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Value, Access and Regulatory Strategy Workshop

Session 1: Different Perspectives on Unmet Medical Need

Session Chair(s)

Claudine  Sapède, PharmD

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.


François  Houyez

A Patient’s Perspective

François Houyez

  • Information and Access Director, Health Policy Advisor
  • European Organisation for Rare Diseases (EURORDIS), France
Michael  Berntgen, PhD

A Regulator’s Perspective

Michael Berntgen, PhD

  • Head of Scientific Evidence Generation
  • European Medicines Agency, Netherlands
Antje  Behring, PharmD, PhD

An HTA Body’s Perspective

Antje Behring, PharmD, PhD

  • Head, Early Benefit Assessment, Pharmaceuticals Department
  • Federal Joint Committee (G-BA), Germany