CMS announces drugs selected for third cycle of Medicare drug price negotiations

CMS has named the 15 drugs selected for the third cycle of Medicare price negotiations under the Inflation Reduction Act, including the first Part B medicines and the program’s first renegotiation. With timelines now set through 2028, stakeholders are watching how the expanding framework interacts with wider pricing pressures and ongoing litigation over the program.

The Centers for Medicare & Medicaid Services (CMS) has released the list of 15 drugs selected for the third cycle (IPAY 2028) of the Medicare Drug Price Negotiation Program (DPNP) under the Inflation Reduction Act (IRA), marking a further expansion of the program and introducing several new features.

For the first time, the selected drugs include physician-administered medicines covered under Medicare Part B, alongside drugs covered under Part D. The announcement also includes the DPNP’s first renegotiation, with the Boehringer Ingelheim's type 2 diabetes medication, Tradjenta (linagliptin), becoming the first product to undergo renegotiation after being included in the program’s second cycle.

The selected drugs span a wide range of therapeutic areas, including cancer, autoimmune diseases, HIV, respiratory disorders, and CNS conditions. According to CMS, approximately 1.8 million Medicare Part D or Part B beneficiaries used the 15 medicines in the 12 months ending October 31, 2025. Over that period, the drugs accounted for ~US$27 billion in Medicare pharmaceutical spending, representing ~6% of combined Part D and Part B drug expenditure.

Under the timeline outlined by CMS, manufacturers have until February 28, 2026 to sign agreements to participate in the negotiation program. By October 31, 2026, companies must accept or reject CMS’s proposed maximum fair price (MFP), after which final negotiated prices will be published by November 30, 2026. The negotiated prices are scheduled to take effect on January 1, 2028, requiring manufacturers to begin operational planning well in advance to ensure systems, contracts, and downstream partners are prepared.

The list of medicines selected under CMS’s final guidance for the third negotiation cycle includes:

1. Trulicity (dulaglutide; Eli Lilly) – type 2 diabetes; type 2 diabetes with cardiovascular disease or multiple cardiovascular risk factors
2. Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide; Gilead Sciences) – HIV‑1 infection
3. Orencia (abatacept; Bristol Myers Squibb) – rheumatoid arthritis; psoriatic arthritis
4. Cosentyx (secukinumab; Novartis) – plaque psoriasis; psoriatic arthritis
5. Erleada (apalutamide; Johnson & Johnson) – prostate cancer
6. Kisqali (ribociclib; Novartis) – breast cancer
7. Entyvio (vedolizumab; Takeda) – Crohn’s disease; ulcerative colitis
8. Verzenio (abemaciclib; Eli Lilly) – breast cancer
9. Botox/Botox Cosmetic (onabotulinumtoxinA; AbbVie) – chronic migraine; overactive bladder; spasticity; other Medicare-covered movement disorders
10. Lenvima (lenvatinib; Eisai/Merck) – thyroid cancer; endometrial cancer; liver cancer; kidney cancer
11. Xolair (omalizumab; Roche/Novartis) – asthma; chronic spontaneous urticaria
12. Rexulti (brexpiprazole; Otsuka/Lundbeck) – major depressive disorder; schizophrenia; agitation associated with dementia due to Alzheimer’s disease
13. Xeljanz/Xeljanz XR (tofacitinib; Pfizer) – rheumatoid arthritis; psoriatic arthritis; ulcerative colitis
14. Anoro Ellipta (umeclidinium/vilanterol; GSK) – chronic obstructive pulmonary disease
15. Cimzia (certolizumab pegol; UCB) – Crohn’s disease; plaque psoriasis; psoriatic arthritis; rheumatoid arthritis

The selection of Tradjenta for renegotiation introduces a new dimension to the program as it matures, raising questions about how CMS will approach subsequent pricing cycles for drugs that have already undergone negotiation.

Ahead of the announcement, researchers have used spending and eligibility criteria to predict which products would be selected, aiming to reduce uncertainty for stakeholders preparing for negotiation timelines. One recent analysis correctly identified 13 of the 15 drugs ultimately selected by CMS, suggesting growing predictability in CMS’s approach despite remaining implementation uncertainties.

Building on these observations, Tim Wright of Genesis Research Group noted that the final selections largely align with existing Medicare spending patterns. “Maximum Fair Pricing introduced under President Biden continues to be a relatively straightforward and transparent approach to reducing Medicare spending, and it is significantly easier to understand and evaluate than what we expect to emerge from initiatives such as GENEROUS, GUARD, or GLOBE,” he said. “The selection of the next 15 drugs for negotiation, with implementation in 2028, contains few surprises, but it does highlight the outsized impact of cardiometabolic disorders and cancer treatments on CMS spending.”

Wright has previously noted that the IRA negotiations are unfolding alongside other pricing pressures facing manufacturers, including renewed policy discussions around Most-Favored-Nation (MFN) pricing models. While MFN pricing has not been formally reintroduced, its continued presence in policy debates reinforces the view that Medicare negotiation under the IRA is only one element of a broader and evolving US drug pricing environment.

The announcement also comes against an increasingly complex legal backdrop. Drug pricing challenges under the IRA continue to progress through the US court system, with multiple cases now approaching the Supreme Court. Endpoints News recently reported that Novartis has become the sixth pharmaceutical company to file a petition challenging the IRA, joining AstraZeneca, Bristol Myers Squibb, Johnson & Johnson, Novo Nordisk, and Boehringer Ingelheim. Other legal challenges brought by Merck and PhRMA are still moving through the courts.

In parallel, a group of pharmaceutical companies and industry organizations, including Bausch Health, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, Sanofi, and the Biotechnology Innovation Organization, have filed an amicus brief supporting Teva Pharmaceuticals’ appeal of a federal ruling that upheld CMS guidance on the DPNP. The brief argues that CMS exceeded its statutory authority by aggregating products with the same “active moiety” into a single negotiation entity, a concept not explicitly defined in the statute. According to the brief, this approach risks subjecting newly approved medicines to price negotiation earlier than Congress intended, with potential implications for post-approval research, investment decisions, and long-term innovation incentives.

As CMS moves forward with the third negotiation cycle, the program now sits at the intersection of expanding policy scope, operational complexity, and intensifying legal scrutiny. How these forces interact will shape not only the future of Medicare drug pricing, but also how manufacturers approach evidence generation, pricing strategy, and market access planning in the years ahead.