OBJECTIVES: National Health Authority (HAS) submissions seeking market access of a drug in France require demonstration of its additional benefit, based on direct or indirect treatment comparisons (ITC). Transparency Committee (TC) and Economic and Public Health Committee (CEESP) requirements may differ based on their respective guidelines. The objective of this analysis is to perform a critical assessment of ITC methods submitted compared to HAS final appraisal for both committees.

METHODS: The analysis is based on a comprehensive review of published TC and CEESP opinions mentioning ITC from 2015 to 2020. A selection grid was constructed based on eligibility criteria (publication date, type of submission, literature reviews related to ITC, drug or vaccine), to include relevant opinions. An extraction grid was developed according to the NICE evaluation checklist to identify relevant information and methodological items.

RESULTS: In total, 160 ITCs out of 109 TC opinions and 89 ITCs out of 66 CEESP opinions were identified.

For the TC opinions, the majority (57%) of indirect comparisons were NMA, 11% were MAIC and 8% were Bucher. Regarding NMAs, 51% were considered non-acceptable by the TC. The main limits highlighted were the quality of the included studies or comparators, the relevance of the target population, the richness of the network, the heterogeneity and effect modifiers.

For the CEESP opinions, the majority (60%) of indirect comparisons were also NMA, 9% were MAIC and 8% were Bucher. Concerning NMAs, 13% led to major objections (i.e. methodology rejected) by the CEESP, mostly related to the modelling approach, unjustified extrapolation methods or the comparators included in the network.

CONCLUSIONS: To obtain consistent appraisal between TC and CEESP in the reimbursement process in France, guidelines and technical support documents should be developed and used as referential, while taking into account the specificities and requirements of each committee.