What’s Next? Year 1 Learnings of Evidence Planning for IRA Drug Price Negotiation

Moderator

Taylor T Schwartz, Avalere Health, Valencia, CA, United States

Speakers

Peter Neumann, ScD, Tufts Medical Center, Boston, MA, United States; Michael Ciarametaro, BS, MA, MBA, Avalere Health, Washington, DC, United States; Russ Montgomery, PhD, GSK US, Nashville, TN, United States

ISSUE: Two years following the passing of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services (CMS)?released?the maximum fair prices (MFPs) for the 10 Part D drug selected for Medicare drug price negotiation in August of 2024. These prices will go into effect on January 1, 2026. CMS’s detailed rationale for each negotiated MFP is not expected until closer to the March 1, 2025 deadline. However, key learnings can be considered based on a number of factors. This issue panel will explore the initial outcomes and insights from the first year of Medicare drug price negotiations. OVERVIEW: Taylor Schwartz will provide an overview of the results of the first year of Medicare price negotiation and summarize the value evidence manufacturers can submit for Year 2 negotiation. Michael Ciarametaro will provide an analysis of Year 1 MFPs, including the likely drivers of MFPs for each product, nuances due to key product characteristics, and what impact this could have on the market. Peter Neumann will discuss the importance of therapeutic alternative selection and analyze the potential weighting of negotiation factors, including the value evidence submitted by manufacturers. Russ Montgomery will highlight key considerations for manufacturers moving into future years of negotiation and describe best practices and timing for price negotiation preparation.

Code

023

Topic

Health Policy & Regulatory