OBJECTIVES: Even in Germany’s solidarity-based healthcare system, cancer patients frequently encounter financial distress, which significantly impacts health outcomes (Mehlis et al. 2020). However, there is only limited perception of it by regulatory authorities. In the dossiers of pharmaceutical companies for the early benefit assessment (EBA) of the Federal Joint Committee (G-BA), financial distress is often measured as a subscale of HRQoL of the EORTC-C30-QLQ. We aim to (1) analyze the reporting of financial distress within the G-BA EBA and (2) identify patterns for the occurrence of financial distress in referenced clinical trials.

METHODS: All completed G-BA EBA of oncology drugs were analyzed. Data of financial distress subscale (EORTC-C30-QLQ) was extracted and additional clinical trial data for dossiers not reporting the subscale were searched. Descriptive statistics were used to describe reporting of financial distress within the dossiers. A qualitative content analysis of the material was applied.

RESULTS: A total of 379 EBA with 460 HRQoL measurements were analyzed. 48% (n=210) dossiers provided data based on the EORTC-C30-QLQ measurement. However, only 43% (n=91) dossiers reported results for financial distress. In the dossiers without reporting, it was often noted that financial distress may not be a patient-relevant outcome in Germany. G-BA usually did not mention missing data of the subscale in their decisions and supporting reasons, except in three EBA, where the results were highlighted. Explorative analysis of financial distress showed, that patterns regarding cancer entity and drug-based therapy forms could be determined.

CONCLUSIONS: Since increasing financial distress needs to be addressed by healthcare systems, it is necessary to provide and discuss data about financial distress within the EBA. This could support information for therapy decisions, differentiation for indication with smaller additional benefits and later price negotiations. Additionally, specific measures of financial distress should be used in upcoming clinical trials to highlight the importance of this issue.