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

The French National Authority for Health 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 in September 2022. Thirty-eight 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. Opinions concern cardiovascular and peripheral vascular, neurovascular and neuromodulation, orthopedic, endocrine, ENT, dermatological, and spine-related devices, as well as digital care and 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:

• Carotid stent PROTEGE RX by MEDTRONIC (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
• Self-expanding venous stent SINUS-VENOUS by OPTIMED (application for registration; sufficient actual benefit; level V of clinical added value);
• Vascular access system for percutaneous creation of an arterio-venous anastomosis by thermofusion ELLIPSYS by AVENU MEDICAL (application for registration; insufficient actual benefit);
• Vascular embolization plugs AMPLATZER VASCULAR PLUG 4 by ABBOTT (application for registration; sufficient actual benefit; level V of clinical added value);
• Vascular embolization plugs AMPLATZER VASCULAR PLUG I by ABBOTT (application for registration; sufficient actual benefit; level V of clinical added value);
• Vascular embolization plugs AMPLATZER VASCULAR PLUG II by ABBOTT (application for registration; sufficient actual benefit; level V of clinical added value);
• Iliac bifurcation stent GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE) by WL GORE & ASSOCIATES (application for modification and renewal of registration; sufficient actual benefit; level V of clinical added value);
• Coronary stent coated with everolimus XIENCE SKYPOINT by ABBOTT (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value);
• Coronary stent coated with zotarolimus ONYX FRONTIER by MEDTRONIC (application for registration; sufficient actual benefit; level V of clinical added value);

Recommendations for neurovascular and neuromodulation devices:

• Self-expanding intracranial stent NEUROFORM ATLAS by STRYKER (application for the renewal of registration; sufficient actual benefit; level V of clinical added value);
• Transcutaneous electrical nerve stimulation device VITALITENS by SUBLIMED (application for registration; sufficient actual benefit; level V of clinical added value);
• Self-expanding intracranial stent with controlled release PIPELINE VANTAGE WITH SHIELD TECHNOLOGY by MEDTRONIC (application for registration; sufficient actual benefit; level V of clinical added value);
• Octopolar percutaneous electrodes for implantable spinal cord stimulation systems VECTRIS SURESCAN MRI by MEDTRONIC (application for the renewal of registration; sufficient actual benefit; level V of clinical added value);
• Decahexapolar surgical electrodes for implantable spinal cord stimulation systems SPECIFY SURESCAN MRI by MEDTRONIC (application for the renewal of registration; sufficient actual benefit; level V of clinical added value);
• Stent retriever SOLITAIRE X by MEDTRONIC (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value);

Recommendations for orthopedic devices:

• Non-absorbable meniscal repair system FAST-FIX 360 by SMITH & NEPHEW (application for the renewal of registration; sufficient actual benefit; level V of clinical added value);

Recommendations for spine-related devices:

• Distraction system for the reduction of vertebral fractures SPINEJACK by STRYKER (application for registration; sufficient actual benefit; level IV of clinical added value);

Recommendations for endocrine devices:

• Blood glucose self-monitoring kit and cassette ACCU-CHEK MOBILE by ROCHE DIABETES CARE (application for the renewal of registration; sufficient actual benefit; level V of clinical added value);
• Continuous interstitial glucose monitoring system DEXCOM ONE by DEXCOM (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value);

Recommendations for ENT devices:

• Osseointegrated hearing aid processor PONTO 5 SUPER POWER by PRODITION (application for registration; sufficient actual benefit; level V of clinical added value);

Recommendations for digital care:

• Digital psychotherapy DEPREXIS by ETHYPHARM DIGITAL THERAPY (application for registration; sufficient actual benefit and level V of clinical added value for mild depressive episodes and insufficient actual benefit for moderate or severe depressive episodes);

Recommendations for devices used in dermatology:

• Negative pressure wound therapy system PICO 7 by SMITH & NEPHEW (application for registration; sufficient actual benefit; level V of clinical added value);

Recommendations for medical aids:

• Food for special medical purposes KETOCAL 3:1 POWDER - NEUTRAL FLAVOR by NUTRICIA (application for registration; sufficient actual benefit; level V of clinical added value);
• Therapeutic shoes serial for prolonged use for adults SHIRLEY_HV by FARGEOT & CIE (application for registration; sufficient actual benefit; level V of clinical added value);
• Nebulization system for aerosol therapy AIRFORCE MAX / EVO by DRIVE DEVILBISS HEALTHCARE (application for registration; sufficient actual benefit; level V of clinical added value);
• Nebulization system for aerosol therapy AIRFORCE MAX / MEDELJET PLUS by DRIVE DEVILBISS HEALTHCARE (application for registration; insufficient actual benefit);
• Urinary catheters SPEEDICATH COMPACT, SPEEDICATH COMPACT PLUS, SPEEDICATH COMPACT EVE by COLOPLAST (application for the renewal of registration; sufficient actual benefit; level IV of clinical added value);
• Food for special medical purposes FORTIMEL CREME PROTEIN 125 G by NUTRITION CLINIQUE (application for registration; sufficient actual benefit; level V of clinical added value);
• Class III energy return foot FREEDOM AGILIX by PROTEOR (application for registration; sufficient actual benefit; level V of clinical added value);
• Hydrocellular anatomic dressings with high absorption BIATAIN SILICONE (anatomical shape) by COLOPLAST (application for modification and renewal of registration; sufficient actual benefit; level V of clinical added value);
• Hydrocellular dressings with high absorption BIATAIN SILICONE (standard shape) by COLOPLAST (application for registration; sufficient actual benefit; level V of clinical added value);
• Hydrocellular dressings with high absorption BIATAIN SILICONE NON-BORDER by COLOPLAST (application for registration; sufficient actual benefit; level V of clinical added value);
• Hydrocellular dressings with medium absorption BIATAIN SILICONE LITE by COLOPLAST (application for registration; sufficient actual benefit; level V of clinical added value);
• Dressing URGOSTART PLUS by URGO (application for modification of registration conditions; sufficient actual benefit; level III or IV of clinical added value depending on indications);
• Mandibular advancement orthosis PROSOMNUS EVO by PROSOMNUS SLEEP TECHNOLOGIES (application for registration; insufficient actual benefit);
• Dual band venous compression system 3M COBAN 2 by 3M FRANCE (application for registration; sufficient actual benefit; level V of clinical added value);
• Food for special medical purposes NUTRAMIGEN PURAMINO by RECKITT BENCKISER (application for the renewal of registration; sufficient actual benefit; level V of clinical added value);
• Class III energy return foot CHALLENGER 1E95 by OTTO BOCK (application for modification and renewal of registration; sufficient actual benefit; level V of clinical added value).

See the details in French here.

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