Presentation (CTI)

OBJECTIVES: The Institute for Quality and Efficiency in Health Care (IQWiG) recently called for mandatory indirect treatment comparisons (ITCs) in the absence of head-to-head evidence, in alignment with the EU Joint Clinical Assessment. However, ITC acceptance by the Federal Joint Committee (G-BA) has historically been low, reflecting the G-BA’s strict methodological criteria. As Germany’s influence on global pricing and market access grows, we examined the factors driving the low ITC acceptance rate in this increasingly critical market.
METHODS: G-BA reports (June 2016-June 2026) were analysed using a large language model (Google Gemma 4 31B). Reports were screened for ITCs which were categorised as accepted, partially accepted (e.g., select components considered), or rejected. The model extracted ITC methodological characteristics, added benefit ratings, and other potential contributors of acceptance versus rejection, including disease area and therapy class. Manual review of model outputs verified results relating to intertreatment ITCs (excluding historical comparisons).
RESULTS: Of 128 ITCs included in analysed G-BA reports, 5% were accepted and 15% were partially accepted; all accepted intertreatment ITCs were conducted using the Bucher method. Of the accepted / partially accepted ITCs (n=26), 62% were from oncology indications, 3% from rare indications, while 12% were deemed to have indication of major added benefit, compared with 9% of rejected ITCs. No ITCs involving advanced therapy medicinal products were accepted. Common reasons for rejection of ITCs conducted using the Bucher method included inadequately matched patient populations and trial designs, and methodological validity concerns (e.g., incorrect common comparator).
CONCLUSIONS: Although IQWiG permits adjusted ITCs, including network meta-analyses, only single intertreatment comparisons using the Bucher method have been accepted by the G-BA in the last 10 years, if deemed sufficiently robust. Our findings guide ITC best practices and emphasise the importance of ensuring trial compatibility to support robust intertreatment comparisons.