Understanding the relevance of the Orphan Drug-Regulation within AMNOG for patient care

With the evolution of AMNOG-regulations, Germany has emerged as one of the most complex healthcare markets globally from a pricing and market access (P&MA) perspective. While Orphan Drugs (ODs) currently receive certain protections under the AMNOG framework, ongoing health policy debates are raising questions about the potential restriction or elimination of these OD-specific privileges. What would such changes mean for the German healthcare market and the accessibility of these critical therapies?

Our latest report, Relevance of the Orphan Drug-Regulation within AMNOG for Patient Care, reveals that if Germany’s OD-specific protections under AMNOG were removed, more than half of the ODs would face a very high to maximum risk of market withdrawal due to their inability to demonstrate an added benefit, exposing them to dramatic price reductions.…