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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsCountyCare Adakveo Coverage Update | OpenPayer
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    CurrentCountyCarePolicy 5002.CC

    Adakveo (crizanlizumab-tmca) Coverage Criteria for Sickle Cell Disease

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    This policy governs prior authorization under the CountyCare medical benefit for Adakveo in practitioners treating members with sickle cell disease. It establishes initial approval and annual reauthorization requirements for members age 16 or older.

    Policy Summary
    PayerCountyCare
    PolicyAdakveo (crizanlizumab-tmca) coverage for sickle cell disease
    Policy CodePolicy 5002.CC
    Change TypeMaterial revision
    Effective DateJune 1, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization and submit documentation of the required VOC history, treatment history, clinical criteria, and FDA-label dosing.
    SourceLink
    POLICY UPDATE CHANGES

    Oxbryta was removed from the guideline because it was withdrawn from the market.

    A manufacturer-label dosing criterion was added to the reauthorization requirements.

    16+Minimum member age
    Hb ≥4Hemoglobin threshold
    ≥2 VOCsRequired crisis history
    AnnualReauthorization frequency

    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.

    J0791Billing code
    MedicaidLine of business

    Coverage Criteria

    Initial Therapy

    Covered for initial therapy when all of the following requirements are met, including one of the two qualifying vaso-occlusive crisis and hydroxyurea pathways.

    Initial therapy requirements

    • Disease, age, prescriber, dosing, and baseline requirements

      • Eligible sickle cell disease genotype

        • ONE of

          • The member has homozygous hemoglobin S (HbSS).
          • The member has hemoglobin Sβ0-thalassemia.
          • The member has hemoglobin Sβ+-thalassemia.
          • The member has hemoglobin SC (HbSC).
      • The member is age 16 or older.Age ≥16
      • Adakveo is prescribed by or in consultation with a hematologist or other specialist trained in management of sickle cell disease.
      • The prescribed dose is within the manufacturer’s dosing guidelines based on the FDA-approved labeling, including diagnosis, weight, and related factors.
      • The member’s hemoglobin level is at least 4 g/dL.Hb ≥4 g/dL
      • The baseline frequency of vaso-occlusive crises (VOCs) over the previous 12 months is provided.

    • ONE of the following VOC and hydroxyurea pathways

      • Hydroxyurea at up to maximally indicated doses

        • The member experienced at least 2 VOCs within the past 6 months while receiving hydroxyurea at up to maximally indicated doses.≥2 VOCs in 6 months

      • Hydroxyurea intolerance or contraindication

        • The member has intolerance or contraindication to hydroxyurea.
        • The member experienced at least 2 VOCs within the past 12 months.≥2 VOCs in 12 months

    • L-glutamine requirement

      • There is documentation of a trial and failure of L-glutamine at up to maximally tolerated doses, unless L-glutamine is contraindicated or caused clinically significant adverse effects.

    • Concurrent treatment and transfusion requirements

      • Adakveo is prescribed concurrently with hydroxyurea, unless hydroxyurea is contraindicated or causes clinically significant adverse effects.
      • The member is not concurrently being treated with chronic prophylactic blood transfusion therapy.

    Reauthorization / Continuation Therapy

    Covered for reauthorization when all continuation requirements are met. Reauthorization is reviewed annually and may be approved for up to one year.

    Continuation therapy requirements

    • Recent chart documentation shows a reduction in the frequency of vaso-occlusive crises.Reduction in VOC frequency
    • The prescribed Adakveo dose is within the manufacturer’s dosing guidelines based on the FDA-approved labeling, including diagnosis, weight, and related factors.

      Approval may be granted for up to one year.

    Coverage is not supported when Adakveo is used concurrently with chronic prophylactic blood transfusion therapy. The member must not be receiving this transfusion therapy as part of the covered treatment pathway.

    Coding and Clinical Thresholds

    Applicable CodeHCPCSCovered
    J0791Injection, crizanlizumab-tmca, 5mg
    Hemoglobin
    Minimum hemoglobin≥ 4 g/dL
    Vaso-occlusive crises with hydroxyurea
    Required VOC historyAt least 2 VOCs within the past 6 months while on hydroxyurea at up to maximally indicated doses
    Vaso-occlusive crises with hydroxyurea intolerance or contraindication
    Required VOC historyAt least 2 VOCs within the past 12 months when the member has hydroxyurea intolerance or contraindication

    Prior Authorization and Documentation

    Prior Authorization

    Medical-Benefit Prior Authorization Required

    Prior authorization is required for Adakveo (crizanlizumab-tmca) under the Health Plan’s medical benefit. Requests are reviewed against FDA criteria and the plan’s Medical Necessity requirements; requests that do not meet established criteria may be referred to a Medical Director when required.

    • Applicable drug: Adakveo (crizanlizumab-tmca), HCPCS J0791.
    • Prescribe within the manufacturer’s dosing guidelines in the FDA-approved labeling.
    Step Therapy

    Hydroxyurea and VOC Treatment Pathway

    Adakveo may be authorized when the member has qualifying sickle cell disease and meets the required vaso-occlusive crisis and hydroxyurea treatment pathway.

    • Qualifying genotypes: HbSS, HbSβ0-thalassemia, HbSβ+-thalassemia, or HbSC.
    • Member must be age 16 or older and have hemoglobin (Hb) level ≥ 4 g/dL.

