OBJECTIVES: Commencing 2025, new oncology medicines and advanced therapy medicinal products will be assessed at EU level. The EU Coordination Group on HTA recently published methodological and practical guidelines for evidence synthesis in terms of JCA, which were developed in close collaboration with German healthcare authorities. Here, we identified differences between these guidelines and the HTA methods used by German authorities.

METHODS: The European Methodological and Practical Guidelines for Quantitative Evidence Synthesis, the General Methods by the Institute for Quality and Efficiency in Health Care (IQWiG) and the Rules of Procedure by the Federal Joint Committee (G-BA) were compared to identify differences and similarities in the recommended approaches for evidence synthesis.

RESULTS: The general approach and the specifications for direct comparisons are largely congruent between JCA and German methodology. Both approaches show strong preferences for direct comparisons. However, there are differences in the recommended methodology for indirect comparisons. Whereas JCA does not explicitly exclude the submission of non-adjusted indirect comparisons, these are currently not accepted in Germany, as the benefit assessments for e.g., pembrolizumab, trastuzumab deruxtecan, and dezaparvovec, have shown. For any indirect comparisons, German authorities require an adjusted comparison and an adequate connecting comparator. For indirect comparisons without common comparators to be considered, Germany requires full access to individual patient data (IPD) for all trials, whereas JCA requests IPD for at least one trial, but does not endorse this approach.

CONCLUSIONS: Comparing the HTA methodologies, differences in the requirements for presenting indirect comparisons were identified. Germany currently only accepts adjusted comparisons and demands IPD in the case of no common comparator. By including non-adjusted indirect comparison in the guidelines, it appears that JCA is more amenable to the use of these methods.