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MMIT Reality Check on Kidney Cancer (July 2021)

July 30, 2021

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 52% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In March 2021, the FDA approved Aveo Oncology’s Fotivda (tivozanib) for the treatment of adults with relapsed or refractory advanced renal cell carcinoma who have received at least two prior systemic therapies.

by Matt Breese

Trends That Matter for Zeposia

July 29, 2021

On May 27, the FDA gave an additional indication to Bristol Myers Squibb’s Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis. It is the first and only sphingosine 1-phosphate (S1P) receptor modulator approved for this indication. However, according to payers responding to a survey by Zitter Insights, the treatment may have some challenges breaking into the space, AIS Health reported.

On May 27, the FDA gave an additional indication to Bristol Myers Squibb’s Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis. It is the first and only sphingosine 1-phosphate (S1P) receptor modulator approved for this indication. However, according to payers responding to a survey by Zitter Insights, the treatment may have some challenges breaking into the space, AIS Health reported.

How much will Zeposia cost?

  • Treatment is initiated with a 0.23 mg dose once daily on days one through four, then 0.46 mg once daily on days five through seven and then 0.92 mg once daily afterwards. The price of a starter kit consisting of the initial 37-day supply is $9,110, and a 30-day supply is $7,387 for an annual wholesale acquisition cost of just under $90,000.

How will payers manage Zeposia?

  • For the Managed Care Biologics & Injectables Index: Q3 2020, between Aug. 25, 2020, and Sept. 28, 2020, Zitter Insights polled 50 commercial payers with 127.5 million covered lives. Payers with 67% of covered lives said they are unlikely to prefer Zeposia over other therapies approved for ulcerative colitis or to incentivize physicians to prescribe it. Almost one-quarter said they are likely to exclude it from formulary.

How will gastroenterologists prescribe Zeposia?

  • During the same time frame, Zitter Insights polled 50 gastroenterologists about their anticipated prescribing of Zeposia. Almost two-thirds said that they are likely to prescribe the agent for people with ulcerative colitis who had not responded to a previous treatment, and more than half said they are unlikely to prescribe the new drug as a first-line therapy for ulcerative colitis.

Almost half said they would prescribe it over certain agents in the class, with those respondents citing AbbVie Inc.’s Humira (adalimumab) and Simponi (golimumab) from Janssen Biotech, Inc., a Johnson & Johnson company, as the drugs they were likely to prescribe instead of Zeposia.

by Angela Maas

 

Radar on Market Access: Senate Will Likely Decide Fate of Drug Pricing, PBM Reforms

July 29, 2021

Congress is inching closer to passing the largest individual spending bill in U.S. history through budget reconciliation. D.C. insiders say some combination of Medicare Part D out-of-pocket spending caps, Medicare drug price negotiation, caps on launch prices and/or price growth, or PBM reform might make its way through both chambers, AIS Health reported. 

Congress is inching closer to passing the largest individual spending bill in U.S. history through budget reconciliation. D.C. insiders say some combination of Medicare Part D out-of-pocket spending caps, Medicare drug price negotiation, caps on launch prices and/or price growth, or PBM reform might make its way through both chambers, AIS Health reported.

Drug pricing measures: 

  • Consideration of drug pricing measures has moved to the Senate. Insiders expect H.R. 3has the votes to make it out of the lower chamber. However, few expect that the bill would make it through the Senate intact. H.R. 3, titled the Lower Drug Costs Now Act, caps Part D out-of-pocket costs, allows Medicare to negotiate drug prices and bans the price of drugs from increasing faster than the annual rate of inflation. Some — but not all — of those provisions could clear the Senate.

Patent reform: 

  • The Senate Judiciary Committee’s Subcommittee on Competition Policy, Antitrust and Consumer Rights held a hearing on July 13 on how patent reform could help lower drug prices. Experts and lobbyists from industry groups held forth on subjects including patent thickets and the biosimilar pipeline.

