The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of many medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in March 2020.
The first step in the assessment is the clinical benefit, which can be either sufficient or insufficient. This step determines the insertion into the LPPR list. If sufficient, the clinical added value is graded on a scale from I (major) to V (absent), which supports the pricing decisions.
Nine (9) decision was released for cardiovascular devices:
- SILK +, intracranial stent (application for registration; sufficient clinical benefit; level IV clinical added value)
- COREVALVE EVOLUT AOA, aortic heart valve, animal origin (removal from the LPPR list)
- COREVALVE AOA, aortic heart valve, animal origin (removal from the LPPR list)
- IMPELLA CP (application for registration; insufficient clinical benefit)
- IMPELLA 5.0 (application for registration; sufficient clinical benefit for one of the two indications; level II clinical added value)
- CELLO, balloon guide catheter (application for registration; sufficient clinical benefit; level IV clinical added value)
- SOFIA, distal access catheter used in a thrombo-aspiration system (application for registration; sufficient clinical benefit; level V clinical added value)
- SOFIA PLUS, distal access catheter used in a thrombo-aspiration system (application for registration; sufficient clinical benefit; level V clinical added value)
- AMPLATZER PFO OCCLUDER (application for registration; sufficient clinical benefit; level V clinical added value)
Two (2) decision was released for orthopaedic devices:
- GLASSBONE INJECTABLE PUTTY, synthetic bone substitute (application for registration; sufficient clinical benefit; level V clinical added value)
- MERCURY CEMENT, hip prosthesis (element): acetabulum (application for registration; sufficient clinical benefit; level V clinical added value compared to simple mobility cups with a conventional polyethylene insert)
Sixteen (16) decisions were released for other devices:
- BIOMONITOR III, cardiac monitor for more efficient insertion and monitoring (application for registration; sufficient clinical benefit; level V clinical added value, compared to REVEAL LINQ)
- HYLOVIS GEL MULTI (application for registration; sufficient clinical benefit; level V clinical added value)
- VISMED GEL MULTI (application for registration; sufficient clinical benefit; level V clinical added value compared to other lacrimal substitutes in the LPPR list)
- PROCLAIM 5 (3661) and 7 (3663), spinal ganglion stimulator (application for registration; sufficient clinical benefit; level V clinical added value compared to other devices in the LPPR list)
- URGOSTART PLUS, pads for ulcer treatment and wound healing (application for registration; sufficient clinical benefit; level IV clinical added value in one, level III in another indication)
- DEXCOM G6, continuous glucose monitoring system (application for registration; sufficient clinical benefit; level III clinical added value compared to glycemic self-monitoring by capillary glycemia reader only)
- OMNIPOD DASH INSULIN MANAGEMENT SYSTEM (application for registration; sufficient clinical benefit; level V clinical added value compared to OMNIPOD)
- MOVYMIA PEN, parathyroid hormone injector pen (application for registration; sufficient clinical benefit; level V clinical added value)
- BRAVA SUPPORT PLUS, peripheral reinforcements for ostomy (application for registration; sufficient clinical benefit; level V clinical added value)
- PEPTAMEN JUNIOR, nutritional formula (application for modification and renewal; sufficient clinical benefit in one of the two indications; level V clinical added value compared to the generic mixtures)
- ACTIVA SC PATIENT REMOTE CONTROL (application for registration; sufficient clinical benefit; level V clinical added value)
- ACTIVA RC PATIENT REMOTE CONTROL (application for registration; sufficient clinical benefit; level V clinical added value)
- ACTIVA PC PATIENT REMOTE CONTROL (application for registration; sufficient clinical benefit; level V clinical added value)
- ACTIVA PC, brain simulator (application for renewal of registration; sufficient clinical benefit; level V clinical added value in the treatment of Parkinson’s disease; level II clinical added value in the treatment of severe disabling tremors; level I clinical added value in the treatment of generalized primary dystonia)
- ACTIVA SC, brain simulator (application for renewal of registration; sufficient clinical benefit; level II clinical added value in the treatment of severe disabling tremors; level I clinical added value in the treatment of generalized primary dystonia and Parkinson’s disease)
- ACTIVA RC, brain simulator (application for renewal of registration; sufficient clinical benefit; level V clinical added value in the treatment of Parkinson’s disease, in the treatment of severe disabling tremors, and in the treatment of generalized primary dystonia)
See the news in French here.
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