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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsClover Health Casgevy Prior Auth | OpenPayer
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    CurrentClover HealthPolicy 6291-A

    Casgevy Coverage for Sickle Cell Disease

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    This policy governs Medicare Part B coverage and prior authorization for Casgevy (exagamglogene autotemcel) in members with sickle cell disease. Coverage is limited to members meeting the specified age, genotype, vaso-occlusive episode, transplant eligibility, and prior-treatment criteria.

    Policy Summary
    PayerClover Health
    PolicyCasgevy Coverage for Sickle Cell Disease
    Policy CodePolicy 6291-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization for one Casgevy dose under Standard Medicare Part B management after confirming all initial-approval criteria are met.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12+ yearsMinimum member age
    ≥2/year for 2 yearsRequired severe vaso-occlusive episode history
    1 dose totalAuthorization quantity
    3 genotypesEligible sickle cell disease genotypes listed

    Casgevy Coverage Criteria

    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.

    Initial approval for sickle cell disease

    Covered when all of the following criteria are met:

    • Age: Member is 12 years of age or older.≥ 12 years
    • Eligible genotype: Member has a diagnosis of sickle cell disease with one of the following genotypes confirmed by molecular or genetic testing: βs/βs, βs/β0, or βs/β+.βs/βs, βs/β0, or βs/β+
    • Vaso-occlusive episode history: Member has a documented history of at least 2 severe vaso-occlusive episodes per year during the previous 2 years.≥ 2 per year during the previous 2 years

      See the appendix for examples of severe vaso-occlusive events.

    • Transplant eligibility and donor status: Member is eligible for a hematopoietic stem cell transplant (HSCT) but is unable to find a human leukocyte antigen (HLA)-matched related donor.
    • No prior HSCT: Member has not received a prior hematopoietic stem cell transplant (HSCT).0 prior HSCTs
    • No prior gene therapy: Member has not received Casgevy or any other gene therapy previously.0 prior gene therapies

    Coverage requires that the member has not received a prior hematopoietic stem cell transplant (HSCT), Casgevy, or any other gene therapy.

    Clinical Thresholds

    Member age
    Minimum age12 years or older
    Severe vaso-occlusive episode history
    Required historyAt least 2 severe vaso-occlusive episodes per year during the previous 2 years
    Prolonged priapism example
    Qualifying durationPriapism lasting more than 2 hours and requiring a visit to a medical facility

    Authorization and Submission Requirements

    Prior Authorization

    One-Time Part B Authorization

    Standard Medicare Part B prior authorization is required. Authorization is limited to one dose total for sickle cell disease when all initial approval criteria are met and no exclusions apply.

    • Member is 12 years of age or older.
    • Member has sickle cell disease with genotype βs/βs, βs/β0, or βs/β+.
    • Member has at least 2 severe vaso-occlusive episodes per year during the previous 2 years.
    • Member is eligible for hematopoietic stem cell transplant (HSCT) but cannot find an HLA-matched related donor.
    • Member has not previously received an HSCT.
    • Member has not previously received Casgevy or any other gene therapy.
    Documentation Required

    Required Clinical Documentation

    Before submitting, ensure the required clinical documentation is available upon request. The records must support both the sickle cell disease genotype and the member’s history of severe vaso-occlusive episodes.

    • Molecular or genetic testing results documenting the sickle cell disease genotype.
    • Chart notes or medical records documenting a history of severe vaso-occlusive episodes.
    Denial Risk

    Failure to Meet Initial Approval Criteria

    Coverage may be denied if any initial approval criterion is not met, including age, qualifying genotype, vaso-occlusive episode history, HSCT eligibility and donor status, prior HSCT, or prior gene therapy.

    • Confirm that all initial-approval criteria are satisfied before requesting authorization.
    • Authorization is not available when the member has previously received Casgevy or another gene therapy.
    Note

    Unlisted Indication

    Indications other than the FDA-approved indication—sickle cell disease in patients age 12 years and older with recurrent vaso-occlusive crises—are assessed individually. Submit supporting evidence from Medicare-approved compendia with the request.

    • FDA-approved indication: sickle cell disease in patients 12 years and older with recurrent vaso-occlusive crises.
    • For unlisted indications, include evidence from Medicare-approved compendia.

    Casgevy Policy Background

    Casgevy (exagamglogene autotemcel) is indicated for members 12 years of age or older with sickle cell disease and recurrent vaso-occlusive crises. Coverage requires a qualifying sickle cell disease genotype, a documented history of at least 2 severe vaso-occlusive episodes per year during the previous 2 years, eligibility for hematopoietic stem cell transplant without an HLA-matched related donor, and no prior HSCT or gene therapy.

    Severe Vaso-Occlusive Event

    Severe vaso-occlusive event
    Acute pain eventRequires a visit to a medical facility and administration of pain medications—opioids or intravenous non-steroidal anti-inflammatory drugs—or RBC transfusions
    Acute chest syndromeQualifying severe vaso-occlusive event
    Prolonged priapismLasting more than 2 hours and requiring a visit to a medical facility
    Sequestration eventsSplenic sequestration or hepatic sequestration

    Initial Casgevy Therapy

    Initial Casgevy therapy

    Authorization of one dose total may be granted when all of the following criteria are met:

    • Age: Member is 12 years of age or older.≥ 12 years
    • Qualifying genotype: Sickle cell disease genotype is confirmed by molecular or genetic testing as βs/βs, βs/β0, or βs/β+.βs/βs, βs/β0, or βs/β+
    • Severe vaso-occlusive episode history: Member has at least 2 severe vaso-occlusive episodes per year during the previous 2 years.≥ 2 per year during the previous 2 years

      See the appendix for examples of severe vaso-occlusive events.

    • HSCT eligibility and donor status: Member is eligible for a hematopoietic stem cell transplant (HSCT) but is unable to find a human leukocyte antigen (HLA)-matched related donor.
    • No prior HSCT: Member has not received a prior hematopoietic stem cell transplant (HSCT).0 prior HSCTs
    • No prior gene therapy: Member has not received Casgevy or any other gene therapy previously.0 prior gene therapies

    Casgevy Quantity Limit

    Casgevy
    Total quantity limit1 dose total per course
    Policy Summary
    PayerClover Health
    PolicyCasgevy Coverage for Sickle Cell Disease
    Policy CodePolicy 6291-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization for one Casgevy dose under Standard Medicare Part B management after confirming all initial-approval criteria are met.
    SourceLink
    On This Page
    Casgevy Coverage CriteriaClinical ThresholdsAuthorization and Submission RequirementsCasgevy Policy BackgroundSevere Vaso-Occlusive EventInitial Casgevy TherapyCasgevy Quantity Limit