Biosimilars Without Interchangeable Status Proposed for Medicare Coverage by CMS

In a proposed rule on technical changes to the Medicare program, CMS said it wants to permit biosimilar biologic products to be substituted for the reference product, even if the FDA has not yet deemed the biosimilar to be interchangeable.

CMS had previously proposed to permit Part D sponsors to immediately substitute interchangeables for their reference products and/or to treat the substitution as a change, with 30 days’ notice to Medicare enrollees currently taking the reference drug.

 This issue becomes more significant as it is intertwined with one of the requirements of the Inflation Reduction Act (IRA) for Medicare to negotiate prices on the top 10 most costly drugs in the program. Since the passage of the legislation, some pharmaceutical manufacturers whose drugs were selected for the top 10 have sued HHS claiming the price negotiation program is unconstitutional.

Comments are due on the proposed rule by Jan. 5, 2024.

Read the proposed rule here.

To read the whole story, click here to subscribe.

Related Topics