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.

In this episode of our Simon-Kucher Better Market Access webinar series, we will present the findings from our retrospective market simulation analyzing the impact of a hypothetical abolition of this OD-regulation on the risk of market withdrawal of these innovative therapies. In addition, we will highlight important strategic implications for pharma companies to plan and optimize P&MA for their ODs in Germany.

This webinar will explore:

• Current OD-regulation landscape within AMNOG and its vital role for P&MA
• Results of a P&MA simulation for the German OD-market without OD-regulation
• Resulting risk of market withdrawals across different therapeutic areas
• Strategic recommendations to optimize P&MA success for ODs in Germany

By attending, you will gain actionable insights to prepare your organization for potential regulatory shifts in the P&MA environment for ODs and support patient access to these essential therapies.

This webinar is free of charge. Don’t miss this opportunity to learn from industry experts about the evolving relevance of OD regulations and how to strategically optimize P&MA success in Germany.