Trump Administration Proposes Rules to Apply Medicare Price Negotiations to Some Reformulated Drugs

The Trump administration last month proposed rules to close a loophole that drugmakers could use to reset eligibility clocks for Medicare price negotiations by adding active ingredients. Forbes reported that the Centers for Medicare and Medicaid Services intends to group original and reformulated products together when the new ingredient enables a different route of administration.

The proposal applies specifically to biologics reformulated from intravenous to subcutaneous injectable products.

Adding hyaluronidase, for example, would allow subcutaneous injections of existing drugs. Subcutaneous versions of Keytruda and Opdivo would therefore face negotiations on the same schedule as their intravenous counterparts. CMS also seeks to codify the negotiation process in permanent regulations beginning with the initial price applicability year 2029.

Forbes reported that the rules would cover every stage from drug selection through the offer and counteroffer process to publication of maximum fair prices. The first round of ten drugs selected in 2023 saw maximum fair prices take effect in January 2026.

Eligibility requires small-molecule drugs to be at least seven years post-launch without bona fide generic competition and large-molecule biologics to be eleven years post-launch without biosimilar competition.

Selected products must rank among the top fifty by Medicare Part D spending, and beginning this year also among the top fifty by Part B spending. Keytruda and Opdivo treat a wide array of cancers. Their intravenous formulations approach patent expiration in 2028, with biosimilar entry unlikely before the end of that year.