Medicare coverage expansion: 

  • According to Loren Adler, an associate director of the USC-Brookings Schaeffer Initiative for Health Policy, Democrats’ highest priority seems to be making expanded subsidies for marketplace enrollees permanent — but after that, expanding Medicare to include vision and dental is the most popular health care policy among the Democratic caucus.

James Gelfand, senior vice president for health policy at the ERISA Industry Committee, expects that a cap on out-of-pocket spending on Part D drugs will be included if plumping Medicare benefits does become a centerpiece of the Democrats’ health care agenda. But he thinks that’s a bad idea if it is not combined with negotiated prices in Part D or a cap on drug price hikes tied to inflation.

by Peter Johnson

 

Radar on Market Access: Rezurock Is Approved With More Transplant Agents in Pipeline

July 27, 2021

The FDA on July 16 approved Rezurock (belumosudil) for the treatment of patients 12 years and older who have chronic graft vs. host disease (GVHD) and for whom at least two prior systemic therapies have failed. But that isn’t the only therapy used to treat organ and tissue transplant patients that payers should be watching, AIS Health reported.

The FDA on July 16 approved Rezurock (belumosudil) for the treatment of patients 12 years and older who have chronic graft vs. host disease (GVHD) and for whom at least two prior systemic therapies have failed. But that isn’t the only therapy used to treat organ and tissue transplant patients that payers should be watching, AIS Health reported.

Background:

  • Rezurock targets patients whose cases are more difficult to treat, and it appears to be safe and well tolerated, according to Mesfin Tegenu, R.Ph., president and CEO of RxParadigm. Roughly 60% of chronic GVHD patients fail two or more lines of systemic therapy, meaning they could benefit from Rezurock — a first-in-class ROCK2 inhibitor and Kadmon Holdings, Inc.’s first FDA-approved drug.
  • With GVHD, “the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign, and the donated cells/bone marrow attack the host’s body. This is in contrast to organ transplant rejection where the recipient’s immune system attacks (rejects) the transplanted organ,” explains Arash Sadeghi, a clinical pharmacist at UnitedHealth Group’s OptumRx.

Other agents for transplant patients:

  • Maintenance treatments for prevention of organ transplant rejection (the opposite of  GHVD) include drugs like calcineurin inhibitors (such as tacrolimus and cyclosporine), mTOR inhibitors (including sirolimus and everolimus), antimetabolic agents (e.g., mycophenolate and azathioprine), and glucocorticoids like prednisone, Sadeghi says.
  • Mesfin Tegenu, R.Ph., president and CEO of RxParadigm, highlights polyclonal antibodies, which include thymoglobulin and atgam, and monoclonal antibodies (rituximab), as other available treatments.

How payers manage those therapies:

  • “These agents are generally on formulary; however, there may be variations in tiering,” Tegenu says. “Additionally, formulary positioning for monoclonal and polyclonal antibodies [is] more closely monitored with prior authorizations and placement in [the] specialty tier.”
  • OptumRx, however, does not have clinical utilization management in place for anti-organ-rejection drugs, according to Sadeghi. Generally, such therapies are generic and inexpensive, he says; a point on which Tegenu agrees.

More drugs in pipeline:

The drug pipeline for GVHD is beginning to get interesting. For acute GVHD, agents being studied include an anti-CD6 antibody that prevents T-cell activation and T-cell migration, called alpa-1 antitrypsin, and a double antibody conjugate that is an anti-CD3 and anti-CD7 agent, Tegenu says.

by Leslie Small

 

Industry Voices—For payers, determining Aduhelm coverage is a waiting game

July 26, 2021

While it has been over a month since the FDA announced its controversial decision to approve Biogen’s Alzheimer’s drug, Aduhelm, payers have been slow to make any decisions—and for good reason.

While the excitement around the approval is undeniable given the long-overdue unmet need for Alzheimer’s patients, there are still many questions stemming from the therapy’s stated efficacy and the FDA’s waffling over the label’s indication and usage section. With CMS’s recent move to open a National Coverage Determination (NCD) analysis, many payers will likely delay their initial reviews even further or use interim policies until CMS makes its final coverage decision in nine months.

