OBJECTIVES: In France, since 2013, pharmaceutical companies seeking reimbursement for innovative products claiming an improved medical benefit (ASMR) level III or higher and with significant impact on health expenditures (turnover > €20 million 2-year post-commercialization) are required to submit an economic analysis to the French National Authority for Health. The Economic and Public Health Assessment Committee (CEESP) evaluates the dossier and publishes efficiency opinions (EOs). This study aimed at synthesizing outcomes of these evaluations.

METHODS: We collected all the EOs released by CEESP until End June 2021. For each opinion, we extracted information including therapeutic area, methodological concern (MC), ICER (if multiple ICER were notified in the conclusion, the minimum was used), among other variables.

RESULTS: We identified 144 EOs (including 43% in oncology, 10% for medical device and 8% in hematology), in which 1288 MCs were reported: 692 minor (54%), 507 important (39%) and 89 major (7%), 41% of the MCs referred to “modelling”. Among all EOs, 58 (40%) reported at least one major concern (40% in oncology, 16% for medical device, 12% in hematology), and 61 (42%) evaluations were considered as invalid; this was most frequently the case for medical devices (67%), hematology (64%) and oncology (45%). Between 2014 and 2017, the EO invalidation rate was 33%, and increased to 52% between 2018 and 2021 (increase by 57%). The mean ICER published in the EO conclusion was €271,060/QALY, varying from €12,648/QALY (virology) to €1,330,934/QALY (rare disease), and varying from €251,009/QALY in 2014-2017 vs. €326,424/QALY in 2018-2021 (increase by 30%).

CONCLUSIONS: This analysis shows that in France, pharmaceutical companies present higher and higher ICERs over years, with economically evaluations are increasingly challenged by the CEESP.