On January 17, 2025, HHS announced a selection of 15 additional drugs for Medicare price negotiations under the Inflation Reduction Act (IRA).
The IRA requires the HHS Secretary to directly negotiate the prices of certain high-expenditure, single-source drugs without generic or biosimilar competition. For each selected drug, the negotiation process aims to arrive at a maximum fair price (MFP) based on clinical benefits, therapeutic alternatives, and manufacturer-specific factors.
Drugs included in the second round are Ozempic, Rybelsus, and Wegovy; Trelegy Ellipta; Xtandi; Pomalyst; Ibrance; Ofev; Linzess; Calquence; Austedo and Austedo XR; Breo Ellipta; Tradjenta; Xifaxan; Vraylar; Janumet and Janumet XR; and Otezla. Together, the 15 drugs on the second negotiation list were used by 5.3 million people with Medicare Part D coverage from November 2023 to October 2024, resulting in approximately $41 billion in gross costs under Medicare Part D, or almost 14% of expenditures during that period.