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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsClover Health Ixempra Prior Auth Policy | OpenPaye…
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    CurrentClover HealthPolicy C22977-A

    Ixempra (ixabepilone) Coverage Criteria

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    This policy governs prior authorization for Ixempra in patients with breast cancer, including initiation and continuation requirements, disease characteristics, prior therapy, combination use, HER2 testing, treatment benefit, and hepatic laboratory parameters.

    Policy Summary
    PayerClover Health
    PolicyIxempra (ixabepilone) Coverage Criteria
    Policy CodePolicy C22977-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit HER2 status testing results upon request for eligible recurrent or metastatic disease.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Breast cancerCovered diagnosis
    2HER2 disease categories
    1Continuation requirement
    >2.5× ULNHepatic laboratory threshold

    General 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.

    General Approval Criteria

    Coverage requires that all applicable general approval criteria are met.

    ALL of the following

    • The patient has breast cancer.

    • ONE of the following requested-medication statuses applies:

      • The patient is currently receiving therapy with the requested medication.
      • The patient is not currently receiving therapy with the requested medication.

    Continuation Therapy

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

    ALL of the following

    • The patient is currently receiving therapy with the requested medication.
    • The patient is receiving benefit from therapy with the requested medication, defined as no evidence of unacceptable toxicity and no evidence of disease progression while on the current regimen.

    Initiation Therapy

    Initiation therapy is covered when all of the following are met:

    ALL of the following

    • The disease and regimen meet ONE of the following combinations:

      • ALL of the following

        • The patient has human epidermal growth factor receptor 2 (HER2)-negative recurrent or metastatic disease.

          Documentation of HER2 status testing results must be submitted upon request.

        • The requested medication will be used as a single agent.

      • ALL of the following

        • The patient has human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic disease.

          Documentation of HER2 status testing results must be submitted upon request.

    Initiation therapy requires that the patient's aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels are not greater than 2.5 times the upper limit of normal (ULN), and that bilirubin is not greater than 1 time the ULN.

    Laboratory Thresholds

    AST or ALT
    Laboratory measureAspartate aminotransferase (AST) or alanine aminotransferase (ALT)
    Threshold>2.5 times the upper limit of normal (ULN)
    Policy significanceA level above this threshold is a hepatic laboratory coverage barrier requiring review.
    Bilirubin
    Laboratory measureBilirubin
    Threshold>1 time the upper limit of normal (ULN)
    Policy significanceA level above this threshold is a hepatic laboratory coverage barrier requiring review.

    Authorization and Documentation Requirements

    Prior Authorization

    Ixempra Prior Authorization Review

    Submit a prior authorization request for Ixempra (ixabepilone) with documentation addressing the patient's diagnosis, current therapy status, HER2 status, planned regimen, disease extent, prior treatment history, and relevant laboratory results.

    • Confirm whether the patient has breast cancer or another diagnosis.
    • Indicate whether the patient is currently receiving Ixempra.
    • Document HER2 testing results when requested.
    • Specify whether Ixempra will be used alone or with trastuzumab and whether the disease is metastatic or locally advanced.
    • Provide prior anthracycline and taxane treatment history and AST, ALT, and bilirubin values.
    Documentation Required

    Prior Anthracycline and Taxane Therapy

    Document that the patient has tried and failed both an anthracycline and a taxane. For taxane-resistant disease, also document a contraindication to further anthracycline therapy.

    • Prior anthracycline therapy and failure are required.
    • Prior taxane therapy and failure are required.
    • Taxane resistance must be accompanied by a contraindication to further anthracycline therapy.
    Documentation Required

    HER2 Testing Documentation

    Submit HER2 status testing results upon request when evaluating Ixempra for HER2-negative or HER2-positive recurrent or metastatic disease.

    • Document HER2-negative or HER2-positive status as applicable.
    • HER2 testing documentation may be requested during review.

