National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) positively appraised Verrata and Verrate Plus guidewires for add-on reimbursement via LPPR title V. Level of added clinical value was considered moderate (ASA III) in comparison with management strategy, based solely on angiography data.
Fractional flow reserve was firstly introduced into French payment system in 2016 following the creation of procedure (CCAM) code DDQF202 “Mesure du flux de réserve coronarien [FFR] au cours d’une artériographie coronaire” in October 2015.
Conditions for reimbursement were established in the report of National Authority of Health (HAS) in 2015. The estimated target population for FFR is about 26,000 – 31,000 patients annually.
In order to create specific and sufficient reimbursement for guidewire device, Philips Volcano applied for add-on reimbursement via LPPR title V, which is dedicated for invasive non-implantable devices. MTRC has reported recently that Medtronic’s IN.PACT Admiral was among first invasive non-implantable devices to get add-on reimbursement in France.
No specific clinical data were available for guidewires in scope. The applicant claimed equivalence to the PRESSUREWIRE device (St. Jude Medical, now Abbott), which was used in the landmark FAME I and FAME II trials. Verrata guidewire was partly used in the French FUTURE study, which was stopped preliminary. Decision of the Committee was mainly based on the results of FAME I and FAME II trials.
The inscription is expected after negotiation about price, which will be determined nationally for technology. It can take about a year until reimbursement will be established. Once established, inscription will be valid for 3 years.
Decision of CNEDiMTS is available in French here.
Positive decision of CNEDiMTS in relation to products of Philips Volcano just 2 months after positive decision in relation to Abbott’s (previously – St. Jude Medical) PressureWire (Certus, Aeris and X) devices indicates that two companies will have more or less simultaneous start with add-on reimbursement on the French market.
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