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    v1.0.28
    OpenPayerPolicy UpdatesHematology/OncologyAvMed Casgevy β-thalassemia Prior Auth Coverage | …
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    CurrentAvMedPolicy N/A

    Casgevy - β - Thalassemia (Medical)

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    Medical prior authorization form and clinical coverage criteria for one lifetime treatment of Casgevy (exagamglogene autotemcel) for members with β-thalassemia. Defines clinical eligibility requirements, dosing limits, required documentation, provider qualifications, and administration site options.

    Policy Summary
    PayerAvMed
    PolicyCasgevy - β - Thalassemia (Medical)
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective Date
    Next Review Date
    Key ActionPrescribing physician must sign and print name on the PA request and submit complete documentation including labs, diagnostics, and chart notes; incomplete or illegible information may delay authorization.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes.

    1Lifetime treatments allowed
    ≥12Minimum age

    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.

    3e6/kgMinimum CD34+ cells/kg dose
    2Transfusion-dependence options

    Coverage Summary

    Scope: This is a medical prior authorization form and clinical coverage criteria for one lifetime treatment of Casgevy (exagamglogene autotemcel) for members with β-thalassemia, defining clinical eligibility requirements, dosing limits, required documentation, provider qualifications, and administration site options.

    Coverage stance: Covered with criteria — authorization is provided when all specified criteria are met and required documentation is submitted; one treatment per lifetime is allowed and the course may not be renewed.

    Subject: Casgevy (exagamglogene autotemcel) for β-thalassemia.

    Payer: AvMed (medical prior authorization/step-edit request; Medicare Part B guidance referenced where applicable).

    Status: CURRENT.

    One-sentence overview: This policy permits one lifetime administration of Casgevy when all clinical criteria are met and requires prior authorization with supporting documentation; prior authorization must be signed by the prescribing physician and necessary labs/diagnostics submitted.

    Dosing and Eligibility Thresholds
    Minimum recommended dose3 × 10^6 CD34+ cells per kg of body weight
    Age≥ 12 years
    HemoglobinTotal hemoglobin ≥ 11 g/dL prior to mobilization and ≥ 11 g/dL prior to myeloablative conditioning
    Transfusion-dependence option AReceipt of ≥ 100 mL packed RBC per kg per year in the previous 2 years
    Transfusion-dependence option BReceipt of ≥ 10 units packed RBC per year in the previous 2 years
    Contraception durationUse effective contraception from start of mobilization through at least 6 months after Casgevy administration

    Approval Criteria and Dosing Limits

    Dosing Limits and Treatment Frequency

    Limits on dosing and lifetime treatments.

    ALL of the following

    • Casgevy is supplied in one or more vials; one carton contains a single lot consisting of 1 to 9 vials

      NDC 51167-290-09

    • Minimum recommended dose is 3 × 10^6 CD34+ cells per kg of body weight3 × 10^6 CD34+ cells per kg
    • One treatment (dose) per lifetime

    Relevant Codes

    Drug HCPCS/J-codeHCPCSCovered
    J3392Exagamglogene autotemcel (Casgevy)
    NDC listed in policyNDC
    51167-290-09Casgevy vial/carton NDC (frozen suspension of genome edited autologous CD34+ cells)

    Actions for Providers (Prior Authorization, Documentation, Billing)

    Prior Authorization

    Prior authorization required with signed form

    The prescribing physician must sign and clearly print their name on the prior authorization request (preprinted stamps not valid). All required documentation — including labs, diagnostics, and chart notes — must be submitted; incomplete, incorrect, or illegible information may delay authorization.

    Documentation Required

    Document genotype and transfusion history

    Submit genetic testing confirming the member's β-thalassemia genotype and documentation supporting transfusion dependence (either ≥100 mL packed RBC/kg/year or ≥10 units packed RBC/year in the previous 2 years). Also submit cellular infectious disease screening results as part of the documentation package.

    Documentation Required

    Background and Product Information

    Background: Casgevy (exagamglogene autotemcel) is supplied as an autologous, genome edited CD34+ cell gene therapy product for the treatment of β-thalassemia (HCPCS J3392; NDC listed for the frozen suspension vial/carton).

    This document is a medical prior authorization/step-edit form outlining clinical eligibility criteria, required screening and infectious disease testing, conditioning and treatment logistics (mobilization, apheresis, myeloablative conditioning such as busulfan), administration site options or specialty pharmacy, and program-specific documentation and provider signature requirements.

    Where applicable for Medicare members, outpatient (Part B) drug coverage guidance (Medicare Benefit Policy Manual, NCDs and LCDs) is referenced and must be followed in addition to this prior authorization process.

    Defined Terms

    Transfusion-dependent: Either ≥ 100 mL of packed red blood cells per kg per year in the previous 2 years OR ≥ 10 units of packed red blood cells per year in the previous 2 years.

    Severe iron overload: Examples include myocardial T2* < 10 msec; liver iron concentration ≥ 15 mg/g; abnormal liver biopsy; or clinical evidence of organ damage such as endocrine comorbidities.

    Revision History

    Policy Summary
    PayerAvMed
    PolicyCasgevy - β - Thalassemia (Medical)
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective Date
    Next Review Date
    Key ActionPrescribing physician must sign and print name on the PA request and submit complete documentation including labs, diagnostics, and chart notes; incomplete or illegible information may delay authorization.
    SourceLink
    On This Page
    Coverage SummaryApproval Criteria and Dosing LimitsRelevant CodesActions for Providers (Prior Authorization, Documentation, Billing)Background and Product InformationDefined TermsRevision History

    Verify prior gene therapy

    Verify that the member has not previously received a gene therapy for beta-thalassemia (Casgevy or Zynteglo) via medical paid claims; if claims are unavailable, the prescribing physician must attest that the member has not previously received these therapies.

    Billing Rule

    One lifetime administration

    Benefit covers one treatment course per member lifetime and may not be renewed. Bill using HCPCS J3392 for Casgevy where applicable.

    Documentation Required

    Weight and hemoglobin documentation

    Current body weight must be documented and obtained within 30 days. Total hemoglobin values of ≥ 11 g/dL must be documented prior to mobilization and prior to myeloablative conditioning.

    Documentation Required

    Iron overload assessment

    Submit documentation that the member has been evaluated for the presence of severe iron overload and demonstrate absence of severe iron overload. Examples of severe iron overload include myocardial T2* < 10 msec, liver iron concentration ≥ 15 mg/g, abnormal liver biopsy, or clinical evidence of organ damage (e.g., endocrine comorbidities).

    Documentation Required

    Reproductive safety documentation

    For females of reproductive potential, confirm a negative serum pregnancy test prior to the start of mobilization and re-confirm prior to myeloablative conditioning, and document use of effective contraception from the start of mobilization through at least 6 months after Casgevy administration. For males of reproductive potential, document use of effective contraception from the start of mobilization through at least 6 months after Casgevy administration.