And since Medicare is expected to shoulder most of the financial burden—senior citizens make up the majority of patients living with Alzheimer’s—there needs to be a high level of certainty about the drug’s clinical benefit. As a result, we may see a more restrictive NCD with respect to Aduhelm.

While it has been over a month since the FDA announced its controversial decision to approve Biogen’s Alzheimer’s drug, Aduhelm, payers have been slow to make any decisions—and for good reason.

While the excitement around the approval is undeniable given the long-overdue unmet need for Alzheimer’s patients, there are still many questions stemming from the therapy’s stated efficacy and the FDA’s waffling over the label’s indication and usage section. With CMS’s recent move to open a National Coverage Determination (NCD) analysis, many payers will likely delay their initial reviews even further or use interim policies until CMS makes its final coverage decision in nine months.

And since Medicare is expected to shoulder most of the financial burden—senior citizens make up the majority of patients living with Alzheimer’s—there needs to be a high level of certainty about the drug’s clinical benefit. As a result, we may see a more restrictive NCD with respect to Aduhelm.

Of the few policies we’ve seen written to date (in draft or final version), some payers are excluding the product as “investigational and not medically necessary,” and others are covering the product with stringent prior authorization requirements that reflect the inclusion and exclusion criteria from the clinical trials.

The policies are also requiring routine MRIs before the seventh and 12th infusions, an additional consideration contributing to the cost for the patient and the system. While routine monitoring is common for patients dealing with chronic disease states, the burden of monitoring these patients could contribute to nonadherence and, therefore, denial of reauthorization.

What’s more, blocking access may not be an option for many payers outside of self-insured employers. Certain states and federal agencies do not allow for the exclusion of most FDA-approved treatments. Some payers will be required to bear the costs of this new treatment.

What can we expect moving forward?

As it stands, Aduhelm is in Phase IV of the clinical research process. Phase IV studies, which typically involve thousands of people, look at drugs that have already been approved by the FDA. The drugs are available for healthcare providers to prescribe to patients, but questions—about the drug itself and the FDA’s intentions—still need to be answered.

Some are considering the approval of Aduhelm a rallying cry for debating the FDA’s evaluation of therapies. As a pharmacist, I can see both sides of the debate. On one side, patient advocacy groups representing Alzheimer’s patients and their families say any new therapy showing any amount of benefit should be approved.

And if you’ve ever witnessed someone decline from Alzheimer’s, as I have, then you can understand the argument. But many experts warn that fast-tracking the drug without showing solid clinical benefit could set a dangerous precedent, making payers the regulators of utilization based on questionable clinical benefit.

Time will tell if there is a real clinical benefit to Aduhelm with Biogen’s confirmatory trials and with its use in the broader population. In the meantime, we wait. We wait to see if CMS creates a national coverage policy to set guidance on reimbursement. We wait for payers to create their own policies. We wait to see the results of the federal investigation as to whether interactions between Biogen executives and FDA officials during the review process violated FDA rules, which could undermine the public confidence in the approval.

We look forward to learning whether Aduhelm’s effect on brain plaque associated with Alzheimer’s actually benefits patients, especially since other manufacturers have molecules in clinical trials that work similarly. If clinical results show that Aduhelm truly makes an impact on the disease itself, a little competition is always healthy for drug pricing and may even bring down the cost.

Jayne Hornung is the Chief Clinical Officer at MMIT (Managed Markets Insight & Technology).

