The Supply of a licensed factor IX gene therapy
St James's Hospital · Ireland
Key facts
- Procedure
- Negotiated without prior call for competition
- Buyer type
- Health
Description
People with severe or moderately-severe factor IX deficiency are at risk of severe, life threatening bleeding unless factor IX is replaced. The current method of treatment is to replace factor IX using factor IX clotting factor concentrate which is given intravenously on a regular weekly schedule (prophylaxis). The current standard of care for people with severe or moderately-severe factor IX deficiency in Ireland is that all patients are treated with factor IX prophylaxis. Despite regular prophylaxis, certain patients do not achieve adequate bleed control and require increased amounts of FIX replacement leading to higher-than-average FIX consumption. In addition, some patients have difficulty with venous access meaning that an intravenous treatment is not suitable. Factor IX gene therapy has been developed and licensed to address these needs by providing a continuous source of factor IX through transfection of the patient’s own liver cells, generally with much higher trough factor IX levels than would be achieved with prophylaxis. There is a clinical need for certain patients to have access to factor IX gene therapy to provide better bleed protection and reduce factor IX concentrate consumption. The factor IX gene therapy is an advanced therapeutic medicinal product which would replace the need for factor IX clotting factor concentrate for prophylaxis in treated patients. The contracting authority intends to award a control to CSL Behring GmbH for 3 years for product for its licensed Factor IX Gene Therapy Hemgenix (etranacogene dezaparovec-drib)
Categories (CPV)
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