Over the past decade, Germany has emerged as one of the most influential reference markets for pharmaceutical pricing in Europe, particularly for orphan drugs (OD). While manufacturers set list prices at launch, subsequent negotiations and statutory rebates under the GKV system have had a significant impact on net prices and market access conditions. Leveraging CRA’s proprietary RADAR database, this presentation explores the evolution of list prices for orphan drugs in Germany between 2013 and 2024 and analyzes how U.S. WAC benchmarks are reflected in German OD pricing. Furthermore, it examines the key factors driving GKV rebate levels in practice – from disease prevalence and budget impact to therapeutic alternatives and negotiation strategies. The session provides a unique evidence-based perspective on the dynamics of price setting, rebate determination, and long-term affordability of orphan drugs in a highly regulated market environment. In this session, you will learn:

• How orphan drug list prices in Germany have evolved over the past decade and their relationship to U.S. WAC levels
• Which factors most strongly influence GKV rebates and how these affect net pricing outcomes
• What lessons can be drawn from 2013–2024 rebate and price evolution for future orphan drug launches in Germany and Europe