDrug ensures members are matched with the best high-quality pharmacy to fulfill their needs,” Justin Petronzi, IngenioRx’s vice president of strategic growth, explains to AIS Health via email. Services offered by ZipDrug include “guaranteed prescription delivery, multi-dose compliance packaging that provides specific instructions to empower patients to manage their medications at home safely on a daily basis, along with other targeted clinical programs,” he says.

Petronzi adds that IngenioRx’s interest in ZipDrug materialized after it began a pilot program in 2018 in New York and New Jersey markets that was focused on matching members with the best pharmacy for their needs and providing deliveries of lower cost prescriptions.

To Avalere Health consultant Tim Epple, IngenioRx’s purchase of ZipDrug makes sense. “It’s an investment that follows a lot of trends and themes that we’re seeing in the industry,” he tells AIS Health. “And I think certainly from a PBM perspective, [ZipDrug’s services are] something that we’re hearing that a lot of payers and a lot of plans want, because they’re thinking through these same strategies on their end, and giving them the ability to do that in a sort of ‘one-stop shop’ is a logical and probably good move.”

In general, “we’ve actually seen a lot more interest in the pharma services sector,” Epple says, explaining that helping “lowest-hanging fruit patients” — those who are high cost but struggle with medication adherence — is an area that plan sponsors “are really looking hard at now as they think about how to bend the cost curve and really figure out where they can save money at a relatively simple level.”

The acquisition also aligns with the ongoing trend of specializing pharmacy assets, he adds. “I think we’re seeing a little bit of a movement toward specialty pharmacy platforms that really have specific expertise in either certain disease states, certain patient types [or] certain intervention types,” Epple says.

Trends That Matter for Racial Disparities in MA Plans

July 16, 2020

As protests erupt across the U.S. calling for racial justice and police reforms, the COVID-19 pandemic continues to bring to light many of the racial disparities in health care, putting pressure on policymakers and the industry to take a hard look at health and access inequities, AIS Health reported.

As protests erupt across the U.S. calling for racial justice and police reforms, the COVID-19 pandemic continues to bring to light many of the racial disparities in health care, putting pressure on policymakers and the industry to take a hard look at health and access inequities, AIS Health reported.

Meanwhile, CMS’s Office of Minority Research in April released a stratified report highlighting the racial and ethnic differences in health care experiences and care of Medicare Advantage (MA) enrollees. The data showed that black members enrolled in MA plans in 2018 received worse clinical care than white enrollees on 20 out of 44 measures, similar care for 20 and better care for four. And all minority populations reported experiences with care that were either worse than or similar to the experiences reported by white enrollees, including the experience measure for getting appointments and care quickly.

Not getting the proper care when it’s needed is a reflection of the provider network, says John Gorman, chairman and CEO of Nightingale Partners LLC. “And then when you look at the clinical measures where there’s huge racial disparities, all of those tie back to a lack of culturally competent physicians serving these populations in a manner that speaks to the way that they need to access health care,” he observes.

Radar On Market Access: Remdesivir’s $3,120 Price Tag Stirs Debate

July 14, 2020

Gilead Sciences, Inc. recently revealed that for promising COVID-19 treatment remdesivir, it will charge $2,340 for a typical five-day, six-vial treatment course for people covered by U.S. government health programs and $3,120 for those covered by private insurance, AIS Health reported.

In an open letter, Gilead CEO Daniel O’Day argued that Gilead priced remdesivir “well below” its estimated value, considering it can save the U.S. health care system approximately $12,000 per patient by reducing the length of COVID-19 patients’ hospital stays.

Gilead Sciences, Inc. recently revealed that for promising COVID-19 treatment remdesivir, it will charge $2,340 for a typical five-day, six-vial treatment course for people covered by U.S. government health programs and $3,120 for those covered by private insurance, AIS Health reported.

In an open letter, Gilead CEO Daniel O’Day argued that Gilead priced remdesivir “well below” its estimated value, considering it can save the U.S. health care system approximately $12,000 per patient by reducing the length of COVID-19 patients’ hospital stays.

But not everyone is convinced by that argument.

“So they’re saying by shortening hospital stays, the system is going to save all these monies, but I always ask the question, ‘Why is it that the drug company should get to pocket all or some substantial portion of that savings?'” says Jack Hoadley, Ph.D., a research professor emeritus at Georgetown University’s Health Policy Institute. “That’s a savings we should accumulate for consumers, for payers [and] everybody else.”

Hoadley is not alone in those views. The advocacy group Patients for Affordable Drugs, in a June 29 statement, wrote that “Gilead’s price for remdesivir shows once again that we can’t trust Big Pharma to act responsibly — even in the face of a global pandemic.”

The U.S. government helped fund the development of remdesivir, and dexamethasone — a generic steroid — is priced at less than $1 per day even though it ‘showed promise for combating severe COVID-19 cases and reducing potential mortality rates,” the organization said.

The Institute for Clinical and Economic Review (ICER) also brought up dexamethasone in its statement. The U.S. price range of $2,340 to $3,120 is “is largely in line with ICER’s independent assessment suggesting that a price of approximately $2,800 would be reasonable in proportion to the added benefits for patients and the cost offsets in the health system now that dexamethasone is rapidly becoming standard of care,” wrote ICER President Steven D. Pearson, M.D.

Leerink analyst Geoffrey Porges, in a June 29 note to investors, pointed out that the U.S. commercial price set for remdesivir was below his firm’s expectations. Still, “we believe the disclosed [remdesivir] pricing is reasonable, and should provide significant value to the Gilead shareholders and still deflect much of the criticism the company might face in this emergency,” Porges wrote.

MMIT Reality Check on Acute Lymphoblastic Leukemia (July 2020)

July 10, 2020

According to our recent payer coverage analysis for acute lymphoblastic leukemia treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for acute lymphoblastic leukemia treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for acute lymphoblastic leukemia treatments shows that under the pharmacy benefit, about 49% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, the FDA cleared an investigational new drug (IND) application for Autolus Therapeutics plc’s AUTO1, a CD19-targeting chimeric antigen receptor T-cell therapy for the treatment of adults with acute lymphoblastic leukemia.

Radar On Market Access: Upheld Transparency Rule Is Slated to Reshape Payer-Provider Negotiations

July 9, 2020

In another blow to an industry already beleaguered by the COVID-19 pandemic, a federal judge recently upheld a federal rule that requires hospitals to engage in unprecedented price transparency measures, AIS Health reported.

The rule would require hospitals to disclose the rates they negotiate with payers for all items and services they offer. It is slated to go into effect on Jan. 1, 2021, but the American Hospital Association (AHA) and other trade groups and health systems sued to block it.

In another blow to an industry already beleaguered by the COVID-19 pandemic, a federal judge recently upheld a federal rule that requires hospitals to engage in unprecedented price transparency measures, AIS Health reported.

The rule would require hospitals to disclose the rates they negotiate with payers for all items and services they offer. It is slated to go into effect on Jan. 1, 2021, but the American Hospital Association (AHA) and other trade groups and health systems sued to block it.

The crux of the plaintiffs’ argument in American Hospital Association v. Azar is that CMS exceeded its authority by redefining the “standard charges” that hospitals must disclose under the Affordable Care Act to include negotiated rates. But in a decision issued June 23, U.S. District Court Judge Carl Nichols determined that CMS’s interpretation of the statute was reasonable.

The AHA has already appealed the decision, and depending on how the D.C. Circuit Court rules on that appeal, the case could make it to the Supreme Court, says David Kaufman, a partner at Laurus Law Group LLC.

“Insurers today actually do have a pretty good sense of how hospitals are charging, but this is going to be a quantum leap forward for them in understanding the strategy that hospitals take in negotiating across insurance markets,” Dan Mendelson, founder of Avalere Health says regarding what will happen if the rule does take effect.

However, “the insurer will have more information, but I question whether they will have more leverage,” Mendelson says. “I think over time what this [rule] is likely to do is to drive more consistency in pricing — not necessarily lower prices across the board.”

Kaufman observes that the disclosure of hospitals’ negotiated rates may not have a uniform impact across different types of insurers.

“In certain ways, it’s a procompetitive kind of rule by providing more transparency,” he says. “However, large established insurers that have the advantage of broad networks with lower prices based on their large membership benefit by keeping their prices confidential. It helps them with providing better prices to large employers, etc. So by making those prices more transparent, it might ease barriers to entry [for] other insurers.”

Perspectives on MedImpact’s New Program to Accelerate Pharmacogenomics

July 9, 2020

With precision medicine an increasingly hot topic in health care, MedImpact is betting that a newly launched program — which reviews every drug prescribed to patients against their genetic profile — will simultaneously give the PBM a competitive edge and improve care, AIS Health reported.

In a Feb. 26 press release, MedImpact describes its new program as the industry’s first “any drug, any time, any prescriber” approach to pharmacogenomics (PGx).

With precision medicine an increasingly hot topic in health care, MedImpact is betting that a newly launched program — which reviews every drug prescribed to patients against their genetic profile — will simultaneously give the PBM a competitive edge and improve care, AIS Health reported.

In a Feb. 26 press release, MedImpact describes its new program as the industry’s first “any drug, any time, any prescriber” approach to pharmacogenomics (PGx).

“Pharmacogenetics, in the most basic sense, is looking at someone’s genes to determine their drug-metabolizing enzymes,” explains Emily Cicali, a clinical assistant professor at the University of Florida’s College of Pharmacy. For people who have lower levels of drug-metabolizing enzymes, certain medications may be less effective or ineffective, and for those have too much of those enzymes, that could overactivate drugs and “put people at risk for toxicity,” Cicali adds.

The concept of a PBM having a PGx program isn’t new, MedImpact acknowledges in its release. But up until now, most PGx programs generally operated along the lines of “one gene being tested for one drug at one point in time” to determine if there’s a potential conflict, says Karen Geary, the company’s vice president of strategy and innovation. MedImpact’s program, however, screens for genetic interactions with more than 240 commonly prescribed medications and then reviews all future prescriptions for potential drug-gene issues.

Michael Schneider, a principal at Avalere Health, says that if a program like MedImpact’s is able to significantly avert problems like adverse drug events, “then I think this type of analysis could have a big impact on the PBM industry and potentially become the standard of care.”

However, if genetic testing becomes more commonplace across wider swaths of the population, there could be downsides, he suggests. For example, the expense of large-scale genetic testing might trickle down from plan sponsors to consumers in the form of higher premiums.

Radar On Market Access: Reports Show Medicaid MCOs Are ‘Dominant,’ Increase Affordability

July 7, 2020

Two recent reports found that Medicaid managed care plans now enroll most Medicaid members, help keep costs and premiums low in the markets where they participate, and are competitive with commercial plans at the low end of the individual market in areas including network quality and benefit design, AIS Health reported.

One white paper was prepared by consultancy The Menges Group for America’s Health Insurance Plans (AHIP), and the other was authored by researchers at the Robert Wood Johnson Foundation (RWJF) and Urban Institute.

Two recent reports found that Medicaid managed care plans now enroll most Medicaid members, help keep costs and premiums low in the markets where they participate, and are competitive with commercial plans at the low end of the individual market in areas including network quality and benefit design, AIS Health reported.

One white paper was prepared by consultancy The Menges Group for America’s Health Insurance Plans (AHIP), and the other was authored by researchers at the Robert Wood Johnson Foundation (RWJF) and Urban Institute.

The Menges Group-AHIP white paper, which had a national scope, found that Medicaid MCO enrollment increased by 121% between fiscal years 2010 and 2018, from 26 million to over 56 million members, and that as of 2018, more than 75% of all Medicaid enrollees are members of an MCO, up from 50% in 2010. The report also found that, since 2017, capitated payments to MCOs have exceeded fee-for-service expenditures.

The RWJF-Urban Institute paper, which relied on case study surveys in Arkansas, California, Florida, New York, Ohio, and Washington state, concluded that MCOs offer coverage that is at least as good as commercial plans in the low end of the Affordable Care Act individual market.

“Many [stakeholders] feel there are no longer major distinctions between Medicaid and commercial insurers in the marketplaces. Most interviewees have positive perceptions of Medicaid insurers, crediting their ability to increase choice and affordability in the individual health insurance market,” wrote the paper’s authors.

Most of the surveyed stakeholders, which the paper says “included representatives from state departments of insurance, hospital associations, medical or primary care provider associations, insurance brokers, and consumer advocates,” believe that Medicaid MCOs have improved the level of competition in their state marketplace, and offer their members similar network quality to commercial plans.

MMIT Reality Check on Hemophilia A or B With Inhibitors (July 2020)

July 3, 2020

According to our recent payer coverage analysis for hemophilia A or B with inhibitors treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for hemophilia A or B with inhibitors treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for hemophilia A or B with inhibitors treatments shows that under the pharmacy benefit, about 48% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, the FDA approved Laboratoire Francais du Fractionnement et des Biotechnologies S.A.’s Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes in people at least 12 years old with hemophilia A or B with inhibitors.

Trends That Matter for DMD Therapies

July 2, 2020

Since 2016, the FDA has approved a handful of therapies to treat Duchenne muscular dystrophy (DMD). But some uncertainty exists over their effectiveness, in addition to concerns about their costs.

When DMD is suspected, a blood test that measures creatine kinase (CK) levels is performed. “CK is an enzyme found in abnormally high levels when muscle is damaged,” Mesfin Tegenu, R.Ph., president of PerformRx, LLC., tells AIS Health. “The detection of an elevated CK level leads to molecular genetic testing to confirm a definitive diagnosis of DMD.”

Since 2016, the FDA has approved a handful of therapies to treat Duchenne muscular dystrophy (DMD). But some uncertainty exists over their effectiveness, in addition to concerns about their costs.

When DMD is suspected, a blood test that measures creatine kinase (CK) levels is performed. “CK is an enzyme found in abnormally high levels when muscle is damaged,” Mesfin Tegenu, R.Ph., president of PerformRx, LLC., tells AIS Health. “The detection of an elevated CK level leads to molecular genetic testing to confirm a definitive diagnosis of DMD.”

In February 2017, the FDA approved then-manufacturer Marathon Pharmaceuticals LLC’s Emflaza (deflazacort). The company said it would be priced at $89,000, which sparked outrage since people have been buying a generic version from overseas since the 1990s for about $1,000 per year. After the backlash, Marathon ultimately sold the drug to PTC Therapeutics Inc., which launched it later that year with a $35,000 annual price tag. Since then, PTC has raised the price to more than Marathon’s original one.

In September 2016, the FDA gave accelerated approval to Sarepta Therapeutics, Inc.’s Exondys 51 (eteplirsen). The dystrophin gene has 79 exons, and about 80% of people with DMD have genotypes that are amenable to exon skipping. Exondys 51 targets those with a mutation of the DMD gene that is amenable to exon 51 skipping.

Sarepta also has a second exon-skipping therapy, Vyondys 53 (golodirsen), which treats DMD in people with a mutation amenable to exon 53 skipping. The FDA gave the drug accelerated approval in December, almost four months after the agency rejected the drug through a complete response letter.

Both drugs are weight-based with similar prices: about $300,000 per year but up to $1 million annually.

“It’s unclear how much a health plan may spend on someone with DMD; however, a recent study from the Muscular Dystrophy Association found that the annual cost for DMD for U.S. society as a whole is around $362-$488 million dollars,” says Tegenu. “The price of the newer DMD therapies (Exondys 51 and Vyondys 53) are both estimated to cost approximately $750,000 per year for the treatment of one patient.”

Radar On Market Access: Insurers Are Required to Cover Only ‘Medically Necessary’ COVID-19 Tests

July 2, 2020

As more employers turn to COVID-19 testing to see if employees are safe to return to the workplace, the Trump administration has clarified that insurers must cover only physician-ordered “medically necessary” diagnostic and antibody tests, AIS Health reported.

The guidance, released jointly on June 23 by HHS, the Dept. of Labor and the Dept. of the Treasury, also says self-funded employer plans must pay for COVID-19 testing that’s medically appropriate.

