Whitepaper: Registry requirements for the German Benefit Assessment of pharmaceutical products

The implementation of the German law for more safety in the provision of medicinal products (Gesetz für mehr Sicherheit in der Arzneimittelversorgung; GSAV) continuously gains momentum and confronts especially costly and innovative orphan drugs as well as gene therapies with an increased risk of being imposed with a registry requirement by the Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA), if evidence gaps are identified at the time of the initial benefit assessment. This post-launch data collection is expected to improve the evidence basis regarding the efficacy and safety of a novel pharmaceutical product in comparison to a comparator therapy and is thus associated with high methodological standards and several formal procedural steps specific for the German healthcare context.

To date, the G-BA already demanded registries for a total of six medicinal products, with the gene therapy medicine Zolgensma® being the first case under GSAV conditions. With respect to the high strategic relevance of this topic, SKC analyzed the implications and risks of the GSAV and provides an overview of related post-launch data collection requirements in a comprehensive Whitepaper. As the GSAV triggers a high degree of uncertainty and strategic challenges for novel orphan drugs and gene therapies, the Whitepaper provides recommendations for pharmaceutical entrepreneurs who prepare for market access in Europe and Germany. 

If you would like to learn more about the implications of the GSAV for the benefit assessment and price negotiations in Germany, please feel free to request a free copy of the Whitepaper below.