OBJECTIVES: Acceptance of indirect comparisons (IC) is one key challenge in HTA. EU HTA will set new standards on the European level. Hence, recently published method guidelines by EUnetHTA on IC might have an impact on national appraisal. This study analyzes (1) the current problems in accepting ICs in (national) HTAs, (2) what methods are set out by EUnetHTA, and (3) what are the implications for upcoming national assessments post 2025. German HTA will be analyzed here, as it can be considered one of the most rigorous national HTA within the EU.

METHODS: All ICs are identified by screening G-BA resolutions since 2011, excluding orphan drug assessments. Reasons for acceptance or non-acceptance are extracted and categorized. EU HTA standards on IC are extracted from recently published method guidelines.

RESULTS: In 416 assessments in Germany 107 ICs have been submitted. 30 ICs have been accepted by G-BA, with the majority providing only additional evidence or not impacting the assessment outcome for other reasons. 77 ICs have been rejected by G-BA. Reasons for this decision were insufficient similarity of study design, patient characteristics, or inadequate methodology.

EUnetHTA guidelines provide detailed guidance for assessing similarity, homogeneity, consistency and corresponding requirements for reporting, as well as recommendations on possible approaches when the assumptions are violated. In consequence, the likelihood of acceptance should be increased on EU HTA level.

CONCLUSIONS: One of the key principles of EU HTA is that joint clinical assessment should be considered in subsequent national HTA processes. EU HTA promises to provide much needed methodological clarity for ICs and therefore the hopes for increased acceptance of ICs are high. It remains to be seen if reality meets this promise.