Spotlight on Market Access

Payers covering 81% of commercial lives have implemented copay accumulator programs as of September 2023, compared with 89% in 2022, according to data collected by MMIT (AIS Health’s parent company) on 35 insurers and PBMs representing 117.8 million lives. Payers covering 71% of people were enrolled in plans with copay maximizers, down from 76% in 2022. However, on average, payers anticipated a 30% increase in the number of plan sponsors opting into such programs next year and a 14% increase in member enrollment in plans with copay accumulators and maximizers.

Since the FDA approved the first biosimilar — Zarxio (filgrastim-sndz) from Sandoz, then a division of Novartis Pharmaceuticals Corp. — on March 6, 2015, the agency has approved more than 40 additional agents via the 351(k) pathway established under the Biologics Price Competition and Innovation Act (BPCIA), itself part of the Affordable Care Act (ACA). This past year has been especially busy in the space, with highlights including the launch of nine biosimilars of AbbVie Inc.’s Humira (adalimumab) and approvals of the first biosimilars of three different biologics: Biogen’s Tysabri (natalizumab), Actemra (tocilizumab) from Genentech USA, Inc., a member of the Roche Group and Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson. As the FDA approves more biosimilars, uptake of these agents will continue to increase, say industry experts.

“2023 was a banner year for the biosimilar market,” contends Andy Szczotka, Pharm.D., chief pharmacy officer at AscellaHealth. “The availability of biosimilars across multiple therapeutic areas provides opportunities for physicians, patients and payers to have additional clinical and cost-saving treatment choices.”

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.