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 July 2022. Twenty 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, neurovascular and neuromodulation, orthopedic, endocrine, and ENT devices, as well as breast implants and medical aids. Except for this, CNEDiMTS published two positive and 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:
- Device for transcutaneous closure of the left atrial appendage WATCHMAN FLX by BOSTON SCIENTIFIC (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
- Device for transcutaneous closure of the left atrial appendage AMPLATZER AMULET LAAO by ABBOTT MEDICAL (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
- Paclitaxel-eluting peripheral balloon LUTONIX 018 by BECTON DICKINSON (application for registration; sufficient actual benefit; level V of clinical added value).
Recommendations for neurovascular and neuromodulation devices:
- Self-expanding intracranial stents LEO PLUS by BALT EXTRUSION (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value);
- Rechargeable stimulator for deep brain stimulation VERCISE GEVIA by BOSTON SCIENTIFIC (application for modification and renewal of registration; sufficient actual benefit in both registered indications; level V of clinical added value in both registered indications).
Recommendations for orthopedic devices:
- Highly cross-linked polyethylene insert with vitamin E VIVACIT-E by ZIMMER BIOMET (application for registration; sufficient actual benefit in certain indications; level V of clinical added value).
Recommendations for spine-related devices:
- Cervical disc prosthesis PRODISC-C VIVO by CENTINEL SPINE SCHWEIZ (application for registration; insufficient actual benefit).
Recommendations for endocrine devices:
- External insulin pump without outer tubing WELLION MICRO-PUMP by MED TRUST (application for registration; insufficient actual benefit);
- Continuous interstitial glucose monitoring system coupled with an external insulin pump SYSTEME MINIMED 740G by MEDTRONIC (application for registration; sufficient actual benefit; level V of clinical added value);
- Continuous interstitial glucose monitoring system FREESTYLE LIBRE 3 by ABBOTT (application for registration; sufficient actual benefit; level V of clinical added value).
Recommendations for ENT devices:
- Middle ear implant VIBRANT SOUNDBRIDGE by MED-EL (application for renewal of registration; sufficient actual benefit; level IV of clinical added value both in children and adults).
Recommendations for surgery-related devices:
- Breast implant, round, pre-filled with silicone gel MONOBLOC by LABORATOIRES ARION (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value).
Recommendations for medical aids:
- Administration kit for the treatment of benign prostatic hyperplasia REZUM by BOSTON SCIENTIFIC (application for registration; sufficient actual benefit in certain indications; level IV of clinical added value);
- Disposable handpiece for resection of benign prostatic hyperplasia by pulsed water jet AQUABEAM ROBOTIC SYSTEM by PROCEPT BIOROBOTICS (application for registration; sufficient actual benefit in certain indications; level IV of clinical added value);
- Adhesive for fixing the components of the PROVOX systems (respiratory prostheses for total laryngectomy) PROVOX STABILIBASE by ATOS MEDICAL (application for registration; sufficient actual benefit; level V of clinical added value);
- Foot-ankle prosthetic system with microprocessor PROPRIO FOOT by OSSUR EUROPE (application for registration; sufficient actual benefit; level IV of clinical added value);
- Class III energy return prosthetic foot AERIS PERFORMANCE LP by ORTHO EUROPE (application for registration; sufficient actual benefit; level V of clinical added value);
- Class III energy return prosthetic foot AERIS PERFORMANCE 2 by ORTHO EUROPE (application for registration; sufficient actual benefit; level V of clinical added value);
- Partial external silicone breast prosthesis, technical model, non-adherent AMOENA BALANCE ADAPT AIR by AMOENA FRANCE (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value);
- Total external silicone breast prosthesis, technical model, non-adherent VELVETY SOFTLITE by ANITA DR HELBIG GMBH (application for registration; sufficient actual benefit; level V of clinical added value).
Except for these recommendations, CNEDiMTS also published opinions concerning the request for transitional coverage. Two positive opinions of the following devices were published: Chyme reinfusion system THE INSIDES SYSTEM by THE INSIDES COMPANY and Renal denervation catheter SYMPLICITY SPYRAL by MEDTRONIC. Two negative opinions of the following devices were published: Mitral contour system CARILLON by CARDIAC DIMENSIONS EUROPE GMBH and Device for percutaneous arterialization of the deep venous network LIMFLOW SYSTEM by LIMFLOW.
See the details in French here.
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