New application process for coverage within the RIHN 2.0 framework in France

On November 29, 2024, the Ministry of Health and Access to Care published an Order in the Official Journal of the French Republic outlining the requirements for application files to request coverage of innovative biology or pathology procedures within the new RIHN 2.0 framework. The Order concerns the application file model and list of supporting documents for coverage requests.

The application files should include a justification for the request, existing clinical and economic evidence, identified gaps in data with plans for ongoing studies, a description of the technology, and an estimate of the target population. The file must also include a detailed protocol for data collection (research questions, study design) and a justification of the proposed reimbursement value of the innovative test.

In addition to standard supporting documents, specific requirements are provided for supporting documents for the following technologies:

• Companion tests associated with the drugs eligible for early access authorization;
• In vitro diagnostic medical devices (DM-DIV) or medical devices (DM);
• DM-DIV or digital DM incorporating machine learning or requiring personal data processing.

The full details in French can be found here.

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