Session 1: Different Perspectives on Unmet Medical Need
Claudine Sapède, PharmD
Director, Global HTA Policy
NOVARTIS INTERNATIONAL, Switzerland
Addressing unmet medical need is a key criterion for medicine prioritization and for a molecule to qualify for accelerated regulatory review processes. Yet, there is not a common definition of the term and the interpretations may also vary between stakeholder groups (regulators, HTA bodies/payers, patients, medicine developers…). To what extend and how is unmet medical need considered in reimbursement decision-making? Could we make progress and advance these questions? This is what will be explored in this session.
A Patient’s Perspective: François Houyez
Treatment Information and Access Director, Health Policy Advisor
European Organisation for Rare Diseases (EURORDIS), France
A Regulator’s Perspective: Michael Berntgen, PhD
Head of Scientific Evidence Generation
European Medicines Agency, Netherlands
An HTA Body’s Perspective : Antje Behring, PharmD, PhD
Head, Early Benefit Assessment, Pharmaceuticals Department
Federal Joint Committee (G-BA), Germany
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