As more employers turn to COVID-19 testing to see if employees are safe to return to the workplace, the Trump administration has clarified that insurers must cover only physician-ordered “medically necessary” diagnostic and antibody tests, AIS Health reported.

The guidance, released jointly on June 23 by HHS, the Dept. of Labor and the Dept. of the Treasury, also says self-funded employer plans must pay for COVID-19 testing that’s medically appropriate.

“Testing conducted to screen for general workplace health and safety (such as employee ‘return to work’ programs), for public health surveillance for SARS-CoV-2, or for any other purpose not primarily intended for individualized diagnosis or treatment of COVID-19 or another health condition is beyond the scope” of the requirements embedded in the legislation approved by Congress earlier this year that requires insurers to pay for COVID-19 testing, the FAQ document said.

“I think now that [the insurers] have had this clarification, they’re going to use that as part of their determination of coverage,” Ashraf Shehata, KPMG national sector leader for health care and life sciences, tells AIS Health.

Richard Hughes IV, managing director at Avalere Health, says that it’s possible to argue that Congress intended insurers to cover all tests for their members, regardless of whether a physician ordered them, whether the person was symptomatic, or whether the test was needed to return to work.

However, Hughes says it’s also possible to argue that Congress gave CMS the authority to implement these testing requirements with some restrictions. “There could be tremendous variability across payers’ approaches to coverage policy and how they process claims,” he says.

In fact, many insurers already have moved to limit testing coverage in some ways, although their policies are fluid and have been updated frequently, says Danielle Showalter, principal at Avalere.

Individuals whose plans will not cover a test can turn to what Shehata calls the “retail model,” which is direct-to-consumer COVID-19 testing sites that don’t require a health care provider’s permission. Costs vary for this type of testing, which generally wouldn’t be covered by insurance unless the person is symptomatic.

Radar On Market Access: CMS Proposes New Medicaid Best Price Rules for Pricey Therapies

June 30, 2020

In an effort to boost adoption and lower costs for curative therapies, CMS proposed a new rule that the agency says would allow state Medicaid plans to enter into value-based, outcome-dependent purchasing agreements with drug manufacturers using a new interpretation of best price rules, AIS Health reported.

CMS proposed an updated interpretation of Medicaid “best price” rules by clarifying best price reporting requirements and enabling new structures including year-to-year scheduled prices that could change in relation to patient outcomes.

In an effort to boost adoption and lower costs for curative therapies, CMS proposed a new rule that the agency says would allow state Medicaid plans to enter into value-based, outcome-dependent purchasing agreements with drug manufacturers using a new interpretation of best price rules, AIS Health reported.

CMS proposed an updated interpretation of Medicaid “best price” rules by clarifying best price reporting requirements and enabling new structures including year-to-year scheduled prices that could change in relation to patient outcomes.

New curative therapies present a novel financial challenge for payers. Curative therapies eliminate the need for intensive treatment of chronic and terminal conditions, which create substantial savings for payers, patients and providers alike.

However, their high up-front cost is borne by payers and patients, and the initial payer may not see the entire financial benefit of the curative therapy. What’s more, under a traditional payment model, insurers are unable to recoup costs if a new, experimental therapy with curative potential has limited effect.

In order to spread risk and value across all stakeholders involved, some drug benefit industry leaders have called for broad adoption of the value-based pricing methods CMS’s proposed rule seeks to create, backed by a reinsurance mechanism.

Avalere Health principal Mike Schneider tells AIS Health that, although CMS’s proposal does not include a reinsurance mechanism, it should advance adoption of curative therapies. He says that, as they are currently implemented, Medicaid’s best price rules have made it difficult for commercial payers to negotiate with drug manufacturers to include outcomes and proof of concept in purchasing agreements.

Though the proposed rule applies directly to state Medicaid plans, Schneider says that the rule could have a substantial impact on the commercial market as plans bidding on Medicaid contracts gain experience with the new paradigm.

Still, barriers remain in adopting new curative therapies. Drug Channels Institute CEO Adam Fein points out that the rule does not address the challenge presented by copay accumulators to patients who might benefit from expensive, new specialty drugs — which suggests the rule might not speed up curative therapy adoption as quickly as patients might hope.

MMIT Reality Check on Ankylosing Spondylitis (June 2020)

June 26, 2020

According to our recent payer coverage analysis for ankylosing spondylitis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for ankylosing spondylitis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for ankylosing spondylitis treatments shows that under the pharmacy benefit, about 69% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: The FDA’s recent approvals of two interleukin-17A (IL-17A) antagonists — Eli Lilly and Co.’s Taltz (ixekizumab) and Novartis Pharmaceuticals Corp.’s Cosentyx (secukinumab) — to treat active non-radiographic axial spondyloarthritis, a less advanced form of ankylosing spondylitis, provide a new mechanism of action.

Perspectives on COVID-19 Vaccine Rollout

June 25, 2020

The rollout of a vaccine for SARS-CoV-2, the virus that causes COVID-19, is an unprecedented logistical challenge. So will be deciding who gets it: experts say that the initial vaccine supply will not be large enough to dose everyone who wants it — and payers and PBMs will have a large role to play in distributing the medicine to the right people quickly.

David Simchi-Levi, Ph.D., a systems engineer who studies manufacturing and supply chain at MIT, tells AIS Health that it’s inevitable that vaccine supply will not meet demand when it is available. “The question will be, who gets it?” he says.

The rollout of a vaccine for SARS-CoV-2, the virus that causes COVID-19, is an unprecedented logistical challenge. So will be deciding who gets it: experts say that the initial vaccine supply will not be large enough to dose everyone who wants it — and payers and PBMs will have a large role to play in distributing the medicine to the right people quickly.

David Simchi-Levi, Ph.D., a systems engineer who studies manufacturing and supply chain at MIT, tells AIS Health that it’s inevitable that vaccine supply will not meet demand when it is available. “The question will be, who gets it?” he says.

Mike Schneider, a principal at Avalere Health and a former executive at CVS Health Corp.’s Caremark PBM, says that given the likely scarcity of the vaccine, areas hardest hit by COVID-19 should be the focus of the initial supply.

“I think the payers will probably try to stay out of the way as much as possible, and let local laws determine who can get a vaccine and probably local health departments determine who can get the vaccine before others,” Schneider says. He adds that payers should also use prior authorization matched to FDA guidance to ensure the right people are dosed.

When a vaccine is available, Schneider expects retail pharmacies to play a large role in delivery. He cites retail pharmacy chains’ rollout of drive-through SARS-CoV-2 testing and the annual ritual of getting a flu shot from a pharmacist as examples of what delivering the coronavirus vaccine could look like. Along the same lines, he expects primary care practitioners to perform some inoculations.

Even a well-managed rollout will only be a first step. Manufacturing and supply chain concerns will dictate the supply of vaccines available in the U.S. going forward. So will trade, as most medicines are manufactured in China and India. Those countries will certainly want to care for their own citizens as soon as possible, which could delay the release of vaccine here.

Given all that uncertainty, Schneider expects that a SARS-CoV-2 vaccine could be a perennial component of formularies, along the lines of the flu vaccine. Schneider expects that receiving the coronavirus vaccine will be a routine preventive treatment that costs patients little to nothing.

Radar On Market Access: Telehealth Regulation and Reimbursement Issue Sparks Debates

June 25, 2020

Telehealth use has surged during the COVID-19 pandemic, and is likely to remain higher than it was before the crisis on a permanent basis. However, the difficult work of regulating and establishing rate structure for telehealth beyond the COVID-19 pandemic has only just started, AIS Health reported.

On June 17, the Senate Health, Education, Labor and Pensions Committee held a hearing about how to consolidate the gains in telehealth made necessary by the pandemic.

Telehealth use has surged during the COVID-19 pandemic, and is likely to remain higher than it was before the crisis on a permanent basis. However, the difficult work of regulating and establishing rate structure for telehealth beyond the COVID-19 pandemic has only just started, AIS Health reported.

On June 17, the Senate Health, Education, Labor and Pensions Committee held a hearing about how to consolidate the gains in telehealth made necessary by the pandemic.

The most important policy decision that Congress must make is on reimbursement. CMS has elected to compensate telehealth visits at the same rate as in-person visits for the duration of the pandemic, but whether that will continue is likely to be decided in the coming weeks. At present, commercial plans have a wide variation in telehealth reimbursement amounts.

Providers will likely oppose setting telehealth reimbursement at rates lower than in-person visits, and experts predict the balance of visits will shift more heavily toward remote consultations going forward.

Yet part of the allure of telehealth for payers and patients is that a remote visit generally costs less than an in-person consultation. The stakes are high for the payer industry: Provider services seem to be the main driver behind higher overall health care spending in the last decade. If telehealth visits account for a meaningful share of overall visits across the industry, a lower rate of reimbursement will make a big difference in lowering costs.

The other major regulatory challenge for telehealth is provider licensing. State medical boards exercise control over whether a clinician can practice in their state, and it is typically illegal for a practitioner licensed in one state to care for patients in another.

“We think the best way to handle [state licensure] is through a compact,” said Krista Drobac, the executive director of the Alliance for Connected Care, during a session at America’s Health Insurance Plans’ Institute & Expo. “We would like to see licensure reciprocity or mutual recognition, what we refer to as licensure portability.…Congress can’t step in and take over licensing — that’s just not a federal responsibility.”

Yet Avalere Health founder Dan Mendelson takes a different view. “The licensure issues are problematic. The Congress needs to act more aggressively to make it easier to deliver telemedicine in the United States,” he says.

Radar On Market Access: CMS Report Shows Increasing Racial Disparities in MA Plans

June 23, 2020

As protests erupt across the U.S. calling for racial justice and police reforms, the COVID-19 pandemic continues to bring to light many of the racial disparities in health care, putting pressure on policymakers and the industry to take a hard look at health and access inequities, AIS Health reported.

As protests erupt across the U.S. calling for racial justice and police reforms, the COVID-19 pandemic continues to bring to light many of the racial disparities in health care, putting pressure on policymakers and the industry to take a hard look at health and access inequities, AIS Health reported.

Meanwhile, CMS’s Office of Minority Research in April released a stratified report highlighting the racial and ethnic differences in health care experiences and care of Medicare Advantage (MA) enrollees. The data showed that black members enrolled in MA plans in 2018 received worse clinical care than white enrollees on 20 out of 44 measures, similar care for 20 and better care for four. And all minority populations reported experiences with care that were either worse than or similar to the experiences reported by white enrollees, including the experience measure for getting appointments and care quickly.

Not getting the proper care when it’s needed is a reflection of the provider network, says John Gorman, chairman and CEO of Nightingale Partners LLC. “And then when you look at the clinical measures where there’s huge racial disparities, all of those tie back to a lack of culturally competent physicians serving these populations in a manner that speaks to the way that they need to access health care,” he observes.

John Weis, CEO of Quest Analytics, LLC, predicts that “there will be a significant impact on practice consolidation” from the pandemic. “Given the potential risk to providers, we predict that coming out of COVID, we’ll see an uptick in providers that want to minimize their exposure and consider retirement,” he suggests. And with fewer providers available, “if plans are not prepared, this will drive both out-of-network utilization and increase health care costs in rural areas.”

Dan Mendelson, founder of Avalere Health, suggests that while MA plans have the tools to address racial disparities, they don’t necessarily have the incentives to prioritize them. “I think Medicare Advantage plans are uniquely equipped to measure, understand, identify and mitigate disparities…. So, a proactive form of engagement that is focused on disparities can work,” says Mendelson. “One thing that is not there at this point is any kind of direct incentive to the plans to act.”

MMIT Reality Check on Urothelial/Bladder Cancer (June 2020)

June 19, 2020

According to our recent payer coverage analysis for urothelial/bladder cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for urothelial/bladder cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for urothelial/bladder cancer treatments shows that under the pharmacy benefit, about 54% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, the FDA approved UroGen Pharma Ltd.’s Jelmyto (mitomycin) for adults with low-grade upper tract urothelial cancer. The agency gave the pyelocalyceal solution priority review, breakthrough therapy, fast track and orphan drug designations.

Trends That Matter: Enrollment Shift Into ACA Exchanges

June 18, 2020

As the impact of the COVID-19 pandemic continues to reverberate throughout the U.S. economy, it’s become clear that there will be a major enrollment shift away from employer-sponsored plans and into Medicaid and the individual market, AIS Health reported.

In fact, one recent analysis suggested that there could be “unprecedented growth” in the individual health insurance market. “The impact of COVID-19-related job losses will likely more than double the current enrollment in Individual & Marketplace plans, with the potential for the Individual market to triple in size to over 35 million in a sustained and severe economic contraction,” stated the analysis from A2 Strategy Group.

As the impact of the COVID-19 pandemic continues to reverberate throughout the U.S. economy, it’s become clear that there will be a major enrollment shift away from employer-sponsored plans and into Medicaid and the individual market, AIS Health reported.

In fact, one recent analysis suggested that there could be “unprecedented growth” in the individual health insurance market. “The impact of COVID-19-related job losses will likely more than double the current enrollment in Individual & Marketplace plans, with the potential for the Individual market to triple in size to over 35 million in a sustained and severe economic contraction,” stated the analysis from A2 Strategy Group.

Such growth, the report said, “will come from newly unemployed individuals in all states who exceed Medicaid eligibility thresholds” because of money they receive from the Coronavirus Aid, Relief, and Economic Security Act. And in states that haven’t expanded Medicaid, nearly all of the newly unemployed who earn below 100% of the federal poverty level could qualify for Affordable Care Act premium subsidies.

Another analysis from the Urban Institute and Robert Wood Johnson Foundation (RWJF), estimated that if U.S. unemployment reaches 20%, 25 million people would lose employer-sponsored health insurance. “Of these, 11.8 million would gain Medicaid coverage, 6.2 million would gain marketplace or other private coverage, and 7.3 million would become uninsured,” it stated.

Katherine Hempstead, the senior adviser to the executive vice president at RWJF, says it’s possible the coming enrollment shifts will cause some health insurers to re-evaluate their level of participation in the ACA exchanges, which some large insurers left in 2017 and 2018 before the market stabilized.

Radar On Market Access: Pricey Treatments Face Challenges on Cost Sharing and Data Analysis

June 18, 2020

Genomic, curative drugs for chronic and terminal diseases are perhaps the most exciting new treatments in medicine. But even though these highly tailored therapies come to market with the potential to save costs for the health care system, the industry is struggling to pay for them because of their high up front costs, AIS Health reported.

Neil Lund, chief actuary and vice president emeritus of CVS Health Corp., observes that PBMs are already perceived as honest brokers by the plans they contract with. He says PBMs are a possible conduit to share the information necessary for the evaluations of health care products and services with all stakeholders.

Genomic, curative drugs for chronic and terminal diseases are perhaps the most exciting new treatments in medicine. But even though these highly tailored therapies come to market with the potential to save costs for the health care system, the industry is struggling to pay for them because of their high up front costs, AIS Health reported.

Neil Lund, chief actuary and vice president emeritus of CVS Health Corp., observes that PBMs are already perceived as honest brokers by the plans they contract with. He says PBMs are a possible conduit to share the information necessary for the evaluations of health care products and services with all stakeholders.

“At the core [of a PBM] is this claims processing engine,” Lund says. “[They have] a lot of real-time electronic data and the ability with really excellent record keeping as the fundamentals involved.”

While the rebate-driven model for purchasing traditional pharmacy products works well for maintenance and incidental treatments, purchasing curative specialty pharmacy products is more complicated. For payers, such therapies have the benefit of reducing the need for chronic care and lessening risk of an inpatient stay, but they also have to front a high capital cost that disproportionately benefits providers and manufacturers, Lund observes.

Yet different metrics can yield different understandings of a new therapy’s value, said Brian Leinwand, an associate principal for health economics at Avalere Health, during a recent webinar on alternative financing models for emergent therapies.

