Regulatory Interactions and Conditional Coverage

Regulatory interactions & conditional coverage / Access with evidence development

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 is currently preparing abstract submissions for the coming HTAi 2017 Annual Meeting, Rome, Italy.

Recent 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

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.

Executive Team

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

Vice Chair: Dr. Michelle Mujoomdar (Canada), 2017-2019

Technical Officer: Lorena Pozzo (Brazil)

Dr. Franz Pichler (Australia)
Prof. Dr. Urs Brgger (Switzerland), Past Chair
Richard Charter (Switzerland), 2017-2019, Past Vice Chair

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.