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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsJefferson Health Plans Casgevy Prior Auth | OpenPa…
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    ModifiedPartners Insurance Company dba Jefferson Health PlansPolicy DR.020.C

    Casgevy (exagamglogene autotemcel) Coverage Criteria

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    Coverage and prior authorization for Casgevy, an autologous genome-edited hematopoietic stem cell gene therapy, for FDA-approved treatment of patients aged 12 years and older with sickle cell disease with recurrent vaso-occlusive crises or transfusion-dependent beta-thalassemia. Gene therapy is excluded and non-covered for Individual and Family ACA products.

    Policy Summary
    PayerPartners Insurance Company dba Jefferson Health Plans
    PolicyCasgevy (exagamglogene autotemcel) Coverage Criteria
    Policy CodePolicy DR.020.C
    Change TypeModified
    Effective DateN/A
    Last ReviewDec 17, 2025
    Next Review DateN/A
    Key ActionObtain prior authorization for Casgevy; approved requests authorize 1 infusion for 18 months.
    SourceLink
    POLICY UPDATE CHANGES

    The policy history reports revisions to FDA-approved indications, prior authorization criteria, dosage and administration, and monitoring sections.

    HCPCS and ICD-10 diagnosis codes were added to the policy.

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    18 monthsPrior authorization duration
    1 infusionAuthorized treatment quantity
    Age 12+Minimum patient age
    3 × 10^6 cells/kgMinimum recommended dose
    100 mL/kg/year or 8 episodes/yearBeta-thalassemia transfusion threshold
    Gene therapy excludedACA product restriction

    Coverage Criteria

    Initial Casgevy Therapy

    Prior authorization is required for Casgevy® (exagamglogene autotemcel). Requests for prior authorization will be approved for 18 months for 1 infusion. Casgevy® may be considered medically necessary when ALL of the following apply:

    ALL of the following

    • Casgevy® (exagamglogene autotemcel) is prescribed for an indication included in the U.S. Food and Drug Administration (FDA)-approved package labeling.
    • The member is age-appropriate according to FDA-approved package labeling.
    • The prescribed dose and number of treatments are consistent with FDA-approved package labeling.
    • Casgevy® is prescribed by a specialist at an authorized treatment center for Casgevy®.
    • The member does not have a contraindication to the prescribed medication.
    • The member is clinically stable for transplantation based on the prescriber's assessment.

    • ONE of the following disease-specific pathways

      • For treatment of sickle cell disease, BOTH of the following

        • Has sickle cell disease with confirmatory genetic testing.

        • ONE of the following

          • Has a history of vaso-occlusive episodes (e.g., pain crises, acute chest syndrome, splenic sequestration, or priapism) that required a medical facility visit (e.g., emergency department or hospital).
          • Is currently receiving chronic transfusion therapy for recurrent vaso-occlusive episodes.

      • For treatment of transfusion-dependent β-thalassemia, BOTH of the following

        • Has genetic testing confirming the diagnosis of β-thalassemia.

    This policy applies to all Jefferson Health Plans lines of business unless noted below.

    Gene therapy is a benefit exclusion for Individual and Family (ACA) product lines and therefore is non-covered.

    N/A

    Coding and Clinical Parameters

    Drug and procedure codingHCPCS
    N/AN/A
    J3392Injection, exagamglogene autotemcel, per treatment
    Diagnosis codesICD-10
    D56.1Beta thalassemia
    D57.00Hb-SS disease with crisis, unspecified
    D57.01Hb-SS disease with acute chest syndrome
    D57.02Hb-SS disease with splenic sequestration
    D57.03Hb-SS disease with cerebral vascular involvement
    D57.04Hb-SS disease with dactylitis
    D57.09Hb-SS disease with crisis with other specified complication
    HCPCSHCPCS
    N/AN/A
    J3392Injection, exagamglogene autotemcel, per treatment
    ICD-10ICD-10
    D56.1Beta thalassemia
    D57.00Hb-SS disease with crisis, unspecified
    D57.01Hb-SS disease with acute chest syndrome
    D57.02Hb-SS disease with splenic sequestration
    D57.03Hb-SS disease with cerebral vascular involvement
    D57.04Hb-SS disease with dactylitis
    D57.09Hb-SS disease with crisis with other specified complication
    Patient age
    Minimum age12 years and older
    Sickle cell disease indicationSickle cell disease with recurrent vaso-occlusive crises
    Transfusion-dependent beta-thalassemia indicationTransfusion-dependent beta-thalassemia
    Packed red blood cell transfusion burden
    Annual transfusion volumeAt least 100 mL/kg/year of packed red blood cell transfusions
    Annual transfusion episodesAt least 8 packed red blood cell transfusion episodes per year

    Authorization and Documentation

    Prior Authorization

    Obtain prior authorization before treatment

    Prior authorization is required for Casgevy (exagamglogene autotemcel). Approved requests authorize 1 infusion for 18 months.

    Documentation Required

    Submit complete clinical documentation

    Submit documentation supporting the FDA-approved indication, FDA-labeled age, prescribed dose and number of treatments, specialist prescribing at an authorized Casgevy treatment center, absence of contraindication, and clinical stability for transplantation.

    Documentation Required

    Document sickle cell disease eligibility

    For sickle cell disease, provide confirmatory genetic testing and documentation of either vaso-occlusive episodes requiring a medical facility visit, such as an emergency department or hospital, or current chronic transfusion therapy for recurrent vaso-occlusive episodes.

