Regulatory Interactions & Conditional Coverage (RICC) Interest Group
HTAi Interest Group on HTA - 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
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
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
Dr. Franz Pichler (Chair)
Prof. Dr. Urs Brügger (vice-Chair)
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.
Non-members of HTAi are also welcome express interest in joining this IG, with membership pending approval of the IG chair. For enquiries, please contact the HTAi Secretariat.
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.