Of the new drugs coming onto the market, one in four costs more than € 100,000 per year.
The analysis of the benefit assessment according to the Drug Market Restructuring Act (AMNOG) has been in place since 2011. The fifth AMNOG Report from 2019 discusses the extent to which the high annual therapy costs of newly approved active substances can be further taken over by the insured community. In addition to data on survival chances, pharmaceutical companies are required to present high-quality data on patients‘ quality of life for all indications in order to assess the additional benefit.
This ongoing development of the benefit assessment by the authorities, G-BA and IQWiG, related to this endpoint calls for the design and conduct of clinical trials with precisely fitting and objective endpoints. This is one of our main strengths.