“[Decision-makers] typically evaluate products’ incremental cost per quality-adjusted life-year gained compared to another therapy or therapies. However, a quality-adjusted life-year is not always the most useful metric for decision-makers in these scenarios, [and] other techniques can be employed.”

Lund says member churn adds complication to curative therapy pricing. If a member receives an expensive curative therapy with one plan but departs for a new one a few years later, the new plan benefits but doesn’t share in the cost.

“In the short term, the base case issue here is whoever is covering the person at the time of the very expensive treatment, in the way we handle everything today, is on the hook for the full cost,” Lund observes. “Subsequent insurers or organizations reap the benefit of that, not the organization that necessarily footed the bill.”

Radar On Market Access: MedImpact’s New Program Aims to Accelerate Pharmacogenomics

June 16, 2020

With precision medicine an increasingly hot topic in health care, MedImpact is betting that a newly launched program — which reviews every drug prescribed to patients against their genetic profile — will simultaneously give the PBM a competitive edge and improve care, AIS Health reported.

In a Feb. 26 press release, MedImpact describes its new program as the industry’s first “any drug, any time, any prescriber” approach to pharmacogenomics (PGx).

With precision medicine an increasingly hot topic in health care, MedImpact is betting that a newly launched program — which reviews every drug prescribed to patients against their genetic profile — will simultaneously give the PBM a competitive edge and improve care, AIS Health reported.

In a Feb. 26 press release, MedImpact describes its new program as the industry’s first “any drug, any time, any prescriber” approach to pharmacogenomics (PGx).

“Pharmacogenetics, in the most basic sense, is looking at someone’s genes to determine their drug-metabolizing enzymes,” explains Emily Cicali, a clinical assistant professor at the University of Florida’s College of Pharmacy. For people who have lower levels of drug-metabolizing enzymes, certain medications may be less effective or ineffective, and for those have too much of those enzymes, that could overactivate drugs and “put people at risk for toxicity,” Cicali adds.

The concept of a PBM having a PGx program isn’t new, MedImpact acknowledges in its release. But up until now, most PGx programs generally operated along the lines of “one gene being tested for one drug at one point in time” to determine if there’s a potential conflict, says Karen Geary, the company’s vice president of strategy and innovation. MedImpact’s program, however, screens for genetic interactions with more than 240 commonly prescribed medications and then reviews all future prescriptions for potential drug-gene issues.

Michael Schneider, a principal at Avalere Health, says that if a program like MedImpact’s is able to significantly avert problems like adverse drug events, “then I think this type of analysis could have a big impact on the PBM industry and potentially become the standard of care.”

However, if genetic testing becomes more commonplace across wider swaths of the population, there could be downsides, he suggests. For example, the expense of large-scale genetic testing might trickle down from plan sponsors to consumers in the form of higher premiums.

Since MedImpact rolled out its new program, client interest has been high, Geary says. However, “the challenge that I’ve recently run into is that employers are sitting there looking at what would be a benefit enrichment while, because of COVID-19, they’re having to lay off staff,” she adds.

MMIT Reality Check on Endometriosis (June 2020)

June 12, 2020

According to our recent payer coverage analysis for endometriosis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for endometriosis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access forendometriosis treatments shows that under the pharmacy benefit, about 53% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, Myovant Sciences reported positive results in its Phase III studies of once-daily relugolix combination therapy for pain associated with endometriosis.

Perspectives on ACA Exchanges Amid COVID-19

June 11, 2020

As the impact of the COVID-19 pandemic continues to reverberate throughout the U.S. economy, it’s become clear that there will be a major enrollment shift away from employer-sponsored plans and into Medicaid and the individual market, AIS Health reported.

In fact, one analysis suggested that there could be “unprecedented growth” in the individual health insurance market. “The impact of COVID-19-related job losses will likely more than double the current enrollment in Individual & Marketplace plans, with the potential for the Individual market to triple in size to over 35 million in a sustained and severe economic contraction,” stated the analysis from A2 Strategy Group.

As the impact of the COVID-19 pandemic continues to reverberate throughout the U.S. economy, it’s become clear that there will be a major enrollment shift away from employer-sponsored plans and into Medicaid and the individual market, AIS Health reported.

In fact, one analysis suggested that there could be “unprecedented growth” in the individual health insurance market. “The impact of COVID-19-related job losses will likely more than double the current enrollment in Individual & Marketplace plans, with the potential for the Individual market to triple in size to over 35 million in a sustained and severe economic contraction,” stated the analysis from A2 Strategy Group.

Such growth, the report said, “will come from newly unemployed individuals in all states who exceed Medicaid eligibility thresholds” because of money they receive from the Coronavirus Aid, Relief, and Economic Security Act. And in states that haven’t expanded Medicaid, nearly all of the newly unemployed who earn below 100% of the federal poverty level could qualify for Affordable Care Act premium subsidies.

Another analysis from the Urban Institute and Robert Wood Johnson Foundation (RWJF), estimated that if U.S. unemployment reaches 20%, 25 million people would lose employer-sponsored health insurance. “Of these, 11.8 million would gain Medicaid coverage, 6.2 million would gain marketplace or other private coverage, and 7.3 million would become uninsured,” it stated.

Katherine Hempstead, the senior adviser to the executive vice president at RWJF, says it’s possible the coming enrollment shifts will cause some health insurers to re-evaluate their level of participation in the ACA exchanges, which some large insurers left in 2017 and 2018 before the market stabilized.

In fact, Maryland Gov. Larry Hogan (R) said on May 12 that UnitedHealth filed to offer plans on the sate’s ACA exchange in 2021, bringing the total number of insurers in that market from two to three.

Ari Gottlieb, a principal at A2 Strategy Group, says the effect may be even stronger after 2021.

“If the market doubles to 25 or 30 million, some of that will probably fall off, but some of that will probably stay,” he says. “I think even a year or two from now, we’re going to have a bigger individual market than we had before.”

Radar On Market Access: Uncertainties Over Effectiveness and High Costs Surround DMD Therapies

June 11, 2020

Since 2016, the FDA has approved a handful of therapies to treat Duchenne muscular dystrophy (DMD). But some uncertainty exists over their effectiveness, in addition to concerns about their costs.

When DMD is suspected, a blood test that measures creatine kinase (CK) levels is performed. “CK is an enzyme found in abnormally high levels when muscle is damaged,” Mesfin Tegenu, R.Ph., president of PerformRx, LLC., tells AIS Health. “The detection of an elevated CK level leads to molecular genetic testing to confirm a definitive diagnosis of DMD.”

Since 2016, the FDA has approved a handful of therapies to treat Duchenne muscular dystrophy (DMD). But some uncertainty exists over their effectiveness, in addition to concerns about their costs.

When DMD is suspected, a blood test that measures creatine kinase (CK) levels is performed. “CK is an enzyme found in abnormally high levels when muscle is damaged,” Mesfin Tegenu, R.Ph., president of PerformRx, LLC., tells AIS Health. “The detection of an elevated CK level leads to molecular genetic testing to confirm a definitive diagnosis of DMD.”

In February 2017, the FDA approved then-manufacturer Marathon Pharmaceuticals LLC’s Emflaza (deflazacort). The company said it would be priced at $89,000, which sparked outrage since people have been buying a generic version from overseas since the 1990s for about $1,000 per year. After the backlash, Marathon ultimately sold the drug to PTC Therapeutics Inc., which launched it later that year with a $35,000 annual price tag. Since then, PTC has raised the price to more than Marathon’s original one.

In September 2016, the FDA gave accelerated approval to Sarepta Therapeutics, Inc.’s Exondys 51 (eteplirsen). The dystrophin gene has 79 exons, and about 80% of people with DMD have genotypes that are amenable to exon skipping. Exondys 51 targets those with a mutation of the DMD gene that is amenable to exon 51 skipping.

Sarepta also has a second exon-skipping therapy, Vyondys 53 (golodirsen), which treats DMD in people with a mutation amenable to exon 53 skipping. The FDA gave the drug accelerated approval in December, almost four months after the agency rejected the drug through a complete response letter.

Both drugs are weight-based with similar prices: about $300,000 per year but up to $1 million annually.

“It’s unclear how much a health plan may spend on someone with DMD; however, a recent study from the Muscular Dystrophy Association found that the annual cost for DMD for U.S. society as a whole is around $362-$488 million dollars,” says Tegenu. “The price of the newer DMD therapies (Exondys 51 and Vyondys 53) are both estimated to cost approximately $750,000 per year for the treatment of one patient.”

Pharma manufacturers continue to focus on the DMD space, and several products, including gene therapies, are in the pipeline.

Radar On Market Access: 2021 MA, Part D Bids Face Challenges Amid COVID-19

June 9, 2020

There are always uncertainties when it comes to projecting plan costs for the year ahead, but Medicare Advantage and Part D organizations that submitted bids on June 1 faced a particularly unpredictable set of circumstances created by the COVID-19 pandemic.

“I think we will all look back on the 2021 bids as the year of COVID-19,” Brad Piper, a principal and consulting actuary in Milliman’s Milwaukee office, tells AIS Health. “That was a big challenge for the organizations that are in the Medicare Advantage program — [perhaps more so] than on the Part D side — and it impacted both sides of the coin: costs and revenue.”

There are always uncertainties when it comes to projecting plan costs for the year ahead, but Medicare Advantage and Part D organizations that submitted bids on June 1 faced a particularly unpredictable set of circumstances created by the COVID-19 pandemic.

“I think we will all look back on the 2021 bids as the year of COVID-19,” Brad Piper, a principal and consulting actuary in Milliman’s Milwaukee office, tells AIS Health. “That was a big challenge for the organizations that are in the Medicare Advantage program — [perhaps more so] than on the Part D side — and it impacted both sides of the coin: costs and revenue.”

From a cost perspective, unknowns include whether there will be “pent-up demand” for health care services next year given that many beneficiaries have deferred doctors’ appointments and elective/non-urgent procedures to avoid the risk of coronavirus exposure.

Adding to that is the question of whether there will be a second wave of COVID-19 “and how much COVID-related utilization and services will occur that plans will have to bear,” points out Matt Kazan, principal with Avalere Health. A third concern is “how much of the cost of all the things Congress is saying plans will need to cover in terms of testing, vaccines…will impact plans,” says Kazan, referring to various legislative requirements, some of which are still pending.

Preparing bids on the revenue side was equally challenging, since it’s the 2020 diagnosis information that drives reimbursement for next year, adds Piper. “As we’re trying to forecast what 2021 revenue will look like, we’ve got to look at what’s going on in today’s environment and understand if we’re not seeing our members as often…that potentially creates a challenge for health plans to capture all that diagnosis information in 2020, which in turn drives their 2021 revenue amount.”

On the Part D side, Milliman principal and consulting actuary Shelly Brandel says COVID-19 had less of an impact on costs because prescription drug utilization or fills weren’t “delayed to the same degree as medical services had been.” The risk score impact, however, created a similar challenge because Part D risk scores are based on medical diagnoses, she adds.

MMIT Reality Check on Chronic Idiopathic Constipation (June 2020)

June 5, 2020

According to our recent payer coverage analysis for chronic idiopathic constipation treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for chronic idiopathic constipation treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for chronic idiopathic constipation treatments shows that under the pharmacy benefit, about 41% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In March 2020, the FDA approved Sebela Pharmaceuticals’ Pizensy (lactitol) for oral solution for the treatment of chronic idiopathic constipation in adults. Unlike solid oral treatments, the medication can be mixed with the patient’s fluid of choice, including water, juice, coffee, tea and soda.

Trends That Matter: The Future of Value-Based Agreements

June 4, 2020

The challenge of improving patient access while reducing treatment costs has led the healthcare sector to explore innovative contract arrangements. Using value-based agreements (also referred to as risk-sharing or outcomes-based contracts) biopharmaceutical manufacturers and payers agree to link coverage and reimbursement levels to a drug’s effectiveness and usage. These agreements have been a necessity in providing patients access to high-cost and high-value gene therapies. However, in chronic disease states like diabetes and cardiovascular disease, value-based contracts have been essential to managing treatment costs associated with the high-volume utilization of these treatments.

The challenge of improving patient access while reducing treatment costs has led the healthcare sector to explore innovative contract arrangements. Using value-based agreements (also referred to as risk-sharing or outcomes-based contracts) biopharmaceutical manufacturers and payers agree to link coverage and reimbursement levels to a drug’s effectiveness and usage. These agreements have been a necessity in providing patients access to high-cost and high-value gene therapies. However, in chronic disease states like diabetes and cardiovascular disease, value-based contracts have been essential to managing treatment costs associated with the high-volume utilization of these treatments.

Current challenges in value-based care include stakeholders’ alignment on which metrics are measurable and are valuable to include in an agreement, along with the presence of extensive technology and an unbiased third-party administrator to track and report on treatment outcomes. Successful implementation of such programs also involves patient adherence to treatments coordinated and monitored by physician practices or hospital systems.

That said, the question remains, how are value-based agreements going to evolve in the future?

Value-based agreements are becoming more prevalent and will continue to grow over the next two years. MMIT’s Special Report on Value Based Agreements Between Payers and Manufacturers surveyed 50 decision-makers covering 136 million commercial members and found that engagement in value-based contracts has steadily increased over the past three years. In this same survey, payers covering 85% of those commercial members reported that they anticipate increasing their participation in such agreements over the next two years.

In addition, the COVID-19 crisis is pushing integrated delivery networks and health care systems to their limits financially, which may prompt them to re-evaluate or renegotiate existing value-based agreements to prioritize their financial recovery. Similarly, accountable care organizations (ACOs) facing a similar financial crisis may experience challenges in meeting their existing value-based contract goals. To alleviate some of the concerns that such organizations are facing, CMS recently announced that it will work toward relaxing quality reporting requirements and prorate losses suffered by Medicare ACOs in 2020.

The special report also illustrates another critical finding – the surveyed payers rated their organizations as highly capable of entering value-based agreements. As a result of the pandemic, recent research suggests there is an increased likelihood of additional vertical integration of payers on one side, in addition to smaller physician practices’ integration into larger hospital systems. This trend stands to improve payers’ and physicians’ ability to track outcomes more effectively, which will bode well for value-based agreements, since they often require interoperability between payers, providers and careful monitoring of patient adherence.

If payers relax their initial and reauthorization restrictions on therapies to ease drug access during the pandemic, they will likely have a chance to revisit existing policies once the dust settles. Exploring innovative contracting methods to help payer organizations control and recuperate costs in the aftermath of the pandemic may become a necessity that could create new opportunities for value-based contracts. With an increasing number of members filing for unemployment and moving to the Medicaid line of business, this segment could also be a focus area for such agreements.

To learn more about the special report on value-based agreements between payers and manufacturers, visit https://bit.ly/3ewzTLV. For more information about the impact of COVID-19 and resources that provide actionable insights, visit https://bit.ly/2yDQoGu.

Radar On Market Access: 1.7K Plans Apply for Trump Admin’s Fixed-Insulin-Copay Program for Seniors

June 4, 2020

The Trump administration on May 26 shared new details about a program that offers diabetic seniors access to a variety of insulin products for a maximum $35-per-month copay, AIS Health reported.

More than 88 health insurers offering about 1,750 standalone Medicare Part D Prescription Drug Plans and Medicare Advantage plans with prescription drug coverage have now applied to participate in the Part D Senior Savings Model, which CMS unveiled in mid-March. Medicare beneficiaries in all 50 states, the District of Columbia and Puerto Rico will be able to enroll in a participating plan during the Medicare open enrollment period that lasts from Oct. 15 to Dec. 7, 2020, for Part D coverage that begins on Jan. 1, 2021.

The Trump administration on May 26 shared new details about a program that offers diabetic seniors access to a variety of insulin products for a maximum $35-per-month copay, AIS Health reported.

