In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts on reimbursement-facing evidence questions for accelerated oncology approvals at ISPOR Europe 2025 in Glasgow, Scotland:


Anja Schiel:Senior Advisor, Norwegian Medical Products Agency


Niklas Hedberg: Chief Pharmacist at The Dental and Pharmaceutical Benefits Agency (TLV)

They unpack why results that are strong inside a clinical trial can be harder to apply to real-world national populations, how decision-makers weigh patient-relevant outcomes and uncertainty at the time of access decisions, and what risk management can look like when early approvals require follow-up evidence and potential reassessment.

Key Topics:


Trial Generalizability: Selection in trials, real-world populations, and health system variation.


Reimbursement Evidence: Patient-relevant outcomes, absolute versus comparative benefit, small-sample challenges.


Conditional Approval: Evidence at authorization, reassessment expectations, withdrawal, and restriction risk.


Risk Tradeoffs: Approving too early versus delaying access, urgency in progressive disease, and equity constraints.


Adaptive Follow-up: Real-world evidence plans, managed entry approaches, learning while treating.

Opinions expressed are those of the speakers. This podcast was supported by Merck Sharp & Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca.

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> speaks with two experts on reimbursement-facing evidence questions for accelerated oncology approvals at ISPOR Europe 2025 in Glasgow, Scotland:
<ul data-start="5108" data-end="5337">
<li data-start="5108" data-end="5246">
<a href="https://www.linkedin.com/in/anjaschiel/?originalSubdomain=no">Anja Schiel:</a> Senior Advisor, <a href="https://www.linkedin.com/company/direktoratetformedisinskeprodukter/">Norwegian Medical Products Agency</a>
</li>
<li data-start="5247" data-end="5337">
<a href="https://www.linkedin.com/in/niklas-hedberg-3947231/">Niklas Hedberg:</a> Chief Pharmacist at <a href="https://www.linkedin.com/company/tlv-the-dental-and-pharmaceutical-benefits-agency/">The Dental and Pharmaceutical Benefits Agency (TLV)</a>
</li>
</ul>
They unpack why results that are strong inside a clinical trial can be harder to apply to real-world national populations, how decision-makers weigh patient-relevant outcomes and uncertainty at the time of access decisions, and what risk management can look like when early approvals require follow-up evidence and potential reassessment.
Key Topics:
<ul data-start="5695" data-end="6250">
<li data-start="5695" data-end="5794">
Trial Generalizability: Selection in trials, real-world populations, and health system variation.
</li>
<li data-start="5795" data-end="5913">
Reimbursement Evidence: Patient-relevant outcomes, absolute versus comparative benefit, small-sample challenges.
</li>
<li data-start="5914" data-end="6028">
Conditional Approval: Evidence at authorization, reassessment expectations, withdrawal, and restriction risk.
</li>
<li data-start="6029" data-end="6146">
Risk Tradeoffs: Approving too early versus delaying access, urgency in progressive disease, and equity constraints.
</li>
<li data-start="6147" data-end="6250">
Adaptive Follow-up: Real-world evidence plans, managed entry approaches, learning while treating.
</li>
</ul>
Opinions expressed are those of the speakers. This podcast was supported by Merck Sharp &amp; Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca.

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…