OBJECTIVES : A French decree requiring economic evaluation of innovative healthcare products was enacted on the 2^nd October 2012. In June 2020, 132 opinions on their efficiency have been published by the French Health Authority “HAS/CEESP”, including 112 on drugs. Among them, 6 were for prostate cancer. Objectives were to identify the choices made by pharmaceutical manufacturers and the objections raised by the HAS regarding improvement areas their health economic submissions, mainly on methodology for prostate cancer.

METHODS : 6 opinions were analysed which evaluated 4 drugs: radium dichloride (1), enzalutamide (3), abiraterone acetate (1), and apalutamide (1). Indications were different for the 6 opinions depending on the stage of prostate cancer. Evaluations were conducted by the HAS/CEESP between March 2014 and September 2019. In each of the 6 opinions, the acceptability level was analysed in terms of major, important, and minor methodological objections.

RESULTS : Opinions covering non-metastatic indications did not lead to any major methodological objections as opposed to metastatic indications (2/4).

Regardless of indication, data sources and probability estimates were the methodological choices leading to the highest number of both major (1) and important (3) objections. They also led to 4 minor objections.

The other methodological settings raising most of major, important, or minor objections regarded simplifying assumptions (6), states of health (5), omission of relevant comparators (2), and uncertainty related to sensitivity analysis (2).

CONCLUSIONS : For the products considered, the HAS/CEESP concluded that two dossiers demonstrated efficiency; the economic evaluation was partially validated in two dossiers and two opinions were not validated due to major objections. The analysis of the objections allowed to highlight the parameters for which pharmaceutical manufacturers need to be more robust and rigorous, as found for prostate cancer cost-effectiveness analyses.