QUALITY OF LIFE – A RARELY ACKNOWLEDGED KEY CATEGORY WITHIN THE AMNOG PROCESS IN GERMANY
Author(s)
Eheberg D1, Shlaen R2, Batscheider A2, Gohlke A2
1IMS HEALTH, Munich, Germany, 2IMS Health, Munich, Germany
Increasingly, quality of life becomes a more important part of the HTA assessments of new products. Assessing quality of life is trickier than changes in clinical parameters as changes of quality of life tend to occur slower and with a high level of variance. Additionally, it is sometimes necessary to assess quality of life indirectly, especially in cognitive disorders. However, the available data are often driven by the requirements for marketing authorization and rarely fit to the requests of HTA agencies. Quality of life is, among mortality, morbidity and safety, one of the key patient relevant outcomes categories in the AMNOG (Arzneimittelmarktneuordnungsgesetz; Law on the Reorganization of the Pharmaceutical Market) process in Germany. OBJECTIVES: Our focus was to review the impact of quality of life data presented by manufacturers since the introduction of the AMNOG in 2011 on the level of additional benefit claimed by the manufacturer and the evaluation by the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Healthcare (IQWiG). METHODS: We screened the IMS HTA database and the assessments published on the G-BA website for assessments including additional benefit claims based on quality of life. We compared these with the corresponding IQWiG reports and the final decision of the G-BA (if available). RESULTS: Data on quality of life was part of 36 additional benefit claims. In most cases, IQWiG (n=23) and G-BA (n=28) considered quality of life data as well. However, in 6 cases IQWiG and G-BA assessed quality of life, even though the manufacturer didn’t include these data. There are only few additional benefit claims acknowledged by G-BA based on quality of life. CONCLUSIONS: Even though quality of life is seen as highly relevant factor for the HTA assessment of a new drug or technology, it is rarely taken into consideration.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PHP231
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Multiple Diseases