This talk provided insight into the system of the AMNOG and the hurdles which have to be overcome in the assessment of a benefit, with focus on the statistical needs. In particular, the process at the German authorities “Gemeinsamer Bundesausschuss” (G-BA) and “Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen” (IQWiG) should be outlined.
On the basis of an example of a medicinal product, which has completed the process, the different steps of the evaluation, according to the early benefit assessment were illustrated and discussed. Further examples display the problems which need to be solved with the use of statistical methods (e.g. subgroup analysis or meta-analysis).