Health-related quality of life (HRQoL)

Quality of life is defined by the WHO as “an individual’s perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns” (WHO 1997).

Health-related quality of life (HRQoL) in clinical studies is a multi-dimensional construct of physical, psychological and social dimension and is usually recorded using standardised questionnaires.

While data on health-related quality of life is of a complementary nature for the approval of medicinal products, data on quality of life for the early assessment of benefits in accordance with Section 35a of the German Social Code (SGB), Book Five, is generally considered, alongside patient-relevant endpoints concerning mortality, morbidity and side effects, to be an equitable criterion for benefits. Unlike in the United Kingdom, the quality of life is no longer measured with “quality-adjusted life years” (QALYs) in the early assessment of benefits.