Presentation (CTI)

OBJECTIVES: In France, health economic evaluation is required for healthcare products claiming substantial added clinical value and expected to significantly impact on healthcare expenditure. The resulting cost-effectiveness evidence is intended to inform price negotiations between manufacturers and the Economic Committee for Healthcare Products (CEPS). This study assessed whether French health economic evaluations generate interpretable evidence and explored the relationship between cost-effectiveness results, added clinical benefit (ASMR), and pricing outcomes.
METHODS: All economic opinions issued by the French Economic and Public Health Assessment Committee (CEESP) since 2020 were reviewed. Evaluations were considered interpretable when no major methodological concern or overall uncertainty was identified by the CEESP. For interpretable evaluations, incremental cost-effectiveness ratios (ICERs) and publicly available list prices were analyzed according to ASMR level and therapeutic area.
RESULTS: Among the 122 economic opinions, 71 (58.2%) were considered interpretable, while 51 (41.8%) were considered non-interpretable due to major methodological concerns (n=37) or major overall uncertainty (n=19). Interpretable evaluations represented 43%, 59%, 64% and 47% of products receiving ASMR I-II, III, IV and V, respectively. Oncology accounted for 61 % of interpretable evaluations. Median ICERs varied substantially across therapeutic areas, with the highest values observed in lung cancer, lymphoma and multiple myeloma, particularly when no active comparator was available. Mean ICERs increased as added clinical benefit decreased, from approximately €167,000 for ASMR III to €210,000 for ASMR V. Comparator availability was consistently associated with lower ICERs (mean €126,442), irrespective of cancer type or ASMR level. Mean Prices per mg decrease with ASMR level, but no clear relationship was observed between prices and ICERs.
CONCLUSIONS: These findings highlight the difficulty of interpreting ICERs in the absence of an explicit willingness-to-pay threshold in France. Therapeutic area-specific benchmarks relating ASMR levels, observed ICER ranges and pricing outcomes could facilitate the interpretation of cost-effectiveness evidence and better support pricing negotiations.