Practical Challenges of Implementing a New Patient-Reported Outcome (PRO) in Oncology Under the German Pharmaceutical Market Restructuring Act (AMNOG) - Results From a Qualitative Focus Group Study

Objectives Cancer as a chronic disease with lifelong individual consequences requires PROs to capture potential side effects beyond clinical endpoints. However, PROs are still not exhaustively considered in health technology assessment (HTA), even though studies indicate that e.g. financial effects correlates with health-related quality of life (HRQoL) or mortality. PROs to comprehensively measure financial effects of cancer are currently under development. We aim to analyse the conditions, needs and Methods A semi-structured focus group with n=6 representatives from four German HTA and payer authorities was conducted. An interview guideline was developed in advance. Transcripts were analysed using qualitative content analysis. Results PROs play a role almost exclusively in the measurement of HRQoL under AMNOG in line with the German law (SGB V). HRQoL data is less often considered to determine an additional benefit in oncology since data are either not available or of minor quality. To develop a new PRO, five categories need to be considered: “objectivity”, “applicability”, “conceptuality”, “methodological quality” and “regulatory conditions”. The development is challenged by the objectifiability of a subjectively perceived Conclusions The integration of new PROs under AMNOG is presently limited by legal regulations. Profound evidence about the construct needs to be gathered beforehand using validated instruments to illustrate the relevance for patients. Further integration of PROs under AMNOG beyond HRQoL should be discussed, e.g. by considering productivity losses in economic evaluations.