MMIT Reality Check on Bipolar Disorder (July 2021)

July 23, 2021

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 21% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In May 2021, the FDA approved Alkermes plc’s Lybalvi (olanzapine and samidorphan) for adults with schizophrenia and for adults with bipolar I disorder, for the acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate and as a maintenance monotherapy treatment.

by Matt Breese

Perspectives on Cigna’s Efforts to Spur Biosimilar Adoption

July 22, 2021

Cigna Corp. revealed in a recent press release that starting in July, it “will offer all eligible customers the option to receive a one-time $500 debit card for health care services and products if they decide to switch to a biosimilar or another preferred medication.” The insurer also gave preferred status on its formularies to two approved biosimilars for Janssen’s immunosuppressive drug Remicade (infliximab), Avsola and Inflectra, AIS Health reported.

Cigna Corp. revealed in a recent press release that starting in July, it “will offer all eligible customers the option to receive a one-time $500 debit card for health care services and products if they decide to switch to a biosimilar or another preferred medication.” The insurer also gave preferred status on its formularies to two approved biosimilars for Janssen’s immunosuppressive drug Remicade (infliximab), Avsola and Inflectra, AIS Health reported.

Background:

  • The new “Shared Savings Program” comes months after the American Journal of Managed Care obtained a letter sent to providers by the insurer, stating that patients could receive a $500 debit card if they switch from Novartis’ Cosentyx (secukinumab) to Eli Lilly & Co.’s Taltz (ixekizumab) or an older biologic before Aug. 31 and then refill the prescription before Dec. 31.
  • At the time, Taltz was already preferred over Cosentyx on most of Cigna’s 2021 formularies, “so the $500 card program may have been a signal that Cigna didn’t feel that their traditional utilization management tools were as effective at migrating existing patients to a preferred drug when it comes to these chronic drugs,” says Omar Hafez, managing director at Avalere Health.

Expert’s view:

  • According to Hafez, patient preferences as well as “continuity of care/non-medical switching/step therapy laws” are all barriers to moving patients from their existing biologics, “but the $500 card could help convince some patients to switch on their own, partially neutralizing these barriers.”

“The fact that Cigna is rolling this out to the infliximabs could be a sign that Cigna was pleased with the results of [the Taltz/Cosentyx] program and is trying to replicate it in a physician administered drug setting,” Hafez says.

by Leslie Small

 

Radar on Market Access: Executive Order Revives Standardized ACA Exchange Plans

July 22, 2021

In President Joe Biden’s new executive order aimed at promoting competition in the American economy, he directs HHS Secretary Xavier Becerra to “implement standardized options in the national Health Insurance Marketplace,” AIS Health reported.

Standardized plans on the federally run health insurance exchange, HealthCare.gov, are not a new concept: They were initially introduced during the Obama administration before being rolled back by the Trump administration. And several states that run their own exchanges currently have some form of standardized plans.

In President Joe Biden’s new executive order aimed at promoting competition in the American economy, he directs HHS Secretary Xavier Becerra to “implement standardized options in the national Health Insurance Marketplace,” AIS Health reported.

Standardized plans on the federally run health insurance exchange, HealthCare.gov, are not a new concept: They were initially introduced during the Obama administration before being rolled back by the Trump administration. And several states that run their own exchanges currently have some form of standardized plans.

What do industry experts say?

  • “Advocates of standardized plans will highlight goals of making plans simpler to use and putting key [health care services] before deductibles, things like that,” says Myra Simon, a principal at Avalere Health. “How standardized plans are implemented is going to affect to whether they contribute to those goals or not.”
  • In Simon’s view, the Biden administration would be wise to improve upon how standardized plans were displayed on HealthCare.gov in prior years. “I think some decision support optimization combined with standard plans would probably be more effective than just standard plans by themselves,” Simon suggests.
  • Joel Ario, a managing director at Manatt Health, notes that in addition to simplifying the shopping experience, standardized plans generally aim to feature lower cost-sharing levels than their non-standard counterparts. But that can result in such plans carrying higher premiums, he says, which makes it all the more important that such plans are paired with robust consumer-shopping tools that guide people to plans that offer the most value overall.

How will plans react to the reintroduction?

