Presentation (CTI)

OBJECTIVES: Unlike several European HTA systems, no explicit Incremental cost-effectiveness ratios (ICER) threshold has been established in France, and the CEESP primarily focuses on assessing the methodological quality and robustness of economic evaluations. This study examines the distribution and variability of ICERs across therapeutic areas to explore potential implicit benchmarks underlying CEESP opinions.
METHODS: A retrospective review of CEESP opinions issued between 01/2021 and 01/2026 was conducted. Reported ICERs (€/QALY gained) were extracted and analyzed. Dominant and dominated strategies were recorded separately due to their limited and inconsistent reporting.
RESULTS: A total of 131 ICERs from 115 CEESP opinions were analyzed, of which 66 (50%) were validated. Validated ICERs were generally lower and less dispersed (mean €283,019/QALY; median €141,461/QALY; interquartile range [IQR] €47,752-€230,200/QALY) and ranged from €18 to €3,965,948/QALY. In contrast, non-validated ICERs were higher and more variable (mean €3,831,421/QALY; median €211,228/QALY; IQR: €74,304-€516,765/QALY), ranging from €10,786 to €156,000,000/QALY. The median ICER was 49% higher than for validated ICERs. Although no specific threshold emerged, therapy with ICERs below €150,000/QALY were more frequently validated, whereas those exceeding €250,000/QALY were increasingly associated with non-validation. Notably, 75% of validated ICERs were <€230,000/QALY, whereas ICERs >€500,000/QALY were predominantly non-validated. Substantial variations were observed across therapeutic areas. Median validated ICERs ranged from below €20,000/QALY in infectious diseases to above €400,000/QALY in neurology. In most areas, non-validated ICERs were markedly higher, particularly in hematology, infectious diseases, and neurology. Oncology showed limited differences between validated and non-validated ICERs. Finally, dominance alone did not ensure validation (7 non-validated vs 5 validated).
CONCLUSIONS: Despite the absence of an explicit French ICER threshold, findings suggest the existence of an implicit range between €150,000 and €230,000/QALY, with substantial variation across therapeutic areas. These results may inform future CEESP submissions and support HEOR and market access strategies in France.