Medicare drug price negotiations enter second cycle with full industry participation

The Centers for Medicare & Medicaid Services (CMS) has confirmed that all companies producing the 15 drugs selected for the second cycle of the Medicare Drug Price Negotiation Program have agreed to participate.

This latest news marks another step in the highly polarizing negotiation process, established under the Inflation Reduction Act and signed into law in August 2022 by the Biden administration to lower prescription drug costs for Medicare beneficiaries. While aimed at reducing healthcare expenses, the initiative has faced resistance from the pharmaceutical industry. In response to industry concerns, the US government has emphasized "greater transparency" in this round of negotiations.

The 15 drugs selected for negotiation include treatments for cancer, respiratory diseases, diabetes, and neurological disorders. The full list includes:

1. Austedo/Austedo XR – Deutetrabenazine (Huntington’s disease, tardive dyskinesia; Teva)
2. Breo Ellipta – Fluticasone furoate/vilanterol (asthma, COPD; GSK)
3. Calquence – Acalabrutinib (lymphoma; AstraZeneca)
4. Ibrance – Palbociclib (breast cancer; Pfizer)
5. Janumet/Janumet XR – Sitagliptin/metformin (type 2 diabetes; Merck)
6. Linzess – Linaclotide (chronic constipation, IBS-C; AbbVie)
7. Ofev – Nintedanib (idiopathic pulmonary fibrosis; Boehringer Ingelheim)
8. Otezla – Apremilast (psoriasis, psoriatic arthritis, Behçet’s disease; Amgen)
9. Ozempic/Rybelsus/Wegovy – Semaglutide (type 2 diabetes, weight management; Novo Nordisk)
10. Pomalyst – Pomalidomide (multiple myeloma, Kaposi sarcoma; Bristol-Myers Squibb)
11. Tradjenta – Linagliptin (type 2 diabetes; Boehringer Ingelheim)
12. Trelegy Ellipta – Fluticasone furoate/umeclidinium/vilanterol (asthma, COPD; GSK)
13. Vraylar – Cariprazine (depression, bipolar disorder, schizophrenia; AbbVie)
14. Xifaxan – Rifaximin (hepatic encephalopathy, IBS-D; Bausch)
15. Xtandi – Enzalutamide (prostate cancer; Astellas Pharma)

The second negotiation cycle will involve extensive engagement between CMS, drug manufacturers, and stakeholders. CMS will invite each company to a meeting to discuss their data submissions and will also host 15 patient-focused roundtables—one for each drug—where patients, caregivers, and advocacy groups can provide input on patient experiences, treatment alternatives, and unmet medical needs. A separate “town hall meeting” will allow clinicians, researchers, and other stakeholders to weigh in on the clinical considerations of the selected drugs.

The negotiation process will formally begin with CMS sending an initial pricing offer to each manufacturer by June 1, 2025. Companies will have 30 days to respond, either by accepting the proposal or making a counteroffer. If an agreement is not reached, additional negotiation meetings will take place throughout the summer and fall before the deadline on November 1, 2025.

This marks another milestone in the federal government’s effort to drive down drug prices, though ongoing political and industry debates could shape the ultimate impact of the program.