The French National Authority for Health released new recommendations about add-on reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies in November 2022. Twenty 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. Opinions concern cardiovascular, neurovascular and neuromodulation, endocrine, ENT, endoscopic and dermatological devices, as well as devices for men’s health and 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.
Examples of recommendations for cardiovascular devices:
- Coronary stent coated with sirolimus (pharmacologically active product) ULTIMASTER by TERUMO (application for modification and renewal of registration; sufficient actual benefit; level V of clinical added value).
Examples of recommendations for neurovascular and neuromodulation devices:
- Percutaneous electrodes for implantable spinal cord stimulation systems AVISTA MRI by BOSTON SCIENTIFIC (application for the renewal of registration; sufficient actual benefit; level V of clinical added value);
- Reperfusion catheter used in a thrombo-aspiration system PENUMBRA RED by PENUMBRA (application for registration; sufficient actual benefit; level V of clinical added value).
Also, recommendations were made in relation to a number of other devices used in endocrine, endoscopic, ENT, dermatology, and men’s health areas, as well as medical aids.
See the details in French here.
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