Relevance of Instruments for Measurements of Quality of Life in the AMNOG Context: An Analysis of the Endpoint Health-Related Quality of Life from Different Perspectives

In the assessment of the additional therapeutic benefit of newly approved drugs, different patient-relevant outcomes are used, such as Health-related Quality of Life (HrQoL). Among the four outcomes (morbidity, mortality, adverse effects), HrQoL is the most subjective and also a relatively new outcome. This thesis focuses on the relevance of HrQoL data within the AMNOG process, including available instruments for the measurement of HrQoL. Moreover, interviews were conducted to investigate different perspectives regarding the relevance of this endpoint in comparison to the others. Until now, HrQoL is perceived more as a supportive tool rather than an equivalent criterion. Possible reasons for that are technical limitations (response rate, validated questionnaires) as well as differences with regard to the profile of requirements for the pharmaceutical company concerning the market authorization (study design).