Kirsten Axelsen: Part D Shift, IRA Penalties, and Access Risks

Kirsten Axelsen is an economist specializing in Medicare reimbursement, payer negotiations, and innovative reimbursement contracts. She’s a fellow of the Aspen Institute and a visiting scholar with the American Enterprise Institute. She joins host Duane Schulthess to unpack bipartisan pressure on drug prices, the Part D redesign’s rapid shift of catastrophic costs to plans, and the resulting premium versus coverage tradeoffs and PDP exits.

Axelson explains why forecasting IRA impacts is uncertain, how nine versus thirteen-year timelines tilt incentives toward biologics, and why price controls can weaken both generic entry and biosimilar uptake. The discussion explores MFN-style ideas and trade uncertainties, vertical integration around biosimilars, and practical fixes from EPIC-like timelines to building a faster, more connected U.S. clinical-trial ecosystem with better participant support.

• Politics & Incentives: Trump MFN attempts, bipartisan pressure on high drug prices, and insurer dynamics versus the pace of biomedical innovation.
• Part D Redesign: The rapid shift of catastrophic costs to plans, premium versus coverage tradeoffs, PDP exits, and access challenges in rural areas.
• Modeling & Consequences: Limits of CBO forecasts, uncertainty bands, design choices around price controls, and risks to post-market and follow-on research.
• Competition Levers: Small molecule disincentives, low biosimilar uptake on formularies, generic entry pressures under price controls, and plan behavior.
• Policy Paths: EPIC-style timeline fixes, negotiation mechanics, MFN and trade uncertainties, and making U.S. clinical trials faster, more connected, and participant-friendly.

Recorded on July 28, 2025. Opinions expressed are those of the speakers.

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