Recommendations about transitional coverage of medical devices in France in August 2022

Transitional coverage of medical devices (prise en charge (PEC) transitoire), according to article L165-1-5 of the Social Security, is a newly established pathway to obtain coverage for CE-marked medical devices intended for the treatment of rare or serious diseases or compensation for a disability. The transitional coverage is provided for 12 months with an opportunity for renewal before applying for full-time inclusion in the List of Reimbursable Products and Services (LPPR).

On August 23, 2022, the National Committee for the evaluation of medical devices and health technologies (CNEDiMTS) at the French National Authority for Health (HAS) published a positive opinion for the transitional coverage of the cardiac resynchronization system WISE CRT-SYSTEM by EBR System. The CNEDiMTS considered that the device was eligible for temporary reimbursement in the following indication:

• In patients with persistent symptomatic heart failure despite optimal drug therapy, who meet current eligibility criteria for cardiac resynchronization therapy (CRT): non-responders to conventional cardiac resynchronization devices, unable to be treated (lead implantation failure or deactivated lead), at a high risk of upgrading;
• To allow cardiac resynchronization, the system generates endocardial stimulation of the left ventricle synchronized with the stimulation pulse of the right ventricle emitted by an implanted pacemaker or an implanted defibrillator, or an implantable pacemaker with a resynchronization function (CRT-P), or an implantable cardiac defibrillator with resynchronization function (CRT-D).

See the details in French here.

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