Saturday, April 20, 2024

French National Authority for Health Issues Recommendations on Medical Device Reimbursement

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The French National Authority for Health (HAS) has released a set of recommendations about the reimbursement of medical devices and medical aids. These guidelines stem from the deliberations of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in September 2023. The recommendations encompass a variety of medical fields, including peripheral vascular and neurovascular, neurology, neurosurgery, ENT, spine, ophthalmology, orthopedics, and medical aids.

The assessment begins with an evaluation of the clinical (actual) benefit (SA), which can be classified as either sufficient or insufficient. This determination influences the inclusion of devices in the List of reimbursable products and services (LPPR). In cases where the clinical benefit is deemed sufficient, the clinical added value (ASA) is assessed on a scale ranging from I (major) to V (absent) for specific indications, which subsequently informs pricing decisions.

Examples of these recommendations include:

  1. MRI-guided laser thermoablation system VISUALASE by Medtronic (registration application; sufficient actual benefit; level II of clinical added value compared to craniotomy resection surgery).
  2. Liquid embolic agent SQUID by Balt Extrusion (registration application; sufficient actual benefit; level V of clinical added value compared to ONYX).
  3. Paclitaxel-eluting peripheral balloon PASSEO 18 LUX by Biotronik (registration application; sufficient actual benefit; level V of clinical added value compared to IN.PACT Admiral).
  4. Injectable synthetic bone substitute NANOSTIM by Medtronic (registration renewal application; sufficient actual benefit; level V of clinical added value compared to existing synthetic bone substitutes and bone substitutes containing derivatives of animal origin listed on the LPPR).

These recommendations also extend to peripheral vascular devices, ENT, spine, ophthalmology devices, and medical aids, contributing to informed reimbursement decisions in the French healthcare system.

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