Methodological Acceptability of the Economic Analyses Assessed by the HAS in 2024
Author(s)
Cléa SAMBUC1, Lea VACHEROT, PharmD2, Julie Chevalier, MASc, PhD2.
1Paris, France, 2Vyoo Agency, Paris, France.
1Paris, France, 2Vyoo Agency, Paris, France.
OBJECTIVES: In France, the CEESP (Economic and Public Health Assessment Commission) appraises the health technology assessment submitted by the manufacturers in the context of reimbursement demand. The CEESP establishes the methodological acceptability of the health economic assessment through methodological reservations qualified as minor, important or major.
Since 2021, the CEESP also specified the level of uncertainty surrounding the results, could be driven by the difficulty of estimating key parameters, by a lack of credibility of hypotheses or by the interpretability of the results.
A major reservation or uncertainty invalidates the dossier and the economic value that it defends.
Using the Vyoo Agency database, the objective is to analyze the main reasons retained by the CEESP to invalidate the economic information among health economic appraisals published in 2024.
METHODS: All available health economics opinions published by CEESP between January 1st and December 31st, 2024, were reviewed.
RESULTS: In 2024, 19 appraisals were disclosed, 10 of which all results were invalidated. Nine major methodological reservations were stated, invalidating 6 economics analysis and one cost-utility analysis. The major reservations relate to utility estimation (5), effectiveness modelling (2), comparators and objective. Relating to the utility estimations, most reservations (4/5) concern the use of external sources to document utilities, mainly generating a lack of transposability. The final reservation relates to a lack of robustness in the collection of utilities in the trial. In addition, 4 dossiers were invalidated due to major uncertainty mainly supported by uncertainty generated by the methodological choices or statistical variability of the parameters.
CONCLUSIONS: In 2024, 47% of dossiers were likely to provide economic information useful in the decision-making process in France, compared with 64% in 2023. Increasing the number of validated assessments is a key issue to ensure economic information can be fully used in pricing negotiations.
Since 2021, the CEESP also specified the level of uncertainty surrounding the results, could be driven by the difficulty of estimating key parameters, by a lack of credibility of hypotheses or by the interpretability of the results.
A major reservation or uncertainty invalidates the dossier and the economic value that it defends.
Using the Vyoo Agency database, the objective is to analyze the main reasons retained by the CEESP to invalidate the economic information among health economic appraisals published in 2024.
METHODS: All available health economics opinions published by CEESP between January 1st and December 31st, 2024, were reviewed.
RESULTS: In 2024, 19 appraisals were disclosed, 10 of which all results were invalidated. Nine major methodological reservations were stated, invalidating 6 economics analysis and one cost-utility analysis. The major reservations relate to utility estimation (5), effectiveness modelling (2), comparators and objective. Relating to the utility estimations, most reservations (4/5) concern the use of external sources to document utilities, mainly generating a lack of transposability. The final reservation relates to a lack of robustness in the collection of utilities in the trial. In addition, 4 dossiers were invalidated due to major uncertainty mainly supported by uncertainty generated by the methodological choices or statistical variability of the parameters.
CONCLUSIONS: In 2024, 47% of dossiers were likely to provide economic information useful in the decision-making process in France, compared with 64% in 2023. Increasing the number of validated assessments is a key issue to ensure economic information can be fully used in pricing negotiations.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA230
Topic
Economic Evaluation, Health Technology Assessment
Topic Subcategory
Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas