Casgevy®

    Drug - Casgevy® (exagamglogene autotemcel) [Vertex Pharmaceuticals Inc.]

    July 2025

    Therapeutic Area - Sickle Cell Disease (SCD)

    Approval criteria

    • Patient is at least twelve (12) years of age; AND 
    • Patient has prior use of, or intolerance to hydroxyurea (per health care professional judgement) at any point in the past; AND
    • Patient is clinically stable and fit for transplantation; AND
    • Patient has been screened and found negative for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus 1 & 2 (HIV-1/HIV-2) in accordance with clinical guidelines prior to collection of cells (leukapheresis); AND
    • Patient has not received other gene therapies for sickle cell disease [e.g., Lyfgenia® (lovotibeglogene autotemcel)]; AND
    • Patient does not have a known and suitable 10/10 human leukocyte antigen matched related donor willing to participate in an allogeneic hematopoietic stem cell transplant (HSCT); AND
    • Patient is a candidate for autologous HSCT and has not had prior HSCT; AND
    • Patient has a confirmed diagnosis of sickle cell disease with confirmatory genetic testing; AND
    • Patient has experienced recurrent VOCs* (defined as more than or equal to two (2) documented VOCs per year in the previous twenty-four (24) months, based on provider attestation); AND
    • Casgevy is prescribed in consultation with a board-certified hematologist with SCD expertise

    *Vaso-Occlusive Crisis (“VOC”): A VOC occurs when sickled red blood cells block blood flow to the point that tissues become deprived of oxygen. This in turn sets in motion an inflammatory response as the body tries to rectify the problem.

    Duration of approval

    Prior authorization approval is effective for 12 months from the approval date. Approval may be extended for another 6 months if patient is unable to receive treatment within 12 months from the approval date.

    Quantity limits

    • 1 administration per lifetime
    • Patient’s most current weight (in kg) and the dose to be administered must be provided at time of request

    Billing for Casgevy

    • If prescribed for SCD with recurrent VOCs and approved for payment, Casgevy must be billed as a professional claim
    • If prescribed for transfusion-dependent β-thalassemia (TDT), Casgevy is covered under an inpatient DRG and is not separately payable.

    Questions

    Provider Call Center (844) 575-7887

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