Orphan vs. Non-Orphan Drugs in Germany

Approximately 300 million people worldwide suffer from one of an estimated 8000 rare diseases. However, due to the low incidence and prevalence, the development of therapies and, in particular, the generation of high-quality evidence is significantly more difficult. In Germany, orphan drugs (OD) therefore enjoy certain privileges in the benefit assessment (§ 35a SGB V). However, this justified special position is increasingly being called into question and was most recently further restricted in November 2022 by the SHI Financial Stabilization Act. Based on a comprehensive comparison between OD and non-orphan procedures, this analysis aims to provide information on how well or advantageously OD are actually positioned in the German AMNOG system, and whether further restrictions of OD privileges therefore appear appropriate.

All further information on methods, results and our discussion can be found in our poster.