OBJECTIVES: For healthcare products with moderate to major Clinical Added Value, a cost-effectiveness model is expected to be submitted to the CEESP as part of the market access procedure in France. The CEESP doctrine, published in July 2021, aims to set out the general economic evaluation framework. The objective of this analysis was to evaluate the impact of this doctrine on economic evaluation, by comparing pre- and post-doctrine CEESP opinions.

METHODS: CEESP opinions published 18 months before and after the doctrine were selected from IQVIA internal and exhaustive database of published economic opinions and analyzed using an extraction grid.

RESULTS: Within our sample, 36 opinions were published before and 43 after the doctrine publication. Most opinions were about drug evaluations. The main therapeutic area was solid oncology-tumors: 49% of opinions published post-doctrine compared to 27% pre-doctrine.

Similar proportion of opinions with major reservations were observed pre-and post-doctrine publication (33% versus 30%), the main driver being clinical data integration in the model.

On the post-doctrine opinions sample, 9 opinions received a global major uncertainty (GMU) which is a new criterion defined in the doctrine. GMU main drivers were the number of important reservations and insufficiently explored uncertainty. Scenario analyses were the main source of uncertainty leading to GMU without a clear threshold since variations between 11% to 1000% of the ICER in these scenario analyses versus base case were observed in opinions with GMU.

CONCLUSIONS: Based on previous criteria used by the CEESP, the pre- and post-doctrine periods do not seem to differ significantly: the doctrine’s publication impact seems limited. However, the introduction of the major global uncertainty enables to integrate uncertainty as a determining factor for invalidating the CEA, in addition to the major reservation, both being potential challenges for price negotiation with the Economic Committee in France.