Recommendations about add-on reimbursement for medical devices in France in March 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 March 2022. More than 15 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, orthopedic, and neurovascular 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:

• Coronary stent coated with sirolimus CRE8 EVO by ALVIMEDICA MEDICAL TECHNOLOGIES (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value)
• Pulmonary valve bioprosthesis implanted by transcutaneous approach MELODY combined with its ENSEMBLE II delivery system by Medtronic (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Paclitaxel Eluting Balloon IN.PACT ADMIRAL by MEDTRONIC (application for modification of registration conditions and renewal of registration; sufficient actual benefit; level III of clinical added value)
• Self-expanding carotid stent PRECISE PRO RX by CARDINAL HEALTH (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Paclitaxel Eluting Balloon IN.PACT PACIFIC by Medtronic (application for renewal of registration; sufficient actual benefit; level V of clinical added value).

Recommendations for orthopedic devices:

• Modular Proximal Tibia Reconstruction System PROXIMAL TIBIA METS SYSTEM by STRYKER (application for renewal of registration; sufficient actual benefit; level V and level IV of clinical added value depending on a comparator)
• Highly cross-linked polyethylene insert enriched with vitamin E INSERT VIVACIT-E by ZIMMER BIOMET (application for registration; insufficient actual benefit)
• Highly cross-linked polyethylene inserts INSERTS XLPE by SMITH & NEPHEW (application for renewal of registration; sufficient actual benefit; level V and level IV of clinical added value depending on a comparator)
• Femoral head in zirconium oxide for total hip prosthesis OXINIUM by SMITH & NEPHEW (application for renewal of registration; sufficient actual benefit; level V and level IV of clinical added value depending on a comparator).

Recommendations for neurovascular devices:

• Self-expanding intracranial stent LVIS EVO by MICROVENTION (application for renewal of registration; sufficient actual benefit; level V of clinical added value).

Recommendations for medical aids:

• Class I energy restitution foot UPYA by EXONEO (application for registration; sufficient actual benefit; level V of clinical added value)
• Hydrocellular dressing with non-standard geometric shape CUTIMED SORBION SACHET S DRAINAGE by BSN-RADIANTE (application for registration; sufficient actual benefit; level V of clinical added value)
• Anatomic hydrocellular dressing ECLYPSE CONTOUR by BRIGHTWAKE LTD t/a ADVANCIS MEDICAL (application for registration; sufficient actual benefit; level V of clinical added value)
• Respiratory prosthesis with or without a voice implant PROVOX FLEXIVOICE by ATOS MEDICAL (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Respiratory prosthesis with or without a voice implant PROVOX HME by ATOS MEDICAL (application for renewal of registration; sufficient actual benefit; level V of clinical added value)
• Food for special medical purposes for oral nutrition NEOCATE SPOON by NUTRICIA NUTRITION CLINIQUE (application for renewal of registration; sufficient actual benefit; level V of clinical added value).

See the details in French here.

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