REGULATORY INTERACTIONS & CONDITIONAL COVERAGE / ACCESS WITH EVIDENCE DEVELOPMENT

Overview

The development and commercialisation of health technology evolves toward a more coordinated approach between regulatory and health technology assessment bodies integrating more evidence from real world. This Interest Group focuses on the activities and strategies which involve developing evidence for multiple stakeholders which can also involve conditionality of access.

Aims & Objectives

  • Early dialogue / scientific advice involving both regulators and HTA bodies
  • HTA-Regulatory Interactions relating to evidence development
  • Managed entry agreements
    • Performance-linked Risk Sharing Agreements (PBRSAs)
    • Coverage with evidence development (CED)
    • Conditional treatment continuation (CTC)
    • Adaptive pathways
  • Post-marketing additional evidence generation

Executive Team

Chair: Dr. Massoud Toussi (France), 2017-2019

Co-Chair: Elena Petelos & Dimitra Lingri (Greece)

Technical Officer: Lorena Pozzo (Brazil)

Richard Charter (Switzerland), Past Vice Chair

François Meyer (France), Past executive committee

 

Join this IG

Involvement in the IGs is open to all HTAi members with current membership, which allows you to join the IG mailing lists to receive notifications about IG activities and opportunities to get more involved in specific working groups and projects.

To join, or if you have further questions, please contact interestgroups@htai.org

HTAi Membership

As a member of HTAi, you're become part of an international society of experts and leaders in the HTA field. You can gain access to our Annual Meeting, Policy Forums and Interest Groups, where you can participate in the critical conversations that help inform policy on the use of effective technologies in health assessment.