More than 88 health insurers offering about 1,750 standalone Medicare Part D Prescription Drug Plans and Medicare Advantage plans with prescription drug coverage have now applied to participate in the Part D Senior Savings Model, which CMS unveiled in mid-March. Medicare beneficiaries in all 50 states, the District of Columbia and Puerto Rico will be able to enroll in a participating plan during the Medicare open enrollment period that lasts from Oct. 15 to Dec. 7, 2020, for Part D coverage that begins on Jan. 1, 2021.

That “widespread voluntary participation” from health plans “was essential for the program’s success,” says Marc Guieb, Pharm.D., a consultant at Milliman, Inc. Still, “many plans were hesitant to participate in the inaugural year of this program due to uncertainty around its financial impact,” he says. “It is likely that, in future years, more plans will jump on the bandwagon.”

CMS estimates that Medicare beneficiaries who use insulin and join a plan participating in the Part D Senior Savings Model could save an average of $446 annually on out-of-pocket insulin costs, or 66%. Three insulin manufacturers — Eli Lilly and Co., Novo Nordisk Inc. and Sanofi U.S. — have agreed to participate.

On the one hand, the concept of a fixed insulin copay should be attractive to seniors and can improve medication adherence, says Brian Anderson, a principal at Milliman. Still, “the benefit coordination and claims processing is going to be tricky,” he suggests, adding that “the pharmacy reimbursements, manufacturer payments, application of the Part D benefit phases and reinsurance will all come into play.”

“Overall, this has the opportunity to improve the Part D benefit and drive formulary competition from a cost standpoint,” Anderson concludes.

America’s Health Insurance Plans (AHIP) gave the program a glowing assessment. “Innovative voluntary programs like this Part D Senior Savings Model are an excellent example of public-private partnerships where everyone wins, but especially patients,” AHIP President and CEO Matt Eyles said in a statement released May 26.

Radar On Market Access: Payers and PBMs May Play Key Role in COVID-19 Vaccine Rollout

June 2, 2020

The rollout of a vaccine for SARS-CoV-2, the virus that causes COVID-19, is an unprecedented logistical challenge. So will be deciding who gets it: experts say that the initial vaccine supply will not be large enough to dose everyone who wants it — and payers and PBMs will have a large role to play in distributing the medicine to the right people quickly.

The rollout of a vaccine for SARS-CoV-2, the virus that causes COVID-19, is an unprecedented logistical challenge. So will be deciding who gets it: experts say that the initial vaccine supply will not be large enough to dose everyone who wants it — and payers and PBMs will have a large role to play in distributing the medicine to the right people quickly.

David Simchi-Levi, Ph.D., a systems engineer who studies manufacturing and supply chain at MIT, tells AIS Health that it’s inevitable that vaccine supply will not meet demand when it is available. “The question will be, who gets it?” he says.

Mike Schneider, a principal at Avalere Health and a former executive at CVS Health Corp.’s Caremark PBM, says that given the likely scarcity of the vaccine, areas hardest hit by COVID-19 should be the focus of the initial supply.

“I think the payers will probably try to stay out of the way as much as possible, and let local laws determine who can get a vaccine and probably local health departments determine who can get the vaccine before others,” Schneider says. He adds that payers should also use prior authorization matched to FDA guidance to ensure the right people are dosed.

When a vaccine is available, Schneider expects retail pharmacies to play a large role in delivery. He cites retail pharmacy chains’ rollout of drive-through SARS-CoV-2 testing and the annual ritual of getting a flu shot from a pharmacist as examples of what delivering the coronavirus vaccine could look like. Along the same lines, he expects primary care practitioners to perform some inoculations.

Even a well-managed rollout will only be a first step. Manufacturing and supply chain concerns will dictate the supply of vaccines available in the U.S. going forward. So will trade, as most medicines are manufactured in China and India. Those countries will certainly want to care for their own citizens as soon as possible, which could delay the release of vaccine here.

Given all that uncertainty, Schneider expects that a SARS-CoV-2 vaccine could be a perennial component of formularies, along the lines of the flu vaccine. Schneider expects that receiving the coronavirus vaccine will be a routine preventive treatment that costs patients little to nothing.

MMIT Reality Check on Narcolepsy (May 2020)

May 29, 2020

According to our recent payer coverage analysis for narcolepsy treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for narcolepsy treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for narcolepsy treatments shows that under the pharmacy benefit, about 55% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In August 2019, the FDA approved Harmony Biosciences, LLC’s Wakix (pitolisant) for the treatment of excessive daytime sleepiness in adults with narcolepsy. The product is a first-in-class medicine, a selective histamine 3 (H3) receptor antagonist/inverse agonist.

Radar On Market Access: Will COVID-19 Advance Automatic Health Insurance Enrollment?

May 28, 2020

As the COVID-19 pandemic continues to ravage the U.S. economy, it would seem to be the perfect time for policymakers to explore a policy option that has garnered rare bipartisan support: automatic health insurance enrollment.

As the COVID-19 pandemic continues to ravage the U.S. economy, it would seem to be the perfect time for policymakers to explore a policy option that has garnered rare bipartisan support: automatic health insurance enrollment.

“We have huge numbers of people who are losing employer-based coverage; most of them are eligible for some kind of help, but we know historically most laid-off workers do not enroll in coverage for which they qualify,” Stan Dorn, director of the National Center for Coverage Innovation and senior fellow at Families USA, told AIS Health. “It’s just overwhelming to be grappling with job loss and therefore it becomes imperative to make enrollment as easy, seamless and automatic as possible.”

Dorn was among several panelists who spoke during a May 18 webinar about automatic health insurance enrollment, hosted by the USC-Brookings Schaeffer Initiative for Health Policy and the American Enterprise Institute. Current crisis aside, Dorn said he advocates helping eligible uninsured individuals sign up for coverage when they’re filing their tax returns.

Christen Linke Young, a fellow at the USC-Brookings Schaeffer Initiative for Health Policy, said that “retroactive enrollment” is the best option. A federal “backstop” program would pay all claims for uninsured people when they receive care, but when filing taxes they would be responsible for paying income-adjusted premiums for the “plan” they used. “It’s the path toward universal coverage that is in my view most feasible,” she said.

Other panelists advocated for a more state-driven approach. One way to accomplish that would be for the federal government to create an incentive program that grants states new tools and authorities to build automatic enrollment programs, according to James Capretta, a visiting fellow at the American Enterprise Institute and senior fellow at the Ethics and Public Policy Center.

During the current pandemic-related economic downturn, one solution could be for states to move people who have lost their employer-based coverage to a comparable Affordable Care Act marketplace plan, suggested Lanhee Chen, a David and Diane Steffy fellow in American public policy studies at the Hoover Institution. “I think certainly that would be a more affordable route than, for example, subsidizing COBRA continuation coverage,” he said.

Perspectives on Surge of Mental Health Meds Use Amid COVID-19

May 28, 2020

Newly released data from Express Scripts shows that the number of prescriptions filled per week for antidepressants, anti-anxiety and anti-insomnia medications combined jumped 21% between mid-February and mid-March — reaching a zenith during the week ending March 15, when the COVID-19 outbreak officially reached pandemic status. And analytics from UnitedHealth Group’s OptumRx showed prescription increases of 15% for anti-anxiety medications, 14% for antidepressants and 5% for anti-insomnia medications during the month of March.

Newly released data from Express Scripts shows that the number of prescriptions filled per week for antidepressants, anti-anxiety and anti-insomnia medications combined jumped 21% between mid-February and mid-March — reaching a zenith during the week ending March 15, when the COVID-19 outbreak officially reached pandemic status. And analytics from UnitedHealth Group’s OptumRx showed prescription increases of 15% for anti-anxiety medications, 14% for antidepressants and 5% for anti-insomnia medications during the month of March.

Industry consultants tell AIS Health that they’re not at all surprised that the use of such medications is spiking. And they say that situation creates an urgent opportunity for companies that combine a health insurer with a PBM — like Express Scripts parent company Cigna Corp. and its peers — to leverage their unique insights into members’ health.

“Pharmacies are often the most utilized part of the benefit compared to medical or behavioral, but now, an increase in some pharmacy utilization can actually signal a need to use more of the behavioral benefit,” Peter Manoogian, principal at the health care consulting firm ZS Associates, tells AIS Health.

Rita Numerof, Ph.D., president and founder of the consulting firm Numerof & Associates, says health care organizations should conduct generalized outreach to members that stresses non-pharmaceutical coping mechanisms when appropriate. “Practical guidance, and not looking at this as a mental illness or a mental health issue, in the face of this kind of crisis, is really important,” she tells AIS Health.

For its part, UnitedHealth opened up an emotional support help line and is offering a free on-demand emotional support mobile app called Sanvello to help people “cope with stress, anxiety and depression during the COVID-19 pandemic,” according to a company spokesperson.

Express Scripts, meanwhile, is offering a “digital mental health platform” to its clients at no cost, which “enables members to build resilience and develop skills to better manage stress and sleep issues,” according to Rochelle Henderson, Ph.D., vice president of health services research at the PBM.

Radar On Market Access: COVID-19 Pandemic May Change Rx Delivery Permanently

May 26, 2020

Industry experts expect the COVID-19 pandemic and related economic crisis, in addition to the trend of vertical integration in the PBM sector, will increase those companies’ direct interaction with consumers, AIS Health reported.

Industry experts expect the COVID-19 pandemic and related economic crisis, in addition to the trend of vertical integration in the PBM sector, will increase those companies’ direct interaction with consumers, AIS Health reported.

The recent wave of payer acquisitions of PBMs has kept the latter on strong footing despite the crisis. CVS Health Corp.’s Caremark, UnitedHealth Group’s OptumRx and Cigna Corp.’s Express Scripts control approximately 74% of the market, according to a January 2020 estimate by Drug Channels Institute CEO Adam Fein, Ph.D.

Fein said in a May 8 webinar that he expects the dominant PBMs’ bargaining clout, deepening synergies and cash reserves to drive more aggressive formulary management during the COVID-19 crisis.

Vertical integration has changed the revenue mix of large PBMs. According to Fein, rebates account for a declining amount of profits for the big three PBMs, and they are largely passed through to payer clients.

The vertical integration trend has also helped PBMs adapt to new consumer choices driven by COVID-19, according to Fein. “Mail pharmacies [had] a huge spike [in fills] into March, and right now, mail pharmacy growth has now flatlined again. Retail pharmacy has taken a very big hit. Once the lockdown started to go into effect, [retail] prescriptions started to decline because people couldn’t get to the retail pharmacy,” Fein said.

Still, he is skeptical about the durability and scale of the consumer shift away from retail toward mail order.

“[Mail order] gained a little, but it’s not some runaway shift in the market,” Fein explained, citing its still-small share of the overall prescription drug market. “The notion of a retail-to-mail shift — it’s going to happen, but it may not last too much longer. So for PBMs, it’s a short-term boost, but perhaps not a long-term shift.”

However, Mike Schneider, a principal at Avalere Health, says that he’s bullish on the trend toward mail order. Schneider says consumers with chronic conditions and long-term medications are likely to stick with mail-order fills — assuming they are still available after the pandemic ends. The key to continuing that trend, he adds, is whether seniors, the largest demographic group of prescription drug users, take a liking to the mail order system.

MMIT Reality Check on Low Testosterone (May 2020)

May 22, 2020

According to our recent payer coverage analysis for low testosterone treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for low testosterone treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for low testosterone treatments shows that under the pharmacy benefit, about 58% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In February 2020, Clarus Therapeutics, Inc. said that its Jatenzo (testosterone undecanoate) is available by prescription in the U.S. In March 2019, the FDA approved the medication for the treatment of males with low testosterone levels because of specific genetic disorders or pituitary glanddamaging tumors.

Trends That Matter for Medical-Benefit Drug Spending

May 21, 2020

Spending on prescription drugs that are covered under the medical benefit increased by 65% between 2014 and 2018 for commercial insurers and 40% for Medicare, according to Magellan Rx Management’s annual Medical Pharmacy Trend Report.

Spending on prescription drugs that are covered under the medical benefit increased by 65% between 2014 and 2018 for commercial insurers and 40% for Medicare, according to Magellan Rx Management’s annual Medical Pharmacy Trend Report.

“The increase in medical pharmacy spend seems to largely be driven by inflation,” Kristen Reimers, Magellan’s senior vice president of specialty clinical solutions, tells AIS Health. “This can be a combination of two things, increasing costs of existing drugs and providers utilizing newer more expensive drugs. The pipeline was extremely robust and new therapies to market are contributing to inflation, driving the trend.”

According to the report, new oncology therapies are both emblematic and a primary driver of growth in drug prices. A new generation of highly effective, biologic oncology drugs have emerged in the last decade. However, these pioneering drugs are expensive. According to the report, oncology drugs and the drugs needed to support them accounted for 43% of per-patient per-month medical pharmacy spending for commercial carriers.

Like other biologic drugs, most biologic oncology drugs have yet to see significant biosimilar competition due to barriers in the biosimilar market and development pipeline.

“The most exciting biosimilars are those currently in the oncology space. Herceptin, Avastin and Rituxan have been the top five drugs in terms of spend for the last 10 years,” says Reimers. “Rituxan and Avastin now have two biosimilars on the market, and Herceptin has five marketed products. There will be competition, which will help to flatten the trend for these products, although there is still expected to be growth.”

Radar On Market Access: COVID-19 Pandemic Drives Home Infusion Utilization

May 21, 2020

With numerous hospitals focused on the COVID-19 pandemic and many areas under stay-at-home mandates, home infusion is more important than ever. Changes within the industry already have been seen, and the current situation is likely to result in permanent shifts within the home infusion space, AIS Health reported.

With numerous hospitals focused on the COVID-19 pandemic and many areas under stay-at-home mandates, home infusion is more important than ever. Changes within the industry already have been seen, and the current situation is likely to result in permanent shifts within the home infusion space, AIS Health reported.

“If you can do infusion at home, you need to do it there,” maintains Ashraf Shehata, KPMG national sector leader for Healthcare & Life Sciences. “This is about controlling infection risk in the near term, and many home infusion candidates are in a high-risk category. Longer term, there has been a shift toward delivering care in the most economical and clinically appropriate setting, largely driven by payers.”

“We have seen an increase in some home infusion utilization of select therapies in certain markets where patient administration sites of care are shifting from the acute care or hospital outpatient setting to the home, related to the pandemic,” says Drew Walk, CEO of Soleo Health.

Some plans already have been shifting administration of certain therapies to patient homes and provider offices, which are more cost-effective settings than hospitals, points out Elan Rubinstein, Pharm.D., EB Rubinstein Associates.

“There could be more home infusion, with drugs that pose low risk of serious adverse events during or immediately after infusion or where a patient tolerated prior infusions of these drugs with no or minimal difficulty,” says Rubinstein.

Lisa Kennedy, Ph.D., chief economist and managing principal at Innopiphany LLC, points out that while CMS has changed some policies in support of home infusion, “not everyone is on board.” She notes that the Community Oncology Alliance “has raised safety concerns about home infusion centered on a lack of training of those in the community administering treatment at home versus trained oncology nurses.”

“Going forward there will be a lot of candidates for home infusion, and some customers/patients may like the convenience of getting care at home,” says Shehata. “There might be opportunities for alternative care models to be introduced here. The ability for nurses to teach patients how to self-administer the medicines is an important facet to this.”

Radar On Market Access: PBMs See Solid 1Q Results Despite Challenges Ahead

May 19, 2020

Major PBMs reported strong results for the first quarter of 2020 as members rushed to fill prescriptions in March ahead of the COVID-19 pandemic. However, financial analysts warn the pandemic could have unpredictable effects on PBMs’ finances for the rest of 2020 and moving into 2021, AIS Health reported.

Major PBMs reported strong results for the first quarter of 2020 as members rushed to fill prescriptions in March ahead of the COVID-19 pandemic. However, financial analysts warn the pandemic could have unpredictable effects on PBMs’ finances for the rest of 2020 and moving into 2021, AIS Health reported.

The 2021 PBM selling season could be disrupted in still-unknown ways, analysts said, and members are cutting back on routine physician visits and elective procedures, resulting in lower script volume overall.

