A new project received a favorable opinion for coverage under the Forfait Innovation program in France

Forfait innovation is the most advanced ‘coverage with the evidence development’ program in France. Established in 2015, the program focuses solely on medical devices, procedures, and in vitro diagnostic technologies. The objective of the program is to provide early support for breakthrough innovations and generate the missing evidence needed for regular reimbursement. The scheme involves a government-co-sponsored study. The budget comes from three sources: the Ministry of Health (experimental arm), regular statutory health insurance (control arm), and an applicant (study infrastructure).

Eligibility for the Forfait Innovation is assessed by the National Authority for Health (HAS) based on several criteria, including the innovative nature of the technology and the appropriateness of the proposed evidence-generation study protocol. Final coverage decisions are taken by the Ministry of Health following HAS’s opinion.

On September 11, 2026, HAS issued a favorable opinion recommending coverage of the SAPIEN M3 transcatheter mitral valve replacement system under the Forfait Innovation program for the following indication:

• Treatment of patients with symptomatic primary or secondary moderate-to-severe or severe (≥ 3+) mitral regurgitation who are considered ineligible for surgery or transcatheter edge-to-edge repair by the multidisciplinary heart team.

The final coverage decision by the Ministry of Health is currently pending.

This news is just one of about 300 market access news and updates collected by our team in the premium subscription service MTRC Access Intelligence every week from more than 80 organizations. Access our paid service to stay on top of all developments, specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, six-week, no-obligation trial.