Anja Schiel & Nicholas Hedberg: Accelerated Approvals, Evidence Gaps, and Reimbursement Risk

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.

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