Recommendations about add-on reimbursement for medical devices in France in April 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 April 2023. Twenty-three 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, orthopedic, nephrology and urology, and surgical 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.

• Transcatheter mitral valve repair system Edwards PASCAL Precision (mitral) by Edwards Lifesciences (application for registration; sufficient actual benefit; level V of clinical added value compared to other edge-to-edge mitral repair clips listed on the LPPR in the selected indications);
• Bone substitute derived from derivatives of bovine origin Geistlich Bio-Oss Pen by Geistlich Pharma (application for registration; sufficient actual benefit; level V of clinical added value compared to synthetic bone substitutes and bone substitutes containing derivatives of animal origin already listed on the LPPR);
• Modular system for massive pelvic reconstruction Mutars Lumic by Implantcast (application for modification and renewal of registration; sufficient actual benefit; level IV of clinical added value compared to custom-made pelvic reconstruction prostheses);
• Copolymer ureteral implant Deflux by Kebomed (application for renewal of registration; sufficient actual benefit; level V of clinical added value compared to other implants for the treatment of vesicorenal reflux registered on the LPPR).

Also, recommendations were made in relation to other cardiovascular and orthopedic devices, surgical devices, and a number of medical aids.

See the details in French here.

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