OBJECTIVES: Health-related quality of life (HRQoL) is generally defined as the personal well-being in important areas of life including physical, mental, social, family-, and work-related factors. The inclusion of HRQoL data is regularly requested and a deciding factor in the German early benefit assessment. This research aims at defining the current relevance of HRQoL in early benefit assessment by analyzing benefit assessments between 2017 and 2021.

METHODS: Using the existing AMNOG database from Pharm-Analytics, all early benefit assessments since 01/01/2017 until 01/01/2022 were analyzed. All G-BA resolutions were assessed for consideration of HRQoL data, taking the disease area and the extent of additional benefit into account.

RESULTS: Between 2017 and 2021 HRQoL data were considered by the G-BA in 208 of 442 terminated benefit assessments (47%). 54 of these 208 assessments (26%) showed a positive effect in HRQoL. Regarding disease areas, HRQoL data were considered most often in oncology in absolute numbers (n = 113), but proportionally most often in diseases of the muscle-skeletal-system (69%). HRQoL data were considered in 6 out of 7 assessments (86%) with the highest possible additional benefit (major additional benefit) but only 26% of assessments (51/193) without additional benefit. The majority of G-BA assessments in which HRQoL data were not taken into account show no additional benefit (142/234, 61%). Conversely, assessments in which HRQoL data were considered display an equal distribution among the awarded benefit categories.

CONCLUSIONS: Benefit assessments in which the G-BA considers HRQoL data seem to correlate with a better outcome and a higher additional benefit than assessments in which HRQoL data are not taken into account. However, HRQoL data do not automatically lead to a benefit as the high methodical requirements posed by the G-BA need to be met. Consideration of HRQoL data is a potential indicator of a high-quality study.