On March 30, 2020, the French High Authority for Health, HAS, has published the opinion of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) regarding the Impella 5.0 device.
The device demonstrated sufficient clinical benefit, in management of adults in cardiogenic shock (CC) refractory to optimal medical treatment without refractory respiratory failure requiring extracorporeal respiratory assistance and without severe multi-organ failure, occurring following cardiac surgery. The reasons for the sufficient clinical benefit are:
- The therapeutic interest of Impella 5.0 in the indication chosen was demonstrated
- The interest of the public health, in view of the extreme severity of the pathology, and the urgency of its management
Regarding the same indication, Impella 5.0 received level II (important) of the clinical added value (on the scale I to V), compared to the currently optimal medical treatment.
The available evidence did not establish sufficient clinical benefit of Impella 5.0 for the other indication - management of adults under 65 in cardiogenic shock refractory to optimal drug treatment and without refractory respiratory failure requiring extracorporeal respiratory assistance and / or without severe multi-visceral failure, awaiting long-term cardiac or circulatory assistance transplantation. Thus, Impella 5.0 will not be reimbursed for this indication.
After the negotiation with CEPS, Impella might be the first short-term VAD to enter add-on reimbursement list LPPR.
See all details in French here.
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