OBJECTIVES : Since 2013, the HAS/CEESP evaluates efficiency of new innovative products that would have a significant impact on health expenditures in France. The CEESP assesses the robustness of submitted health economic analyses and expresses minor, important, or major objections. The aim of this study was to analyze the evolution of the CEESP’s objections on cost-effectiveness models over time.

METHODS : An analysis was conducted using the database www.efficience.heva-heor.com referencing all French published efficiency appraisals and was performed from December 2014 to May 2020 on 119 efficiency appraisals. Different items were analyzed: evaluation date, therapeutic area, number and type of objections, objections’ subtype (modelling, costs...). Objections were also distinguished according to their inevitability: objections related to available clinical data (presumed unavoidable) versus those related to methodological aspects only.

RESULTS : The average number of objections per efficiency appraisal decreased from 13 in 2014 to 7.4 in 2019. Over the same period, the proportion of objections on modeling increased while those on results and sensitivity analysis declined. Although non-oncology efficiency appraisals had more objections than oncology appraisals, the gap seems to reduce over time. Finally, the proportion of clinical objections, although never above 15%, tends to be higher over time, mainly driven by the increase in clinical major objections.

CONCLUSIONS : The CEESP seems to express less objections over time, especially minor ones that not significantly impact the results of the cost-effectiveness model. Although clinical data were also assessed by the Transparency Commission, they were the cause of 25% of major objections since 2014, and may have an impact on price negotiations.