METHODOLOGICAL RESERVATIONS IN RECENT FRENCH CEESP ECONOMIC OPINIONS: WHAT CHARACTERISES THE MOST CHALLENGING SUBMISSIONS
Author(s)
Marine Sivignon, PharmD1, Romain Supiot, MSc2, Rahma Sellami, PharmD2, Mateo Crec’hriou, MSc2.
1Pharmacist and Health Economist, Inizio Ignite Putnam, Lyon, France, 2Inizio Ignite Putnam, Paris, France.
1Pharmacist and Health Economist, Inizio Ignite Putnam, Lyon, France, 2Inizio Ignite Putnam, Paris, France.
OBJECTIVES: Methodological reservations are a key component of economic opinions issued by the French Economic and Public Health Assessment Committee (CEESP). This study aimed to describe the methodological reservations raised in recent CEESP opinions, identify common patterns across submissions, and characterise the most challenged submissions.
METHODS: All CEESP economic opinions published between 2021 and 2025 were reviewed, corresponding to evaluations assessed after the update of the French methodological guidelines for economic evaluation. Reservations were classified by severity and methodological dimension. A weighted score was calculated by assigning one, three and five points to minor, important and major reservations, respectively, providing an overall measure of methodological concern for each assessment. Opinions were then grouped into three categories representing low, intermediate and high scores, and their clinical and methodological characteristics were compared. This approach was applied separately to cost-effectiveness (CE) and budget impact (BI) assessments.
RESULTS: A total of 112 economic opinions, involving 980 reservations, were included. For CE assessments, low-scoring opinions predominantly included oncology submissions relying on partitioned survival models (50%) and head-to-head comparisons (90%). In contrast, high-scoring opinions more frequently involved rare diseases (44%), microsimulation models (20%), and reservations related to model validation (94%), health utility estimation (94%) and modelling assumptions (81%). Compared with low-scoring opinions, they received more CE reservations (mean: 12 vs. 5) and a higher proportion of important (56% vs. 32%) and major reservations (7% versus 1%). Applying the same approach to BI assessments showed identical score levels to CE assessments in 47% of submissions.
CONCLUSIONS: Beyond describing methodological reservations, this approach provides a framework for identifying submissions at higher methodological risk and may support more targeted evidence generation before CEESP submission.
METHODS: All CEESP economic opinions published between 2021 and 2025 were reviewed, corresponding to evaluations assessed after the update of the French methodological guidelines for economic evaluation. Reservations were classified by severity and methodological dimension. A weighted score was calculated by assigning one, three and five points to minor, important and major reservations, respectively, providing an overall measure of methodological concern for each assessment. Opinions were then grouped into three categories representing low, intermediate and high scores, and their clinical and methodological characteristics were compared. This approach was applied separately to cost-effectiveness (CE) and budget impact (BI) assessments.
RESULTS: A total of 112 economic opinions, involving 980 reservations, were included. For CE assessments, low-scoring opinions predominantly included oncology submissions relying on partitioned survival models (50%) and head-to-head comparisons (90%). In contrast, high-scoring opinions more frequently involved rare diseases (44%), microsimulation models (20%), and reservations related to model validation (94%), health utility estimation (94%) and modelling assumptions (81%). Compared with low-scoring opinions, they received more CE reservations (mean: 12 vs. 5) and a higher proportion of important (56% vs. 32%) and major reservations (7% versus 1%). Applying the same approach to BI assessments showed identical score levels to CE assessments in 47% of submissions.
CONCLUSIONS: Beyond describing methodological reservations, this approach provides a framework for identifying submissions at higher methodological risk and may support more targeted evidence generation before CEESP submission.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA396
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas