OBJECTIVES: To approximate the delays between the different steps of the economic evaluation by the French Commission for Economic and Public Health Evaluation (CEESP) and identify some parameters that may have impact these delays.

METHODS: Dates of eligibility decisions for the economic evaluation and CEESP sessions were gathered from the French Health Authority (HAS) website for the 2021 appraisals. In France only certain products are eligible for economic evaluation, so the eligibility decision corresponds to the assessment decision once the application has been submitted. After different intermediate steps in the assessment, the CEESP session is the last step before the publication of the economic assessment. The dates of an intermediate step, the economic technical groups, are also collected.

RESULTS: 26 eligibility decisions for the economic evaluation were granted in 2021. Delays between eligibility decision and first passage in CEESP range from 47 to 278 days, and 136.4 days on average (SD 59.3). These same delays seem to be shorter for first-time registrations (mean=92.8, SD=27.4), compared to extensions of indication (mean=168.3, SD=56.2). Early access authorization and therapeutic area do not appear to have an impact on these delays. Variations in these delays have been observed for orphan drugs. For the extensions of indication, the average delay for orphan drugs is 124 days (n=4) versus 184.5 days (n=11). For first-time registrations, the average delay for orphan drugs is 115.3 days (n=4) compared to 77.8 days (n=5).

CONCLUSIONS: This analysis gives an idea of the time frame for the medico-economic evaluation. Although the delays presented here are not fixed, they give an overview to laboratories and allow them to anticipate the arrival on the market of their product.