OBJECTIVES

: BACKGROUND

Dedicated to innovative medical devices (MDs) and/or medical procedures, the French coverage with evidence development (CED) scheme (“Forfait Innovation”) was first introduced in 2009 and amended in 2015 in order to clarify access criteria and the selection process. It provides temporary and early access to innovative MDs and/or medical procedures likely to provide significant benefits to patients pending final assessment and reimbursement decision. Health technologies must fulfil four criteria to be considered innovative: (i) novelty degree; (ii) early dissemination on French market; (iii) potential risks for patients and users previously described; and (iv) available clinical and/or economic data in favor of a potential significant clinical benefit or a decrease of healthcare expenditure. Candidates apply simultaneously to the French HTA body (HAS) and the Ministry of Health (MoH) respectively in charge of assessing innovativeness and study plan, and forecasted study budget.

OBJECTIVE

This analysis aims to assess the use of “Forfait Innovation” over the 2016-2017 period by looking at the number of applications and health technologies funded.

METHODS

: We included data from the files submitted and from the information published by the HAS.

RESULTS

: Over the 2016-2017 period, 13 applications were submitted (3 in 2016, 10 in 2017) for 11 health technologies among which 2 were considered by the HAS as directly eligible to “Forfait Innovation” funding which were granted after approval of their study budgets by the MoH. Besides, 3 among 4 applications originally considered non-eligible by the HAS finally received an approval after furnishing further information. One was funded by “Forfait Innovation”. The other 7 applications were considered as inadmissible (incomplete files).

CONCLUSIONS

: Despite a limited number of “Forfait Innovation” funding granted over the period, the growing number of applicants reveals its appropriation by manufacturers. Additional works could improve its operational use and give more predictability to candidates.