23
Nov
2023

Real-World Evidence over the Medicine’s Lifecycle to Inform HTA/Payer Decisions

  • 09:00-14:00 CET
  • BIP Meeting Center (Room ‘Salles des Guichets’), Rue Royale 2-4, 1000 Bruxelles

PROGRAMME

09:00

Registration opens

09:30 – 09:35

Opening Session

  • Introductory remarks from the co-moderators
    Hans-Georg Eichler
    Consulting physician, Association of Austrian Social Insurance Institutions
    Bio
    Karen Facey
    Senior Adviser HTA, FIPRA RWE4Decisions Facilitator
    Bio
09:35 – 09:45
  • Data policies and patient access – EU Spanish Presidency priorities
    Enrique Terol García
    Coordinating Advisor on Health, Permanent Representation of Spain to the European Union
    Bio
09:45 – 10:50

The Policy Context for Real-World Evidence

Presentations and panel discussion

  • The role of Real-World Evidence for Sustainable Healthcare Systems
    Marco Marsella
    Director of Digital, EU4Health and Health Systems Modernisation, DG SANTE, European Commission
    Bio
  • Scaling-up Real-World Evidence generation in Europe – DARWIN EU
    Patrice Verpillat
    Head of Real-World Evidence Workstream, European Medicines Agency
    Bio
  • Patients’ perspectives
    Dimitrios Athanasiou
    Board Member, World Duchenne Organisation
    Bio
  • Health technology developers’ perspectives
    Alexander Natz
    Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
    Bio
  • Q&A
10:50 – 11:00

Learnings about Real-World Evidence Generation and Evaluation

Presentation: RWE4Decisions 2023

  • Karen Facey
    Senior Adviser HTA, FIPRA International RWE4Decisions Facilitator
    Bio
11:00 – 11:25

Break

11:25 – 12:20

The Potential for Collecting Real-World Data in Early Access to Inform HTA/Payer Decisions

Presentations and panel discussion

  • Review of Early Access Schemes in relation to HTA
    Entela Xoxi
    Senior Researcher, Università Cattolica del Sacro Cuore Roma
    Bio
  • Early Access Programme in France (HTA Perspective)
    Camille Thomassin
    Head of the Real-World Evidence Coordination Unit, Haute Autorité de Santé (HAS)
    Bio
  • Payer perspective
    Jo de Cock
    Former CEO, National Institute of Health and Disability Insurance, Belgium (INAMI-RIZIV)
    Bio
  • Health technology developers’ perspectives
    Andre Vidal Pinheiro
    Vice-President, Head of Patient Value & Access EUCAN, Global Pricing & Access, Takeda
    Bio
  • Q&A
12:20 – 12:55

Closing Session: Building Better RWE for Decisions – What’s Next?

  • Looking ahead to the Belgian EU Presidency
    Pedro Facon
    Deputy CEO, National Institute of Health and Disability Insurance, Belgium (INAMI-RIZIV)
    Bio
  • RWE4Decisions Priorities – Steering Group Members’ Reflections
    Niklas Hedberg
    Chief Pharmacist, Swedish Dental and Pharmaceuticals Benefits Agency (TLV)
    Bio
  • Matti Aapro MD
    Oncologist, Genolier Cancer Center
    Bio
  • Simone Boselli
    Public Affairs Director, EURORDIS-Rare Diseases Europe
    Bio
  • Eline Van Overbeeke
    Director, Global Access Strategy, DMD Gene Therapy, Pfizer
    Bio
12:55 – 13:00

Looking ahead to 2024 – the RWE4Decisions agenda

  • Hans-Georg Eichler
    Consulting Physician, Association of Austrian Social Insurance Institutions
    Bio
13:00 – 14:00

Lunch

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