  • “It’s interesting to have it proposed as a way to increase competition, because I think what the issuers always said is that it was anti-competition,” points out Katherine Hempstead, senior adviser to the executive vice president at the Robert Wood Johnson Foundation. Insurers, she adds, said “that if you make them all sell the same thing, they can’t differentiate enough. I would expect that maybe they would say that again.”

On the other hand, “I feel kind of like standardizing plans has become more accepted, or it’s gotten a little more mainstream” since states like California have championed the concept, Hempstead says.

by Leslie Small

 

Radar on Market Access: UnitedHealth Touts Clinical Assets in 2Q Earnings Call

July 20, 2021

UnitedHealth Group — which in recent months has been tightening the screws on spending drivers like unnecessary emergency care and out-of-network utilization — is signaling that its greater goal for cost containment comprises much more than simply site-of-care management, AIS Health reported. Rather, the company’s emphasis on its care-delivery assets during its second-quarter earnings conference call may suggest that UnitedHealth is increasingly pursuing the strategy of “if you can’t beat them, own them.”

UnitedHealth Group — which in recent months has been tightening the screws on spending drivers like unnecessary emergency care and out-of-network utilization — is signaling that its greater goal for cost containment comprises much more than simply site-of-care management, AIS Health reported. Rather, the company’s emphasis on its care-delivery assets during its second-quarter earnings conference call may suggest that UnitedHealth is increasingly pursuing the strategy of “if you can’t beat them, own them.”

Pushing practices toward value-based care:

  • “I think you’re really starting to see OptumHealth…starting to demonstrate [its] capacity for growth because of the scale of the footprint that they now [have] established across the country,” UnitedHealth CEO Andrew Witty said of the company’s health services division during a July 15 call to discuss quarterly earnings.
  • OptumHealth expects to add about 10,000 clinicians this year, and “we’re well over halfway through that journey,” Witty said.
  • Beyond “simply having the practices and the clinicians,” UnitedHealth is placing an ever-increasing focus on shifting how care is delivered and reimbursed.
  • Wyatt Decker, M.D., who is the CEO of OptumHealth, noted that the UnitedHealth subsidiary is particularly focused on taking best practices from markets that have used capitated payment models for years — such as Texas and Southern California — and transferring them to markets that have historically been fee-for-service-centric, such as the Pacific Northwest and the Northeast.

UnitedHealth’s 2Q performance:

  • As health care utilization levels have begun to return to normal after ultra-high, peak-pandemic care deferral levels last year, UnitedHealth’s medical loss ratio (MLR) has ticked back up to 82.8% compared with 70.2% in the year-ago quarter. Still, UnitedHealth’s MLR beat the Wall Street consensus estimate of 83%, observed Citi analyst Ralph Giacobbe in a July 15 research note.
  • The firm continues to expect a $1.80 COVID-related negative impact on its earnings per share (EPS) for 2021 as a whole, with most of those effects predicted in the second half of the year.
  • During the second quarter, UnitedHealth recorded an adjusted EPS of $4.70, beating the consensus of $4.43.

by Leslie Small

 

The Power of Partnerships: Why Pharma Needs to Redefine its Role With IDNs

July 19, 2021

Large healthcare conglomerates, or integrated delivery networks (IDNs), have long been fixtures in the market access landscape—a dynamic that has gone unchanged despite the disruption caused by COVID-19. While M&A activity slowed down during 2020, IDNs are seeing a bout of positive recognition: Many have received accolades on their ability to deliver quality coordinated care during a year of upheaval for healthcare. Partly thanks to this reputation boost, we expect that merger activity will start picking up where it left off pre-pandemic, but what will a surge of newly consolidated healthcare stakeholders mean for pharma manufacturers?

IDNs will no doubt continue to expand their reach and influence, further shifting the balance of power away from payers. While IDNs held sway over drug administration decisions before COVID-19, this trend accelerated during the early months of the pandemic as we saw large healthcare systems request that patients administer their own injections rather than risk infection at the hospital. While this might sound situational to the pandemic, consider what it might look like if IDNs continue flexing their muscles when it comes to drug administration.

