The role of financial distress as a patient-relevant endpoint in early benefit assessments for oncology drugs: a mixed-methods document analysis

Abstract Objectives The importance of Financial Distress (FD) for German cancer patients is rising and data on FD is increasingly being collected in clinical trials. However, the role of FD in German early benefit assessments (EBAs) remains unclear. We systematically analyze the role of FD in EBAs for oncology drugs in Germany by investigating how often and for what reasons FD is excluded for EBA by pharmaceutical companies, how often and in which ways FD is referenced in scientific assessments by German HTA authorities (IQWiG and G-BA), and how FD influences added benefit decisions. Methods Our analysis covered all completed, currently valid German EBAs of oncology drugs from 2011 to 2024. We calculated exclusion rates, reference rates and benefit decisions, stratified by drug type, FD results, exclusion and reference status. In qualitative analyses, we inductively categorized reasons for FD exclusion and types of FD references. Results FD currently plays at most a subordinated role for German EBAs across all involved stakeholders. Almost half of dossier submissions excluded FD from EBA, even though data on FD was collected. The IQWiG referenced FD in only 25 percent of their scientific assessments. Furthermore, the G-BA referenced FD in only three out of 215 justifications of resolution. HTA authorities have divergent and inconsistent approaches to FD. Conclusions German HTA authorities should strengthen the role of patient-reported outcomes and provide clearer methodological guidance for integrating psychosocial dimensions such as FD. Future research should focus on refining measurement strategies to better capture the multidimensional nature of FD.