Regulatory Interactions & Conditional Coverage (RICC) Interest Group

HTAi Interest Group on HTA - regulatory interactions & conditional coverage / Access with evidence development

Overview

This Interest Group will focus on the changing dynamics around evidence development that are leading to greater interaction with regulatory stakeholders as well as the increasing interest in mechanisms that involve conditionality of access relating specifically to evidentiary development.

The scope of this Interest Group includes: 

  • Adaptive pathways
  • Early dialogue / scientific advice involving both regulators and HTA bodies
  • HTA-Regulatory Interactions relating to evidence development
  • Managed entry agreements (focussed on outcomes-based agreements)

    • Performance-linked Risk Sharing Agreements (PBRSAs)
    • Coverage with evidence development (CED)
    • Conditional treatment continuation (CTC)

  • Post-marketing additional data collection

RICC Repository

This interest group provides a regularly updated repository for the benefit of our members and the wider community. This repository contains a bibliography of peer-reviewed publications relating to HTA-Regulatory Interaction and also Conditional Coverage. In addition, there is a list of governmental and non-governmental initiatives relating to new HTA-Regulatory Interactions, such as emerging parallel scientific advice initiatives.

News and meetings

Upcoming activities:

RICC activities at the HTAi 2016 Annual Meeting, Tokyo, Japan

  • Panel on Clinical Uncertainty and Risk Sharing
    11:30-13:00 Thursday 12 May, Starlight
  • RICC Annual Business Meeting
    12:45-14:15, Friday 13 May, Keyaki

News 

Chairs

Dr. Franz Pichler (Chair)

Prof. Dr. Urs Brügger (vice-Chair)

Membership

All members of HTAi are welcome to participate in the RICC IG. To join, simply log in to the website and return to this page. A link to join the IG mailing list will appear automatically.

Would you like to join this IG? Become a member of HTAi.

Background

The RICC Interest Group was formed in 2016 through the merger of two existing Interest Groups that were found to have increasing overlap in their activities. The two Interest Groups that were merged were the HTA-Regulatory Interaction IG and the Conditional Coverage/Access with Evidence Development IG.