Perspectives

Perspectives on New-to-Market Oral Drugs

January 7, 2021

In its latest quarterly Drug Pipeline Insights Report, OptumRx includes a diverse array of medications that the UnitedHealth Group-owned PBM believes are likely to make a market impact when they’re approved by the FDA, AIS Health reported. One interesting trend that applies to three of the five highlighted drugs is the fact that each is the first oral option in its respective category.

While oral medications tend to be thought of as more convenient than injectable or IV-administered therapies, that factor alone may not confer as much of a competitive advantage as one might think, according to one OptumRx executive.

In its latest quarterly Drug Pipeline Insights Report, OptumRx includes a diverse array of medications that the UnitedHealth Group-owned PBM believes are likely to make a market impact when they’re approved by the FDA, AIS Health reported. One interesting trend that applies to three of the five highlighted drugs is the fact that each is the first oral option in its respective category.

While oral medications tend to be thought of as more convenient than injectable or IV-administered therapies, that factor alone may not confer as much of a competitive advantage as one might think, according to one OptumRx executive.

Take roxadustat, which if approved would be the first novel therapy for chronic kidney disease-related anemia since 1989 and would offer an oral alternative to the injectable erythropoiesis-stimulating agents (ESAs) currently being used to treat the condition.

“Dialysis-dependent patients usually get their ESAs administered with dialysis via IV infusion, so the oral alternative in these patients doesn’t provide a convenience benefit necessarily,” says Bill Dreitlein, senior director of pipeline and drug surveillance at OptumRx. “However, there may be alternative benefits around safety.”

Then there’s Orladeyo (berotralstat), BioCryst Pharmaceuticals, Inc.’s treatment for hereditary angioedema (HAE) attacks. When the FDA approved Orladeyo on Dec. 3, it became the first oral plasma kallikrein inhibitor for the prevention of HAE attacks, Dreitlein says.

“The convenience benefit for berotralstat would have been more significant,” he says, but the 2018 approval of approval of Takhzyro, which is subcutaneously administered every two to four weeks and can be self-administered, “diminishes that because it already reduced the number of injections vs. older C1 concentrate products.”

The FDA on Dec. 18 approved relugolix, the first oral GnRH receptor antagonist on the market for advanced prostate cancer.

Relugolix’s oral administration gives it an advantage over Firmagon (degarelix), which requires monthly subcutaneous injections by a health care provider “and hasn’t garnered much commercial success because of the frequent injections and injection site reactions,” Dreitlein says.

The more common GnRH receptor agonists, on the other hand, require intramuscular injections at intervals ranging from one to six months. “Compared to these drugs, relugolix might confer some clinical advantages, but the convenience benefit is reduced because you are replacing an injection given potentially every six months with an oral daily medication,” Dreitlein adds.

Perspectives on Amazon Pharmacy

December 24, 2020

Amazon.com, Inc. made a splash in the health care world on Nov. 17 when the online retail powerhouse unveiled new pharmacy offerings that aim to disrupt the prescription drug market with increased convenience and savings, AIS Health reported.

In addition to setting up its own online pharmacy, Amazon is partnering with one of the three largest PBMs — Cigna Corp.’s Express Scripts — to offer a prescription-savings benefit that will be available to Amazon Prime members. “It can be used for discounts up to 80% off generic and 40% off brand name medications at over 50,000 participating pharmacies nationwide,” according to a press release.

Amazon.com, Inc. made a splash in the health care world on Nov. 17 when the online retail powerhouse unveiled new pharmacy offerings that aim to disrupt the prescription drug market with increased convenience and savings, AIS Health reported.

In addition to setting up its own online pharmacy, Amazon is partnering with one of the three largest PBMs — Cigna Corp.’s Express Scripts — to offer a prescription-savings benefit that will be available to Amazon Prime members. “It can be used for discounts up to 80% off generic and 40% off brand name medications at over 50,000 participating pharmacies nationwide,” according to a press release.

Notably, Amazon’s new service offers similar functionalities that health insurers, PBMs and major retail pharmacies have included in their prescription-drug shopping tools — but with the twist of making it clear to consumers when it might be cheaper to purchase their drugs without insurance.

To SVB Leerink analyst Stephen Tanal, that constitutes the only notable — and likely minimal — threat to PBMs’ business models.

“The way in which it could be potentially somewhat bad for PBMs is pretty indirect,” says Tanal. “It’s the idea that to the extent that Amazon is now going to be showing every Prime customer two prices for every pharmacy transaction they do with Amazon, it’s really going to highlight the disparities of the cost to you of any given drug if you use insurance or if you choose not to use insurance.”

“What I worry about a little on the margin is, if a lot of people, a lot of the time, for a lot of different drugs start to see that cash pay’s better than insurance, boy, that’s not going to help sentiment and people’s perceptions of insurers and PBMs,” he adds. If that happens, it could increase policymakers’ appetite to regulate PBMs, Tanal points out.

Still, Ashraf Shehata, KPMG’s national sector leader for health care and life sciences, says that payer-owned PBMs have an advantage that Amazon would be hard-pressed to replicate. “The broader value proposition is the drug spend in combination with the total medical spend,” he says, noting that employers, in particular, want to look at the whole picture when trying to keep down costs.

Perspectives on Biden Administration’s Drug-Pricing Moves

December 10, 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.

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.”

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.

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.