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Value, Access and Regulatory Strategy Workshop


Session 1: Different Perspectives on Unmet Medical Need

Session Chair(s)

Claudine  Sapède

Claudine Sapède

  • Global HTA and Payment Policy Lead
  • F. Hoffmann-La Roche, 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)

François  Houyez

A Patient’s Perspective

François Houyez

  • Treatment Information and Access Director, Health Policy Advisor
  • EURORDIS, France
Michael  Berntgen, PhD

A Regulator’s Perspective

Michael Berntgen, PhD

  • Head of Product Development Scientific Support Department
  • European Medicines Agency, European Union, United Kingdom
Antje  Behring, PhD

An HTA Body’s Perspective

Antje Behring, PhD

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