CSL Behring and the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds) have negotiated a reimbursement price of Hemgenix®.
This agreement marks the availability of the first gene therapy approved in Europe for haemophilia B under an innovative, national, success-based reimbursement model, being implemented for the first time in Germany.
Hemgenix represents significant progress in the treatment of haemophilia B. The aim of this one-time gene therapy is to eliminate the need for regular factor IX infusions, thereby offering patients the possibility of more freedom from prophylaxis and significantly improving their quality of life. This development not only provides substantial relief for those affected but also has the potential to reduce long-term costs for the healthcare system.
Hemgenix was granted conditional marketing authorisation by the European Commission (EC) for the European Union and European Economic Area in February 2023, following approval from the US Food and Drug Administration (FDA) in November 2022. Hemgenix has also received regulatory approval in Canada, the UK, Switzerland, Australia, Saudi Arabia, Taiwan, South Korea and Hong Kong.
