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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsWashington HCA Abiraterone Prior Auth | OpenPayer
    Ask Trek AI about this page
    CurrentWashington State Health Care AuthorityPolicy 21.40.60-1

    Androgen Biosynthesis Inhibitors - Abiraterone

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    This policy governs Apple Health coverage and prior authorization for abiraterone (Yonsa and Zytiga) for specified prostate cancer indications, including initial and reauthorization criteria, preferred-drug requirements, concurrent therapies, dosage limits, and documentation requirements.

    Policy Summary
    PayerWashington State Health Care Authority
    PolicyAndrogen Biosynthesis Inhibitors - Abiraterone
    Policy CodePolicy 21.40.60-1
    Change TypeNo material change
    Effective DateAugust 1, 2024
    Next Review DateNot specified
    Key ActionFor non-preferred agents, document inadequate response or severe adverse reaction or contraindication to at least two preferred agents, or to one preferred agent if only one is available.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 monthsAuthorization period when criteria are met
    18+ yearsMinimum age for specified initial-therapy indications
    2 agentsPreferred agents generally required for non-preferred new-to-market agents
    250 or 500 mg

    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.

    Generic tablet strengths addressed
    120 tablets/30 days250 mg Zytiga quantity limit
    60 tablets/30 days500 mg Zytiga quantity limit

    Indication-Specific Coverage Criteria

    Metastatic castration-resistant prostate cancer — initial therapy

    Covered when all applicable criteria are met:

    Initial therapy criteria

    • Tablet strength

      • The request is for generic abiraterone 250 mg tablets.250 mg tablets
      • The request is for generic abiraterone 500 mg tablets, with documentation of clinical rationale explaining why 250 mg tablets would not be an effective regimen.500 mg tablets

        Convenience of taking fewer tablets does not meet medical necessity.

    • Concurrent steroid: Abiraterone will be used in combination with a steroid consistent with FDA labeling, such as prednisone with Zytiga or methylprednisolone with Yonsa.

    Metastatic castration-resistant prostate cancer — reauthorization

    Covered when all applicable criteria are met:

    Reauthorization criteria

    • Tablet strength

      • The request is for generic abiraterone 250 mg tablets.250 mg tablets
      • The request is for generic abiraterone 500 mg tablets, with documentation of clinical rationale explaining why 250 mg tablets would not be an effective regimen.500 mg tablets

        Convenience of taking fewer tablets does not meet medical necessity.

    • Response evidence: Submit documentation of disease stability or a positive clinical response, such as stabilization of disease, decreased tumor size or spread, or lack of disease progression.

    Metastatic high-risk castration-sensitive or castration-naïve prostate cancer — initial therapy

    Covered when all applicable criteria are met:

    Initial therapy criteria

    • High-risk features: Gleason score ≥7 (Grade Group >2); bone lesions; or measurable visceral metastases.At least 2 of 3 risk factors

    • Tablet strength

      • The request is for generic abiraterone 250 mg tablets.250 mg tablets
      • The request is for generic abiraterone 500 mg tablets, with documentation of clinical rationale explaining why 250 mg tablets would not be an effective regimen.500 mg tablets

    Metastatic high-risk castration-sensitive or castration-naïve prostate cancer — reauthorization

    Covered when all applicable criteria are met:

    Reauthorization criteria

    • Tablet strength

      • The request is for generic abiraterone 250 mg tablets.250 mg tablets
      • The request is for generic abiraterone 500 mg tablets, with documentation of clinical rationale explaining why 250 mg tablets would not be an effective regimen.500 mg tablets

        Convenience of taking fewer tablets does not meet medical necessity.

    • Response evidence: Submit documentation of disease stability or a positive clinical response, such as stabilization of disease, decreased tumor size or spread, or lack of disease progression.

