(Washington, D.C.) — The Pharmaceutical Care Management Association (PCMA) supports the Centers for Medicare and Medicaid Services’ (CMS) proposal to promote the use of biosimilars in Medicare Part D. Pharmacy benefit companies, or PBMs, have long supported the development of a healthy biosimilar market to increase competition and reduce costs for biologic medications, as well as to provide added choice and flexibility for health plan sponsors.

“We applaud the Biden administration’s effort to remove barriers to patient and provider uptake of biosimilars. CMS’ move to enable Part D plans the flexibility to substitute biosimilars for reference products on their formularies mid-year could significantly accelerate biosimilar adoption and the ability to reduce costs for beneficiaries and taxpayers,” said PCMA President and CEO JC Scott. “PBMs unwaveringly support a robust biosimilar market. Bringing more biosimilars to market, over time, will reduce barriers created by drug manufacturers’ abuse of patents and allow PBMs to more effectively leverage competition to reduce drug costs for health plan sponsors and patients.”

In 2022, PCMA issued a set of policy recommendations designed to put an end to brand manufacturers’ tactics and increase biosimilar uptake. The PCMA policy recommendations include:

• Removing the “interchangeability designation” on biosimilars which is a barrier to biosimilar uptake because it causes unnecessary confusion related to just how “similar” biosimilars are to their branded reference biologic. A biosimilar is just as similar to a reference biologic as two separate batches of reference biologics are to one another. This designation does not exist in other countries, and the confusion it creates is a barrier to adoption of highly effective, lower-cost alternatives.
• Enabling plan flexibility. To lower the cost of drugs quicker, as new biosimilars are released, PCMA recommends that the Centers for Medicare & Medicaid Services allow plans the flexibility to make midyear changes to formularies, replacing reference products with biosimilars not designated as interchangeable, without the need for additional permissions and notifications.
• Prohibiting anticompetitive practices that unnecessarily extend branded biologic monopolies. Product hopping occurs when a brand manufacturer makes marginal changes to a product and moves customers from one branded drug to a remarkably similar branded drug with a longer patent life to extend market exclusivity. Patent thickets are a group of overlapping patents, added deliberately over time and used to delay competition far beyond policymakers’ intent.
• Ending drug companies’ “pay for delay” agreements. Monetary agreements that drug companies make with biosimilar manufacturers that involve paying biosimilar manufacturers large amounts to keep their safe and effective alternatives to brand medication off the market for long time periods are anticompetitive and prevent price-lowering competition.
• Revising the innovator biologic exclusivity to seven years. Shortening the exclusivity period for biologics may allow competitors to enter the market sooner. Research shows that prices substantially decrease – not with the first biosimilar to enter the market as with a generic but instead with the second or third. The industry needs more incentives for biosimilars to provide cost-saving competition.

View PCMA’s Website on Biosimilars: PBMs Support and Encourage Biosimilar Competition

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PCMA is the national association representing America’s pharmacy benefit companies. Pharmacy benefit companies are working every day to secure savings, enable better health outcomes, and support access to quality prescription drug coverage for more than 275 million patients. Learn more at www.pcmanet.org