Anthem, Inc., posted a particularly strong start for its new IngenioRx PBM, with earnings of $349 million, well above the $275 million to $300 million quarterly earnings that had been expected.

The impact from COVID-19 included a large spike in prescription refills during March, which helped the PBM’s performance, Anthem Executive Vice President and CFO John Gallina said in the company’s earnings conference call. Still, investors shouldn’t expect script numbers to remain elevated, he added: “We have seen a slight drop in new scripts here in April over historical patterns.”

CVS Health Corp. reported first-quarter earnings per share (EPS) of $1.91, well above what analysts had anticipated. Citi analyst Ralph Giacobbe wrote in a May 6 investor note that the company’s Caremark PBM “put up solid results with revenue and operating profit also exceeding consensus with higher claims growth of 12.4%.” This was “aided by pull-forward of scripts due to COVID-19,” plus the partnership between CVS and Anthem on IngenioRx.

Cigna Corp.’s first-quarter adjusted EPS came in 8% above consensus, with better-than-anticipated performances in its Health Services unit, which houses PBM Express Scripts, and in its Integrated Medical segment. Health Services reported an operating profit of $1.08 billion, slightly ahead of expectations, with revenue well ahead of projections — $27.2 billion versus $25.1 billion expected, noted Giacobbe.

At UnitedHealth Group, earnings for Optum, the division that includes OptumRx, missed analysts’ expectations by about 5%, despite stronger-than-expected revenue, Jefferies equities analyst David Windley wrote in a note to investors. “OptumHealth and OptumRx both contributed to the underperformance,” which was offset by stronger-than-expected performance by OptumInsight, he said.

MMIT Reality Check on Pain Narcotic Opioid (May 2020)

May 15, 2020

According to our recent payer coverage analysis for pain narcotic opioid treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for pain narcotic opioid treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for pain narcotic opioid treatments shows that under the pharmacy benefit, about 35% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Many brand name products (Xtampza ER, Oxaydo) continue to enter this market despite the numerous generics. Given assumed parity in efficacy among remaining name-brand products, contracting for position after a generic is common.

Perspectives on Coronavirus Antibody Testing

May 14, 2020

With the Trump administration anxious to “reopen” the U.S. economy and ease the social-distancing measures meant to slow the spread of COVID-19, officials have pointed to antibody testing as a critical tool to accomplish those goals. To that end, the administration on April 11 issued a document clarifying that most private health plans must cover such tests, which detect antibodies against the new coronavirus found in the blood of people who have been infected and now may be immune.

With the Trump administration anxious to “reopen” the U.S. economy and ease the social-distancing measures meant to slow the spread of COVID-19, officials have pointed to antibody testing as a critical tool to accomplish those goals. To that end, the administration on April 11 issued a document clarifying that most private health plans must cover such tests, which detect antibodies against the new coronavirus found in the blood of people who have been infected and now may be immune.

“It’s not exactly a surprise, [but] I don’t know that it was 100% expected,” Jason Karcher, a Milliman Inc. actuary, tells AIS Health regarding the requirement. “It seems like as much a point of clarification rather than a ‘hey, we’re going to require something totally out of the blue.'”

So far, at least serological tests have received an Emergency Use Authorization from the FDA.

Cost information is not as readily available for serological tests as it is for tests that diagnose COVID-19, which cost around $51 until CMS increased the reimbursement rate for “high-throughput” diagnostic tests to $100. Cellex, which makes one of the antibody tests that received emergency authorization by the FDA, did not respond to an inquiry about the price of its test as of press time, but Vox reported that “a serological test can be less than $10.”

William Schaffner, M.D., a professor of preventive medicine and infectious diseases at Vanderbilt University, says there are good reasons to temper expectations about how testing people for COVID-19 antibodies could help the U.S. reopen businesses, schools and events.

Since the FDA is essentially allowing companies to do their own evaluation of serological tests’ effectiveness, that will naturally invite questions about whether their results can be trusted, Schaffner says, suggesting that some tests may be more rigorously evaluated than others. “Then there’s the question of availability of the tests — we’ve been down this road once before, where people were told that the nasal swab test for the virus itself would be widely available, and anybody can have it who wants it,” he says. “Well, we’re still struggling with that, and we would like not to repeat that fiasco.”

Radar On Market Access: COVID-19 May Drive More Insurers Into ACA Exchanges

May 14, 2020

As the impact of the COVID-19 pandemic continues to reverberate throughout the U.S. economy, it’s become clear that there will be a major enrollment shift away from employer-sponsored plans and into Medicaid and the individual market, AIS Health reported.

As the impact of the COVID-19 pandemic continues to reverberate throughout the U.S. economy, it’s become clear that there will be a major enrollment shift away from employer-sponsored plans and into Medicaid and the individual market, AIS Health reported.

In fact, one recent analysis suggested that there could be “unprecedented growth” in the individual health insurance market. “The impact of COVID-19-related job losses will likely more than double the current enrollment in Individual & Marketplace plans, with the potential for the Individual market to triple in size to over 35 million in a sustained and severe economic contraction,” stated the analysis from A2 Strategy Group.

Such growth, the report said, “will come from newly unemployed individuals in all states who exceed Medicaid eligibility thresholds” because of money they receive from the Coronavirus Aid, Relief, and Economic Security Act. And in states that haven’t expanded Medicaid, nearly all of the newly unemployed who earn below 100% of the federal poverty level could qualify for Affordable Care Act premium subsidies.

Another analysis from the Urban Institute and Robert Wood Johnson Foundation (RWJF), estimated that if U.S. unemployment reaches 20%, 25 million people would lose employer-sponsored health insurance. “Of these, 11.8 million would gain Medicaid coverage, 6.2 million would gain marketplace or other private coverage, and 7.3 million would become uninsured,” it stated.

Katherine Hempstead, the senior adviser to the executive vice president at RWJF, says it’s possible the coming enrollment shifts will cause some health insurers to re-evaluate their level of participation in the ACA exchanges, which some large insurers left in 2017 and 2018 before the market stabilized.

In fact, Maryland Gov. Larry Hogan (R) said on May 12 that UnitedHealth filed to offer plans on the sate’s ACA exchange in 2021, bringing the total number of insurers in that market from two to three.

Ari Gottlieb, a principal at A2 Strategy Group, says the effect may be even stronger after 2021.

“If the market doubles to 25 or 30 million, some of that will probably fall off, but some of that will probably stay,” he says. “I think even a year or two from now, we’re going to have a bigger individual market than we had before.”

Radar On Market Access: CVS Sees COVID Testing Sites as Part of Bigger HealthHUB Strategy

May 12, 2020

Since acquiring Aetna, CVS Health Corp. has touted its HealthHUB stores — which include expanded clinics, labs for health screening and space for wellness pursuits — as the linchpin of its plan to stand out among other large, diversified firms that include a health insurer. Yet as one analyst pointed out during CVS’s first-quarter 2020 earnings call on May 6, that strategy could face new challenges amid the COVID-19 pandemic when many people are reluctant to venture outside their homes.

Since acquiring Aetna, CVS Health Corp. has touted its HealthHUB stores — which include expanded clinics, labs for health screening and space for wellness pursuits — as the linchpin of its plan to stand out among other large, diversified firms that include a health insurer. Yet as one analyst pointed out during CVS’s first-quarter 2020 earnings call on May 6, that strategy could face new challenges amid the COVID-19 pandemic when many people are reluctant to venture outside their homes.

CVS executives said that while the company is indeed seeing less foot traffic at its brick-and-mortar locations, it is still leveraging the power of having a vast retail footprint by offering testing for the new coronavirus, AIS Health reported.

The firm teamed up with federal, state and local governments to open “large-scale diagnostic testing sites across five states,” according to a slide deck that accompanied CVS’s earnings presentation. As of May 4, the company had administered nearly 90,000 tests, and it is planning to establish additional testing sites.

As CEO Larry Merlo put it: “We’re focused on COVID testing today, but there is a broader universe of diagnostics and monitoring that we see becoming an important part of our HealthHUB strategy.”

Merlo also pointed out that virtual visits through the company’s MinuteClinic platform rose 600% in the first three months of 2020 compared with the prior-year quarter. Retail prescription home delivery increased more than 1,000% and specialty pharmacy digital refills jumped about 50%.

The effects of the COVID-19 crisis weren’t all rosy, however. Jonathan Roberts, CVS’s executive vice president and chief operating officer, acknowledged that “the biggest headwind we’re seeing now in pharmacy is really around new therapy starts.” Because doctor visits have decreased significantly, CVS saw at least a 25% dip in new prescriptions in April compared with the same month in 2019, whereas it normally sees about 7% growth.

Overall in the quarter, CVS recorded adjusted earnings per share (EPS) of $1.91, “well above” the Wall Street consensus of $1.62, as Citi analyst Ralph Giacobbe highlighted in a May 6 investor note. Total revenues increased 8.3% in the first quarter of 2020 compared with the prior-year quarter.

MMIT Reality Check on Anemia — Chronic Kidney Disease (May 2020)

May 8, 2020

According to our recent payer coverage analysis for anemia treatments due to chronic kidney disease, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for anemia treatments due to chronic kidney disease, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for anemia treatments due to chronic kidney disease shows that under the pharmacy benefit, about 55% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In November 2019, AstraZeneca said its FibroGen-partnered drug roxadustat, an oral first-in-class drug to treat anemia in patients with chronic kidney disease, demonstrated positive results in its Phase III trial.

Trends That Matter for Biosimilar Medications Cost Savings

May 7, 2020

Biosimilar medications can offer meaningful cost savings for payers, but market and regulatory barriers are still preventing them from realizing their full economic potential, according to a March 31 Johns Hopkins University study funded by the ERISA Industry Committee.

Biosimilar medications can offer meaningful cost savings for payers, but market and regulatory barriers are still preventing them from realizing their full economic potential, according to a March 31 Johns Hopkins University study funded by the ERISA Industry Committee.

“We could see and empirically prove that patients…tended to be better off if they were on the biosimilar,” Mariana Socal, a physician and researcher at the Johns Hopkins Bloomberg School of Public Health and one of the study’s authors, tells AIS Health. “They had lower out-of-pocket costs when they were on the biosimilar.”

While 16 biosimilars have earned FDA approval, according to the report, most of those drugs are the only biosimilar in their category, creating a duopoly price structure rather than robust market competition with at least three drugs.

Per the report, multiple biosimilars have entered the market for only two drugs, Remicade (infliximab) and Neupogen (filgrastim). The report concludes that, in those categories, biosimilar competition has generated remarkable cost savings and has the potential to generate much more through increased biosimilar use.

For infliximab, the reference biologic Remicade currently has the most covered lives among commercial formularies, while for filgrastim, Zarxio (a biosimilar for Neupogen) is the leader in market access, according to MMIT data.

Radar On Market Access: Anthem, Cigna Brace for Recession-Induced Enrollment Shift

May 7, 2020

Anthem, Inc., and Cigna Corp. both reported slightly better-than-expected medical loss ratios (MLRs) as part of their first-quarter 2020 earnings, in part due to delays in elective procedures resulting from the COVID-19 pandemic. Both insurers also reaffirmed their overall earnings-per-share (EPS) guidance for 2020, AIS Health reported.

Anthem, Inc., and Cigna Corp. both reported slightly better-than-expected medical loss ratios (MLRs) as part of their first-quarter 2020 earnings, in part due to delays in elective procedures resulting from the COVID-19 pandemic. Both insurers also reaffirmed their overall earnings-per-share (EPS) guidance for 2020, AIS Health reported.

But the insurers warned that MLRs may tick up later this year. In addition, they predicted that the impact of COVID-19 may lead to significant shifts in enrollment, as workers who are laid off shift to Medicaid or to the Affordable Care Act exchanges.

Anthem posted a first-quarter MLR of 84.2%, slightly better than the consensus estimate of 84.3%, “likely aided to a limited degree by COVID-19 toward the latter part of the quarter,” Citi analyst Ralph Giacobbe pointed out in an investor note.

Anthem’s second-quarter MLR “should be historically low” due to delayed procedures, but that will be offset by a rebound in volumes, buyback suspension and low net interest/investment income during the second half of the year, Jefferies equities analyst David Windley wrote in an investor note.

Anthem management indicated that 40% to 50% of disenrolled commercial lives will move to Medicaid, while 30% will move into individual health insurance, Windley wrote. “However, this creates an unfavorable mix,” with lower per-member per-month payments, especially in Medicaid, and a move to lower-margin products, he noted.

Meanwhile, Cigna reported an MLR of 78.3%, compared with analysts’ consensus estimate of 79.3%, Giacobbe pointed out in an investor note. Cigna is maintaining its 2020 guidance for EPS and revenue, while dropping its outlooks for MLR and other specific financial metrics.

“The impact of COVID-19 is still developing,” Cigna President and CEO David Cordani said April 30. “We clearly see headwinds driven by the recession that it’s causing, including, for example, disenrollment within our commercial customers, both in our integrated medical business [and] our health service business, as well as some pressure in our group disability business.”

However, Cigna expects “the strength of our first quarter to drive us to another strong year for revenue, earnings and free cash flow,” he added.

Radar On Market Access: Humana, Centene Maintain 2020 Earnings Outlook Amid COVID-19 Pandemic

May 5, 2020

Humana Inc. and Centene Corp. are both maintaining their 2020 earnings outlook despite the emergence of the COVID-19 pandemic and economic contraction at the end of the first quarter, AIS Health reported.

Humana Inc. and Centene Corp. are both maintaining their 2020 earnings outlook despite the emergence of the COVID-19 pandemic and economic contraction at the end of the first quarter, AIS Health reported.

Humana’s revenues increased to $18.9 billion, and it reported $5.40 in adjusted earnings per share (EPS), beating the Wall Street consensus of $4.66 adjusted EPS. Centene’s first quarter revenues increased 41% year-over-year to $26 billion, and it reported an adjusted EPS of $0.86. Centene fell short of the consensus with $0.99 adjusted EPS. Both insurers affirmed their projections for the end of the year, with Humana forecasting adjusted EPS of $18.25 to $18.75 and Centene $4.56 to $4.76.

But both companies warned that the pandemic and recession presented substantial risk, and noted that utilization could spike in the latter half of 2020 due to pent-up demand. They also reported that utilization dropped toward the end of the first quarter, and anticipated the same result for the second.

Analysts were cautiously optimistic about both firms’ outlook for the rest of the year. “We believe that Humana boasts a compelling growth opportunity in the increasingly appealing [Medicare Advantage] market. Furthermore, the company also has an opportunity to drive margins given a potentially more favorable reimbursement environment and the maturation of its high-growth member base,” Oppenheimer’s Michael Wiederhorn wrote in an April 29 note.

Despite Centene’s seemingly less impressive results, analysts were positive or neutral about the firm’s first-quarter performance.

Windley wrote in an April 28 note regarding Centene that “we aren’t expecting ridiculously low 2Q [medical loss ratios] as management guards against an increase in utilization and claims severity. That said, the delay in procedures and incremental revenue from higher Medicaid/[health exchange] membership helps absorb new headwinds such as slower WellCare synergy capture, COVID-19 treatment costs, and adverse impacts on investment income/interest expense.”

Though Centene’s results were less robust than Humana’s, the company indicated it is in a strong position for the remainder of the year. The company has a large Medicaid managed care book, and Medicaid enrollment is certain to spike due to layoffs caused by the COVID-19 pandemic.

MMIT Reality Check on Ophthalmic Anti-Inflammatory (Apr 2020)

May 1, 2020

According to our recent payer coverage analysis for ophthalmic anti-inflammatory treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for ophthalmic anti-inflammatory treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for ophthalmic anti-inflammatory treatments shows that under the pharmacy benefit, almost 57% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: In March 2020, Noveome Biotherapeutics said it will evaluate its ST266, a first-of-its-kind cell-free platform biologic drug that was initially developed for ophthalmology indications, as a potential treatment of severe cytokine storm associated with COVID-19.

