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Value, Access and Regulatory Strategy Workshop
Session 1: Different Perspectives on Unmet Medical Need
Session Chair(s)
Claudine Sapède, PharmD
- Director, Global HTA Policy
- Novartis Pharma AG, 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.
Speaker(s)
A Patient’s Perspective
François Houyez
- Treatment Information and Access Director, Health Policy Advisor
- European Organisation for Rare Diseases (EURODIS), France
A Regulator’s Perspective
Michael Berntgen, PhD
- Head of Product Development Scientific Support Department
- European Medicines Agency (EMA), Netherlands
An HTA Body’s Perspective
Antje Behring, PhD
- Team Lead, Early Benefit Assessment, Pharmaceuticals Department
- Federal Joint Committee (G-BA), Germany
