CMS announces manufacturer participation in third cycle of Medicare drug price negotiation

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Dr. Mehmet Oz, Administrator at Centers for Medicare & Medicaid Services | Centers for Medicare & Medicaid Services

CMS announces manufacturer participation in third cycle of Medicare drug price negotiation

The Centers for Medicare & Medicaid Services (CMS) announced on March 13 that drug companies manufacturing the 15 drugs selected for the third cycle of the Medicare Drug Price Negotiation Program have chosen to participate in the program, along with one company whose drug was selected for renegotiation.

According to CMS, these negotiations target high expenditure, single source drugs without generic or biosimilar competition. The list of participating manufacturers includes GlaxoSmithKline Intellectual Property Development Ltd. England (Anoro Ellipta), Gilead Sciences Inc (Biktarvy), AbbVie Inc. (Botox; Botox Cosmetic), UCB, Inc. (Cimzia), Novartis Pharmaceuticals Corporation (Cosentyx and Kisqali), Takeda Pharmaceuticals U.S.A., Inc. (Entyvio), Janssen Biotech, Inc. (Erleada), Eisai Inc (Lenvima), Bristol-Myers Squibb Company (Orencia), Otsuka Pharmaceutical Company, Ltd. (Rexulti), Boehringer Ingelheim Pharmaceuticals, Inc. (Tradjenta1), Eli Lilly and Company (Trulicity and Verzenio), PF PRISM CV (Xeljanz; Xeljanz XR), and Genentech, Inc. (Xolair).

Key milestones in this process include CMS issuing draft guidance for public comment on May 12, 2025, followed by final guidance on September 30, 2025 detailing requirements for the third negotiation cycle set to occur during 2026. Negotiated prices from this round will become effective beginning in 2028.

On January 27, 2026, CMS announced both the selection of these drugs and the statutory deadline of February 28 for manufacturers to agree to participate in negotiations. By March 1, participating companies and the public could submit data regarding selected drugs and their therapeutic alternatives.

Next steps outlined by CMS involve inviting each manufacturer to meetings about their data submissions and hosting patient-focused roundtable events as well as town hall meetings open to clinicians and researchers focused on clinical considerations related to each drug. Initial offers from CMS proposing maximum fair prices are scheduled no later than June 1, with a structured negotiation period running through November if agreement is not reached earlier.

Further details about this negotiation process can be found according to the official roster page.