Perspectives on ACA and Medicaid Enrollment Growth Amid COVID-19

April 30, 2020

The COVID-19 pandemic is shaping up to be a stress-test for the post-Affordable Care Act insurance market. The crisis has already caused mass layoffs, and experts say the individual health insurance exchanges and Medicaid could see record enrollment in the coming months as a result, AIS Health reported.

The COVID-19 pandemic is shaping up to be a stress-test for the post-Affordable Care Act insurance market. The crisis has already caused mass layoffs, and experts say the individual health insurance exchanges and Medicaid could see record enrollment in the coming months as a result, AIS Health reported.

“This would be the first recession since the Affordable Care Act went into effect, so we are in somewhat uncharted territory in terms of what might happen in a recession under both the ACA marketplace and the Medicaid expansion,” Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, said during a March 18 conference call with reporters.

Levitt said the ACA marketplace is likely to see rapid growth in enrollment as workers lose jobs or hours, making them eligible for special enrollment periods in some cases.

“Household income is going to tend to fall, and that will put more people into that lowest income category with the broadest enrollment in the ACA marketplace,” Levitt said. That influx of enrollees, he added, “has the potential to improve the risk pool in the ACA marketplace and shouldn’t, by itself, have a big effect on premiums.”

Meanwhile, “as people lose their jobs and their incomes fall below 138% of poverty in those states that have expanded Medicaid, we’re likely to see growth in Medicaid enrollment — as we typically do during recessions,” Levitt said.

“Medicaid traditionally has been countercyclical….It’s an economic balancer,” says David Anderson, a health policy researcher at Duke University’s Margolis Center for Health Policy. “In 2009 [during the last economic recession], the federal government raised the federal payment rate — the federal share of Medicaid — by 6.2 points. What that did is it gave states breathing room in their budget…That extra federal share takes a little bit of pressure off the rest of the state budget.”

To that end, President Donald Trump on March 18 signed the Families First Coronavirus Response Act, which, among a host of other provisions, temporarily increased the Medicaid federal medical assistance percentage by 6.2 points.

Radar On Market Access: Oncology Drugs Drive Price Growth in Medical-Benefit Spend

April 30, 2020

Spending on prescription drugs that are covered under the medical benefit increased by 65% between 2014 and 2018 for commercial insurers and 40% for Medicare, according to Magellan Rx Management’s annual Medical Pharmacy Trend Report.

Spending on prescription drugs that are covered under the medical benefit increased by 65% between 2014 and 2018 for commercial insurers and 40% for Medicare, according to Magellan Rx Management’s annual Medical Pharmacy Trend Report.

“The increase in medical pharmacy spend seems to largely be driven by inflation,” Kristen Reimers, Magellan’s senior vice president of specialty clinical solutions, tells AIS Health. “This can be a combination of two things, increasing costs of existing drugs and providers utilizing newer more expensive drugs. The pipeline was extremely robust and new therapies to market are contributing to inflation, driving the trend.”

According to the report, new oncology therapies are both emblematic and a primary driver of growth in drug prices. A new generation of highly effective, biologic oncology drugs have emerged in the last decade. However, these pioneering drugs are expensive. According to the report, oncology drugs and the drugs needed to support them accounted for 43% of per-patient per-month medical pharmacy spending for commercial carriers.

Like other biologic drugs, most biologic oncology drugs have yet to see significant biosimilar competition due to barriers in the biosimilar market and development pipeline.

“The most exciting biosimilars are those currently in the oncology space. Herceptin, Avastin and Rituxan have been the top five drugs in terms of spend for the last 10 years,” says Reimers. “Rituxan and Avastin now have two biosimilars on the market, and Herceptin has five marketed products. There will be competition, which will help to flatten the trend for these products, although there is still expected to be growth.”

Emerging competition could bolster the already-improving price outlook for more established biologic drugs. However, growth in oncology spending is not likely to stop any time soon. In some ways, this is good news for patients: according to Reimers and the Magellan report, promising new, targeted therapies for hard-to-treat cancers will account for much of the increased spending in coming years.

“The pipeline for oncology is extremely robust, with over 700 drugs being studied for a variety of different cancer types,” Reimers says.

Radar On Market Access: PBMs Say Use of Mental Health Meds Surges Amid COVID-19

April 28, 2020

Newly released data from Express Scripts shows that the number of prescriptions filled per week for antidepressants, anti-anxiety and anti-insomnia medications combined jumped 21% between mid-February and mid-March — reaching a zenith during the week ending March 15, when the COVID-19 outbreak officially reached pandemic status. And analytics from UnitedHealth Group’s OptumRx showed prescription increases of 15% for anti-anxiety medications, 14% for antidepressants and 5% for anti-insomnia medications during the month of March.

Newly released data from Express Scripts shows that the number of prescriptions filled per week for antidepressants, anti-anxiety and anti-insomnia medications combined jumped 21% between mid-February and mid-March — reaching a zenith during the week ending March 15, when the COVID-19 outbreak officially reached pandemic status. And analytics from UnitedHealth Group’s OptumRx showed prescription increases of 15% for anti-anxiety medications, 14% for antidepressants and 5% for anti-insomnia medications during the month of March.

Industry consultants tell AIS Health that they’re not at all surprised that the use of such medications is spiking. And they say that situation creates an urgent opportunity for companies that combine a health insurer with a PBM — like Express Scripts parent company Cigna Corp. and its peers — to leverage their unique insights into members’ health.

“Pharmacies are often the most utilized part of the benefit compared to medical or behavioral, but now, an increase in some pharmacy utilization can actually signal a need to use more of the behavioral benefit,” Peter Manoogian, principal at the health care consulting firm ZS Associates, tells AIS Health.

Rita Numerof, Ph.D., president and founder of the consulting firm Numerof & Associates, says health care organizations should conduct generalized outreach to members that stresses non-pharmaceutical coping mechanisms when appropriate. “Practical guidance, and not looking at this as a mental illness or a mental health issue, in the face of this kind of crisis, is really important,” she tells AIS Health.

For its part, UnitedHealth opened up an emotional support help line and is offering a free on-demand emotional support mobile app called Sanvello to help people “cope with stress, anxiety and depression during the COVID-19 pandemic,” according to a company spokesperson.

Express Scripts, meanwhile, is offering a “digital mental health platform” to its clients at no cost, which “enables members to build resilience and develop skills to better manage stress and sleep issues,” according to Rochelle Henderson, Ph.D., vice president of health services research at the PBM.

MMIT Reality Check on Juvenile Idiopathic Arthritis (Apr 2020)

April 24, 2020

According to our recent payer coverage analysis for juvenile idiopathic arthritis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for juvenile idiopathic arthritis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for juvenile idiopathic arthritis treatments shows that under the pharmacy benefit, about 70% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In November 2019, the FDA approved Pfizer Inc.’s Abrilada (adalimumab-afzb) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. It is the fifth biosimilar of AbbVie Inc.’s Humira (adalimumab) that the agency has approved.

Trends That Matter for Bipolar Disorder Medications

April 23, 2020

A recently approved brand drug for bipolar disorder will have little impact on how health plans cover these medications, experts tell AIS Health. Health plans will continue to encourage the use of less expensive generic bipolar drugs.

A recently approved brand drug for bipolar disorder will have little impact on how health plans cover these medications, experts tell AIS Health. Health plans will continue to encourage the use of less expensive generic bipolar drugs.

The brand drug, Allergan plc’s Vraylar (cariprazine), was approved by the FDA to treat depressive episodes associated with bipolar 1 disorder in adults. It is an oral, once-daily atypical antipsychotic.

Health plans employ several utilization management techniques for bipolar drugs, according to Mesfin Tegenu, R.Ph., president of PerformRx. Some examples include prior authorization, duplicate therapy edits, age restrictions and step therapy.

For Vraylar, health plans will use prior authorization or steps to encourage the use of a generic bipolar drug first, Michael Schneider, a principal at Avalere Health, tells AIS Health. There also could be some higher out-of-pocket costs for Vraylar even when compared to some of the other branded antipsychotic drugs.

Vraylar is in a protected drug class on the Medicare side, Schneider says. Because it is the first brand drug of a particular chemical entity, plans have to cover it. In some Medicare plans, Vraylar is disadvantaged because even through it is in a protected class, there are still utilization management techniques placed on the product, as well as higher cost sharing, he says.

In Medicaid, many states require all the antipsychotic bipolar drugs to be on the formulary with no utilization management, Schneider adds.

The graphic below show how bipolar disorder medications are covered among commercial health plans, health exchange programs, Medicare and Medicaid programs under the pharmacy benefit.

Radar On Market Access: Medicaid MCOs Are Likely to See COVID-Related Enrollment Growth

April 23, 2020

As the COVID-19 pandemic continues to dominate the news cycle, headlines related to rising unemployment often underscore the impact to Medicaid, but what about the Medicaid managed care organizations that will absorb the newly jobless and uninsured?

As the COVID-19 pandemic continues to dominate the news cycle, headlines related to rising unemployment often underscore the impact to Medicaid, but what about the Medicaid managed care organizations that will absorb the newly jobless and uninsured?

“I think that Medicaid MCOs are clearly in the best position to handle the influx of folks,” remarks Jerry Vitti, founder and CEO of Healthcare Financial, Inc. While onboarding a wave of new members may put some initial stress on plans, the real “strain” will come from covering new members who have unmet health care needs, he tells AIS Health.

Vitti says new enrollees will likely fall into one of two buckets. “One is the previously insured folks who had commercial insurance before they lost their job and have been in the health care system,” he observes. This is not likely to be a “super high-demand population.” But the second grouping, previously uninsured individuals who may end up enrolling as awareness goes up and barriers to enrollment go down, are likely to have “pent-up and untreated medical [needs] and substance use issues,” he predicts.

“I’m hearing from plans I’ve worked with that on both the MA and the Medicaid side…their [medical loss ratios] have dropped substantially,” says Jeff Myers, senior vice president, reimbursement strategy and market access with Catalyst Health Care Consulting. “And though I think their net income is certainly looking up, that means they’re busy strengthening their capital position for what they expect to be the next phase, which is a big enrollment spike on both the [Affordable Care Act] marketplace and Medicaid programs.”

Myers points out that this is usually the time when managed care rate negotiations would begin with states. “I think the challenge for the few state folks I’ve talked to is modeling out, in states with extensive managed care programs, what that influx of people is going to look like given what the unemployment rate may look like, and also given whether they’ve expanded [Medicaid] or not,” he adds.

For states whose budgets have been stretched thin by COVID-19 testing and presumptive eligibility determinations to guarantee payments to hospitals, the pandemic could be the driving factor in expanding Medicaid where a legislature has historically blocked it. Or it may result in states seeking to expand federal Medicaid funding rather than limit it through block grants, suggests Myers.

Radar On Market Access: Insurers Are Now Required to Cover Coronavirus Antibody Testing

April 21, 2020

With the Trump administration anxious to “reopen” the U.S. economy and ease the social-distancing measures meant to slow the spread of COVID-19, officials have pointed to antibody testing as a critical tool to accomplish those goals. To that end, the administration on April 11 issued a document clarifying that most private health plans must cover such tests, which detect antibodies against the new coronavirus found in the blood of people who have been infected and now may be immune.

With the Trump administration anxious to “reopen” the U.S. economy and ease the social-distancing measures meant to slow the spread of COVID-19, officials have pointed to antibody testing as a critical tool to accomplish those goals. To that end, the administration on April 11 issued a document clarifying that most private health plans must cover such tests, which detect antibodies against the new coronavirus found in the blood of people who have been infected and now may be immune.

“It’s not exactly a surprise, [but] I don’t know that it was 100% expected,” Jason Karcher, a Milliman Inc. actuary, tells AIS Health regarding the requirement. “It seems like as much a point of clarification rather than a ‘hey, we’re going to require something totally out of the blue.'”

So far, at least serological tests have received an Emergency Use Authorization from the FDA.

Cost information is not as readily available for serological tests as it is for tests that diagnose COVID-19, which cost around $51 until CMS increased the reimbursement rate for “high-throughput” diagnostic tests to $100. Cellex, which makes one of the antibody tests that received emergency authorization by the FDA, did not respond to an inquiry about the price of its test as of press time, but Vox reported that “a serological test can be less than $10.”

William Schaffner, M.D., a professor of preventive medicine and infectious diseases at Vanderbilt University, says there are good reasons to temper expectations about how testing people for COVID-19 antibodies could help the U.S. reopen businesses, schools and events.

Since the FDA is essentially allowing companies to do their own evaluation of serological tests’ effectiveness, that will naturally invite questions about whether their results can be trusted, Schaffner says, suggesting that some tests may be more rigorously evaluated than others. “Then there’s the question of availability of the tests — we’ve been down this road once before, where people were told that the nasal swab test for the virus itself would be widely available, and anybody can have it who wants it,” he says. “Well, we’re still struggling with that, and we would like not to repeat that fiasco.”

MMIT Reality Check on Acute Myeloid Leukemia (Apr 2020)

April 17, 2020

According to our recent payer coverage analysis for acute myeloid leukemia treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for acute myeloid leukemia treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for acute myeloid leukemia treatments shows that under the pharmacy benefit, about 65% and 80% of the lives under commercial and Medicare formularies are covered with utilization management restrictions.

Trends: In June 2019, Daiichi Sankyo Company, Ltd. said that the FDA had issued a complete response letter (CRL) for its new drug application (NDA) for quizartinib for the treatment of adults with R/R FLT3-internal tandem duplications acute myeloid leukemia.

Perspectives on COVID-19 Outbreak’s Impact on Drug Supply

April 16, 2020

Industry experts say the COVID-19 outbreak is unlikely to limit U.S. drug supplies in the short or middle term. However, they tell AIS Health that increased demand for longer-duration stocks of medication from self-isolating patients could strain supplies going forward.

Industry experts say the COVID-19 outbreak is unlikely to limit U.S. drug supplies in the short or middle term. However, they tell AIS Health that increased demand for longer-duration stocks of medication from self-isolating patients could strain supplies going forward.

“We are told at this point that we’re not seeing any [drug] shortages in the marketplace today,” says Kelly McGrail-Pokuta, Prime Therapeutics’ vice president of pharmaceutical trade.

On Feb. 27, FDA Commissioner Stephen Hahn released a statement that said disruptions to the pharmaceutical supply chain have been minimal so far. The statement also said that the FDA was especially focused on 20 manufacturers that are particularly dependent on operations in China, and found that “none of these firms have reported any shortage to date.”

But on March 10, the FDA postponed all inspections of overseas drug manufacturing facilities “through April, effective immediately,” according to another statement released by Hahn.

During a pandemic, the CDC recommends anyone taking prescription medication to manage a chronic condition keep an expanded supply of their medicine on hand. As more people self-isolate, and consumers seek to spend less time in stores and other public places, demand for backup medication is likely to increase.

Mike Schneider, a principal at Avalere Health who previously worked for CVS Caremark, says PBMs and payers will have to rethink their typical posture toward chronic medication as enrollees stock up in anticipation of self-isolation.

“Hopefully, with everything going on related to coronavirus and people wanting to stock up, those quantity limits would be eased or eliminated for the most part for chronic meds,” says Schneider.

The Blue Cross Blue Shield Association’s “network of 36 independent and locally operated” affiliates have all decided to waive prescription refill limits on maintenance medications, according to America’s Health Insurance Plans. Other non-Blues insurers have also taken steps to allow members to refill prescriptions in advance.

Experts say it’s difficult to know whether the drug supply will be affected down the road. Schneider says consumer stockpiling and the FDA’s move to suspend foreign inspections could both make an impact on future supply.

Radar On Market Access: Slow Biosimilar Adoption and Opaque Markets Impede Potential Savings

April 16, 2020

Biosimilar medications can offer meaningful cost savings for payers, but market and regulatory barriers are still preventing them from realizing their full economic potential, according to a March 31 Johns Hopkins University study funded by the ERISA Industry Committee.