    Non-metastatic high-risk prostate cancer — initial therapy

    Covered when all applicable criteria are met:

    Initial therapy criteria

    • High-risk or very high-risk definition

      • The patient is node positive.
      • The patient is node negative and has at least two of the following: Gleason score ≥8, tumor stage T3 or T4, or prostate-specific antigen concentration ≥40 ng/mL.At least 2 risk factors
      • The patient has experienced a PSA doubling time of <6 months or PSA ≥20 ng/mL while receiving androgen deprivation therapy, such as GnRH analogs.PSA doubling time <6 months or PSA ≥20 ng/mL on ADT

    • Tablet strength

    Non-metastatic high-risk prostate cancer — reauthorization

    Covered when all applicable criteria are met:

    Reauthorization criteria

    • Tablet strength

      • The request is for generic abiraterone 250 mg tablets.250 mg tablets
      • The request is for generic abiraterone 500 mg tablets, with documentation of clinical rationale explaining why 250 mg tablets would not be an effective regimen.500 mg tablets

        Convenience of taking fewer tablets does not meet medical necessity.

    • Response evidence: Submit documentation of disease stability or a positive clinical response, such as stabilization of disease, decreased tumor size or spread, or lack of disease progression.

    For new-to-market non-preferred agents in this class, standard prior authorization requires documentation of an inadequate response or documented intolerance due to a severe adverse reaction or contraindication to at least two preferred agents. If only one preferred agent is available in the class, documentation for that one agent is required. Preferred-agent requirements are based on the current Apple Health Preferred Drug List.

    Choosing generic abiraterone 500 mg tablets solely because the patient would take fewer tablets does not establish medical necessity when 250 mg tablets would be an effective regimen. Requests for the 500 mg strength must include clinical rationale explaining why the 250 mg strength would not be effective.

    Coding and Clinical Classification

    Codingmixed
    N/AN/A
    Metastatic high-risk castration-sensitive or castration-naïve prostate cancer
    Required risk factorsAt least 2 risk factors are required
    Gleason score≥7 (Grade Group >2)
    Other qualifying factorsBone lesions or measurable visceral metastases
    Non-metastatic high-risk disease, node-negative
    Required risk factorsAt least 2 risk factors are required for node-negative disease
    Gleason score≥8
    Tumor stage

    Authorization, Documentation, and Denial Risks

    Prior Authorization

    Prior Authorization and Preferred Status

    Prior authorization is required for abiraterone products under this policy. New-to-market agents in the class that are non-preferred on the Apple Health Preferred Drug List (AHPDL) are subject to these criteria.

    • Check the current AHPDL to determine preferred status.
    • Submit documentation supporting the applicable clinical criteria and requested product, strength, and quantity.
    Prior Authorization

    Six-Month Authorization

    When all applicable initial or continuation criteria are met, authorization is issued for 6 months. Reauthorization requires the applicable continuation criteria, including documentation of disease stability or a positive clinical response.

    • Initial authorization: 6 months when all required criteria are met.
    • Reauthorization: 6 months when all required continuation criteria are met.
    • Apply the relevant criteria for metastatic castration-resistant, metastatic high-risk castration-sensitive or castration-naïve, and non-metastatic high-risk prostate cancer.

    Clinical Background

    Prostate cancer may be treated with androgen deprivation therapy, with or without an androgen receptor pathway inhibitor, particularly in advanced disease. Abiraterone inhibits intracellular conversion of androgen precursors in the testes, adrenal glands, and prostate tumor tissue. It is used with ongoing hormone suppression and a corticosteroid. This policy addresses metastatic castration-resistant, metastatic high-risk castration-sensitive or castration-naïve, and non-metastatic high-risk prostate cancer.

    Initial Therapy Criteria

    Metastatic castration-resistant prostate cancer — initial therapy decision tree

    Initial therapy requires all of the following:

    mCRPC initial therapy

    • Tablet strength

      • Generic abiraterone 250 mg tablets are requested.
      • Generic abiraterone 500 mg tablets are requested, with clinical rationale explaining why 250 mg tablets would not be an effective regimen.

