Medicare could delay some drug price talks for biosimilars

The Secretary would delay selecting some biological medicines for Medicare price negotiation. The rule applies to a biological medicine that could be selected for Medicare price negotiation and has a potential biosimilar. The biosimilar maker must have disclosed, or the Secretary must have learned, that its application was accepted for review or approved, or that required studies were underway, complete, or unnecessary. The Secretary must find that the maker expects to market the biosimilar within two years of the selection date. Before deciding, the Secretary must share the information relied on and require the maker to confirm or correct it in writing under penalty of perjury. Pending or expected patent litigation alone would not prevent the delay. The delay applies to the initial price year for which the biological medicine otherwise could have been selected.

The Secretary would select a delayed medicine for a later price year, and its maker would owe rebates if the biosimilar misses the stated licensing and marketing deadline. This applies to a biological medicine whose selection was delayed under the proposed biosimilar rules. The later selection applies if, during the delay period, the Secretary determines that the biological medicine is not the reference product for a biosimilar that has been licensed and marketed. The maker owes rebates if that biosimilar has not been licensed and marketed by the deadline. The rebate covers years when the maker would have provided access to the negotiated price, with different formulas for Medicare drug coverage and physician-administered medicines. The later price year begins two years after the year in which the medicine otherwise would have been selected. The rebate deadline is two years after the original selection date.