Presentation (CTI)

OBJECTIVES: In France, medical devices (MDs) claiming an ASA of level I, II, or III are subject to a mandatory CEESP economic evaluation at initial listing or renewal when their annual turnover reaches or exceeds €20 million, in accordance with HAS eligibility criteria. This study aimed to assess the impact of CEESP opinions on MD price negotiation.
METHODS: All CEESP opinions on MDs published since 2015 (data freeze: 08 May 2026) were identified. Opinions with sufficient clinical benefit and a published price in the Official Journal (JORF) were included for price/negotiation analyses. Negotiation time, price variation (claimed vs. published price), and price-stability duration were computed and compared descriptively between invalidated and non-invalidated opinions.
RESULTS: Of 16 CEESP opinions, 56% (n=9) were invalidated, all for major methodological reservations. Mean negotiation time was numerically longer for invalidated (319 days; n=8) than non-invalidated opinions (306 days; n=6). Mean price variation between claimed and published price was similar between groups: -10.1% (invalidated, n=9) vs. -11.1% (non-invalidated, n=7), as was mean price-stability duration: 3.2 years (invalidated, n=9) vs. 3.4 years (non-invalidated, n=7). CEESP opinion volume was irregular (1-4/year), with none in 2022-2023, followed by a rebound in 2024-2025 (5 opinions) coinciding with the framework agreement.
CONCLUSIONS: In this small, exploratory sample, CEESP opinion invalidation was not clearly associated with longer negotiation, larger price discounts, or shorter price stability versus non-invalidated opinions, suggesting other factors may drive CEPS negotiation outcomes for MDs. These preliminary findings should be revisited as the number of CEESP opinions on medical devices grows.