        Convenience of taking fewer tablets does not meet medical necessity.

    Metastatic high-risk castration-sensitive or castration-naïve prostate cancer — initial therapy decision tree

    Initial therapy requires all of the following:

    Metastatic high-risk CSPC or castration-naïve disease

    Reauthorization and Continuation

    Reauthorization — continuation criteria and response evidence

    Reauthorization may be approved when all applicable criteria are documented:

    Continuation criteria

    • Tablet strength

      • Generic abiraterone 250 mg tablets are requested.
      • Generic abiraterone 500 mg tablets are requested, with clinical rationale explaining why 250 mg tablets would not be an effective regimen.

        Convenience of taking fewer tablets does not meet medical necessity.

    • Response evidence: Submit documentation of disease stability or a positive clinical response, such as stabilization of disease, decreased tumor size or spread, or lack of disease progression.

    • Indication-specific concurrent therapy

    Preferred Drug Requirements

    StepPreferred-agent requirementRequired documentation
    1Try at least two preferred agents in the class.Document inadequate response, or intolerance due to a severe adverse reaction or contraindication, to each required preferred agent using the current Apple Health Preferred Drug List.
    1 (if only one preferred agent exists)Try the one preferred agent available in the class.Document inadequate response, or intolerance due to a severe adverse reaction or contraindication, to that preferred agent using the current Apple Health Preferred Drug List.

    Tablet Quantity Limits

    Quantity limit
    DrugAbiraterone (Yonsa)
    Tablet strength125 mg tablets
    Quantity limit120 tablets per 30 days
    Quantity limit
    DrugAbiraterone (Zytiga)
    Tablet strength250 mg tablets
    Quantity limit120 tablets per 30 days
    Policy Summary
    PayerWashington State Health Care Authority
    PolicyAndrogen Biosynthesis Inhibitors - Abiraterone
    Policy CodePolicy 21.40.60-1
    Change TypeNo material change
    Effective DateAugust 1, 2024
    Next Review DateNot specified
    Key ActionFor non-preferred agents, document inadequate response or severe adverse reaction or contraindication to at least two preferred agents, or to one preferred agent if only one is available.
    SourceLink
    On This Page
    Indication-Specific Coverage CriteriaCoding and Clinical ClassificationAuthorization, Documentation, and Denial RisksClinical BackgroundInitial Therapy CriteriaReauthorization and ContinuationPreferred Drug RequirementsTablet Quantity Limits
  1. Concurrent steroid: Abiraterone will be used in combination with a steroid consistent with FDA labeling, such as prednisone with Zytiga or methylprednisolone with Yonsa.

    2. Convenience of taking fewer tablets does not meet medical necessity.

  2. Concurrent therapy: Abiraterone will be used in combination with prednisone.
  3. Docetaxel condition: If abiraterone is used in combination with docetaxel, the provider attests that the client has high-volume metastatic burden.

    The policy does not define a numeric threshold for high-volume metastatic burden.

  4. Concurrent therapy: Abiraterone will be used in combination with prednisone.
  5. The request is for generic abiraterone 250 mg tablets.250 mg tablets
  6. The request is for generic abiraterone 500 mg tablets, with documentation of clinical rationale explaining why 250 mg tablets would not be an effective regimen.500 mg tablets

    Convenience of taking fewer tablets does not meet medical necessity.

