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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAgency Adakveo Prior Auth Coverage | OpenPayer
    Ask Trek AI about this page
    CurrentAgency for Health Care AdministrationPolicy N/A

    Adakveo (crizanlizumab-tmca) Prior Authorization Criteria

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    This policy governs prior authorization and continuation of Adakveo (crizanlizumab-tmca) for patients with sickle cell disease. It applies to requests for patients age 16 or older and establishes clinical eligibility, specialist prescribing, response, dosing, and authorization-duration requirements.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyAdakveo (crizanlizumab-tmca) Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionDocument at least one vaso-occlusive crisis within the past 12 months for initial authorization.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Age 16+Minimum patient age
    1 crisisVaso-occlusive crises required
    1 yearAuthorization duration
    100 mg/10 mLVial strength

    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.

    Positive response
    Continuation requirement

    Coverage Criteria

    Initial Therapy

    Initial therapy is covered when all of the following are met.

    Initial review criteria

    • ALL of the following

      • Patient is 16 years of age or older.Age >= 16
      • Patient has a diagnosis of sickle cell disease.
      • Adakveo is prescribed by or in consultation with a hematologist, or another specialist with expertise in the diagnosis and management of sickle cell disease.
      • Patient has experienced at least one vaso-occlusive crisis within the past 12 months.>= 1 vaso-occlusive crisis in the past 12 months

        Documentation of the vaso-occlusive crisis is required.

    Continuation Therapy

    Continuation therapy is covered when all of the following are met.

    Continuation of therapy

    • ALL of the following

      • Patient met the initial review criteria.
      • Documentation demonstrates a positive clinical response, such as a reduction in blood transfusions, vaso-occlusive crises, hospitalizations, or similar clinical events.Positive clinical response documented
      • Dosing is appropriate according to product labeling or is supported by compendia or standard-of-care guidelines.

    Authorization and Documentation Requirements

    Prior Authorization

    Initial Authorization Criteria

    Initial authorization requires that the patient meet all applicable eligibility requirements before ADAKVEO therapy is approved.

    • Patient is 16 years of age or older.
    • Patient has a documented diagnosis of sickle cell disease.
    • The medication is prescribed by, or in consultation with, a hematologist or other specialist with expertise in sickle cell disease diagnosis and management.
    • The patient has experienced at least one vaso-occlusive crisis within the past 12 months, with documentation required.
    Prior Authorization

    Continuation Authorization Criteria

    Continuation authorization requires evidence that the patient was previously approved under the initial review criteria and continues to receive specialist-directed therapy with clinically appropriate dosing.

    • Patient previously met the initial review criteria.

    Policy Background

    Adakveo (crizanlizumab-tmca) is subject to prior authorization for patients with sickle cell disease. The policy addresses initial treatment for patients age 16 years or older who have experienced at least one documented vaso-occlusive crisis within the past 12 months. Treatment must be prescribed by or provided in consultation with a hematologist or another specialist experienced in sickle cell disease management. Continued coverage requires documented clinical benefit and dosing consistent with product labeling, compendia, or standard-of-care guidelines.

    Key Definitions

    Vaso-occlusive crisis
    DefinitionAn acute complication of sickle cell disease.
    Policy timeframeThe event must have occurred within the past 12 months.
    Documentation requirementDocumentation of at least one vaso-occlusive crisis is required for initial authorization.

    Adakveo Initial Therapy

    Adakveo Initial Criteria

    Initial therapy is authorized when all criteria are met.

    Initial therapy

    • ALL of the following

      • Patient is 16 years of age or older.Age >= 16
      • Patient has a diagnosis of sickle cell disease.
      • Treatment is prescribed by or in consultation with a hematologist, or another specialist with expertise in the diagnosis and management of sickle cell disease.
      • Patient has experienced at least one vaso-occlusive crisis within the past 12 months.

    Adakveo Continuation Therapy

    Adakveo Continuation Criteria

    Continuation is authorized when all criteria are met.

    Continuation therapy

    • ALL of the following

      • Patient met the initial review criteria.
      • Documentation demonstrates a positive clinical response, such as a reduction in blood transfusions, vaso-occlusive crises, hospitalizations, or similar clinical events.Positive clinical response documented
      • Dosing is appropriate according to product labeling or is supported by compendia or standard-of-care guidelines.
    Policy Summary
    PayerAgency for Health Care Administration
    PolicyAdakveo (crizanlizumab-tmca) Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionDocument at least one vaso-occlusive crisis within the past 12 months for initial authorization.
    SourceLink
    On This Page
    Coverage CriteriaAuthorization and Documentation RequirementsPolicy BackgroundKey DefinitionsAdakveo Initial TherapyAdakveo Continuation Therapy
  1. Documentation demonstrates a positive clinical response.
  2. Prescribing remains by or in consultation with a hematologist or other qualified sickle cell disease specialist.
  3. Dosing is appropriate according to product labeling, compendia, or standard-of-care guidelines.
    4. Documentation Required

    Recent Vaso-Occlusive Crisis Documentation

    For initial authorization, the record must document at least one vaso-occlusive crisis during the 12 months preceding the request.

    • Document the occurrence and timing of at least one vaso-occlusive crisis within the past 12 months.
    • A request without the required recent crisis documentation does not satisfy the initial eligibility requirements.
    Documentation Required

    Response Documentation Required

    Continuation requests must include documentation of a positive clinical response to ADAKVEO therapy, such as improvement in disease-related utilization or complications.

    • Examples include a reduction in blood transfusions.
    • Examples include a reduction in vaso-occlusive crises.
    • Examples include a reduction in hospitalizations.
    • Other documented clinical improvement may support continuation when consistent with the treatment response.
    Denial Risk

    Initial Eligibility Not Met

    Initial therapy is not eligible for authorization when any required initial criterion is unmet or cannot be documented.

    • Patient is younger than 16 years.
    • Sickle cell disease is not documented.
    • The prescription is not from, or made in consultation with, a hematologist or other specialist with relevant expertise.
    • At least one vaso-occlusive crisis within the past 12 months is not documented.
    Denial Risk

    Continuation Criteria Not Met

    Continuation therapy is not eligible for authorization when prior approval, clinical response, specialist oversight, or appropriate dosing cannot be established.

    • The patient did not meet the initial review criteria or prior approval cannot be confirmed.
    • Positive clinical response is not documented.
    • Prescribing is not by or in consultation with an appropriate sickle cell disease specialist.
    • Dosing is not consistent with product labeling, compendia, or standard-of-care guidelines.
    >= 1 vaso-occlusive crisis in the past 12 months

    Documentation of the vaso-occlusive crisis is required.