OBJECTIVES : The French CED called “Forfait Innovation” aims to accelerate the entry of promising medical technologies on French market. It was created in 2009 and redesigned in 2015. This analysis aims to provide an overview of the CED program evolution over the 2009-2019 period according to the characteristics of the funded technologies.

METHODS : The analysis was conducted on the accepted projects (with published decree, from 2009 to 2019) and on all the submissions since the new design (2015 to 2019). We looked at the therapeutic areas, number of patients included, number of participating centers and their geographic distribution, device price and allocated budgets. Studies status on clinicaltrials.gov were also analyzed. Concerning the submissions, we analyzed the number of positive opinions and the average times between applications and assessments.

RESULTS : Among the accepted projects, 7 decrees were published. Per study, from 40 to 5,100 patients were included. Two to 63 sites per study were participating, distributed as: 70% public and 30% private hospitals. Per patient, the budgets ranged from 310€ to 123k€. Budgets per study give a very different distribution (from 780k € to 15 million €). Therapeutic areas were oncology and ophthalmology (29% each), neurology, cardiology and metabolic diseases (14% each). On clinicaltrials.gov, trial statuses were mainly Recruiting and Not started yet (29% each).

On the 14 submissions (10 devices) since 2015, 8 received a favorable opinion. Two devices on 10 did not received positive opinion, even with a second submission. The average time between the file application and the decree publication is 13.2 months. The average time between the application and the first answer from HTA Agency is 3.6 months.

CONCLUSIONS : The Forfait Innovation results are various proving that all breakthrough technologies can benefit from an early access on the French Market, provided they respond to an unmet need.