    Medication Background

    Adakveo (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises in adults and pediatric patients age 16 or older with sickle cell disease. The policy evaluates use in specified sickle cell disease genotypes and requires prior authorization based on clinical need, treatment history, and FDA-approved dosing.

    Initial Therapy Criteria

    Initial Therapy Criteria

    Initial therapy requires all applicable clinical, treatment-history, documentation, and dosing requirements.

    Initial Adakveo authorization

    • Clinical eligibility and prescribing oversight

      • ONE eligible sickle cell disease genotype

        • The member has HbSS.
        • The member has HbSβ0-thalassemia.
        • The member has HbSβ+-thalassemia.
        • The member has HbSC.

    Annual Reauthorization

    Annual Reauthorization

    Reauthorization is reviewed annually and may be approved for up to one year.

    Annual reauthorization requirements

    • Recent chart documentation shows a reduction in the frequency of vaso-occlusive crises.Reduction in VOC frequency
    • The prescribed Adakveo dose remains within the manufacturer’s dosing guidelines based on the FDA-approved labeling, including diagnosis, weight, and related factors.

      Approval duration is up to one year.

    Required Prior Therapies

    StepRequirementSupporting criterion
    1Use hydroxyurea at up to maximally indicated doses before Adakveo.At least 2 vaso-occlusive crises within the past 6 months while receiving hydroxyurea at up to maximally indicated doses.
    StepRequirementException documentation
    1Document hydroxyurea intolerance or contraindication.If hydroxyurea is intolerable or contraindicated, document the applicable reason and at least 2 vaso-occlusive crises within the past 12 months.
    StepRequirementException
    2Trial L-glutamine before Adakveo at up to maximally tolerated doses.The trial-and-failure requirement does not apply if L-glutamine is contraindicated or causes clinically significant adverse effects.
    Policy Summary
    PayerCountyCare
    PolicyAdakveo (crizanlizumab-tmca) coverage for sickle cell disease
    Policy CodePolicy 5002.CC
    Change TypeMaterial revision
    Effective DateJune 1, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization and submit documentation of the required VOC history, treatment history, clinical criteria, and FDA-label dosing.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Clinical ThresholdsPrior Authorization and DocumentationMedication BackgroundInitial Therapy CriteriaAnnual ReauthorizationRequired Prior Therapies
  1. Prescriber must be a hematologist or another specialist trained in sickle cell disease management, or prescribing must occur in consultation with one.
  2. The request must document either at least 2 VOCs within the past 6 months while receiving hydroxyurea at up to maximally indicated doses, or hydroxyurea intolerance/contraindication with at least 2 VOCs within the past 12 months.
    3. Step Therapy

    L-Glutamine Trial and Failure Required

    Before requesting Adakveo, document a trial and failure of L-glutamine at up to maximally tolerated doses, unless L-glutamine is contraindicated or caused clinically significant adverse effects.

    • Submit the L-glutamine trial details and outcome.
    • If no trial was completed, document the contraindication.
    • If treatment was stopped, document the clinically significant adverse effects.

    Unsupported block type: documentation

    Unsupported block type: documentation

    Unsupported block type: documentation

    Unsupported block type: documentation

    Denial Risk

    Initial Clinical Criteria Not Met

    An initial request may be denied when the member does not satisfy the required clinical criteria or when supporting documentation is incomplete.

    • Nonqualifying sickle cell genotype, age under 16, Hb level below 4 g/dL, or no qualified hematology specialist involvement.
    • Fewer than the required VOCs, or failure to meet the applicable hydroxyurea treatment, intolerance, or contraindication pathway.
    • No documented L-glutamine trial and failure, contraindication, or clinically significant adverse effects when required.
    • Requested dosing outside the manufacturer’s FDA-approved guidelines or insufficient documentation of baseline VOC frequency.
    Denial Risk

    Reauthorization Criteria Not Met

    Continuation may be denied when annual renewal documentation does not establish ongoing Medical Necessity.

    • No recent chart evidence showing a reduction in VOC frequency.
    • Dose is outside the manufacturer’s FDA-approved dosing guidelines.
    • The request does not continue to meet the initial criteria or lacks required supporting documentation.

    Unsupported block type: denial_risk

  3. The member is age 16 or older.Age ≥16
  4. Adakveo is prescribed by or in consultation with a hematologist or other specialist with training in management of sickle cell disease.
  5. The prescribed dose is within the manufacturer’s dosing guidelines in the FDA-approved labeling, based on diagnosis, weight, and related factors.
  6. The member’s hemoglobin level is at least 4 g/dL.Hb ≥4 g/dL
  7. The baseline frequency of VOCs over the last 12 months is documented.

  8. ONE qualifying VOC and hydroxyurea pathway

    • ALL of the following

      • The member experienced at least 2 VOCs within the past 6 months while on hydroxyurea at up to maximally indicated doses.≥2 VOCs in 6 months

    • ALL of the following

      • The member has intolerance or contraindication to hydroxyurea.
      • The member experienced at least 2 VOCs within the past 12 months.≥2 VOCs in 12 months

  9. Required treatment history and documentation

    • A trial and failure of L-glutamine at up to maximally tolerated doses is documented, unless L-glutamine is contraindicated or caused clinically significant adverse effects.
    • Adakveo is prescribed concurrently with hydroxyurea, unless hydroxyurea is contraindicated or causes clinically significant adverse effects.
    • The member is not concurrently receiving chronic prophylactic blood transfusion therapy.