IRA Under Trump: What Is Next?

ISSUE: The Inflation Reduction Act (IRA) has changed the US policy and drug pricing landscape. However, there is potential for significant shifts as the Trump administration implements its policy agenda with a unified Republican Congress. What changes will the new administration make to the IRA MFP determination and Part D redesign? Will MFP-related changes be accompanied by legislative changes to the orphan exclusions and qualified single-source drug (QSSD) definitions? Or will potential policy changes be driven by cost savings and reintroducing policies incorporating international reference pricing? Will changes extend beyond IRA impacts as we know them today? Will market stabilization policies like the Part D demonstration be rescinded? And what would these changes mean for evidence generation and value assessment? This panel will explore (1) Potential changes to IRA price determination and Part D Redesign under the Trump administration; (2) Implications of these changes for demonstrating and evaluating value; and (3) Consequences of these policy developments for biopharmaceutical access and innovation. OVERVIEW: Potential changes under the Trump administration are uncertain, but some could broadly impact the US healthcare value and innovation ecosystem. This panel will critically evaluate some of the most impactful potential policy changes. Lisa Joldersma will begin the conversation by describing the nature of these potential changes, including the scope of potential changes, and highlighting the events that need to occur for these policies to be implemented. Mike Ciarametaro will discuss the value demonstration and evaluation implications, including potential negotiation impacts and value demonstration ramifications for the Part D market. Ulrich Neumann will review scientific evidence on the potential consequences for future innovation, including implications for the overall level of innovation, incentives for certain types of innovation (disease area, small vs. large molecule, etc.), and impact on patient access. We hope you join us!