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    v1.0.28
    OpenPayerPolicy UpdatesHematology/Oncologyhusky_health Casgevy coverage Prior Auth Update | …
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    Currenthusky_healthPolicy N/A

    Casgevy (exagamglogene autotemcel) gene therapy for sickle cell disease — Prior authorization and medical necessity criteria

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    Prior authorization and medical necessity criteria for single-dose Casgevy gene therapy in individuals with sickle cell disease covered by HUSKY Health (Connecticut Medicaid). Applies to providers and authorized treatment centers participating in the Connecticut Medical Assistance Program.

    Policy Summary
    Payerhusky_health
    PolicyCasgevy (exagamglogene autotemcel) gene therapy for sickle cell disease
    Policy CodePolicy N/A
    Change TypeRevised and added operational clarifications
    Effective DateFeb 1, 2025
    Last ReviewDec 16, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization using the CT DSS HUSKY Health Casgevy PA form with required genetic testing, provider attestation of VOC history or chronic transfusion therapy, prior therapy documentation, and HSCT eligibility attestation.
    SourceLink
    POLICY UPDATE CHANGES

    Removed specific sickle cell genotypes requirement and replaced with requirement for confirmatory genetic testing.

    Vaso-occlusive crisis requirement updated to 'in the setting of appropriate supportive care' and changed wording to require history of ≥2 VOCs per year in prior 2 years or current chronic transfusion therapy.

    Changed prior pharmacologic therapy requirement language from 'trialed' to 'prior use of or intolerance to' listed SCD therapies.

    Removed requirement for 10/10 HLA match per package insert consistency.

    Clarified that Casgevy is considered investigational and not medically necessary for indications other than sickle cell disease and beta thalassemia, with separate guidelines for beta thalassemia.

    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.

    ≥2
    Vaso-occlusive crises per year (each of prior 2 years) or on chronic transfusion
    12Minimum age for treatment
    one-timeAuthorization validity
    J3392HCPCS code
    RequiredPrior authorization

    Coverage Criteria for Casgevy (exagamglogene autotemcel)

    Initial Therapy Criteria

    Covered when ALL of the following are met:

    Initial Therapy Eligibility and Administration: A. Individual is ≥12 years old; B. Confirmed diagnosis of sickle cell disease; C. Treatment is prescribed by or in consultation with a hematologist; D. Treatment will be administered at an authorized treatment center; E. Provider attestation of history of ≥2 vaso-occlusive (VOC) episodes per year in each of the prior 2 years or the individual is currently receiving chronic transfusion therapy for recurrent VOCs; F. Individual is eligible for a hematopoietic stem-cell transplant (HSCT) as determined by the hematologist and does not have any of the exclusions listed in the child node; G. No prior hematopoietic stem-cell transplant (HSCT); H. No prior Casgevy or other gene therapy; I. Prior use of, or intolerance to (per clinician judgment), at least one pharmacologic SCD treatment (hydroxyurea, l-glutamine, crizanlizumab, or voxelotor) at any point in the past; J. Provider will follow all FDA recommendations for usage, dosage, preparation, administration, and monitoring.
    HSCT exclusion conditions: 1. Advanced liver disease; 2. A bacterial, viral, fungal, or parasitic infection including active HIV-1, HIV-2, hepatitis B, or hepatitis C; 3. Any prior or current malignancy, myeloproliferative disorder, or significant immunodeficiency disorder; 4. History or presence of Moyamoya disease; 5. For individuals 12–18 years of age only: history of abnormal transcranial Doppler (TAMMV ≥200 cm/sec non-imaging or ≥185 cm/sec imaging)

    These conditions render the individual ineligible for HSCT per policy.

    Coverage for Casgevy (exagamglogene autotemcel) is limited to treatment of individuals with sickle cell disease who meet the policy’s medical necessity criteria. Authorization is contingent on documentation that the patient meets all eligibility requirements, including HSCT eligibility and absence of listed exclusionary conditions, has not previously received HSCT or any gene therapy, and that the provider will follow all FDA recommendations for use, dosage, preparation, administration, and monitoring. Use for indications other than sickle cell disease and beta thalassemia is not covered under this policy; separate coverage guidance exists for beta thalassemia.

    Casgevy is a single-dose autologous CRISPR/Cas9-modified CD34+ hematopoietic stem cell gene therapy and, if authorized, will be approved as a one-time infusion per the coding and authorization provisions of this policy.

    Use of Casgevy is considered investigational and not medically necessary for all indications other than Sickle Cell Disease and Beta Thalassemia. Requests for Casgevy to treat conditions outside of these two indications will be denied as not medically necessary. Refer to the separate Beta Thalassemia coverage guidelines for information on that indication.