  7. Required concurrent therapy: Abiraterone will be used in combination with external beam radiotherapy unless contraindicated, androgen deprivation therapy such as GnRH analogs, and prednisone or prednisolone.All 3 therapies
  8. Required concurrent therapy: Abiraterone will be used in combination with external beam radiotherapy unless contraindicated, androgen deprivation therapy such as GnRH analogs, and prednisone or prednisolone.All 3 therapies
    9. T3 or T4
    PSA concentration≥40 ng/mL
    Non-metastatic disease progression on ADT
    Progression criterionPSA doubling time <6 months or PSA ≥20 ng/mL on androgen deprivation therapy
    PSA doubling time<6 months
    PSA level on ADT≥20 ng/mL
    High-volume metastatic burden with docetaxel
    Provider attestationRequired when abiraterone is used in combination with docetaxel
    AttestationProvider must attest that the client has high-volume metastatic burden
    Numeric thresholdThe policy does not define a numeric threshold for high-volume metastatic burden
    Note

    Case-by-Case Medical-Necessity Review

    Androgen biosynthesis inhibitors may be medically necessary when the listed clinical criteria are met. If all criteria are not met, the clinical reviewer may determine that medical necessity exists and approve the request case by case; for a patient previously established on therapy who is new to Apple Health, the reviewer may use the reauthorization criteria.

    • Approval outside the listed criteria is discretionary and requires case-by-case medical-necessity review.
    • Provide clinical documentation supporting the requested exception.
    Note

    New FDA Indication Review

    If a drug covered by this policy receives a new FDA-approved indication, medical necessity for that indication will be determined case by case according to FDA labeling.

    • Submit the FDA-labeled indication and supporting clinical documentation.
    • Do not assume coverage for a new indication based solely on an existing policy indication.
    Step Therapy

    Preferred-Agent Step Therapy

    Non-preferred agents require documentation of an inadequate response or intolerance due to a severe adverse reaction or contraindication to preferred agents before approval.

    • Document inadequate response, severe adverse reaction, or contraindication to at least two preferred agents.
    • If only one preferred agent exists in the class, document inadequate response to that one preferred agent.
    Documentation Required

    Clinical Eligibility Documentation

    Submit documentation establishing the applicable clinical eligibility for the requested indication. Documentation must identify the patient, diagnosis, prescriber qualifications, disease characteristics, and treatment plan.

    • Patient: age 18 or older when required by the indication.
    • Diagnosis and disease status: metastatic castration-resistant, metastatic castration-sensitive or castration-naïve, or non-metastatic high-risk prostate cancer, as applicable.
    • Prescriber: oncologist or urologist, or prescribing in consultation with one, when required.
    • Disease documentation: progression, risk factors, metastases, node status, tumor stage, Gleason score, PSA findings, or other applicable criteria.
    • Treatment documentation: orchiectomy or concurrent hormone suppression and the required combination therapies.
    Documentation Required

    500 mg Tablet-Strength Rationale

    For requests for generic abiraterone 500 mg tablets, document the clinical rationale explaining why 250 mg tablets would not be an effective regimen. Convenience or taking fewer tablets alone does not meet medical necessity.

    • Include patient-specific clinical rationale for the 500 mg strength.
    • The same rationale is required for initial authorization and reauthorization when the 500 mg strength is requested.
    Documentation Required

    Reauthorization Response Evidence

    For reauthorization, submit evidence that the disease is stable or that the patient has had a positive clinical response to therapy.

    • Examples include stabilization of disease, decreased tumor size or tumor spread, or lack of disease progression.
    • Provide current clinical assessment and relevant objective treatment-response evidence.
    Step Therapy

    Preferred-Drug Trial Documentation

    Before requesting a non-preferred agent, document that preferred-drug therapy was inadequate or could not be used safely.

    • Document inadequate response to the required preferred agent(s).
    • Alternatively, document intolerance due to a severe adverse reaction or a contraindication to the preferred agent(s).
    Documentation Required

    Docetaxel Combination Attestation

    When abiraterone (Zytiga) is used in combination with docetaxel for metastatic high-risk castration-sensitive or castration-naïve prostate cancer, the provider must attest that the client has high-volume metastatic burden.

    • Include the provider attestation with the request.
    • Support the attestation with disease-burden documentation when available.
    Step Therapy

    Preferred-Agent Requirement

    Non-preferred agents remain subject to the preferred-agent requirement unless an exception is documented.