Large healthcare conglomerates, or integrated delivery networks (IDNs), have long been fixtures in the market access landscape—a dynamic that has gone unchanged despite the disruption caused by COVID-19. While M&A activity slowed down during 2020, IDNs are seeing a bout of positive recognition: Many have received accolades on their ability to deliver quality coordinated care during a year of upheaval for healthcare. Partly thanks to this reputation boost, we expect that merger activity will start picking up where it left off pre-pandemic, but what will a surge of newly consolidated healthcare stakeholders mean for pharma manufacturers?

IDNs will no doubt continue to expand their reach and influence, further shifting the balance of power away from payers. While IDNs held sway over drug administration decisions before COVID-19, this trend accelerated during the early months of the pandemic as we saw large healthcare systems request that patients administer their own injections rather than risk infection at the hospital. While this might sound situational to the pandemic, consider what it might look like if IDNs continue flexing their muscles when it comes to drug administration.

For example, with a number of CAR-T therapies in the oncology pipeline, we expect to see many more IDNs invest in the skills and experience needed to administer these drugs instead of relying on external centers of excellence. While the IDNs shoulder the risk, they gain more control over site-of-care administration, and the reimbursement for administering expensive therapies like CAR-T could prove a worthy incentive. That said, in-patient reimbursement for CAR-T therapies is a complex process, so IDNs are also likely to explore the financial implications of outpatient administration.

As we can see with their increasing influence over provider-administered therapies, it’s no surprise that IDNs are looking to exert control where they face the highest level of financial risk. While administration is a large risk, so too is distribution, leading many IDNs to start their own specialty pharmacies to both increase revenue and improve patient care. Moreover, having their own specialty pharmacies allows IDNs to access EHR systems for tracking outcomes and adherence, and intervene when patients aren’t getting the full value of their medication. In fact, many IDNs that already own specialty pharmacies have been able to provide support services like product education, financial assistance and adherence tools.

However, IDNs that own or plan to own specialty pharmacies face challenges, too. Some manufacturers will leave them out of limited distribution networks in an effort to retain visibility into distribution. Others may require IDN-owned specialty pharmacies to have specific accreditations. One area where this scenario is currently playing out is in prostate cancer: We’re seeing that some IDNs are unable to access lifesaving drugs because they’re excluded from a manufacturer’s distribution network. But given the increasing scale of today’s IDNs, and the number of drugs that need to be administered in a healthcare setting, manufacturers would be smart to incorporate IDN specialty pharmacies into their distribution strategies—or risk losing out on a significant share of the market.

Ultimately, pharma can no longer be reticent to partnering with IDNs. These stakeholders have much to offer, including the opportunity to drive increased market share, greater control over contract terms, centralized communication and improved patient outcomes. Forward-looking manufacturers are adjusting their IDN commercial strategies to go beyond financial incentives. How can manufacturers engage IDNs in the clinical trials process? What can they do to improve patient support or education? How can they help operationalize care and improve efficiency?

Each IDN will have its own idea of what’s most valuable, so in addition to monitoring coverage, it’s critical that manufacturers have a strong understanding of their IDN customers’ business models, unique characteristics and evolving needs. After all, how can manufacturers meet IDNs’ unmet needs when they don’t know what they are?

Given the external factors that have positioned IDNs to continue growing in both size and scope, it’s time to rethink the one-size-fits-all approach to IDN engagement. A true strategic partnership—underpinned by robust customer data—isn’t just nice to have. Now, it’s mission critical.

Learn more about MMIT’s Pulse Analytics solution, which allows pharma manufacturers the ability to monitor drug coverage at the brand and IDN level, and offers insights into the structure, clinical pathway alignment and behaviors of more than 200 IDNs.

By: Dinesh Kabaleeswaran, Director, Advisory Services, MMIT, and John Griggs, Senior Solution Consultant, MMIT

This article was originally published on Drug Channels.