Early value dossiers for medical technologies
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Recommendations about add-on reimbursement for medical devices in France in June 2024
The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in June 2024. Twelve recommendations were published concerning the registration of medical devices or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular and endocrine devices, as well as medical aids.
The first step in the assessment is the clinical (actual) benefit (SA), which can be either sufficient or insufficient. This step determines the insertion into the LPPR list. If sufficient, the clinical added value (ASA) is graded on a scale from I (major) to V (absent) for claimed indications, which supports the pricing decisions.
Some examples of the recommendations are provided below:
- Continuous interstitial glucose measurement system DEXCOM ONE+ by Dexcom (application for registration; sufficient actual benefit; level V of clinical added value compared to the previous generation DEXCOM ONE system);
- Device for transcutaneous closure of the left atrial appendage WATCHMAN FLX by Boston Scientific (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value compared to other transcutaneous left atrial appendage closure devices listed on the LPPR).
Recommendations were also made regarding medical aids.
See the details in French here.
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