Medtronic has announced recent reimbursement approvals in both France and Belgium.
A Ministerial decree was published in the Official Journal of French Republic to enlist Medtronic’s IN.PACT Admiral drug-coated balloon (DCB) for the LPPR title V for add-on reimbursement in the treatment of peripheral artery disease (PAD) in the upper leg. The National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) issued a positive opinion and recommended the IN.PACT Admiral drug-coated balloon (DCB) for reimbursement.
This approval makes IN.PACT Admiral the first peripheral DCB approved for reimbursement (as of 7 June, 2017) in France for the treatment of peripheral artery disease. This reimbursement approval in France became effective on 19 May.
The IN.PACT Admiral DCB is now not only the first peripheral DCB to receive reimbursement approval in France, but one of the first invasive non-implantable device to obtain this new add-on reimbursement in France under the newly created LPPR Title V legislation.
Medtronic also received reimbursement approval for IN.PACT Admiral in Belgium, effective as of 1 April, 2017. IN.PACT Admiral is the first DCB to be approved for reimbursement in Belgium, based on a body of robust scientific evidence demonstrating significantly superior clinical outcomes and cost effectiveness vs alternatives.
The Belgian Ministry of health specifies that only DCBs which have demonstrated statistically significant reduction in the rate of revascularisation will be eligible for reimbursement in Belgium.
“The reimbursement approvals for the IN.PACT Admiral DCB in France and Belgium mark significant milestones for Medtronic, further confirming the superiority of IN.PACT DCB in the treatment of PAD,” said Mark Pacyna, vice president and general manager of the Peripheral business in the Medtronic Cardiac & Vascular Group. “This decision will ultimately help to improve patient access to the IN.PACT Admiral, which is the only DCB that has demonstrated consistent and durable outcomes out to three years.”