Recommendations about add-on reimbursement for medical devices in France in June 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 June 2022. Nineteen 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, interventional radiology, orthopedic, neurovascular and neuromodulation, ophthalmology, 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:

• Edge-to-edge mitral repair clip MITRACLIP G4-XTW by ABBOTT (application for registration; sufficient actual benefit; level V of clinical added value)
• Portable external cardiac defibrillator LIFEVEST 4000 by ZOLL MEDICAL (application for modification of registration conditions; insufficient)
• Coronary endoprosthesis coated with biolimus BIOFREEDOM by BIOSENSORS (application for modification and renewal of registration; sufficient actual benefit; level V of clinical added value)

Recommendations for interventional radiology devices:

• Radiofrequency needle electrodes LEVEEN by BOSTON SCIENTIFIC (application for modification of registration conditions; sufficient actual benefit; level II, III, or IV of clinical added value depending on the considered indications and comparators

Recommendations for neurovascular and neuromodulation devices:

• Stent retriever EMBOTRAP III by JOHNSON & JOHNSON (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value)
• Stent retriever EMBOTRAP II by JOHNSON & JOHNSON (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value)
• Intrathoracic phrenic stimulator ATROSTIM by NEURORESP (application for renewal of registration; sufficient actual benefit; level II of clinical added value)

Recommendations for orthopedic devices:

• Highly cross-linked polyethylene insert LONGEVITY by ZIMMER BIOMET (application for renewal of registration; sufficient actual benefit; level IV or V of clinical added value depending on the considered comparators)
• Vertebral body stent system VERTEBRAL BODY STENT by JOHNSON & JOHNSON (application for registration; sufficient actual benefit; level IV or V of clinical added value depending on the considered comparators
• Highly cross-linked polyethylene insert PLASMAFIT VITELENE by B.BRAUN MEDICAL (application for renewal of registration; sufficient actual benefit; level V of clinical added value)

Recommendations for ophthalmological devices:

• Viro-inactivated amniotic membrane VISIO AMTRIX by TBF - TISSUE ENGINEERING (application for registration; insufficient actual benefit)

Recommendations for medical aids:

• Modular ankle joint for lower limb orthosis NEURO SWING by FIOR & GENTZ (application for registration; sufficient actual benefit; level V of clinical added value)
• Electric breast pump for individual use MATERNOV, ELECTRIC BREAST PUMP by MAJORELLE LABORATORIES (application for registration; insufficient actual benefit)
• Telethesis: remote control adapted to the handicap to allow the control of the electric and electronic environment of the person in the situation of handicap GEWA ONE by CREE (application for registration; sufficient actual benefit; level V of clinical added value)
• Hydraulic polycentric hip joint HELIX 3D 7E10 by OTTO BOCK (application for modification and renewal of registration; sufficient actual benefit; level IV of clinical added value)
• Myoelectric elbow for external prosthesis of the upper limb DYNAMICARM by OTTO BOCK (application for registration; sufficient actual benefit; level IV of clinical added value)
• Adult therapeutic shoes for prolonged use AD 8001 by ADOUR PIED CONFORT FRANCIS LAVIGNE (application for registration; sufficient actual benefit; level V of clinical added value)
• Adult therapeutic shoes for prolonged use AD 8000 by ADOUR PIED CONFORT FRANCIS LAVIGNE (application for registration; sufficient actual benefit; level V of clinical added value)

• Secure pill dispenser in pharmacies via a web application MEDIPAC by MEDISSIMO (application for registration; insufficient actual benefit)

See the details in French here.

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