In this special 2025 U.S. Policy Highlights edition of the Vital Health Podcast, we look back at our most important discussions on the Inflation Reduction Act (IRA) and its ripple effects across drug development, Medicare, and patient access. Over the past year, the biopharma industry and the broader healthcare system have undergone a period of rapid change as new rules surrounding drug pricing reshape how therapies are developed, financed, and delivered. In a landscape where policies are still being interpreted and adjusted, and where the long-term impact on innovation and access is far from certain, this episode serves as a year-end guide to what has changed and how to think about the road ahead.

Throughout 2025, we paired our research with a series of podcast episodes where host Duane Schulthess sat down with industry leaders. In this highlights episode, we revisit several of those conversations:
Donna Cryer: Advocacy, Drug Incentives & Research Crisis
Barbara McAneny, Rafael Fonseca, and Steve Potts: Protecting Patients Amid the IRA
Kirsten Axelsen: Part D Shift, IRA Penalties, and Access Risks

Key Topics:
Pill Penalty: How the shorter negotiation window for small molecule medicines relative to biologics is changing the calculus for pursuing oral therapies in areas such as cardiovascular disease, neurodegeneration, and other chronic conditions.
Part D Redesign: Why moving more liability to plans is driving new premium and coverage tradeoffs, influencing which products stay on formularies, and raising questions about access in rural and underserved areas.
Early Stage Investment: What our data suggest about the pullback in trial starts and funding for projects most exposed to IRA mechanics, and how that is influencing company formation, licensing strategies, and pipeline mix.
PBMs, Vertical Integration, & Biosimilars: How consolidated intermediaries and payer-owned biosimilar strategies interact with IRA price setting, rebate flows, and the outlook for generic and biosimilar competition.
Patient Advocacy & Real World Impact: What older adults, cancer patients, and rare disease communities are already experiencing as coverage rules change, cost-sharing is redesigned, and uncertainty grows around long-term treatment availability.
Policy Paths Forward: Ideas from our guests for adjusting timelines, refining negotiation rules, and protecting incentives for follow-on and orphan indications while still improving affordability for patients.

Opinions expressed are those of the speakers.

In this special 2025 U.S. Policy Highlights edition of the Vital Health Podcast, we look back at our most important discussions on the Inflation Reduction Act (IRA) and its ripple effects across drug development, Medicare, and patient access. Over the past year, the biopharma industry and the broader healthcare system have undergone a period of rapid change as new rules surrounding drug pricing reshape how therapies are developed, financed, and delivered. In a landscape where policies are still being interpreted and adjusted, and where the long-term impact on innovation and access is far from certain, this episode serves as a year-end guide to what has changed and how to think about the road ahead.
Throughout 2025, we paired our research with a series of podcast episodes where host Duane Schulthess sat down with industry leaders. In this highlights episode, we revisit several of those conversations:
<ul>
<li>Donna Cryer: Advocacy, Drug Incentives &amp; Research Crisis</li>
<li>Barbara McAneny, Rafael Fonseca, and Steve Potts: Protecting Patients Amid the IRA</li>
<li>Kirsten Axelsen: Part D Shift, IRA Penalties, and Access Risks</li>
</ul>
Key Topics:
<ul>
<li>Pill Penalty: How the shorter negotiation window for small molecule medicines relative to biologics is changing the calculus for pursuing oral therapies in areas such as cardiovascular disease, neurodegeneration, and other chronic conditions.</li>
<li>Part D Redesign: Why moving more liability to plans is driving new premium and coverage tradeoffs, influencing which products stay on formularies, and raising questions about access in rural and underserved areas.</li>
<li>Early Stage Investment: What our data suggest about the pullback in trial starts and funding for projects most exposed to IRA mechanics, and how that is influencing company formation, licensing strategies, and pipeline mix.</li>
<li>PBMs, Vertical Integration, &amp; Biosimilars: How consolidated intermediaries and payer-owned biosimilar strategies interact with IRA price setting, rebate flows, and the outlook for generic and biosimilar competition.</li>
<li>Patient Advocacy &amp; Real World Impact: What older adults, cancer patients, and rare disease communities are already experiencing as coverage rules change, cost-sharing is redesigned, and uncertainty grows around long-term treatment availability.</li>
<li>Policy Paths Forward: Ideas from our guests for adjusting timelines, refining negotiation rules, and protecting incentives for follow-on and orphan indications while still improving affordability for patients.</li>
</ul>
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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