RE: Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026, and Solicitation of Comments

The price of a drug should include all the generic versions in the price estimate. [...] Although the evidence is more limited, market shares for biosimilars have been on the order of 20% to 25% a year after entry.2 The implication is that if the generic or biosimilar shares of the API fall below the trigger values, the API remains in an uncompetitive market and should remain subject to negotiation. [...] This works for the selection of the initial 50 negotiation eligible drugs because it makes the data and the selection process transparent. [...] The negotiation process would benefit from review of the and the findings of these comparative effectiveness studies and the methods used by these countries. [...] This will need to be done on a drug-by-drug basis depending on the circumstances of the negotiated drug and the other drugs in the therapeutic class.