Influence of the early benefit assessment for pharmaceuticals in the German Healthcare System - A summary of the last six years

Tue, 2017 / 08 / 15

Since 2011, the German method of early benefit assessment (acc. §35a SGB V) verifies new pharmaceuticals regarding their novelty and their additional benefits compared with the appropriate comparative therapy, i.e. standard of care. “Money for value” is the therapeutic benefit oriented pricing principle of the AMNOG. Before 2011, the pricing principle was characterized by the manufacturers estimation, only. The aim of the early benefit assessment is to ensure a high quality, innovative and affordable medical care in Germany.

At the beginning of 2017, the Federal Association of the Pharmaceutical Industry e.V. (BPI) published data from a study that analyzed the last six years of the early benefit assessment and assessed their influence on price regulation. The results of the study [AMNOG Data 2017] show that between 2011 and 2016 263 early benefit assessments had been started and 228 were finished until the end of 2016. Nearly half (43%) of all finished early benefit assessments were evaluated with „no additional benefit“. The BPI argues that one reason for these results is the minor “practical handling” of the early benefit assessment which based on “institutional design deficiencies”. The BPI justify their results with help of the study data in which it is shown that primarily methodological errors in data collection and data reporting led to “no additional benefit”. Based on these results, the BPI determines a possible deterioration in the supply of innovative pharmaceuticals in Germany. The BPI will now analyze the G-BA decisions in this way annually to track their current findings with help of further data.

For further information regarding the study contents, please follow this link (only in German):

https://kiosk.bpi.de/de/profiles/e0d97d378e69/editions/60f02abb37671f6e68e0/pages