Vital Health Podcast

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 for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts in European regulation and evidence of new medicines: Steffen Thirstrup: Chief Medical Officer at European Medicines Agency. Richard Bergstrom: Head of Policy at 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 for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Dr. Malina Müller, Head of Health Economics at WifOR Institute, 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 for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess sits down with two Vital Transformation colleagues to explore key trends in drug pricing and macroeconomic policy: Joe Hammang: US Business Director at Vital Transformation. Harry Bowen: Consulting Economist at 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 for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with three leaders advancing precision cancer medicine implementation in Europe: Bettina Ryll: Stockholm School of Economics, Institute for Research; Founder, Melanoma Patient Network Europe. Kjetil Taskén: Head of the Institute for Cancer Research, Oslo University Hospital; Professor, University of Oslo; Coordinator, PRIME-ROSE. Anni Lepland: Head of Personalized Medicine in Oncology, Estonian Cancer Network. They explore how Europe’s new Joint Action can accelerate equitable precision oncology, what 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 for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with John Murphy, President and CEO of the Association for Accessible Medicines (AAM), to discuss how U.S. purchasing dynamics and thin margins drive shortages, the evolving biosimilar landscape amid insurer vertical integration, the Inflation Reduction Act (IRA)’s ripple effects on plan risk and rebates, Most Favored Nation (MFN) policy proposals, and what it will take to reshore capacity while preserving competition and patient access. Key Topics: Generic Pricing Pressures: Purchaser consolidation, sterile injectables, margin squeeze, and exits. Drug Shortage Economics: Quality investments, underpriced redundancy, lessons from saline disruptions. Biosimilar Market Dynamics: Private-label payer programs, rebate tactics, chilling pipeline investment. Inflation Reduction Act (IRA) and Coverage: Part D risk shift to plans, negotiation uncertainty, and Medicare access delays. Tariffs and Reshoring: API onshoring realities, carve-outs to avoid shortages, resilient capacity building. Opinions expressed are those of the speakers.See omnystudio.com/listener for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Patrick Kelly, Chief Advocacy Officer at the Healthcare Distribution Alliance, to discuss why generic markets face razor-thin margins and concentration risk, what is driving recent drug shortages, how tariffs and reshoring could affect costs, potential ripple effects from Most Favored Nation pricing, and the rise of direct-to-consumer pathways and traceability across the supply chain. Key Topics: Generic Market Pressures: Race-to-the-bottom pricing, manufacturer exits, concentration risks. Shortage Drivers: Telemedicine demand spikes for controlled substances, facility shutdowns, and sterile injectable constraints. Tariffs and Reshoring: Section 232 outlook, potential India duties, pass-through pressures to patients. MFN Pricing Impacts: Inventory devaluation risk, price-depreciation clauses, manufacturer responses. DTC and Traceability: Direct-to-consumer models, pharmacy and provider roles, DSCSA unit-level safety. Opinions expressed are those of the speakers.See omnystudio.com/listener for privacy information.

In this Vital Health Podcast, host Duane Schulthess speaks with two leading European voices on oncology and health economics: Andreas Charalambous: Chair of Nursing at Cyprus University and Executive Board Member at MASCC, former President of the European Cancer Organization, Director of the Research Center for Oncology and Palliative Care at eOncoRise Lieven Annemans: Professor of Health Economics at Ghent University, past President of ISPOR Together, they unpack why the EU’s Beating Cancer Plan and Cancer Mission remain only partially implemented and what it will take to turn commitments into action. Key Topics Centralized vs. National Action: Why Europe still needs coordinated cancer strategies alongside national execution, and how fragmentation drives inertia. Costs, Rarity, and Value: The economics of small patient populations, return on investment, and why rare cancers demand inclusion in national plans. Prevention & Early Detection: How shifting budgets from treatment to prevention and screening offers long-term impact but little short-term political payoff. Equity & Access: Unequal survival rates between and within EU member states, limited medicine availability in countries like Greece, and the role of patient engagement. Data & Accountability: Calls for plan-do-check-act cycles, stronger measurement, and better digital health training for Europe’s cancer workforce. Financing & Long-Term Policy: Whether EU-level financing instruments should support health infrastructure, and why tackling social and commercial determinants could reshape outcomes over decades. This episode offers a candid look at the complexity of cancer policy in Europe, exploring prevention, financing, innovation, and political realities that will define cancer care over the next decade. Opinions expressed are those of the speakers, not the institutions listed. Podcast created with the support of Merck Sharp & Dohme. Recorded July 2025.See omnystudio.com/listener for privacy information.

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.See omnystudio.com/listener for privacy information.

In this "Best-of" edition of the Vital Health Podcast, Duane Schulthess revisits two listener favorites on the future of medicines in Europe. First, former MEP Pernille Weiss explains how the European Parliament reshaped the EU’s General Pharmaceutical Legislation (GPL) to better support innovation while respecting member state control over pricing and reimbursement. Then, Niklas Blomberg, Executive Director of the Innovative Health Initiative (IHI), outlines how Europe’s largest public-private partnership is convening pharma, medtech, regulators, HTAs, payers, and patients to solve pre-competitive hurdles from real-world data to digital endpoints. Key Topics Parliament Process: How Parliament shaped the General Pharmaceutical Legislation (GPL) and why it rejected incentives tied to launches in all 27 member states. Innovation and Access: Avoiding rock-bottom pricing that causes shortages and using quality-of-life outcomes in pricing and reimbursement decisions. EU vs National Roles: Where joint procurement helps, and where member-state control over pricing and reimbursement should prevail to reflect health system differences. From IMI to IHI: Evolution from the Innovative Medicines Initiative (IMI) to the Innovative Health Initiative (IHI), a cross-sector platform convening pharma, medical devices, diagnostics, imaging, regulators, health technology assessment (HTA) bodies, payers, clinicians, and patients to solve pre-competitive evidence needs such as real-world data and digital endpoints. Data and Regulation: Working within the General Data Protection Regulation (GDPR), the European Health Data Space (EHDS), and the Artificial Intelligence (AI) Act using federated access, shared standards, and a regulatory sandbox to pilot novel technologies. SME Pathways: How small and medium-sized enterprises (SMEs) join funded consortia via brokering events, with current examples in lung cancer real-world data and cardiovascular prevention and care. Originally broadcast Sep 4, 2024 (Weiss) and Jul 3, 2024 (Blomberg). Edited and compiled Aug 2025. Opinions expressed are those of the speakers.See omnystudio.com/listener for privacy information.