    Policy Background

    Casgevy (exagamglogene autotemcel) is an autologous, genome-edited hematopoietic stem cell therapy. A patient’s CD34-positive hematopoietic stem cells are collected through mobilization and apheresis, edited ex vivo using CRISPR/Cas9, and reinfused after myeloablative conditioning. The therapy increases fetal hemoglobin production to reduce sickling in sickle cell disease and improve hemoglobin production in transfusion-dependent beta-thalassemia. It is indicated for patients aged 12 years and older with sickle cell disease and recurrent vaso-occlusive crises or with transfusion-dependent beta-thalassemia.

    Definitions

    Gene therapy
    DefinitionThe introduction, removal, or change in the content of a person's genetic code with the goal of treating or curing a disease
    ExamplesGene transfer, gene-modified cell therapy, and gene editing
    Casgevy classificationAn autologous genome-edited hematopoietic stem cell-based gene therapy
    Sickle cell disease
    DefinitionAn inherited blood disorder caused by a hemoglobin defect that produces rigid, sickle-shaped red blood cells
    Policy-relevant conditionSickle cell disease with recurrent vaso-occlusive crises
    Coverage confirmation

    Initial Therapy Criteria

    Initial Therapy Criteria

    Initial treatment may be covered when ALL general requirements and ONE disease-specific pathway are met:

    General requirements: The patient is prescribed Casgevy (exagamglogene autotemcel) for an FDA-approved indication; is age-appropriate according to FDA-approved labeling; receives a dose and number of treatments consistent with FDA-approved labeling; has a specialist prescription from an authorized Casgevy treatment center; has no contraindication to the prescribed medication; and is clinically stable for transplantation based on the prescriber's assessment.

    Approval is for 1 infusion over an 18-month authorization period.

    ONE qualifying diagnosis and disease-severity pathway

    • Sickle cell disease: The patient has sickle cell disease confirmed by genetic testing and either has a history of vaso-occlusive episodes requiring a medical facility visit, such as an emergency department or hospital, or is currently receiving chronic transfusion therapy for recurrent vaso-occlusive episodes.

    Quantity and Authorization Limits

    Casgevy quantity limit
    DrugCasgevy (exagamglogene autotemcel)
    Quantity limit1 infusion per course
    Authorization requirementPrior authorization is required
    Casgevy authorization duration
    Authorization duration18 months per course
    Authorized treatment1 infusion
    Authorization requirementPrior authorization is required for Casgevy
    Policy Summary
    PayerPartners Insurance Company dba Jefferson Health Plans
    PolicyCasgevy (exagamglogene autotemcel) Coverage Criteria
    Policy CodePolicy DR.020.C
    Change TypeModified
    Effective DateN/A
    Last ReviewDec 17, 2025
    Next Review DateN/A
    Key ActionObtain prior authorization for Casgevy; approved requests authorize 1 infusion for 18 months.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Clinical ParametersAuthorization and DocumentationPolicy BackgroundDefinitionsInitial Therapy CriteriaQuantity and Authorization Limits
    Has a history of at least 100 mL/kg/year or 8 transfusion episodes/year of packed red blood cell transfusions in the prior 2 years.
    Lookback periodDuring the prior 2 years
    Minimum Casgevy dose
    Minimum recommended dose3 × 10^6 CD34+ cells per kg of body weight
    Administration routeIntravenous infusion
    Product useFor autologous use only
    Documentation Required

    Document beta-thalassemia transfusion dependence

    For transfusion-dependent beta-thalassemia, provide genetic testing confirming beta-thalassemia and transfusion records demonstrating at least 100 mL/kg/year or 8 packed red blood cell transfusion episodes per year during the prior 2 years.

    Denial Risk

    Check ACA product-line coverage

    Casgevy is non-covered for Individual and Family ACA product lines because gene therapy is a benefit exclusion.

    Denial Risk

    Meet all clinical criteria to avoid denial

    Requests may be denied when the patient does not have an FDA-approved indication, is not age-appropriate, has a dose or treatment number inconsistent with FDA labeling, lacks an authorized treatment-center specialist prescriber, has a contraindication, is not clinically stable for transplantation, or does not meet the disease-specific diagnostic and severity criteria.

    Confirmatory genetic testing is required under the sickle cell disease pathway
    Transfusion-dependent beta-thalassemia
    DefinitionThe most severe form of beta-thalassemia
    Clinical characteristicDecreased hemoglobin production causing anemia
    Transfusion requirementRequires regular red blood cell transfusions to correct anemia
    VF12 responder
    DefinitionA patient who does not experience any protocol-defined severe vaso-occlusive crises
    Required periodAt least 12 consecutive months
    Assessment windowWithin the first 24 months after Casgevy infusion
    TI12
    DefinitionTransfusion independence for 12 consecutive months
    Hemoglobin requirementMaintaining a weighted average hemoglobin of at least 9 g/dL
    Transfusion requirementWithout red blood cell transfusions
    Assessment windowAt least 12 consecutive months at any time within the first 24 months after infusion
    Transfusion-dependent beta-thalassemia: The patient has beta-thalassemia confirmed by genetic testing and has a history of at least 100 mL/kg/year or 8 packed red blood cell transfusion episodes per year during the prior 2 years.100 mL/kg/year or 8 episodes/year