The Centers for Medicare & Medicaid Services (CMS) has unveiled the 15 high-cost medications selected for the third cycle of the Medicare Drug Price Negotiation Program. In a significant shift for the pharmaceutical industry, this latest round includes medications covered under Medicare Part B for the first time, alongside traditional Part D selections.
Escalating programme scope
The newly selected list features prominent therapies across several therapeutic areas, including diabetes, HIV, asthma and arthritis. Negotiations are expected to take place throughout 2026, with the resulting maximum fair prices scheduled to go into effect on 25 January 2028. This cycle also introduces the programme’s first renegotiation for a previously selected therapy manufactured by [add in company name]
Background: a growing mandate
The programme, launched in 2022 under the Inflation Reduction Act, claims to aid in fostering a fairer, more sustainable pricing landscape in the US by granting the government power to negotiate prices for single-source drugs that lack generic or biosimilar competition. While the first two cycles focused exclusively on retail pharmacy drugs (Part D), the 2026 cycle marks the expansion into physician-prescribed treatments (Part B), which are typically among the highest-expenditure categories for the health service.
“CMS is taking strong action to target the most expensive drugs in Medicare, negotiate fair prices and make sure the system works for patients,” explains Dr Mehmet Oz, Administrator, CMS. “This approach delivers real savings while strengthening accountability across the programme.”
Industry response and clinical factors
The pharma industry is now evaluating the list, which includes prominent therapies in oncology and immunology. Manufacturers have until 28 February 2026 to enter into negotiation agreements. CMS suggests the process will weigh clinical benefits, R&D costs and the impact on unmet medical needs.
“The publication of the list of top 50 negotiation-eligible drugs evidences CMS’ commitment to transparency,” says Chris Klomp, Deputy Administrator and Director, CMS. “By applying clear eligibility criteria… we are ensuring the programme responds to market changes while delivering fairness and value.”
Future market implications
As the pharma industry prepares for the 2026 negotiation window, stakeholders remain focused on how the inclusion of Part B drugs will alter the competitive landscape and long-term pricing strategies for specialty therapeutics.
