Strategic evidence planning in the IRA: Insights from Year 1 drug price negotiations
Medicare drug price negotiations under the Inflation Reduction Act have shifted from policy to practice, with the first Maximum Fair Prices (MFPs) now set for ten selected drugs. But how were these prices determined, what evidence shaped the outcomes, and what lessons can be drawn for future negotiation cycles?
Moderated by Taylor T Schwartz, Managing Director at Avalere Health, with panelists Michael Ciarametaro (Managing Director, Avalere Health), Peter Neumann (Director, Center for the Evaluation of Value and Risk in Health, Tufts Medical Center), and Russ Montgomery (Head of Value Assessment Strategy and Policy, GSK), a revealing ISPOR panel discussion, “What’s Next? Year 1 Learnings of Evidence Planning for IRA Drug Price Negotiation,” exposed the complex dynamics that shaped Year 1 outcomes.
For manufacturers, the process remains opaque despite extensive evidence submissions, but strategic opportunities exist. Real-world evidence proved influential; however, success requires early planning, methodologically sound studies, and compelling value narratives that educate CMS reviewers who may lack deep therapeutic area expertise.
Catch up on the session in this Deep Dive, with sections covering:
- The evidence foundations of Year 1 negotiations and implications for MFPs
- Drivers of pricing decisions and Year 1 negotiation trends
- Manufacturer strategies: evidence planning amid uncertainty
- How MFPs are reshaping the drug marketplace
- Assessing which evidence makes the greatest impact in MFP decisions
- Importance around selecting therapeutic alternatives
- Balancing evidence generation with resource constraints in IRA planning
- Cost-effectiveness: working within the constraints
Sponsorship for this Deep Dive was provided by Avalere Health.