Recommendations about add-on reimbursement for medical devices in France in April 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 April 2022. Thirty 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, neurovascular, and neuromodulation and other 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 devices in the cardiovascular and peripheral vascular field:

• Implantable pacemaker with atrio-biventricular stimulation for resynchronization EDORA 8 HF-T QP by BIOTRONIK (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
• Implantable pacemaker with atrio-biventricular stimulation for resynchronization EDORA 8 HF-T by BIOTRONIK (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
• Endoprosthesis with controlled expansion for the treatment of complications of portal hypertension VIATORR TIPS by WL GORE (application for renewal of registration; sufficient actual benefit; level III of clinical added value);
• Coronary fractional flow reserve measurement guidewire OMNIWIRE by PHILIPS (application for registration; sufficient actual benefit; level V of clinical added value);
• Self-expanding vein stent SINUS-XL FLEX by OPTIMED (application for registration; sufficient actual benefit; level V of clinical added value);
• Electrically detachable helical peripheral embolization system with Hydrogel AZUR AND AZUR CX by TERUMO (application for registration; sufficient actual benefit; level V of clinical added value).

Recommendations for orthopedic devices:

• Bone substitute derived from derivatives of bovine origin I-FACTOR FLEX FR by CERAPEDICS (application for registration; insufficient actual benefit);
• Bone substitute for cranial reconstruction CROWN by EUROS (application for registration; sufficient actual benefit; level V of clinical added value);
• Bone substitute derived from derivatives of bovine origin I-FACTOR PUTTY by CERAPEDICS (application for registration; sufficient actual benefit; level V of clinical added value);
• Modular shoulder reconstruction system MUTARS by IMPLANTCAST (application for renewal of registration; sufficient actual benefit; level V or level IV of clinical added value depending on the comparator).

Recommendations for neurovascular and neuromodulation devices:

• Self-expanding intracranial stent LVIS JUNIOR by MICROVENTION (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
• Electrodes for vagus nerve stimulation system PerenniaDURA (model 303) and PerenniaFLEX (model 304) by LIVANOVA (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
• Upper airway stimulation system INSPIRE IV by INSPIRE MEDICAL SYSTEMS (application for registration; sufficient actual benefit; level IV of clinical added value).

Recommendations for devices in the gastrointestinal field:

• Device for endoscopic drainage, Hot AXIOS stent and electrocautery assisted delivery system, by BOSTON SCIENTIFIC (application for modification of registration conditions; sufficient actual benefit; level III of clinical added value).

Recommendations for medical aids:

• Foods for special medical purposes for enteral nutrition FRESUBIN 2KCAL HP by FRESENIUS KABI (application for registration; sufficient actual benefit; level V of clinical added value);
• Foods for special medical purposes for enteral nutrition FRESUBIN 2KCAL HP FIBRE by FRESENIUS KABI (application for registration; sufficient actual benefit; level V of clinical added value);
• Continuous interstitial glucose monitoring system DEXCOM ONE by DEXCOM (application for registration; sufficient actual benefit; level V of clinical added value);
• External insulin pump without outer tubing TOUCHCARE by MEDTRUM (application for registration; sufficient actual benefit; level V of clinical added value);
• Lubricating eye drops SYSTANE BALANCE by ALCON LABORATORIES (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
• Dressings URGOCLEAN AG by URGO LABORATORIES (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
• Ostomy collection bag MODERMA FLEX CERAPLUS by HOLLISTER (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value);
• Transportable stairlifts for manual wheelchairs ALBER SCALAMOBIL S35 and ALBER SCALAMOBIL S38 by INVACARE POIRIER (application for registration; sufficient actual benefit; level IV of clinical added value);
• Mandibular advancement orthosis APNOSOM by AGL LABORATORY (application for registration; insufficient actual benefit);
• Hydrocellular adhesive anatomical dressing ABSOFOAM BORDER SACRUM by LABORATOIRE MARQUE VERTE (application for registration; sufficient actual benefit; level V of clinical added value);
• Peripheral myopic defocus corrective lens MIYOSMART by HOYA VISION CARE (application for registration; sufficient actual benefit; level IV of clinical added value);
• Food for special medical purposes KETOVIE 4:1 by Laboratoires Grand Fontaine (application for registration; sufficient actual benefit; level V of clinical added value);
• Hydrocellular dressing with non-standard geometric shape CUTIMED SORBION SACHET MULTI STAR by BSN-RADIANTE (application for registration; sufficient actual benefit; level V of clinical added value);
• Hydrocellular dressing with non-standard geometric shape CUTIMED SORBION SACHET XL by BSN-RADIANTE (application for registration; sufficient actual benefit; level V of clinical added value);
• Class III energy return foot PROTEOR HIGHLANDER by PROTEOR (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
• Electronic automatic modular knee joint for lower limb orthosis NEURO TRONIC by FIOR & GENTZ (application for registration; sufficient actual benefit; level V of clinical added value).

See the details in French here.

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