OBJECTIVES : Since 2013, innovative products claiming an added clinical benefit (ASMR) level ≤III with a substantial impact on healthcare expenditures (≥€20 million the second year) are evaluated by the French economic and public health assessment committee (CEESP). In July 2017, a previous analysis assessed deviations from the French pharmacoeconomic guidelines in the first 19 CEESP opinions and reported 243 methodological concerns (MCs). As of May 2019, four times more opinions are available. This study aimed to review opinions published by CEESP, to summarize MCs and confirm/invalidate preliminary conclusions.

METHODS : Available opinions were reviewed, MCs were extracted and classified by therapeutic area, by type (modelling, etc.) and level (minor, important, major). ASMR and delay between opinion publication and price availability in the Official Journal have been extracted too.

RESULTS : Overall, 802 MCs were identified out of 88 opinions (>40% relative to oncology/hematology, ~12% infections, ~10% medical devices). These included 58 major (7%), 291 important (36%) and 453 minor (57%) concerns, mostly regarding “modelling” (n=300, 18 major), “measurement and valuation of health states, costs or quality of life” (n=223, 7 major), and “results presentation and sensitivity analyses” (n=140, 9 major). Overall 36 opinions (41%) reported ≥1 major concern. The median time between opinion’s publication and price publication in the Official Journal was 428 days (evaluated on 37 dossiers for a first inscription), with a longer period observed when ASMR was IV vs I-III (498 days vs 421 days), or when ≥1 major concern vs 0 was reported (471 days vs 382 days).

CONCLUSIONS : Compared with previous results, CEESP shows similar requirement regarding methodological quality (≈40% of opinion reporting ≥1 major concern), and/or industry still shows difficulties to conduct appropriate economic analyses. This analysis confirms this has a non-negligible impact on negotiations, regarding delay and price.