Vital Health Podcast

2025 U.S. Policy Highlights - Inflation Reduction Act (IRA) Part 1

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: * Douglas Holtz-Eakin: “Indications are going to be deeply affected by the IRA” * Steve Usdin: Tariffs, Price Controls, & Inflation Reduction Act (IRA) * VT’s Grumpies Talk IRA with Virginia Acha 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. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.

Steffen Thirstrup & Richard Bergstrom: Evidence, Access, and Competitiveness in Europe

In this episode of the Vital Health Podcast, host Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/?utm_source=chatgpt.com] speaks with two experts in European regulation and evidence of new medicines: * Steffen Thirstrup [https://www.linkedin.com/in/steffen-thirstrup/]: Chief Medical Officer at European Medicines Agency [https://www.linkedin.com/company/european-medicines-agency/]. * Richard Bergstrom [https://www.linkedin.com/in/richard-bergstrom-62ab07198/]: Head of Policy at IQVIA [https://www.linkedin.com/company/iqvia/]. They compare regulatory benefit-risk decisions with HTA’s comparative effectiveness and economics, unpack the role of conditional versus accelerated approvals, debate surrogate endpoints versus overall survival, and explore how real-world evidence, patient experience data, and joint scientific advice can make adaptive approaches workable across Europe, including through the European Health Data Space and joint clinical assessments. Key Topics * Regulatory Versus HTA: Benefit-risk focus, added benefit comparisons, joint clinical assessments. * Conditional Approvals: Surrogate endpoints, confirmatory commitments, withdrawal, or label narrowing. * Endpoints & Outcomes: Overall survival pressure, validated biomarkers, patient experience relevance. * Real-world Evidence: Registries and randomized rollout, data quality limits, outcomes-based contracting lessons. * Adaptive Pathways & Data Space: Early joint advice, platform and sandbox tools, European Health Data Space. Opinions expressed are those of the speakers. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.

Malina Müller: Rethinking Accelerated Approvals in Europe

In this episode of the Vital Health Podcast, host Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/?utm_source=chatgpt.com] speaks with Dr. Malina Müller [https://www.linkedin.com/in/dr-malina-m%C3%BCller-190754106/?utm_source=chatgpt%2Ecom&originalSubdomain=de], Head of Health Economics at WifOR Institute [https://www.linkedin.com/company/wifor/], to explore the heated debate around accelerated and conditional approvals in Europe, how demographic and budget pressures shape HTA decisions, the tradeoffs between surrogate endpoints and overall survival, the challenges of using real world evidence under GDPR, and the broader pricing and competitiveness threats facing Europe’s life science ecosystem.  Key Topics: * Accelerated Approvals: Uncertainty versus early access, conditional pathways in Europe, and costs of delayed treatment. * Health System Pressures: Aging populations, fixed-price hospital incentives, cross-country budget constraints. * Endpoints & Evidence: Surrogate versus overall survival, patient-reported outcomes, practical limits of real-world evidence in Europe. * HTA & Harmonization: Germany's strict assessments, JCA and EMA alignment, and equity gaps across member states. * Global Pricing Risks: Most Favored Nation (MFN) proposals, launch delays between the FDA and EMA, and Europe’s competitiveness versus China. Opinions expressed are those of the speakers. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.

VT's Grumpies Talk MFN

In this episode of the Vital Health Podcast, host Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/] sits down with two Vital Transformation colleagues to explore key trends in drug pricing and macroeconomic policy: * Joe Hammang [https://www.linkedin.com/in/joseph-hammang-ph-d-18bbb651/]: US Business Director at Vital Transformation [https://www.linkedin.com/company/vital-transformation/]. * Harry Bowen [https://www.linkedin.com/in/harry-p-bowen-10761b31/]: Consulting Economist at Vital Transformation [https://www.linkedin.com/company/vital-transformation/]. They unpack the Trump administration’s “Most Favored Nation” approach as applied to Medicaid, contrast it with past Medicare proposals, and discuss modeled employment, tax, and GDP impacts. The conversation explores why effects would differ by company and therapy area, the EU’s move toward streamlined compulsory licensing, the knock-on risks for premiums and investment, the fragility of the generics market, and how global competition - including China’s growing clinical footprint - could reshape innovation incentives. Key Topics: * MFN Basics: What is MFN?, Medicaid focus versus Medicare, price-leveling concept. * Modeled Impacts: Jobs and GDP effects, tax revenue losses, insurance premium pressure. * Uneven Company Effects: Medicaid-heavy portfolios, orphan and rare disease exposure, negotiation dynamics. * EU Signals: Compulsory licensing push, UK pricing realities, risks of spillover to U.S. policy. * Innovation and Competition: Biologics cost structure, generic market fragility, and China’s rising clinical pipeline. Opinions expressed are those of the speakers. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.

Bettina Ryll, Kjetil Taskén & Anni Lepland: PRIME-ROSE & EU Joint Action

In this episode of the Vital Health Podcast, host Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/] speaks with three leaders advancing precision cancer medicine implementation in Europe: * Bettina Ryll [https://www.linkedin.com/in/bettinaryll/]: Stockholm School of Economics [https://www.linkedin.com/school/stockholm-school-of-economics/], Institute for Research; Founder, Melanoma Patient Network Europe [https://www.linkedin.com/company/mpneurope/]. * Kjetil Taskén [https://www.linkedin.com/in/kjetil-tasken-06a261b/]: Head of the Institute for Cancer Research, Oslo University Hospital [https://www.linkedin.com/company/oslo-universitetssykehus/]; Professor, University of Oslo [https://www.linkedin.com/school/amarjyot-med-college/about/]; Coordinator, PRIME-ROSE [https://www.linkedin.com/company/prime-rose/]. * Anni Lepland [https://www.linkedin.com/in/anni-lepland-898165242/?originalSubdomain=ee]: Head of Personalized Medicine in Oncology, Estonian Cancer Network [https://www.linkedin.com/company/estonian-cancer-network-estcan/]. They explore how Europe’s new Joint Action can accelerate equitable precision oncology, what PRIME-ROSE [https://www.linkedin.com/company/prime-rose/]has learned from aggregating data across national pragmatic trials, and why a distributed, bottom-up model with strong patient involvement and industry collaboration is key to scaling access and evidence generation across member states. Key Topics: * EU Joint Action: Governmental collaboration, precision prevention, diagnosis, and treatment, precision follow-up. * PRIME-ROSE Collaboration: Data sharing agreements, aggregated cohorts, common biomarker definitions, and monthly alignment. * Patient Need First: Options after standard care, access to molecular profiling, pragmatic protocols, and learning from each case. * Widening Country Gaps: Workforce shortages, national coordination, digital tools, and equitable access to innovative drugs. * Industry and Access: Single point of entry for drugs, managed entry agreements, off-label registries, and scaling trials across Europe. Opinions expressed are those of the speakers. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.