Recommendations about add-on reimbursement for medical devices in France in March 2023

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 March 2023. Fifteen recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular and peripheral vascular, endocrine, endoscopy, gastrointestinal, surgical, and diagnostic imaging 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.

• Aortic conduit with mechanical valve VAVGJ 515 by Abbott Medical (application for renewal of registration; sufficient actual benefit; level V of clinical added value compared to other aortic conduits with a mechanical valve already registered on the LPPR);
• Self-expanding venous stent VENOVO by Becton Dickinson (application for registration; sufficient actual benefit; level V of clinical added value compared to other bare self-expanding stents listed in the LPPR in the selected indications);
• Implantable cardiac monitor CONFIRM RX model DM3500 by Abbott Medical (application for renewal of registration; sufficient actual benefit; level V of clinical added value compared to other implantable cardiac monitors registered in the LPPR.);
• Coronary fractional flow reserve (FFR) measurement guide COMET II by Boston Scientific (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value compared to other coronary reserve flow (FFR) measurement guides listed in the LPPR).

Also, recommendations were made in relation to endocrine, endoscopy, gastrointestinal and surgical devices, and a number of medical aids.

See the details in French here.

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