Neovasc Reducer system covered under transitional coverage in France

Transitional coverage of certain products and services (prise en charge (PEC) transitoire), according to the 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 submitting an application for full-time inclusion in the List of Reimbursable Products and Services (LPPR).

On December 14, 2021, the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) at the French National Authority for Health (HAS) published a favorable opinion for the request for transitional coverage of the Neovasc Reducer System by Neovasc in refractory stable angina pectoris.

On March 10, 2022, the Ministry of Solidarity and Health published an Order in the Official Journal of the French Republic on the transitional coverage for the Neovasc Reducer system. The device is now registered under the LPPR code 3156688 “Coronary sinus reduction system, NEOVASC, NEOVASC REDUCER SYSTEM” with a reimbursement tariff of €7,068.

The full details in French can be found here.

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