    Coding and Clinical Thresholds

    Covered HCPCS CodesHCPCSCovered
    J3392Injection, exagamglogene autotemcel, per treatment
    Vaso-occlusive crises clinical threshold
    Vaso-occlusive crisis frequencyHistory of ≥2 vaso-occlusive crises (VOCs) per year in each of the prior 2 years
    Chronic transfusion alternativeCurrently receiving chronic transfusion therapy for recurrent VOCs as an alternative to the VOC frequency requirement
    Documentation requiredProvider attestation stating history of ≥2 VOCs per year in the prior 2 years or documentation of current chronic transfusion therapy must be submitted with the PA request

    Provider Requirements, Prior Authorization, and Documentation

    Prior Authorization

    Prior authorization required and approval period

    Prior authorization is required for Casgevy and must be submitted by the ordering physician using the State of Connecticut PA process; if approved, authorization is for a one-time, single-dose intravenous infusion and is valid for 12 months.

    • Submit request via fax to the number on the PA form as directed.
    Step Therapy

    Document prior pharmacologic SCD therapy or intolerance

    Not a formal step therapy requirement; however, the provider must document prior use of, or intolerance to, at least one pharmacologic SCD treatment (hydroxyurea, l-glutamine, crizanlizumab, or voxelotor) at any point in the past.

    • Document medication name, dates of use, and reason for discontinuation or intolerance in the medical record and include with the PA request.

    Definitions and Medical Necessity

    Casgevy — key facts
    Generic nameExagamglogene autotemcel (Casgevy)
    Product descriptionSingle‑dose CRISPR/Cas9‑modified autologous CD34+ hematopoietic stem cell gene therapy
    Indication (age)For treatment of sickle cell disease in patients aged ≥12 years with recurrent vaso‑occlusive crises
    MechanismReduces BCL11A expression to increase fetal hemoglobin (HbF) and reduce red cell sickling
    Medical Necessity (policy definition)
    DefinitionMedical Necessity: services required to prevent, identify, diagnose, treat, rehabilitate or ameliorate an individual's medical condition, consistent with generally‑accepted standards of medical practice and Connecticut statute

    Clinical Background

    Sickle cell disease (SCD) is an inherited single-gene hemoglobinopathy characterized by predominance of hemoglobin S that causes hemolytic anemia, recurrent vaso-occlusion with acute and chronic pain, and organ ischemia. Casgevy acts on hematopoietic stem cells to reduce BCL11A expression and increase fetal hemoglobin, decreasing red cell sickling; it is indicated for patients aged 12 years and older with recurrent vaso-occlusive crises who meet the policy’s eligibility criteria. Clinical rationale for coverage includes the one-time gene-modifying approach to address the underlying pathophysiology of SCD and the potential to reduce recurrent VOCs and transfusion dependence in appropriately selected patients.

    Policy Summary
    Payerhusky_health
    PolicyCasgevy (exagamglogene autotemcel) gene therapy for sickle cell disease
    Policy CodePolicy N/A
    Change TypeRevised and added operational clarifications
    Effective DateFeb 1, 2025
    Last ReviewDec 16, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization using the CT DSS HUSKY Health Casgevy PA form with required genetic testing, provider attestation of VOC history or chronic transfusion therapy, prior therapy documentation, and HSCT eligibility attestation.
    SourceLink
    On This Page
    Coverage Criteria for Casgevy (exagamglogene autotemcel)Coding and Clinical ThresholdsProvider Requirements, Prior Authorization, and DocumentationDefinitions and Medical NecessityClinical Background
    Documentation Required

    Required prior authorization documentation

    Provide the completed State of Connecticut, Department of Social Services HUSKY Health Casgevy Prior Authorization Request form including the physician's order and signature, plus clinical documents: genetic testing confirming SCD, provider attestation of VOC history or current chronic transfusion therapy, medical record documentation of prior pharmacologic therapies, and signed attestation regarding HSCT eligibility, no prior HSCT, and no prior gene therapy (and for ages 12–18, absence of abnormal TCD).

    • Completed CT DSS HUSKY Health Casgevy PA Request form with physician order and signature
    • Genetic testing confirming diagnosis of sickle cell disease
    • Provider attestation of ≥2 VOCs per year in the prior 2 years or current chronic transfusion therapy for recurrent VOCs
    • Medical record documentation of any prior pharmacologic therapies for SCD
    • Signed attestation confirming HSCT eligibility, no prior HSCT, and no prior gene therapy
    • For individuals 12–18 years: attestation of absence of abnormal transcranial doppler (TCD)
    Denial Risk

    Denial risk for missing required documentation

    Requests missing the completed PA form with physician order/signature or lacking the specified clinical documentation (genetic testing, provider attestation of VOC history or chronic transfusion therapy, prior therapy documentation, and HSCT/gene therapy attestations) may be denied.

    • Absence of the State PA form including physician order/signature
    • Missing genetic testing confirming SCD
    • No provider attestation of ≥2 VOCs per year in the prior 2 years or no documentation of chronic transfusion therapy
    • Lack of medical record documentation of prior pharmacologic therapies
    • Missing signed attestations regarding HSCT eligibility, prior HSCT, or prior gene therapy (and for ages 12–18, TCD attestation)
    Standards basisConsistent with credible scientific evidence, specialty society recommendations, practicing physicians' views, and other relevant factors
    Clinical appropriatenessMust be clinically appropriate in type, frequency, timing, site, extent and duration and considered effective for the individual's condition
    Cost considerationNot primarily for convenience and not more costly than an alternative service or sequence of services at least as likely to produce equivalent results