CSL Behring granted positive reimbursement recommendation for Haemophilia B Gene Therapy, HEMGENIX® in Spain

MARBURG, GERMANY– October 01, 2024 – Global biotechnology leader CSL Behring (ASX: CSL) today announced it has been granted a positive recommendation by the Spanish Interministerial Commission on the Pricing of Medicines (CIPM) resulting in national reimbursement for HEMGENIX^® (etranacogene dezaparvovec) for eligible haemophilia B patients in Spain.¹

HEMGENIX^® is the first one-time gene therapy approved in Spain for adults with severe and moderately severe haemophilia B (congenital Factor IX deficiency) without a history of Factor IX (FIX) inhibitors.²

This significant milestone underscores the value of HEMGENIX^® and means that patients in Spain will have access to this groundbreaking gene therapy through the local healthcare system. This represents a paradigm shift, and transformative approach to haemophilia B management by offering a durable alternative to frequent intravenous Factor IX infusions, which can significantly impact the quality of life and wellbeing of patients.³

“We are proud that the Spanish CIPM has recognized HEMGENIX^®, as an innovative one-time treatment option, marking a pivotal moment for Spanish haemophilia B patients and acknowledging the remaining unmet needs in haemophilia B treatment,” stated Maria Jose Sanchez Losada, General Manager, CSL Behring Iberia. “Following this positive recommendation, our priority will now be to work with healthcare authorities to conclude the agreement and ensure HEMGENIX^® can reach patients and healthcare professionals throughout the country.”

CSL Behring is working with relevant stakeholders to continue the expansion of access to HEMGENIX^® across Europe, building on recent milestone access decisions in UK, Scotland, Denmark, Austria and France.^4-8

“The agreement with the CIPM for HEMGENIX® is an important step forward for Spanish patients, the local healthcare system and regulatory authorities,” said Diego Sacristan, Head of International, CSL Behring. “We are fully committed to continuing our close collaboration with stakeholders and local authorities to bring etranacogene dezaparvovec to all eligible people living with haemophilia B, where the unmet need still remains.”