Biosimilar medications can offer meaningful cost savings for payers, but market and regulatory barriers are still preventing them from realizing their full economic potential, according to a March 31 Johns Hopkins University study funded by the ERISA Industry Committee.

“We could see and empirically prove that patients…tended to be better off if they were on the biosimilar,” Mariana Socal, a physician and researcher at the Johns Hopkins Bloomberg School of Public Health and one of the study’s authors, tells AIS Health. “They had lower out-of-pocket costs when they were on the biosimilar.”

While 16 biosimilars have earned FDA approval, according to the report, most of those drugs are the only biosimilar in their category, creating a duopoly price structure rather than robust market competition with at least three drugs.

Per the report, multiple biosimilars have entered the market for only two drugs, Remicade (infliximab) and Neupogen (filgrastim). The report concludes that, in those categories, biosimilar competition has generated remarkable cost savings and has the potential to generate much more through increased biosimilar use.

Socal says she believes opaque markets are to blame for biologics’ limited impact on drug markets at scale.

“When we looked at [the study companies’] formularies and their utilization, we were surprised to see that even within the same company, they had such a remarkable diversity in terms of biosimilar market share, in terms of the prices they were paying, and how much biosimilars they were able to use,” Socal says. She adds that PBMs should do more to inform their clients about the potential savings from higher biosimilar use in formularies.

Steve Cutts, head of specialty pharmacy for the PBM Magellan Rx Management, says that Magellan makes an overt effort to tell clients about the potential price savings from biosimilars.

Cutts says that many biologics are administered through a medical benefit, rather than a pharmacy benefit. That claims structure could explain some of the limited visibility of biosimilar substitution opportunities for plan administrators designing formularies, and would require coordination with providers to be addressed.

Radar On Market Access: PBMs Use Dispensing Limits to Halt Hoarding of Trump-Touted Malaria Drugs

April 14, 2020

With the death toll from COVID-19 continuing to rise in the U.S., President Donald Trump and some of his advisers have repeatedly touted the promise of anti-malarial drugs to combat the disease caused by the novel coronavirus. That enthusiasm has sparked increasing concern that the surge in demand for such drugs, hydroxychloroquine and chloroquine, is imperiling access for patients who take them to treat autoimmune conditions such as lupus and rheumatoid arthritis, AIS Health reported.

With the death toll from COVID-19 continuing to rise in the U.S., President Donald Trump and some of his advisers have repeatedly touted the promise of anti-malarial drugs to combat the disease caused by the novel coronavirus. That enthusiasm has sparked increasing concern that the surge in demand for such drugs, hydroxychloroquine and chloroquine, is imperiling access for patients who take them to treat autoimmune conditions such as lupus and rheumatoid arthritis, AIS Health reported.

To help alleviate the issue, some major PBMs are placing utilization management controls on off-label use of hydroxychloroquine, chloroquine and other drugs with the potential to treat COVID-19.

CVS Health Corp.’s Caremark unit is placing “appropriate limits” on the quantity of medicines including hydroxychloroquine, the antibiotic azithromycin, one type of protease inhibitor used to treat HIV, and albuterol inhalers that are approved to treat asthma, per a news release. UnitedHealth Group’s OptumRx s limiting prescriptions for hydroxychloroquine and chloroquine to 30 tablets within a 90-day time period, “with an automatic bypass for members utilizing for chronic conditions such as rheumatoid arthritis or systemic lupus,” says Chief Medical Officer Sumit Dutta, M.D. And Prime Therapeutics, LLC, the PBM owned by 18 Blue Cross Blue Shield plans, tells AIS Health that it’s taking similar measures.

“These measures have been effective in controlling the surge in demand that occurred in the first two weeks of March,” for hydroxychloroquine and chloroquine, says Marc Guieb, Pharm.D., a consultant with Milliman, Inc. But with some plans reporting significant spikes in utilization for the medicines, “the alarming question that we should be wondering is, ‘How were patients getting so many prescriptions for these drugs in the first place?'” he tells AIS Health via email.

Results from two small studies — one in China and one in France — have fueled interest in the use of hydroxychloroquine and chloroquine to treat COVID-19, but more evidence is needed to determine whether they’ll actually be effective against the disease, says Esther Krofah, executive director of FasterCures at the Milken Institute.

MMIT Reality Check on Opioid Dependence (Apr 2020)

April 10, 2020

According to our recent payer coverage analysis for Opioid Dependence treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for Opioid Dependence treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for opioid dependence treatments shows that under the pharmacy benefit, about 53% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: In April 2019, the FDA approved Teva Pharmaceuticals’ generic naloxone nasal spray, an equivalent to Emergent BioSolutions’ Narcan, which can be used to reverse opioid overdoses.

Trends That Matter for Cost Impact of Coronavirus Treatment

April 9, 2020

Though many health insurers have removed cost barriers related to testing patients for the new coronavirus that’s sweeping the globe, they largely haven’t pledged to waive out-of-pocket costs for severely sickened members who require hospitalization. A new analysis suggests that the cost of caring for those patients could be steep for members and health plans alike, but experts tell AIS Health it may be too early to say what that will actually mean for commercial insurance markets.

Though many health insurers have removed cost barriers related to testing patients for the new coronavirus that’s sweeping the globe, they largely haven’t pledged to waive out-of-pocket costs for severely sickened members who require hospitalization. A new analysis suggests that the cost of caring for those patients could be steep for members and health plans alike, but experts tell AIS Health it may be too early to say what that will actually mean for commercial insurance markets.

According to the analysis, from the Peterson Center on Healthcare and the Kaiser Family Foundation (KFF), the average total cost — combining employer-plan spending and patient out-of-pocket costs — for a pneumonia-related hospital stay “with major complications and comorbidities” was $20,292 in 2018. For a stay “with complications or comorbidities,” the average cost was $13,767, and for patients without complications, the price tag was $9,763. Looking at out-of-pocket costs alone, the average cost for patients with major complications or comorbidities was $1,300.

But those estimates can only tell us so much about the financial impact of the pandemic, KFF Executive Vice President for Health Policy Larry Levitt said during a March 18 web briefing with reporters.

“We have some information about what the cost for each patient will be, but we have very little information yet about how many patients there may be,” Levitt said in response to a question from AIS Health. “And that’s the big area of uncertainty — how widespread the infection will be and how many people will become severely ill and require hospitalization. So insurers at this point are running blind on how much the total cost may be.”

Generally, regulators do not permit health insurers to recoup prior-year losses through premium increases, “so insurers are going to be focusing a lot on what the ongoing cost” of the coronavirus outbreak could be when pricing their products, Levitt said.

Radar On Market Access: Amid COVID-19 Outbreak, CMS Relaxes Rules on MA Data Collection

April 7, 2020

As efforts to contain the outbreak of COVID-19 continue to evolve, the Trump administration on March 30 issued a series of new flexibilities aimed at increasing hospital and provider capacity. At the same time, CMS in a March 30 memo provided some respite to Medicare Advantage and Part D plans dealing with the crisis by suspending audit and quality reporting activities so that plans and states can focus on providing care to the increasing number of beneficiaries affected by the new coronavirus, AIS Health reported.

As efforts to contain the outbreak of COVID-19 continue to evolve, the Trump administration on March 30 issued a series of new flexibilities aimed at increasing hospital and provider capacity. At the same time, CMS in a March 30 memo provided some respite to Medicare Advantage and Part D plans dealing with the crisis by suspending audit and quality reporting activities so that plans and states can focus on providing care to the increasing number of beneficiaries affected by the new coronavirus, AIS Health reported.

As physicians cater to patients who are or may be infected with COVID-19, and as the federal government advises adults to delay elective surgeries and nonessential procedures during the outbreak, plans are likely to face issues with reporting quality data used to determine future star ratings.

CMS in an interim final rule issued March 30 said it will allow for several key changes to the calculations for the 2021 and 2022 Parts C and D star ratings to account for the expected impact of the public health emergency on data collection and performance.

Up until this point, the potential impact of COVID-19 on CMS’s quality agenda and more specifically quality-based payments to MA plans was a major area of uncertainty for insurers, points out Dan Mendelson, founder of Avalere Health. “The MA quality payment system is based largely on visits that are not possible in a world where COVID-19 has changed the face of American health care, so this program needs to be fundamentally modified for 2021,” says Mendelson. “It appears that CMS still intends to use star ratings, albeit a very different version that relies largely on historical data — which will advantage plans that had a strong prior year.”

But in addition to the interim final rule, more guidance may be needed on the potential impact of COVID-19 on MA payment rates for 2021. And the most important additional guidance that the industry needs, Mendelson says, is for CMS “to allow for telehealth visits to fully substitute for face-to-face visits during this critical and uncertain period of time.”

MMIT Reality Check on COPD (Apr 2020)

April 3, 2020

According to our recent payer coverage analysis for glaucoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for glaucoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for glaucoma treatments shows that under the pharmacy benefit, about 60% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: In March 2020, the FDA approved Allergan plc’s Durysta (bimatoprost implant) 10 mcg to treat open-angle glaucoma or ocular hypertension. This is the first intracameral biodegradable sustained-release implant for the indication.

Perspectives on New Generic HIV Drug

April 2, 2020

A generic version of Truvada coming on the market later this year will affect how payers cover pre-exposure prophylaxis (PrEP), but it will not significantly change how payers cover HIV drugs, experts tell AIS Health.

A generic version of Truvada coming on the market later this year will affect how payers cover pre-exposure prophylaxis (PrEP), but it will not significantly change how payers cover HIV drugs, experts tell AIS Health.

Gilead Sciences, Inc.’s Truvada (emtricitabine/tenofovir disoproxil fumarate) was approved by the FDA in 2004 to treat HIV infection in combination with other antiretroviral drugs. In 2012, it also was approved as the first drug for PrEP. In March 2019, Gilead announced that it had entered into an agreement with Teva Pharmaceutical Industries Ltd. to allow the company to launch its generic version on Sept. 30, 2020.

Payer coverage of PrEP also will be affected by a recommendation from the U.S. Preventive Services Task Force (USPSTF). In 2019, the USPSTF recommended PrEP therapy for those at high risk of HIV acquisition, according to a white paper written by Lynn Nishida, R.Ph., vice president of clinical product and contracting for WithMe Health.

“With the USPSTF recommendation, Medicaid expansion programs and health plans are going to have to cover PrEP without any cost sharing,” says Tim Horn, director of medication access and pricing at the National Alliance of State & Territorial AIDS Directors. Therefore, payers will move toward generic versions.

Dan Mendelson, founder and former CEO of consulting firm Avalere Health, says that whenever a drug goes generic, payers usually have a plan in place to make sure the generic is used. “The more expensive the drug, the more likely that the plan will be comprehensive and aggressive,” he says.

Since HIV is one of the six protected classes in the Medicare Part D program, Part D plans typically cover all HIV products, says Michael Schneider, principal at Avalere Health, as there is little to no rebating in the category. “So, there is really no incentive for the PBMs acting on behalf of their clients, the plans, to do anything in terms of a utilization management standpoint or negotiation standpoint outside of just bringing the generics on formulary.”

Most of the branded HIV products are in the Part D specialty tier, requiring coinsurance, due to their high cost. When a generic comes on the market, plans typically will remove the branded product and then place the generic in the specialty tier or the preferred brand tier depending on the cost of the generic product, he says.

Radar On Market Access: Congress Could Pass Medicare Part D Reform Even Amid COVID-19 Outbreak

March 31, 2020

With the federal government consumed by responding to the COVID-19 outbreak, the possibility of Congress passing drug-pricing legislation might seem dim. But analysts say it’s very possible that something like an overhaul of the Medicare Part D benefit could still make its way into legislation that federal lawmakers pass in the coming weeks or months to address the ongoing public health crisis, AIS Health reported.

With the federal government consumed by responding to the COVID-19 outbreak, the possibility of Congress passing drug-pricing legislation might seem dim. But analysts say it’s very possible that something like an overhaul of the Medicare Part D benefit could still make its way into legislation that federal lawmakers pass in the coming weeks or months to address the ongoing public health crisis, AIS Health reported.

Congress’ latest coronavirus-related stimulus package, which is worth more than $2 trillion, also contains provisions that would extend some Medicare and public health funding. That’s important for those watching drug-price reform because, when Congress failed to include measures addressing surprise medical billing or drug pricing in the budget bill it passed in December, many expected those issues to be addressed in legislation passed by a May 22 deadline to renew certain health care “extenders.”

However, just because the latest stimulus bill wiped out the May deadline, it doesn’t preclude the possibility of Congress passing other health care legislation in the near future that could be a vehicle for drug-pricing measures, Matt Kazan, a principal at Avalere Health, tells AIS Health.

In fact, because so many Americans will be struggling economically in the coming months, the calls for the Trump administration and lawmakers to increase drug affordability will only get “louder and louder,” Andrew Baum, the head of global health care research at Citi, said during a March 24 call with analysts about the effect of the coronavirus on the health care sector.

And it appears that the drug-pricing measure with the greatest chance of passing is an overhaul of the Medicare Part D benefit, Miryam Frieder, a practice director at Avalere Health, said during a recent webinar hosted by the consultancy. It’s the one provision in drug-pricing legislation Congress has considered in the past year that both political parties largely agree on, she pointed out.

Michael Schneider, a principal at Avalere, added that Part D plans need to be prepared for the benefit to get a makeover.

“This is just going to mean that plans are going to have to look at their membership and some other factors and start to decide how they’re going to overcome that additional liability without premiums going through the roof,” Schneider said.

MMIT Reality Check on Glaucoma (Mar 2020)

March 27, 2020

According to our recent payer coverage analysis for glaucoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for glaucoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for glaucoma treatments shows that under the pharmacy benefit, about 60% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: In March 2020, the FDA approved Allergan plc’s Durysta (bimatoprost implant) 10 mcg to treat open-angle glaucoma or ocular hypertension. This is the first intracameral biodegradable sustained-release implant for the indication.

Trends That Matter for Asthma Medications

March 26, 2020

While payers have long used telephone-based care management teams to improve outcomes for members with asthma, now they’re also deploying other strategies to fine-tune their outreach to those who are in most need of support, AIS Health reported.

While payers have long used telephone-based care management teams to improve outcomes for members with asthma, now they’re also deploying other strategies to fine-tune their outreach to those who are in most need of support, AIS Health reported.

Every member with asthma should have an asthma action plan, says Karen Meyerson, director of commercial care management at Michigan-based Priority Health. Such a plan, which is completed by a patient’s doctor, should include a medication list, tips on recognizing worsening symptoms and steps for responding in an emergency.

Priority Health members can also use a cost-estimator tool to shop for the lowest-cost drugs. For example, members can use the tool to discover a less-expensive generic drug and a pharmacy where their asthma medications cost less.

Nurses and social workers at EmblemHealth conduct home visits to assess the level of dust and mold in asthma patients’ environments, Richard Dal Col, M.D., the insurer’s chief medical officer, tells AIS Health.

To help promote medication adherence, EmblemHealth charges members who use combination inhalers one copay, instead of two. The insurer also allows a 90-day supply for rescue and maintenance medications; depending on their plan design, members may be able to pay one copay, rather than three.

The graphic below show how Asthma medications are covered among commercial health plans, health exchange programs and Medicare programs under the pharmacy benefit.

Radar On Market Access: ACA Plans and Medicaid May See Enrollment Growth Amid COVID-19 Pandemic

March 26, 2020

The COVID-19 pandemic is shaping up to be a stress-test for the post-Affordable Care Act insurance market. The crisis has already caused mass layoffs, and experts say the individual health insurance exchanges and Medicaid could see record enrollment in the coming months as a result, AIS Health reported.

The COVID-19 pandemic is shaping up to be a stress-test for the post-Affordable Care Act insurance market. The crisis has already caused mass layoffs, and experts say the individual health insurance exchanges and Medicaid could see record enrollment in the coming months as a result, AIS Health reported.

