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 relevance of HRQoL in early benefit assessment by analyzing benefit assessments between 2011 and 2022.

METHODS: Using the existing AMNOG database from Pharm-Analytics, all early benefit assessments since 01/01/2011 until 03/11/2022 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 2011 and 2022 HRQoL data were considered by the G-BA in 352 of 793 completed benefit assessments (44%). Regarding disease areas, HRQoL data were considered most often in oncology in absolute numbers (n = 178), but proportionally most often in diseases of the urogenital system (5/8, 63%). Overall, HRQoL data were considered in 9 out of 12 assessments (75%) with the highest possible additional benefit (major additional benefit) but only 19% of assessments (66/345) without additional benefit. Most G-BA assessments in which HRQoL data were not taken into account show no additional benefit (279/431, 65%). Conversely, assessments in which HRQoL data were considered display a more equal distribution among the awarded benefit categories.

CONCLUSIONS: Benefit assessments in which the G-BA considers HRQoL data 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. Overall, HRQoL data can be supportive for benefit assessment.