The French National Authority for Health 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 in October 2022. Fourteen 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. Opinions concern cardiovascular, neurovascular, orthopedic, and ENT 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.
Recommendations for cardiovascular devices:
- Patent foramen ovale closure implant AMPLATZER TALISMAN PFO OCCLUDER by ABBOTT (application for registration; sufficient actual benefit; level V of clinical added value);
- Aortic valve bioprosthesis implanted by transfemoral approach (COMMANDER system) EDWARDS SAPIEN 3 by EDWARDS LIFESCIENCES (application for modification of registration conditions; sufficient actual benefit; level III or V of clinical added value depending on the indications);
Recommendations for neurovascular devices:
- Self-expanding intracranial stent with the controlled release (stent to divert) P64 MW by CLINSEARCH (application for registration; sufficient actual benefit; level V of clinical added value);
- Stent retriever TIGERTRIEVER by AB MEDICA (application for registration; sufficient actual benefit; level V of clinical added value);
Recommendations for orthopedic devices:
- Non-cemented cup for dual mobility acetabulum QUATTRO SLIMFIT HAP PNP by GROUPE LEPINE (application for registration; insufficient actual benefit);
- Injectable synthetic bone substitute OSTIBONE by FH ORTHO (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
Recommendations for ENT devices:
- Plasma layer soft tissue ablation system COBLATION by SMITH & NEPHEW (application for registration; sufficient actual benefit; level IV of clinical added value);
Recommendations for medical aids:
- Dual band venous compression system 3M COBAN 2 LITE by 3M FRANCE (application for registration; insufficient actual benefit);
- Mobile oxygen concentrator ZEN-O LITE CLARITY by GCE (application for registration; sufficient actual benefit; level V of clinical added value);
- Modular electric scooter CARPO 2 SE by VERMEIREN (application for registration; sufficient actual benefit; level V of clinical added value);
- Compresses impregnated with hyaluronic acid and cream with hyaluronic acid EFFIDIA by FIDIA FARMACEUTICI (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
- Peripheral stoma reinforcements ADAPT ADHESIVE REINFORCEMENTS by HOLLISTER FRANCE (application for registration; sufficient actual benefit; level V of clinical added value);
- Food for special medical purposes for enteral nutrition FRESUBIN 2KCAL HP FIBRE by FRESENIUS KABI (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value);
- Food for special medical purposes for enteral nutrition FRESUBIN 2KCAL HP by FRESENIUS KABI (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value);
See the details in French here.
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