PCMA Releases Statement on CMS Part D Biosimilar Substitution Announcement

(Washington, D.C.) — The Pharmaceutical Care Management Association (PCMA) released the following statement on the recent announcement from the Centers for Medicare and Medicaid Services (CMS) to allow Medicare Part D plans to substitute all FDA-approved biosimilars on their formularies.

“PCMA applauds CMS’ decision to grant Medicare Part D plans and PBMs the flexibility to substitute any lower-cost, therapeutically equivalent biosimilar in place of a high-cost brand name reference biologic without the need for additional permissions and notifications.

“Pharmacy benefit companies are strong proponents of a robust biosimilar market and have advocated for policy changes like this that will unlock the potential of biosimilars by increasing uptake and put an end to brand manufacturers’ tactics to extend exclusivity on brand-name biologics. 

“This decision by CMS will improve patient access to affordable prescription drugs and aligns with the recent Biden Administration budget proposal to eliminate the ‘interchangeable’ designation in the FDA statute entirely. PCMA looks forward to continuing working with all interested policymakers on additional opportunities to accelerate the adoption of biosimilar products and generate further savings for patients and taxpayers.”

Learn more about how pharmacy benefit companies support and encourage biosimilar competition HERE.

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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.