Recommendations about add-on reimbursement for medical devices in France in February 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 February 2022. More than 25 recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration of devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular and peripheral vascular, orthopedic, neurovascular, and neuromodulation devices, as well as breast implants and medical aids. Except for this, CNEDiMTS published two negative opinions concerning transitional coverage of devices.

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:

• Coronary Intravascular Lithotripsy Catheter C2 IVL CATHETER by Shockwave Medical (application for registration; sufficient actual benefit; level IV of clinical added value)

• Implantable pacemaker with atrio-biventricular pacing for resynchronization called “triple chamber” REPLY CRT-P by MICROPORT CRM (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Self-expanding endoprosthesis GORE VIABAHN with bioactive PROPATEN coating by WL GORE ET ASSOCIES SARL (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value).

Recommendations for orthopedic devices:

• Modular System for Massive Knee Reconstruction MUTARS Knee by IMPLANTCAST (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Dual mobility acetabulum consisting of a non-cemented cup and a conventional polyethylene insert APOGEE (without cement) by BIOTECHNI (application for registration; sufficient actual benefit; level V of clinical added value)
• Dual-mobility acetabulum consisting of a cemented cup and a conventional polyethylene insert APOGEE (cemented) by BIOTECHNI (application for registration; sufficient actual benefit; level V of clinical added value)
• One-piece cup in highly cross-linked polyethylene REFLECTION ALL POLY XLPE by SMITH & NEPHEW (application for renewal of registration; sufficient actual benefit; level IV of clinical added value)
• Injectable synthetic bone substitute CALCIBON INJECT by ZIMMER BIOMET (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Viro-inactivated bone allograft by TUTOPLAST process PUROS by NOVOMEDICS (application for registration; sufficient actual benefit; level V of clinical added value).

Recommendations for neurovascular and neuromodulation devices:

• Self-expanding intracranial stent with controlled release DERIVO by ACANDIS (application for registration; sufficient actual benefit; level V of clinical added value)
• Self-expanding intracranial stent with controlled release DERIVO MINI by ACANDIS (application for registration; sufficient actual benefit; level V of clinical added value)
• Non-Rechargeable Sacral Root Neuromodulation System Electrode INTERSTIM SURESCAN MRI (978B1) by Medtronic (application for registration; sufficient actual benefit; level V of clinical added value).

Recommendations for breast implants:

• Breast implant, round, smooth, pre-filled with silicone gel ERGONOMIX by MOTIVA IMPLANTS (application for registration; sufficient actual benefit; level V of clinical added value)
• Breast implant, round, micro-textured, pre-filled with silicone gel CEREFORM MICRO-TEXTURED by EUROMI BIOSCIENCES (application for registration; sufficient actual benefit; level V of clinical added value)
• Breast implant, round, smooth, pre-filled with silicone gel CEREFORM SMOOTH by EUROMI BIOSCIENCES (application for registration; sufficient actual benefit; level V of clinical added value).

Recommendations for medical aids:

• Sterile solution for ophthalmic use VITADROP by SAM LABORATOIRE DENSMORE (application for registration; sufficient actual benefit; level V of clinical added value)
• Electric propulsion assistance device with control only for the accompanying person ALBER VIAMOBIL V25 by INVACARE POIRIER S.A.S. (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Sterile solution for ophthalmic use OPTIVE by ALLERGAN SALES LLC (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value)
• Food for special medical purposes for oral nutrition NOVALAC AMINA by LABORATOIRE NOVALAC (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Sterile solution for topical ophthalmic use HYLO CONFORT by URSAPHARM ARZNEIMITTEL GmbH (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Foods for special medical purposes for oral nutrition NEOCATE SYNEO by NUTRICIA NUTRITION CLINIQUE (application for registration; sufficient actual benefit; level V of clinical added value)
• Food for special medical purposes for enteral nutrition NUTRISON PEPTISORB PLUS HEHP by NUTRICIA NUTRITION CLINIQUE (application for registration; sufficient actual benefit; level V of clinical added value)
• Electric propulsion assistance device with control only for the accompanying person ALBER VIAPLUS V12 by INVACARE POIRIER (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Electric propulsion assistance device with control only for the accompanying person ALBER VIAMOBIL ECO V14 by INVACARE POIRIER (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Non-electric stair walker ASSISTEP by ASSITECH AS (application for registration; insufficient actual benefit)
• Energy return foot for lower leg amputation PROTEOR PACIFICA LP by PROTEOR USA LLC (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Sterile solution for topical ophthalmic use HYLO CONFORT PLUS by URSAPHARM Laboratories (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Nebulizer system for aerosol therapy VELOX by PARI GmbH (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Processor for osseointegrated hearing aid PONTO 5 MINI by OTICON MEDICAL (application for registration; sufficient actual benefit; level V of clinical added value).

Except for these recommendations, CNEDiMTS also published negative opinions concerning the requests for transitional coverage of the following devices: aortic stent used in type I dissections according to DeBakey classification ASCYRUS medical dissection stent by Cryolife, and device for digital psychotherapy Deprexis by ETHYPHARM DIGITAL THERAPY.

See the details in French here.

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