Transitional coverage as early access to reimbursement of innovative medical devices in France

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

Three prerequisites must be met for a device to be eligible for this transitional coverage: the medical device must have CE marking, it must not already be covered as part of hospitalization services, and the manufacturer must undertake to submit a request for inclusion in the LPPR for this medical device within 12 months of the request for transitional coverage.

The dossier must be submitted simultaneously to the French Authority for Health (HAS) and to the Ministry of Solidarity and Health. On May 31, 2021, the guide for dossier submission, the template of a dossier,  and the document that explains the decision-making process were published on the websites of the Ministry of Solidarity and Health and HAS. The whole process, including the assessment of a device by the National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) at the HAS and decision-making by the Ministry of Solidarity and Health, should take less than five months.

See the details in French here (HAS) and here (Ministry of Solidarity and Health).

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