Value, Access and Regulatory Strategy Workshop

Session Chair(s)

Claudine Sapède, PharmD, MSc

• 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)

A Patient’s Perspective

François Houyez

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

A Regulator’s Perspective

Michael Berntgen, PhD

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

An HTA Body’s Perspective

Antje Behring, PhD

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