Recommendations about add-on reimbursement for medical devices in France in May 2022

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 May 2022. Thirty-one 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 and peripheral vascular, diagnostic imaging, interventional radiology, orthopedic, neurovascular and neuromodulation, endocrine and E-health 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 and peripheral vascular devices:

• Aortic valve bioprosthesis implanted transfemorally (COMMANDER system) EDWARDS KIT SAPIEN 3 ULTRA - TRANSFEMORAL by EDWARDS LIFESCIENCES (application for registration; sufficient actual benefit; level V of clinical added value)
• Thoracic aortic endoprosthesis ZENITH TX2 DISSECTION PROFORM by COOK (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Coronary endoprosthesis releasing biolimus BIOMATRIX ALPHA by BIOSENSORS (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Implantable pacemaker with atrio-biventricular pacing for resynchronization VISIONIST by BOSTON SCIENTIFIC (application for renewal of registration; sufficient actual benefit; level V of clinical added value).

Recommendations for diagnostic imaging devices:

• Coronary fractional flow reserve (FFR) measurement guide OPTOWIRE III by FSCARE (application for registration; sufficient actual benefit; level V of clinical added value).

Recommendations for interventional radiology devices:

• Electrically detachable helical peripheral embolization system with hydrogel AZUR / AZUR CX by TERUMO (application for registration; sufficient actual benefit; level V of clinical added value)
• Yttrium 90 microspheres SIR-SPHERES Y-90 RESIN MICROSPHERES (SIR-SPHERES) by SIRTEX MEDICAL (application for modification and renewal of registration; sufficient actual benefit; level IV of clinical added value).

Recommendations for neurovascular and neuromodulation devices:

• Self-expanding intracranial stents LEO PLUS by BALT EXTRUSION (application for renewal of registration and modification of the conditions of registration; sufficient actual benefit; level V of clinical added value)
• Rechargeable system for deep brain stimulation VERCISE GENUS R16 by BOSTON SCIENTIFIC (application for registration; sufficient actual benefit; level V of clinical added value)
• Directional electrode for deep brain stimulation VERCISE CARTESIA by BOSTON SCIENTIFIC (application for modification and renewal of registration; sufficient actual benefit; level IV or V of clinical added value depending on the considered indications)
• Non-rechargeable system for deep brain stimulation VERCISE PC by BOSTON SCIENTIFIC (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Conventional electrode (standard or non-directional) for deep brain stimulation VERCISE PC by BOSTON SCIENTIFIC (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Non-rechargeable system for deep brain stimulation VERCISE GENUS P16 by BOSTON SCIENTIFIC (application for registration; sufficient actual benefit; level V of clinical added value).

Recommendations for E-Health devices:

• Remote monitoring system for compatible implantable cardiac monitors MERLIN.NET by ABBOTT MEDICAL (application for registration; sufficient actual benefit; level IV of clinical added value).

Recommendations for orthopedic devices:

• Highly cross-linked polyethylene insert LONGEVITY by ZIMMER BIOMET (application for modification of registration conditions; sufficient actual benefit; level IV or V of clinical added value depending on the considered comparators)
• Dual-mobility acetabulum consisting of a non-cemented cup and a highly cross-linked polyethylene insert ARCOMXL or a highly cross-linked polyethylene insert with vitamin E (E1 or VIVACIT-E), COTYLE G7 DM INSERTS ARCOMXL E1 VIVACITE by ZIMMER BIOMET (application for registration; sufficient actual benefit; level V of clinical added value).

Recommendations for endocrine devices:

• Continuous interstitial glucose monitoring system GUARDIAN 4 by MEDTRONIC (application for registration; sufficient actual benefit; level III or V of clinical added value depending on the considered comparators)
• Semi-closed loop system dedicated to the automated management of type I diabetes MINIMED 780G SYSTEM associated with the GUARDIAN 4 continuous interstitial glucose monitoring system by MEDTRONIC (application for registration; sufficient actual benefit; level V of clinical added value)
• Semi-closed loop system dedicated to the automated management of type I diabetes CONTROL-IQ by TANDEM DIABETES CARE (application for registration; sufficient actual benefit; level III of clinical added value).

Recommendations for medical aids:

• Class III energy return prosthetic foot PROTEOR FREEDOM SHOCKWAVE by PROTEOR (application for registration; sufficient actual benefit; level V of clinical added value)
• Food for special medical purposes for nutritional needs in case of dysphagia or swallowing disorders GEL’CLEAR by NUTRISENS MEDICAL (application for registration; sufficient actual benefit; level V of clinical added value)
• Mobile oxygen concentrator Zen-O CLARITY RS-00500C by GCE (application for registration; sufficient actual benefit; level V of clinical added value)
• Modular electric scooter INVACARE LEO by INVACARE POIRIER (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Mobile oxygen concentrator PLATINUM MOBILE by INVACARE POIRIER (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Vein compression kit ROSIDAL SYS by LOHMANN & RAUSCHER LABORATORIES (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Sterile solution for ophthalmic use OPTIVE FUSION UD by ALLERGAN (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Vein compression bandages ROSIDAL K by LOHMANN & RAUSCHER LABORATORIES (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Myoelectric hand for external upper limb prosthesis MICHELANGELO by OTTO BOCK (application for modification and renewal of registration; sufficient actual benefit; level III of clinical added value)
• Myoelectric hand for external upper limb prosthesis MICHELANGELO TRANSCARPAL by OTTO BOCK (application for registration; sufficient actual benefit; level III of clinical added value)
• Mobile oxygen concentrator Zen-O RS-00500 by GCE (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Stationary oxygen concentrator OC-E100 by GCE (application for registration; sufficient actual benefit; level V of clinical added value).

See the details in French here.

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