Presentation (CTI)

OBJECTIVES: In France, health economic assessment informs price negotiations through the incremental cost-effectiveness ratio (ICER). The methodological validity of ICER estimates is appraised by the Economic & Public Health Assessment Commission (CEESP). Under the framework agreement between the pharmaceutical industry and the French Pricing Committee (CEPS), economic evaluation is considered only in the absence of major methodological concerns or uncertainty.This study aimed to describe the level and distribution of ICERs reported in CEESP assessments published in 2025.
METHODS: Using the Vyoo Agency database of CEESP opinions, health economic assessments deemed methodologically acceptable and published between January 1 and December 31, 2025 were reviewed.
RESULTS: In 2025, the CEESP validated 15 of 17 health economic evaluations. These assessments covered nine therapeutic areas and included five orphan drugs, two vaccines, and no medical devices. Fourteen evaluations reported cost per QALY, while one reported cost per life-year gained. The average ICER reached €341,731 per QALY and €165,991 per QALY after excluding an outlier, representing a 28% increase from €129,878 per QALY in 2024. ICERs varied substantially substantial: four were below €50,000, five ranged from €50,000 to €155,000, two from €200,000 to €300,000, two from €400,000 to €500,000, and one exceeded €2 million per QALY. The lowest ICERs were observed for two anticancer treatments (including one gene therapy) and two vaccines, whereas two of the three highest ICERs concerned orphan drugs.
CONCLUSIONS: ICERs reported in CEESP assessments in 2025 remained substantially higher than those typically considered acceptable in countries using explicit cost-effectiveness thresholds. This pattern reflects key characteristics of the French HTA process, including the assessment of technologies at pre-negotiation prices and stringent methodological requirements regarding uncertainty. The marked variability in ICER levels across technologies highlights differences in clinical value, target populations, and evidence maturity. These findings illustrate key features of the French HTA framework