Indirect Treatment Comparisons in Economic Evaluations Submitted to the French Health Authority (CEESP) Since 2014
Author(s)
Thomas GISSLER, PharmD, MSc1, Cléa SAMBUC, PhD2, Julie Chevalier, MASc, PhD2, Sandrine Bourguignon, MSc, PhD3, Bertrand Tehard, MSc, PhD4.
1Vyoo Agency, Châtenay-Malabry, France, 2Vyoo Agency, Paris, France, 3RWEality, BONDOUFLE, France, 4Scientific Director, VYOO AGENCY, Paris, France.
1Vyoo Agency, Châtenay-Malabry, France, 2Vyoo Agency, Paris, France, 3RWEality, BONDOUFLE, France, 4Scientific Director, VYOO AGENCY, Paris, France.
OBJECTIVES: Since 2012, the Commission for Economic and Public Health Evaluation (CEESP) has performed health economic assessments that required for products claiming a significant added clinical value and a substantial budget impact. As many clinical trials lack head-to-head comparisons against all relevant alternatives, indirect treatment comparisons (ITCs) have become increasingly necessary to conduct complete economic analyses. However, their methodological complexity has raised concerns about their robustness and validity. Consequently,the CEESP has regularly issued methodological reservations, particularly regarding the comparators and data sources used in ITCs.Using the Vyoo Agency database, which compiles all published CEESP reports, the objective is to analyze trends in the use of ITCs and associated methodological reservations
METHODS: All CEESP evaluations published between February 2014 and March 2025 were reviewed. For each report, the use of an ITC, the type of comparison, the number and nature of methodological reservations, and the final validation status of the incremental cost-effectiveness ratio (ICER) were extracted and categorized
RESULTS: Out of 252 CEESP reports, 116 (46%) included an ITC. Their annual number peaked in 2015 and 2019 (15 each), with a decline observed since 2020. ITCs were more frequent in oncology, rare diseases, and hematology. Among ICERs based on ITCs, 52% were deemed invalid and only 39% validated, compared to 59% for direct comparisons. ITCs triggered 36 major and 167 important reservations, mostly concerning comparators (n=24) and data sources (n=60). These proportions are higher than for direct comparison
CONCLUSIONS: ITCs are widely used in CEESP submissions but are often associated with major methodological reservations and lower validated ICER. These findings highlight the need for stronger guidance on validated standard methods in the context of ITCs, and a clearer doctrine regarding their appropriate use, to better align CEESP expectations with industrial practices
METHODS: All CEESP evaluations published between February 2014 and March 2025 were reviewed. For each report, the use of an ITC, the type of comparison, the number and nature of methodological reservations, and the final validation status of the incremental cost-effectiveness ratio (ICER) were extracted and categorized
RESULTS: Out of 252 CEESP reports, 116 (46%) included an ITC. Their annual number peaked in 2015 and 2019 (15 each), with a decline observed since 2020. ITCs were more frequent in oncology, rare diseases, and hematology. Among ICERs based on ITCs, 52% were deemed invalid and only 39% validated, compared to 59% for direct comparisons. ITCs triggered 36 major and 167 important reservations, mostly concerning comparators (n=24) and data sources (n=60). These proportions are higher than for direct comparison
CONCLUSIONS: ITCs are widely used in CEESP submissions but are often associated with major methodological reservations and lower validated ICER. These findings highlight the need for stronger guidance on validated standard methods in the context of ITCs, and a clearer doctrine regarding their appropriate use, to better align CEESP expectations with industrial practices
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE552
Topic
Economic Evaluation, Health Technology Assessment, Methodological & Statistical Research
Disease
No Additional Disease & Conditions/Specialized Treatment Areas