Presentation (CTI)

OBJECTIVES: Indirect treatment comparisons (ITCs) estimate the relative effectiveness of new therapies where head-to-head trials are lacking. Given the multiple comparators anticipated in EU Joint Clinical Assessment (JCA), their use can be expected to become more prominent. Acceptance of ITCs conducted for EU JCA will also be vital for local value assessment. This research aims to explore the similarities and differences between ITC guidelines at an EU and country level to bridge potential gaps for national decision-making.
METHODS: EUNetHTA member agencies were prioritised based on the quantity and recency of ITC guidelines and their influence. Key ITC methodological elements of interest included guidance on data sources (such as single-arm trials and real-world evidence), treatment effect modifiers, population-adjustment, and proportional hazards assumption violation. Detail on each element was extracted and compared across EUNetHTA member and JCA guidelines.
RESULTS: Belgium, France, Germany, the Netherlands, Norway, Portugal and the UK were identified as the most relevant countries for inclusion. The level of detail varied widely across guidelines. JCA guidelines were more extensive than most, with latest updates from Belgium (2025) now directly referencing JCA. Greatest contrast was seen in the acceptance of data sources; single-arm trials and real-world evidence were not accepted by some agencies yet accepted with justifications by others. Generally, statistical methods did not differ across countries; however, where greater detail was provided on key components (such as population-adjustment and proportional hazards assumption violation) there was more clarity on accepted methods.
CONCLUSIONS: There is variation in the level of detail provided within national and JCA guidelines for conducting ITCs. Given the importance of ITCs in addressing multiple PICOs (Population, Intervention, Comparison, and Outcomes) for EU JCA, their acceptance at a national level will inevitably influence decision-making. As national HTA guidelines are updated, increasing reference to JCA guidelines and greater parity of ITC acceptance is anticipated.