HHS Targets 15 Drugs for Medicare Part D Negotiations, Including Semaglutide

The US Department of Health and Human Services (HHS), through the Centers for Medicare and Medicaid Services (CMS), announced an additional 15 drugs covered under Medicare Part D for price negotiations in 2025, targeted for chronic conditions including type 2 diabetes, COPD, and schizophrenia.

As circulated by the HHS on January 17, 2025, negotiations with participating drug companies will transpire in 2025, with any negotiated prices becoming effective in 2027, in line with the Inflation Reduction Act (IRA) passed in August 2022.1

“Last year, we proved that negotiating for lower drug prices works. Now we plan to build on that record by negotiating for lower prices for 15 additional important drugs for seniors,” Xavier Becerra, HHS Secretary, said in a statement. “Today’s announcement is pivotal–the Inflation Reduction Act is lowering prices for people on Medicare. HHS will continue negotiating in the best interest of people with Medicare to have access to innovative, life-saving treatments at lower costs.”

HHS announced the 15 selected drugs for the second round of negotiations included:

• Semaglutide (Ozempic; Rybelsus; Wegovy) - Diabetes
• Fluticasone furoate, umeclidinium, and vilanterol inhalation powder (Trelegy Ellipta) - COPD
• Enzalutamide (Xtandi) - Metastatic Castration-Resistant Prostate Cancer
• Pomalidomide (Pomalyst) - Multiple Myeloma
• Palbociclib (Ibrance) - HR-positive, HER2-negative advanced or metastatic breast cancer
• Nintedanib (Ofev) - Idiopathic Pulmonary Fibrosis, ILDs with Progressive Phenotype, SSo-ILD
• Linactolide (Linzess) - IBS-C, Chronic Idiopathic Constipation in Adults, Functional Constipation in Pediatrics
• Acalabrutinib (Calquence) - Mantle Cell Lymphoma, CLL, SLL
• Deutetrabenazine (Austedo; Austedo XR) - Chorea associated with Huntington’s disease
• Fluticasone furoate / Vilanterol (Breo Ellipta) - COPD, Asthma
• Linagliptin (Tradjenta) - Type 2 Diabetes
• Rifaximin (Xifaxan) - IBS-D, Hepatic Encephalopathy, Traveler’s Diarrhea
• Cariprazine (Vraylar) - Schizophrenia, Bipolar I Disorder
• Sitagliptin/Metformin (Janumet; Janumet XR) - Type 2 Diabetes
• Apremilast (Otezla) - Psoriatic Arthritis, Plaque Psoriasis

HHS indicated nearly 5.3 million people with Medicare Part D coverage used these drugs between November 2023 and October 2024, accounting for $41 million in total gross covered prescription drug costs under Medicare Part D (~14%). Combined with the total gross covered prescription drug costs for the 10 drugs selected for the first round of negotiations in August 2023, these costs represented more than a third of total gross covered prescription drug costs under Medicare Part D.1

“Improving prescription drug affordability for Medicare enrollees is the core of the Inflation Reduction Act, and the next cycle of negotiations will continue to strengthen Medicare for generations to come,” Chiquita Brooks-LaSure, CMS Administrator, said in a statement.1

Under the final guidance for the second cycle of the Drug Price Negotiation Program, drug companies will have until February 28, 2025, to determine their negotiation participation. CMS will evaluate the selected drug’s clinical benefit, how it addresses an unmet medical need, and its payoff for specific populations, including those on Medicare. Negotiations will also focus on research and development costs and production and distribution for the 15 selected drugs.1

In the first cycle of negotiations, CMS negotiated with drug manufacturers and agreed on lower prices for all 10 drugs to become effective January 1, 2026. These new prices ranged from 38–79% discounts off list prices.2 People with Medicare prescription drug coverage are expected to see aggregated estimated savings of $1.5 billion in their out-of-pocket spending in 2026, according to HHS.1

CMS will select for negotiation up to an additional 15 drugs for the third cycle of negotiation, including drugs covered under Medicare Part B and Part D, and up to 20 more for each subsequent cycle after that, as summarized in the Inflation Reduction Act.3

“Today, I’m proud to announce that my Administration has selected the next 15 drugs for Medicare drug price negotiation. The drugs treat conditions such as diabetes and cancer, and seniors across the country rely on them,” President Joe Biden, said in a statement.4 “These 15 drugs, together with the 10 drugs that Medicare already negotiated, represent about a third of Medicare Part D spending on prescription drugs, which means the lower prices my Inflation Reduction Act is delivering will put money back in seniors’ pockets across the country.

References

1. HHS announces 15 additional drugs selected for Medicare Drug Price negotiations in continued effort to lower prescription drug costs for seniors. CMS.gov. January 17, 2025. Accessed January 17, 2025. https://www.cms.gov/newsroom/press-releases/hhs-announces-15-additional-drugs-selected-medicare-drug-price-negotiations-continued-effort-lower.
2. Campbell P. Biden administration, CMS reveal first 10 drugs set for price negotiation. HCP Live. August 29, 2023. Accessed January 17, 2025. https://www.hcplive.com/view/biden-administration-cms-reveal-first-10-drugs-set-for-price-negotiation.
3. Assistant Secretary for Public Affairs (ASPA). Inflation reduction act and Medicare. HHS.gov. January 16, 2025. Accessed January 17, 2025. https://www.hhs.gov/inflation-reduction-act/index.html.
4. Statement from president Joe Biden on the next fifteen drugs selected for Medicare Drug Price Negotiation. The White House. January 17, 2025. Accessed January 17, 2025. https://www.whitehouse.gov/briefing-room/statements-releases/2025/01/17/statement-from-president-joe-biden-on-the-next-fifteen-drugs-selected-for-medicare-drug-price-negotiation/.