Four years of early benefit assessment of new drugs in Germany: a qualitative study on methodological requirements for quality of life data
详细信息 查看全文
- 作者：Christine Blome ; Matthias Augustin…
- 关键词：AMNOG ; Quality of life ; Qualitative research ; Health technology assessment ; Early benefit assessment ; Comparative effectiveness research
- 刊名：The European Journal of Health Economics
- 出版年：2017
- 出版时间：March 2017
- 年：2017
- 卷：18
- 期：2
- 页码：181-193
- 全文大小：
- 刊物类别：Business and Economics
- 刊物主题：Public Health; Health Economics; Public Finance; Pharmacoeconomics and Health Outcomes; Economic Policy; Health Care Management;
- 出版者：Springer Berlin Heidelberg
- ISSN：1618-7601
- 卷排序：18
文摘
BackgroundSince 2011, an early benefit assessment (EBA) of new drugs constricts free price setting in Germany. According to the Pharmaceutical Market Restructuring Act (AMNOG), pharmaceutical companies are obliged to demonstrate added benefit of new drugs over comparative treatment. Benefit is usually evaluated by the Institute for Quality and Efficiency in Health Care (IQWiG). The final appraisal is made by the Federal Joint Committee, Germany’s highest-ranking decision body in the health sector, triggering drug prize negotiations between companies and statutory health insurance funds. One of four evaluation criteria is quality of life (QoL). QoL outcomes have, however, only rarely been pivotal in EBAs.