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.

<a href="https://www.linkedin.com/in/kirsten-axelsen-5129b15/">Kirsten Axelsen</a> is an economist specializing in Medicare reimbursement, payer negotiations, and innovative reimbursement contracts. She&rsquo;s a fellow of the <a href="https://www.linkedin.com/company/the-aspen-institute/">Aspen Institute</a> and a visiting scholar with the <a href="https://www.linkedin.com/company/american-enterprise-institute/">American Enterprise Institute</a>. She joins host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> to unpack bipartisan pressure on drug prices, the Part D redesign&rsquo;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.
<ul>
<li>Politics &amp; Incentives:&nbsp;Trump MFN attempts, bipartisan pressure on high drug prices, and insurer dynamics versus the pace of biomedical innovation.</li>
<li>Part D Redesign: The rapid shift of catastrophic costs to plans, premium versus coverage tradeoffs, PDP exits, and access challenges in rural areas.</li>
<li>Modeling &amp; Consequences: Limits of CBO forecasts, uncertainty bands, design choices around price controls, and risks to post-market and follow-on research.</li>
<li>Competition Levers: Small molecule disincentives, low biosimilar uptake on formularies, generic entry pressures under price controls, and plan behavior.</li>
<li>Policy Paths: EPIC-style timeline fixes, negotiation mechanics, MFN and trade uncertainties, and making U.S. clinical trials faster, more connected, and participant-friendly.</li>
</ul>
Recorded on July 28, 2025. Opinions expressed are those of the speakers.

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess, Managing Director of Vital Tran…

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