OBJECTIVES: In France, since 2013, pharmaceutical companies are required to submit an economic analysis to the French National Authority for Health (HAS) for presumed innovative products according to submission criteria updated recently in 2022. The Economic Evaluation and Public Health Committee (CEESP) evaluates the dossier and publishes economic opinions (EOs). This study aimed at synthesizing outcomes of these evaluations.

METHODS: All the EOs released by CEESP until End December 2022 were extracted. For each opinion, information including therapeutic area, methodological reservations (MR), Incremental Cost-Effectiveness Ratio (ICER ; if multiple ICER were notified in the conclusion, the minimum was used), among other variables were extracted.

RESULTS: Overall, 199 EOs were identified (including 43% in oncology, 10% in onco-hematology and 9% for medical device), in which 1751 MRs were reported: 928 minor (53%), 707 important (40%) and 116 major (7%). Among all EOs, 96 (48%) evaluates monotherapy medicines, 97 (49%) had an early access before the economic evaluation, 76 (38%) reported at least one major reservation (39% in oncology, 13% in onco-hematology, 12% for medical device) and 85 (43%) evaluations were considered as invalid; this was most frequently the case for oncology (39%), onco-hematology (15%) and medical devices (13%). Between 2014 and 2016, the EO invalidation rate was 36%, 48% between 2017 and 2019 and 44% between 2020 and 2022. The mean ICER published in the EO conclusion was €242,706€/QALY, varying from €1,961/QALY (gynaecology) to €2,661,514/QALY (rare disease), and varying from €190,440/QALY in 2014-2016 to €267,626/QALY in 2017-2019 (increase by 41%) vs. €271,080/QALY in 2020-2022 (increase by 1%). Overall, mean ICER seems increase by 42% between 2014-2016 and 2020-2022 periods in France.

CONCLUSIONS: This analysis shows that in France, as pharmaceutical companies present higher and higher ICERs over years, the economics evaluation methodology used is more and more challenged by the CEESP.