    Unsupported block type: denial_risk not_covered

    Denial Risk

    Initiation Criteria Must Be Met

    Initiation criteria may not be met if the required HER2 status, regimen, disease extent, or prior-therapy elements are not documented. Review the treatment plan against the applicable pathway before submitting the request.

    • For HER2-negative recurrent or metastatic disease, document that Ixempra will be used as a single agent.
    • For HER2-positive recurrent or metastatic disease, document that Ixempra will be used in combination with trastuzumab.
    • Document metastatic or locally advanced disease.
    • Document failure of an anthracycline and a taxane; where applicable, document taxane resistance and a contraindication to further anthracycline therapy.
    Denial Risk

    Abnormal Hepatic Laboratory Values

    Review hepatic laboratory results before authorization. AST or ALT greater than 2.5 times the upper limit of normal, or bilirubin greater than 1 time the upper limit of normal, requires review.

    • AST > 2.5 × ULN requires review.
    • ALT > 2.5 × ULN requires review.
    • Bilirubin > 1 × ULN requires review.
    Denial Risk

    Ongoing Treatment Benefit Required

    For continuation requests, document that the patient is receiving benefit from Ixempra on the current regimen, with no evidence of unacceptable toxicity and no evidence of disease progression.

    • Lack of ongoing treatment benefit may result in nonapproval.
    • Unacceptable toxicity may result in nonapproval.
    • Disease progression while on the current regimen may result in nonapproval.

    Policy Background

    Ixempra (ixabepilone) is evaluated for breast cancer treatment, including recurrent or metastatic disease and, when applicable, locally advanced disease. For initiation, the policy distinguishes between HER2-negative disease treated with Ixempra as a single agent and HER2-positive disease treated in combination with trastuzumab. Continuation requires ongoing benefit without unacceptable toxicity or disease progression on the current regimen.

    Clinical Definitions

    HER2 status
    Full termHuman epidermal growth factor receptor 2 (HER2)
    ClassificationRecurrent or metastatic breast cancer is classified as HER2-negative or HER2-positive.
    DocumentationHER2 status testing results must be submitted upon request.
    Recurrent or metastatic disease
    Recurrent diseaseBreast cancer that has returned.
    Metastatic diseaseBreast cancer that has spread to other sites.
    Related disease extentThe criteria also include locally advanced disease.
    Benefit from therapy
    Current regimenThe patient is receiving the requested medication.
    Treatment benefitThere is no evidence of unacceptable toxicity.
    Disease statusThere is no evidence of disease progression while the patient is on the current regimen.

    Ixempra Initial Therapy

    Ixempra Continuation

    Ixempra Continuation

    Continuation requires ongoing benefit from the requested medication:

    Clinical benefit

    • There is no evidence of unacceptable toxicity and no evidence of disease progression while the patient is on the current regimen.

    Prior Treatment Requirements

    StepRequirementFailure criteria
    1Prior anthracycline and taxane therapy, with a contraindication to further anthracycline therapyTried and failed an anthracycline and a taxane; cancer is taxane resistant.
    Policy Summary
    PayerClover Health
    PolicyIxempra (ixabepilone) Coverage Criteria
    Policy CodePolicy C22977-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit HER2 status testing results upon request for eligible recurrent or metastatic disease.
    SourceLink
    On This Page
    General Coverage CriteriaLaboratory ThresholdsAuthorization and Documentation RequirementsPolicy BackgroundClinical DefinitionsIxempra Initial TherapyIxempra ContinuationPrior Treatment Requirements
  1. The requested medication will be used in combination with trastuzumab.
  2. The requested medication will be used for metastatic or locally advanced disease.
  3. The patient has tried and failed an anthracycline and a taxane.
  4. The cancer is taxane resistant and the patient has a contraindication to further anthracycline therapy.
  5. Hepatic laboratory values meet the AST, ALT, and bilirubin thresholds specified below.