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 December 2022. Nine 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 the device used for neuromodulation, the device for the treatment of benign prostatic hyperplasia, orthopedic 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.
Recommendations for neuromodulation devices:
- Percutaneous electrodes for implantable spinal cord stimulation systems INFINION CX by BOSTON SCIENTIFIC (application for modification and renewal of registration; sufficient actual benefit; level V of clinical added value compared to other percutaneous electrodes registered in the LPPR).
Recommendations for orthopedic devices:
- Dual-mobility acetabular cup consisting of a cemented cup and a highly cross-linked polyethylene insert CEMENTED EUROSCUP MOBILE by EUROS (application for registration; insufficient actual benefit).
Recommendations for devices used for men's health:
- Laser fibers for the treatment of benign prostatic hyperplasia GREENLIGHT HPS and GREENLIGHT MOXY by BOSTON SCIENTIFIC (application for registration). The GREENLIGHT MOXY fiber received sufficient actual benefit in the claimed indications and level IV (minor improvement) of clinical added value compared to transurethral resection of the prostate (TURP). GREENLIGHT HPS fiber received insufficient actual benefit in the claimed indications.
See the details in French here.
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