    • Submit evidence of required preferred-agent trials before requesting a non-preferred agent.
    • Document an exception when a preferred agent is contraindicated or caused a severe adverse reaction, or when the patient had an inadequate response.
    Denial Risk

    Clinical Criteria Not Met

    A request may be denied when required clinical criteria are not met or when supporting documentation is incomplete.

    • The patient does not meet the applicable age, diagnosis, disease-status, risk-factor, or prescriber requirements.
    • Required orchiectomy or concurrent hormone suppression is absent or not documented.
    • Required steroid, radiotherapy, androgen-deprivation therapy, or other combination treatment is absent or not documented.
    • Required preferred-agent trials or documented exceptions are absent.
    • Required response evidence for reauthorization is absent.
    Denial Risk

    Insufficient 500 mg Rationale

    Requests for generic abiraterone 500 mg tablets may be denied when the required clinical rationale is missing, unsupported, or based only on convenience.

    • Explain why 250 mg tablets would not be an effective regimen for this patient.
    • Taking fewer tablets or convenience alone does not meet medical necessity.
    • Apply this requirement to initial requests and reauthorization requests for the 500 mg strength.
    Denial Risk

    Required Combination Therapy

    Ensure all required concurrent therapies are documented before submitting the request. Missing required combination therapy can result in denial.

    • For applicable metastatic disease: use abiraterone with a steroid consistent with FDA labeling, such as prednisone with Zytiga or methylprednisolone with Yonsa.
    • For non-metastatic high-risk disease: use abiraterone with external beam radiotherapy unless contraindicated, androgen-deprivation therapy, and prednisone or prednisolone.
    • For applicable Zytiga regimens: document the required prednisone combination.
    Denial Risk

    No Documented Response

    Reauthorization may be denied when the request does not include evidence of disease stability or a positive clinical response.

    • Submit current evidence such as stable disease, reduced tumor size or spread, or no disease progression.
    • A request without documented response or stability evidence does not satisfy the continuation criteria.
    Billing Rule

    Quantity Limit Exceeded

    Requests exceeding the stated quantity limits require additional coverage review and may not be approved under the listed limits.

    • Abiraterone (Yonsa): 125 mg tablets, 120 tablets per 30 days.
    • Abiraterone (Zytiga): 250 mg tablets, 120 tablets per 30 days; 500 mg tablets, 60 tablets per 30 days.
    • For quantities above the applicable limit, submit documentation supporting coverage outside the stated tablet limits.
    • High-risk features: Gleason score ≥7 (Grade Group >2); bone lesions; measurable visceral metastases.At least 2 of 3
    • Docetaxel condition: If used in combination with docetaxel, the provider attests that the client has high-volume metastatic burden.

    Non-metastatic high-risk prostate cancer — initial therapy decision tree

    Initial therapy requires all of the following:

    Non-metastatic high-risk disease

    • High-risk or very high-risk definition

      • The patient is node positive.
      • The patient is node negative with at least two of: Gleason score ≥8, tumor stage T3 or T4, or PSA concentration ≥40 ng/mL.At least 2 risk factors
      • The patient has PSA doubling time <6 months or PSA ≥20 ng/mL on androgen deprivation therapy.PSA doubling time <6 months or PSA ≥20 ng/mL on ADT
    • For metastatic castration-resistant prostate cancer, continue a steroid consistent with FDA labeling.
    • For metastatic high-risk castration-sensitive or castration-naïve prostate cancer, continue prednisone.
    • For non-metastatic high-risk prostate cancer, continue external beam radiotherapy unless contraindicated, androgen deprivation therapy, and prednisone or prednisolone.
    Quantity limit
    DrugAbiraterone (Zytiga)
    Tablet strength500 mg tablets
    Quantity limit60 tablets per 30 days