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 June 2021. Recommendations concern cardiovascular and peripheral vascular devices, orthopedic devices, liquid for embolization, and medical aids.
The first step in the assessment is the clinical (actual) benefit, which can be either sufficient or insufficient. This step determines the insertion into the LPPR list. If sufficient, the clinical added value is graded on a scale from I (major) to V (absent), which supports the pricing decisions.
Decisions released for cardiovascular devices:
- Mitral valve bioprosthesis implanted by transcatheter route Tendyne (application for registration, insufficient actual benefit);
- Coronary endoprostheses coated with everolimus Synergy XD, Synergy XD (48 mm), Synergy, Synergy Megatron (applications for modification of registration conditions; sufficient actual benefit; level V of clinical added value);
- Coronary endoprosthesis coated with biolimus Biofreedom Ultra (application for registration; sufficient actual benefit; level V of clinical added value);
- Aortic valve bioprosthesis implanted by transfemoral route Acurate Neo (application for renewal of registration; insufficient actual benefit).
Decisions released for peripheral vascular devices:
- Paclitaxel eluting balloon Stellarex (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value);
- Abdominal aortic endoprosthesis Anaconda (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
- Abdominal aortic endoprosthesis Gore Excluder Conformable (application for registration; sufficient actual benefit; level V of clinical added value);
- Abdominal aortic endoprostheses Endurant II and Endurant IIs (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
- Abdominal aortic endoprosthesis Gore Excluder AAA (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
- Abdominal aortic endoprosthesis Anaconda LoPro90 (application for registration; sufficient actual benefit; level V of clinical added value).
Decisions published for orthopedic devices:
- Custom-made bone substitute for cranial reconstruction Medpor CCI (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value);
- Viro-inactivated bone allograft by Phoenix process with collagen fibers from demineralized bone obtained by Phoenix-DBM process (application for registration; insufficient actual benefit).
One decision was released in relation to liquid embolization implant: Onyx LES (application for renewal of registration; sufficient actual benefit; level IV of clinical added value).
Several decisions were released for medical aids:
- Emulsion for ophthalmic use Visuevo (application for registration; insufficient actual benefit);
- External silicone breast prosthesis Velvety 1066X (application for registration; sufficient actual benefit; level V of clinical added value);
- Sterile solutions for ophthalmic use Thealose and Thealose UD (applications for renewal of registration; sufficient actual benefit; level V of clinical added value);
- Venous compression system Gamme Comprilan: Jobst Compri2 (application for registration; insufficient actual benefit);
- External silicone breast prosthesis Velvety Liteshell 1067x (application for registration; sufficient actual benefit; level V of clinical added value);
- Material for stoma reinforcement Eakin Contour Flange Extenders (application for registration; sufficient actual benefit; level V of clinical added value);
- External silicone breast prosthesis Amoena essential light and Amoena adapt light (application for radiation).
See the details in French here.
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