“This would be the first recession since the Affordable Care Act went into effect, so we are in somewhat uncharted territory in terms of what might happen in a recession under both the ACA marketplace and the Medicaid expansion,” Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, said during a March 18 conference call with reporters.

Levitt said the ACA marketplace is likely to see rapid growth in enrollment as workers lose jobs or hours, making them eligible for special enrollment periods in some cases.

“Household income is going to tend to fall, and that will put more people into that lowest income category with the broadest enrollment in the ACA marketplace,” Levitt said. That influx of enrollees, he added, “has the potential to improve the risk pool in the ACA marketplace and shouldn’t, by itself, have a big effect on premiums.”

Meanwhile, “as people lose their jobs and their incomes fall below 138% of poverty in those states that have expanded Medicaid, we’re likely to see growth in Medicaid enrollment — as we typically do during recessions,” Levitt said.

“Medicaid traditionally has been countercyclical….It’s an economic balancer,” says David Anderson, a health policy researcher at Duke University’s Margolis Center for Health Policy. “In 2009 [during the last economic recession], the federal government raised the federal payment rate — the federal share of Medicaid — by 6.2 points. What that did is it gave states breathing room in their budget…That extra federal share takes a little bit of pressure off the rest of the state budget.”

To that end, President Donald Trump on March 18 signed the Families First Coronavirus Response Act, which, among a host of other provisions, temporarily increased the Medicaid federal medical assistance percentage by 6.2 points.

Radar On Market Access: Questions Remain About Cost Impact of Coronavirus Treatment

March 24, 2020

Though many health insurers have removed cost barriers related to testing patients for the new coronavirus that’s sweeping the globe, they largely haven’t pledged to waive out-of-pocket costs for severely sickened members who require hospitalization. A new analysis suggests that the cost of caring for those patients could be steep for members and health plans alike, but experts tell AIS Health it may be too early to say what that will actually mean for commercial insurance markets.

Though many health insurers have removed cost barriers related to testing patients for the new coronavirus that’s sweeping the globe, they largely haven’t pledged to waive out-of-pocket costs for severely sickened members who require hospitalization. A new analysis suggests that the cost of caring for those patients could be steep for members and health plans alike, but experts tell AIS Health it may be too early to say what that will actually mean for commercial insurance markets.

According to the analysis, from the Peterson Center on Healthcare and the Kaiser Family Foundation (KFF), the average total cost — combining employer-plan spending and patient out-of-pocket costs — for a pneumonia-related hospital stay “with major complications and comorbidities” was $20,292 in 2018. For a stay “with complications or comorbidities,” the average cost was $13,767, and for patients without complications, the price tag was $9,763. Looking at out-of-pocket costs alone, the average cost for patients with major complications or comorbidities was $1,300.

But those estimates can only tell us so much about the financial impact of the pandemic, KFF Executive Vice President for Health Policy Larry Levitt said during a March 18 web briefing with reporters.

“We have some information about what the cost for each patient will be, but we have very little information yet about how many patients there may be,” Levitt said in response to a question from AIS Health. “And that’s the big area of uncertainty — how widespread the infection will be and how many people will become severely ill and require hospitalization. So insurers at this point are running blind on how much the total cost may be.”

Generally, regulators do not permit health insurers to recoup prior-year losses through premium increases, “so insurers are going to be focusing a lot on what the ongoing cost” of the coronavirus outbreak could be when pricing their products, Levitt said.

MMIT Reality Check on Major Depressive Disorder (Mar 2020)

March 20, 2020

According to our recent payer coverage analysis for major depressive disorder treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for major depressive disorder treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for major depressive disorder treatments shows that under the pharmacy benefit, about 36% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Nasal spray Spravato (esketamine) entered the market in spring 2019 as the first truly new product for major depressive disorder in years, but despite its potential to be a game-changer for those with treatmentresistant depression, most people with the condition will continue to be treated with tried-and-true generics.

Perspectives on Legality of Closed Medicaid Formularies

March 19, 2020

As part of long-awaited guidance that CMS issued to states on Jan. 30 outlining how they can test-drive a fixed federal Medicaid budget and more program flexibilities, the Trump administration invited states to try out something else that hasn’t been done before: implement a closed drug formulary for a portion of their Medicaid population, AIS Health reported.

As part of long-awaited guidance that CMS issued to states on Jan. 30 outlining how they can test-drive a fixed federal Medicaid budget and more program flexibilities, the Trump administration invited states to try out something else that hasn’t been done before: implement a closed drug formulary for a portion of their Medicaid population, AIS Health reported.

“For the first time, participating states will have more negotiating power to manage drug costs by adopting a formulary similar to those provided in the commercial market, with special protections for individuals with HIV and behavioral health conditions,” CMS said in its press release unveiling the Healthy Adult Opportunity demonstration, which states can apply for via a Section 1115 Medicaid waiver.

Currently, states’ Medicaid programs must cover all FDA-approved drugs, as mandated by federal law. But CMS is suggesting that states can waive that requirement for the population they choose to cover under their demonstration — likely people who are covered by Medicaid expansion — and still participate in the Medicaid Drug Rebate Program.

But some industry experts tell AIS Health they’re not sure whether that will be legally permissible.

“I have my doubts as to whether this will bear legal scrutiny because it goes against the entire Medicaid Drug Rebate Program, which is rebates in exchange for open formularies,” says Jeff Myers, the former CEO of Medicaid Health Plans of America and founder of health care consulting firm OptDis.

Indeed, “the legal side is obviously the giant question with the whole Healthy Adult Opportunity program,” Jason Karcher, an actuary with Milliman, Inc., tells AIS Health. “We just don’t know how the courts will ultimately see this, although I think it would be fair to be skeptical that we’ll actually get to see a waiver under this [guidance] make it in the near future.”

Radar On Market Access: COVID-19 Outbreak Could Impact Drug Supply Long-Term

March 19, 2020

Industry experts say the COVID-19 outbreak is unlikely to limit U.S. drug supplies in the short or middle term. However, they tell AIS Health that increased demand for longer-duration stocks of medication from self-isolating patients could strain supplies going forward.

Industry experts say the COVID-19 outbreak is unlikely to limit U.S. drug supplies in the short or middle term. However, they tell AIS Health that increased demand for longer-duration stocks of medication from self-isolating patients could strain supplies going forward.

“We are told at this point that we’re not seeing any [drug] shortages in the marketplace today,” says Kelly McGrail-Pokuta, Prime Therapeutics’ vice president of pharmaceutical trade.

On Feb. 27, FDA Commissioner Stephen Hahn released a statement that said disruptions to the pharmaceutical supply chain have been minimal so far. The statement also said that the FDA was especially focused on 20 manufacturers that are particularly dependent on operations in China, and found that “none of these firms have reported any shortage to date.”

But on March 10, the FDA postponed all inspections of overseas drug manufacturing facilities “through April, effective immediately,” according to another statement released by Hahn.

During a pandemic, the CDC recommends anyone taking prescription medication to manage a chronic condition keep an expanded supply of their medicine on hand. As more people self-isolate, and consumers seek to spend less time in stores and other public places, demand for backup medication is likely to increase.

Mike Schneider, a principal at Avalere Health who previously worked for CVS Caremark, says PBMs and payers will have to rethink their typical posture toward chronic medication as enrollees stock up in anticipation of self-isolation.

“Hopefully, with everything going on related to coronavirus and people wanting to stock up, those quantity limits would be eased or eliminated for the most part for chronic meds,” says Schneider.

The Blue Cross Blue Shield Association’s “network of 36 independent and locally operated” affiliates have all decided to waive prescription refill limits on maintenance medications, according to America’s Health Insurance Plans. Other non-Blues insurers have also taken steps to allow members to refill prescriptions in advance.

Experts say it’s difficult to know whether the drug supply will be affected down the road. Schneider says consumer stockpiling and the FDA’s move to suspend foreign inspections could both make an impact on future supply.

Radar On Market Access: Insurers, Pharma Spar Over Copay Accumulator Provision

March 17, 2020

Health insurers are praising a provision in a recently proposed regulation that gives commercial plans greater leeway to run so-called copay accumulator programs, which prevent drug manufacturer coupons from counting toward patients’ annual deductibles or out-of-pocket cost limits. But the pharmaceutical industry slammed the proposal as “misguided” and liable to prevent patients from getting vital medications.

Health insurers are praising a provision in a recently proposed regulation that gives commercial plans greater leeway to run so-called copay accumulator programs, which prevent drug manufacturer coupons from counting toward patients’ annual deductibles or out-of-pocket cost limits. But the pharmaceutical industry slammed the proposal as “misguided” and liable to prevent patients from getting vital medications.

“I do think these programs are here to stay, and I do think they will continue to grow in terms of the absolute numbers as we head into ’22 and beyond,” Jayson Slotnik, a partner at Health Policy Strategies, LLC., tells AIS Health. From insurers’ point of view, copay accumulator programs help combat the perverse incentives that drug manufacturer coupons create: steering patients to pricey brand-name drugs by obscuring their true cost.

In its 2021 proposed Notice of Benefit and Payment Parameters, CMS clarifies that all non-grandfathered individual and group market health plans “have the flexibility to determine whether to include or exclude coupon amounts from the annual limitation on cost sharing, regardless of whether a generic equivalent is available.”

To America’s Health Insurance Plans, it’s important to allow the use of copay accumulator programs even for drugs that don’t have a generic version in order to spur competition between branded drugs that can treat the same condition. “Drug manufacturers recognize this and spend billions of dollars to dilute the impact of competition by providing coupons for brand drugs that do not have a generic equivalent,” the trade group wrote in its comment letter about the proposed rule.

But the Pharmaceutical Research and Manufacturers of America (PhRMA) sees it very differently.

“It would compromise patients’ ability to adhere to prescribed medicines at a moment when insurance coverage for medicines continues to erode; it would put patient health and financial security in danger; it would run directly counter to the Administration’s stated policy of lowering patient out-of-pocket costs for prescription drugs; and it could undermine the appeal and availability of high-deductible health plans,” PhRMA wrote.

MMIT Reality Check on Hereditary Angioedema (Mar 2020)

March 13, 2020

According to our recent payer coverage analysis for hereditary angioedema treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for hereditary angioedema treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for hereditary angioedema treatments shows that under the pharmacy benefit, about 67% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: The FDA will review BioCryst Pharmaceuticals, Inc.’s application for oral, once daily berotralstat for the prevention of swelling attacks in patients with hereditary angioedema, with a decision expected by early December 2020.

Trends That Matter for Diabetes Drug Costs

March 12, 2020

With the cost of diabetes drugs still growing, PBMs and payers are looking for more innovative strategies to hold down costs, AIS Health reported. For some, that might include a strategy similar to the one recently unveiled by CVS Health Corp.’s Caremark unit. The plan, called RxZERO, offers a slimmer formulary for the diabetes drug class, but with no out-of-pocket costs for members.

With the cost of diabetes drugs still growing, PBMs and payers are looking for more innovative strategies to hold down costs, AIS Health reported. For some, that might include a strategy similar to the one recently unveiled by CVS Health Corp.’s Caremark unit. The plan, called RxZERO, offers a slimmer formulary for the diabetes drug class, but with no out-of-pocket costs for members.

Mike Schneider, a principal in the commercialization and market access practice at Avalere Health, says the plan is innovative. “You’ve seen Express Scripts do something where they’re offering specific insulins at very low out-of-pocket costs, but this is the first time I’ve seen a PBM come up with a way to eliminate out-of-pocket costs completely,” he tells AIS Health.

With the elimination of copays and other cost-sharing payments for diabetes drugs, CVS is betting members will better adhere to drug regimens and potentially avoid unnecessary hospitalizations and other services.

In January, Eli Lilly and Co. said it planned to sell new versions of Humalog Junior KwikPen and Humalog Mix 75-25 at half of their current U.S. list prices. Novo Nordisk A/S also started to offer generic versions of its frequently prescribed insulin drugs Novolog and Novolog Mix 70-30 at a 50% discount compared to the current list price. The graphics below show how these four medications are covered among commercial health plans, health exchange programs and Medicare and Medicaid programs.

Radar On Market Access: Insurers Deploy Array of Strategies to Manage Asthma

March 12, 2020

While payers have long used telephone-based care management teams to improve outcomes for members with asthma, now they’re also deploying other strategies to fine-tune their outreach to those who are in most need of support, AIS Health reported.

While payers have long used telephone-based care management teams to improve outcomes for members with asthma, now they’re also deploying other strategies to fine-tune their outreach to those who are in most need of support, AIS Health reported.

Every member with asthma should have an asthma action plan, says Karen Meyerson, director of commercial care management at Michigan-based Priority Health. Such a plan, which is completed by a patient’s doctor, should include a medication list, tips on recognizing worsening symptoms and steps for responding in an emergency.

Priority Health members can also use a cost-estimator tool to shop for the lowest-cost drugs. For example, members can use the tool to discover a less-expensive generic drug and a pharmacy where their asthma medications cost less.

Nurses and social workers at EmblemHealth conduct home visits to assess the level of dust and mold in asthma patients’ environments, Richard Dal Col, M.D., the insurer’s chief medical officer, tells AIS Health.

To help promote medication adherence, EmblemHealth charges members who use combination inhalers one copay, instead of two. The insurer also allows a 90-day supply for rescue and maintenance medications; depending on their plan design, members may be able to pay one copay, rather than three.

Blue Shield of California members with asthma can receive a home visit by a nurse or a physician. Phillip Baldi, D.O., lead medical care director at the insurer, says while home visits seem expensive, the insurer’s rates with a company providing home visits is comparable to what it pays for an in-person visit to a doctor’s office. “If we can divert five emergency room visits, we can have 50 home visits,” he tells AIS Health.

The insurer is also evaluating offering select maintenance drugs at lower or no copays for members with asthma.

Radar On Market Access: Florida Saw Strong MA, Individual Results and More Consolidations

March 10, 2020

Florida’s health insurers remain highly profitable as the overall market has grown significantly more concentrated, with companies such as Anthem, Inc. and Florida Blue snapping up numerous smaller HMOs over the past several years, particularly in the Medicare Advantage (MA) space, says the author of a new report on the Florida market.

Florida’s health insurers remain highly profitable as the overall market has grown significantly more concentrated, with companies such as Anthem, Inc. and Florida Blue snapping up numerous smaller HMOs over the past several years, particularly in the Medicare Advantage (MA) space, says the author of a new report on the Florida market.

Independent analyst and consultant Allan Baumgarten, who studies state health care markets, tells AIS Health that he expects consolidation to continue.

“There is a new crop of insurers that started business in 2019, including some new Medicare Advantage plans, plus Bright Health and Oscar [Health Insurance],” Baumgarten says. “I think that the Medicare Advantage plans, if they grow to a certain threshold size — maybe 25,000 enrollees or more — will be targets for acquisition. In fact, I think some of the entrepreneurs that started those new plans [did so] as a build and then sell strategy.”

Baumgarten’s report, which looked at enrollment, profitability and acquisitions in 2018, found that HMOs enjoyed strong profits in 2018 despite enrollment that slipped around 2.2%, mainly as a result of fewer people in Medicaid HMOs.

“For the health plans, two lines of business have been especially profitable — Medicare Advantage, consistently for the past eight years or more, and individual health plans [including exchange coverage] in the past two years,” Baumgarten says.

“The premiums paid to Medicare Advantage plans in Florida are among the highest in the country, which is why health plans are eager to start or acquire Medicare plans here,” the report explains.

Insurers weren’t the only health care players pursuing mergers and acquisitions in 2018, says. Overall, the report spotlights “growing consolidation on both the hospital system and health insurer sides, leading to strong profitability for both hospitals and health plans,” Baumgarten says.

MMIT Reality Check on HIV (Mar 2020)

March 6, 2020

According to our recent payer coverage analysis for HIV treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for HIV treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for HIV treatments shows that under the pharmacy benefit, about 78% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: In September 2019, the FDA expanded the indi