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 2021. In total, 58 recommendations for registration, modification of registration conditions, and removal of devices in the List of reimbursable products and services (LPPR) were published. Opinions concern cardiovascular, orthopedic, peripheral vascular, and other groups of 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.
Examples of the opinions published in September are provided below. The full list of opinions can be found here.
- Coronary endoprosthesis coated with everolimus XIENCE XPEDITION 48 by Abbott (application for registration; sufficient actual benefit; level V of clinical added value);
- Single-chamber and dual-chamber implantable pacemakers ALIZEA SR 1300 and ALIZEA DR 1600 associated with the SMARTVIEW CONNECT remote monitoring system by MICROPORT CRM FRANCE (application for registration; sufficient actual benefit; level V of clinical added value);
- AGENT paclitaxel-coated balloon catheter by Boston Scientific (application for registration; sufficient actual benefit in the treatment of in-stent clinical restenosis, and insufficient Actual Benefit in the treatment of de novo and small vessels; level V of clinical added value);
- Self-expanding carotid stent CAROTID WALLSTENT MONORAIL by Boston Scientific (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
- Self-expanding venous stent ABRE by Medtronic (application for registration; sufficient actual benefit; level V of clinical added value);
- Self-expanding venous stent VENOVO by BARD (application for registration; insufficient actual benefit);
- Dual mobility acetabular cup DUALIS TRIPOD (cementless) by Gruppo Bioimpianti Srl (application for registration; sufficient actual benefit; level V of clinical added value);
- Anatomically shaped bone implant for cranial, facial, and mandibular reconstructions POROUSITI by ORTHOPEDIE BIOMECA LOCOMOTION (application for registration; sufficient actual benefit; level V and level IV of clinical added value depending on the indications);
- Dual mobility insert cup for total hip prosthesis RESTORATION ADM X3 by STRYKER (application for modification of registration conditions; sufficient actual benefit; level IV of clinical added value);
- Food for special medical purposes for enteral nutrition SONDALIS HP 2KCAL by Nestle Health Science (application for registration; sufficient actual benefit; level V of clinical added value).
See the details in French here.
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