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.

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/?utm_source=chatgpt.com">Duane Schulthess</a> speaks with <a href="https://www.linkedin.com/in/dr-malina-m%C3%BCller-190754106/?utm_source=chatgpt%2Ecom&amp;originalSubdomain=de">Dr. Malina M&uuml;ller</a>, Head of Health Economics at <a href="https://www.linkedin.com/company/wifor/">WifOR Institute</a>, 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&rsquo;s life science ecosystem.&nbsp;
Key Topics:
<ul>
<li>Accelerated Approvals: Uncertainty versus early access, conditional pathways in Europe, and costs of delayed treatment.</li>
<li>Health System Pressures: Aging populations, fixed-price hospital incentives, cross-country budget constraints.</li>
<li>Endpoints &amp; Evidence: Surrogate versus overall survival, patient-reported outcomes, practical limits of real-world evidence in Europe.</li>
<li>HTA &amp; Harmonization: Germany's strict assessments, JCA and EMA alignment, and equity gaps across member states.</li>
<li>Global Pricing Risks: Most Favored Nation (MFN) proposals, launch delays between the FDA and EMA, and Europe&rsquo;s competitiveness versus China.</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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