Spotlight on Market Access

Only 2% of Medicare beneficiaries who enrolled in a stand-alone Prescription Drug Plan (PDP) in 2024 will be in contracts with 4 or more stars, compared to 42% in the 2022 plan year and 9% in 2023, according to CMS’s recently released estimates. The average Star Rating for PDPs dropped to 3.11 in 2024 from 3.70 in 2022, with two contracts receiving 1.5 stars.

The distribution change is largely fueled by methodology changes in how many of the Star Ratings are calculated. Known as Tukey outlier deletion, the changes center on removing outlier contract scores when determining the cut points for all non-Consumer Assessment of Healthcare Providers and Systems measures.

Although PBMs are taking increasing heat for spread pricing — or charging payers more for a drug than pharmacies are reimbursed — they aren’t the only players in the drug supply chain that engage in the practice, a new study points out. And one of the study’s authors says its findings suggest that patients may be better off if generic drugs are simply removed from insurance coverage entirely.

The study, published in JAMA Health Forum on Oct. 20, examined data associated with 45 high-utilization Medicare Part D-covered generic drugs.

When the Affordable Care Act (ACA) became law on March 23, 2010, it established the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), which amended the Public Health Service (PHS) Act. Since then, the FDA has approved more than 40 biosimilars, with only a handful of those gaining interchangeable status. That designation, however, may not carry quite the distinction it historically has had if proposed guidance from the agency — which would replace previous guidance — on labeling for interchangeable biosimilars is finalized. Various stakeholders, including manufacturers, pharmacies, patients and providers, stand to be affected, stakeholders say.

In contrast to the EU, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) clarified in September 2022 that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars.

CVS Health is getting into the biosimilars business, the company said in late August, and will officially enter the market on Jan. 1 in partnership with a Humira biosimilar. CVS stressed the importance of driving use of biosimilars and ensuring their supply, which sources say is a positive development. But one industry source questions whether the new company raises potential conflict-of-interest issues.

On Aug. 23, CVS revealed that it had launched the wholly owned subsidiary Cordavis to commercialize and/or co-produce biosimilars in collaboration with drug manufacturers. “Through Cordavis, CVS Health intends to develop a portfolio of products that it expects will facilitate broader access to biosimilars in the U.S. — creating more competition that drives down prices — while encouraging investment in future products,” said the company in a press release.

Following the launch of almost 10 biosimilars of AbbVie Inc.’s Humira (adalimumab) this year, 2025 will be another big year for the U.S. biosimilar market, when no less than three versions of Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson are set to become available. Having the experience of assessing multiple competitors with varying attributes could help payers as they prepare for the launches, say industry experts.

Stelara is a human interleukin-12 (IL-12) and -23 (IL-23) antagonist indicated for the treatment of adults with moderately to severely active Crohn’s disease, adults with moderately to severely active ulcerative colitis, people at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and people at least 6 years old with active psoriatic arthritis.