An introduction to value dossiers for early benefit assessment in Germany – Part 1: Processes and players

Abstract

In Germany in 2011, the Act on the Reform of the Market for Medicinal Products – known as AMNOG – saw a substantial revision of pricing regulations for newly authorised pharmaceuticals come into effect. Since this time, pharmaceutical companies have been required to submit a dossier on product benefit when a new product is launched on the German market or is authorised for a new indication (if a benefit assessment was performed previously for this product).