CSL Behring and GKV-Spitzenverband Agree on Reimbursement Price for HEMGENIX® – Europe's First Gene Therapy for Haemophilia B

Marburg, Germany, 2 April 2025 – CSL Behring and the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds) have successfully concluded negotiations on the 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.^1-4 This development not only provides substantial relief for those affected but also has the potential to reduce long-term costs for the healthcare system.

‘The performance-based payment model at national level which was agreed with the GKV-Spitzenverband is unique in Germany. It addresses key reimbursement challenges, such as the question of long-term efficacy, which is inherent for any one-time therapy.  Reimbursement is linked to treatment success of the individual patient,’ explains Stefan Neudoerfer, CSL Behring's chief negotiator in Germany.

Moreover, this reimbursement model reflects the high therapeutic and innovative value of HEMGENIX^® and sets new standards for integrating innovative gene therapies into the German healthcare system.

‘The agreement on the reimbursement price of HEMGENIX^® is a decisive step for the care of people with haemophilia B in Germany. It enables access to a groundbreaking therapy and recognises the long-term medical and economic benefits of gene therapy,’ explains Christian Wieszner, Managing Director of CSL Behring Germany.

With this agreement, CSL Behring is underlining its commitment to innovative therapies that sustainably improve the lives of patients. At the same time, the agreement is a new step for reimbursement models that consider both individual therapeutic success and societal benefits.

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 U.S. 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.

Following these approvals, CSL Behring is working with relevant stakeholders to ensure eligible patients have access to HEMGENIX^® across Europe and beyond, building on milestone access decisions in Denmark, Switzerland, Spain, the UK (including Scotland) and Austria. Patients in France and Denmark have already experienced successful treatment with HEMGENIX^®.

Additionally, new four-year data from the HOPE-B study presented at the Annual Congress of the European Association for Haemophilia and Allied Disorders 2025 showed that a one-time infusion of HEMGENIX^® continues to offer long-term durability, safety and greater bleed protection versus prophylactic treatment in people living with haemophilia B.¹⁰