The Centers for Medicare & Medicaid Services (CMS) has announced the next 15 high-cost medicines up for price negotiations under the Inflation Reduction Act (IRA).
The third cycle brings prescription drugs with high price tags, which have no biosimilar or generic competition, used by around 1.8 million patients with Medicare Part D or Part B between November 2024 and October 2025.
Drugs in price negotiations this year include Gilead's blockbuster HIV pill Bitkarvy (bictegravir/emtricitabine/tenofovir alafenamide), Eli Lilly's diabetes drug Trulicity (dulaglutide), and Roche’s asthma injection Xolair (omalizumab).
The list also includes cancer therapies from Novartis, Johnson & Johnson (J&J), and Eli Lilly. In addition, several anti-inflammatory medicines are up for price negotiation, such as Takeda's inflammatory bowel disease drug Entyvio (vedolizumab) and Pfizer’s arthritis treatment Xeljanz (tofacitinib).
The 15 selected drugs accounted for approximately $27bn in total prescription drug spending under Medicare Part B and Part D, as per the CMS. Drug companies with a selected drug in this third cycle will have until 28 February of this year to decide if they wish to participate in negotiations.
Cyrus Fan, research analyst in the GlobalData Health Economics and Market Access Research and Analysis team, comments: "The Trump administration continues efforts to advance negotiation efforts in the IRA, despite his preference to implement international reference pricing in the Most Favored Nation (MFN) policies. Much like the previous rounds, I expect all manufacturers with selected drugs to agree to participation in the third round of IRA price negotiations."
Gilead's HIV treatment Biktarvy is the top-selling drug on the list, generating 2024 sales of $13.4bn. In October 2025, the company reached settlements with three generic manufacturers, extending the drug's US patent coverage to April 2036, as per an SEC filing.
There have already been two rounds of negotiations under the Medicare Drug Price Negotiation Program, which operates under the IRA signed into law by former President Joe Biden in 2022.
In August 2024, the Biden administration reached deals on ten prescription drugs, with the price cuts coming into effect in 2026. Medicines such as Pfizer and Bristol Myers Squibb’s blood thinner Eliquis (apixaban) and Amgen’s arthritis drug Enbrel (etanercept) were amongst the first batch negotiated.
Then, in November 2025, the Trump administration reached agreements with a separate set of 15 drugs in the second cycle. Price changes for these drugs, which include Novo Nordisk’s semaglutide brands Ozempic and Wegovy, will take effect from January 2027.
The IRA rounds continue despite uncertainty as to how closely price changes impact the Trump administration’s Most Favored Nation (MFN) policy.
