Recommendations about add-on reimbursement for medical devices in France in September 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 September 2024. Five recommendations were published concerning the registration or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern endocrine and spine 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:

• Device for automatic reading of blood glucose and ketone levels and associated electrodes, Freestyle Optium Neo and Freestyle Optium Beta-Ketone, by Abbott (application for modification of registration conditions; sufficient actual benefit; level III or level V of clinical added value depending on the indications and comparators);
• Distraction system for the reduction of vertebral fractures SpineJack by Stryker (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value compared to all vertebral augmentation techniques (vertebroplasty, balloon kyphoplasty, and spondyloplasty with implant)).

Recommendations were also made regarding medical aids.

In addition, one recommendation was made regarding the application for transitional coverage via LPPR.

See the details in French here.

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