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    Hemgenix®

    Drug - Hemgenix® (etranacogene dezaparvovec-drlb) [CSL Behring LLC.]

    March 2025

    Therapeutic Area - Hemophilia Treatment

    Approval criteria

    • Patient is at least 18 years of age; AND 
    • Prescribed by a hematologist and patient is managed by a hemophilia treatment center; AND 
    • Patient has a diagnosis of congenital factor IX deficiency; AND 
    • Patient has one or more of the following: 
      • Currently uses factor IX prophylaxis therapy; OR 
      • Current or historical life-threatening hemorrhage; OR 
      • Repeated, serious spontaneous bleeding episodes; AND 
    • Patient has been tested and found negative for factor IX inhibitor titers (if test result is positive, re-test within approximately 2 weeks. If re-test is also positive, Hemgenix should not be given); AND 
    • Patient factor IX (FIX) activity will be monitored periodically (e.g., weekly for 3 months); AND 
    • Provider will monitor for presence of inhibitors if bleeding is not controlled 
    • Patient will have baseline liver function assessed prior to and after therapy, weekly, for ≥3 months; AND 
    • Patients with preexisting risk factors for hepatocellular carcinoma (e.g., cirrhosis, advanced hepatic fibrosis, hepatitis C or B, non-alcoholic fatty liver disease [NAFLD], chronic alcohol consumption, non-alcoholic steatohepatitis [NASH], advanced age) will have abdominal ultrasound screenings and be monitored regularly (e.g., annually) for alpha-fetoprotein (AFP) elevations for 5 years following administration; AND
    • Prescriber attests that the patient and/or caregiver understands the risks and benefits of Hemgenix AND
    • Prescriber attests that the patient and caregiver understand all instructions regarding infusion day logistics; AND
    • Prescriber attests that the patient and/or caregiver understands and is committed to receiving all necessary follow-up care and monitoring following Hemgenix administration; AND
    • Documentation of a detailed follow-up plan to track progress must be submitted at time of request.

    Renewal criteria

    • Coverage cannot be renewed.

    Quantity limits

    • 1 kit x 1 dose

    Billing for Hemgenix

    Hemgenix must be billed as a medical claim.

    Questions

    Provider Call Center (844) 575-7887

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