IRA round 2 begins as drugmakers sign on to price negotiation process with CMS

  1. CMS announced on March 14, 2025 that agreements have been signed with manufacturers of all 15 drugs selected for the second cycle of negotiations19.

  2. These 15 drugs are covered under Medicare Part D and were selected in January 2025 for negotiations that will occur in 202519.

  3. The negotiated prices for these drugs will go into effect starting January 1, 202719.

  4. Some key drugs included in this round are Ozempic, Wegovy, Xtandi, Ibrance, and Otezla7.

5. The negotiation process includes several steps19:

  • CMS will invite each participating drugmaker to a meeting about their data submission
  • CMS will host patient-focused roundtables for each selected drug
  • CMS will hold a town hall for clinicians and researchers to discuss clinical considerations
  • CMS will send initial price offers to manufacturers by June 1, 2025
  • Manufacturers have 30 days to accept or counter the offer
  • If needed, up to two additional negotiation meetings can occur before the November 1, 2025 deadline
  1. This builds on the first round of negotiations for 10 drugs that concluded in 2024, with those prices taking effect in 20262.

  2. The IRA allows Medicare to negotiate prices for an increasing number of high-cost drugs each year, aiming to lower drug costs for Medicare and beneficiaries1.

  3. Some drugmakers and Republican lawmakers oppose the program, arguing it could harm pharmaceutical innovation10.

The second round expands Medicare's drug price negotiation efforts, with the process now underway for 15 more widely-used medications. The outcomes will be closely watched by the healthcare and pharmaceutical industries.

Sources:

1. https://www.kff.org/other/issue-brief/faqs-about-the-inflation-reduction-acts-medicare-drug-price-negotiation-program/

2. https://www.cms.gov/newsroom/fact-sheets/medicare-drug-price-negotiation-program-negotiated-prices-initial-price-applicability-year-2026

7. https://www.cms.gov/newsroom/press-releases/hhs-announces-15-additional-drugs-selected-medicare-drug-price-negotiations-continued-effort-lower

10. https://www.fiercehealthcare.com/regulatory/trumps-cms-signals-flexibility-medicare-drug-price-negotiation-sparking-new-questions

19. https://www.cms.gov/newsroom/fact-sheets/cms-announces-manufacturer-participation-second-cycle-medicare-drug-price-negotiation

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