Presentation (CTI)

OBJECTIVES: As part of the early benefit assessment (EBA) of pharmaceuticals in Germany, there is involvement of scientific professional societies in order to give them the opportunity to critically assess the evaluations and to provide insights into relevant aspects of care. The question arises which impact these societies and their opinions have on the outcomes of EBAs. We aimed to investigate the role and influence of medical societies and the Medicines Commission of the German Medical Association (AkDÄ) in Germany’s EBA process for oncology drugs.
METHODS: We conducted a retrospective quantitative and qualitative content analysis. EBAs of IQWiG/G-BA from the G-BA homepage were used. We focused on oncological EBA procedures conducted between 2021 and 2023. Conclusions on added benefit from IQWiG, G-BA, AkDÄ, and involved scientific societies were extracted and categorized, and their justifications were further analyzed using structured keyword mapping. A Python script was developed to automate frequency analysis of key arguments.
RESULTS: Eighty-three EBAs were included. In 65% of the cases, medical societies agreed with IQWiG’s conclusions. However, in 34% of the cases they suggested a higher benefit. Compared to IQWiG, medical societies more frequently emphasized patient-centric aspects, such as real-world tolerability and therapeutic need. In roughly 24% of the cases, G-BA's final resolution aligned more closely with the societies than with IQWiG, indicating moderate influence. The most common society arguments referenced statistically significant improvements in endpoints, perceived misclassification of clinical subgroups, or favorable adverse event profiles.
CONCLUSIONS: The findings suggest that while IQWiG's assessments remain conservative and data-driven, medical societies enrich the EBA process with clinical insights that may affect final reimbursement outcomes. This underlines the value of multidisciplinary input in health technology assessment and highlights a balanced, though not dominant, role of medical societies in shaping access to oncology innovations.