Vital Health Podcast

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.

John Murphy: Generics, Biosimilars, and U.S. Policy

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 John Murphy [https://www.linkedin.com/in/john-murphy-iii-9b19ab1/], President and CEO of the Association for Accessible Medicines (AAM) [https://www.linkedin.com/company/accessiblemeds/?utm_source=chatgpt.com], 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 [https://omnystudio.com/listener] for privacy information.

Patrick Kelly: Inside the Generic Supply Chain Squeeze

In this episode of the Vital Health Podcast, host Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/] speaks with Patrick Kelly [https://www.linkedin.com/in/patrick-kelly-08427a8], Chief Advocacy Officer at the Healthcare Distribution Alliance [https://www.linkedin.com/company/hdma], 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 [https://omnystudio.com/listener] for privacy information.