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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsGeorgia DCH oral prostate cancer Prior Auth | Open…
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    CurrentGeorgia Department of Community HealthPolicy N/A

    Georgia Medicaid Fee-for-Service — Oral Oncology Agents for Prostate Cancer (Prior Authorization)

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    This policy defines prior authorization (PA) coverage criteria for specified oral prostate cancer oncology drugs for Georgia Medicaid Fee-for-Service members, including indications, authorization length, and special requirements.

    Policy Summary
    PayerGeorgia Department of Community Health
    PolicyOral oncology drugs for prostate cancer prior authorization (Georgia Medicaid Fee-for-Service)
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization from OptumRx (call 1-866-525-5827) for listed oral prostate oncology agents; submit letter of medical necessity when non-preferred abiraterone products are requested.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    1 yearLength of authorization
    8+Drugs referenced
    RequiredPA requirement
    OptumRx

    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.

    PA phone

    Coverage Criteria for Oral Prostate Oncology Agents

    Akeega (niraparib/abiraterone) - Initial Therapy

    Approvable when ALL of the following are met:

    Akeega approval: Member has BRCA-mutated (BRCAm) metastatic castration-sensitive prostate cancer (mCSPC) or metastatic castration-resistant prostate cancer (mCRPC) and is receiving a gonadotropin-releasing hormone (GnRH) analog or antagonist concurrently or has had a bilateral orchiectomy, and Akeega is used in combination with prednisone.

    Nubeqa (darolutamide) - Initial Therapy

    Approvable when ALL of the following are met:

    Nubeqa approval: Member has non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic castration-sensitive prostate cancer (mCSPC) and is receiving a gonadotropin-releasing hormone (GnRH) analog or antagonist concurrently or has had a bilateral orchiectomy.

    Orgovyx (relugolix) - Initial Therapy

    Approvable when the following is met:

    Orgovyx approval: Member has advanced prostate cancer.

    Zytiga (abiraterone) - Initial Therapy

    Approvable when the following criteria are met depending on indication and product strength:

    Zytiga 250 mg preferred: Member has metastatic castration-resistant prostate cancer (mCRPC) and is receiving a gonadotropin-releasing hormone (GnRH) analog or antagonist concurrently or has had a bilateral orchiectomy, and Zytiga is used in combination with methylprednisolone; prescriber must submit a written letter of medical necessity stating reasons the preferred product, Zytiga 250 mg, is not appropriate for the member when requested.
    Zytiga 500 mg or non-preferred: For the 500 mg strength (and for non-preferred Yonsa 125 mg), prescriber must submit a written letter of medical necessity stating why the preferred product, Zytiga 250 mg, is not appropriate.

    Exceptions to the coverage conditions in this policy are considered only through the prior authorization process. To request an exception, providers must initiate the PA process as described in the policy (contact OptumRx as listed).

    inv-15: Initial therapy approvals

    Initial approvals follow indication-specific criteria below.

    See individual drug criteria: Approval contingent on indication-specific criteria and, for many agents, concurrent GnRH therapy or prior bilateral orchiectomy as specified in the drug sections.

    Provider Actions and Prior Authorization

    Prior Authorization

    Prior authorization required

    Prior authorization (PA) is required for the oral prostate oncology agents listed in this policy. Exceptions to coverage conditions are considered only through the PA process; to initiate PA call OptumRx at 1-866-525-5827.

    Denial Risk

    PA required — risk of denial

    Failure to obtain prior authorization may result in denial because both preferred and non-preferred agents require prior authorization per policy notes.

    Note

    Check PDL and QLL before prescribing

    Definitions and Terms

    Concurrent androgen‑deprivation therapy (definition)
    DefinitionMember is receiving a gonadotropin-releasing hormone (GnRH) analog or antagonist concurrently or has had a bilateral orchiectomy (removal of both testicles).
    Clinical relevanceMany oral prostate oncology agents (e.g., Akeega, Erleada, Nubeqa, Xtandi, Zytiga) are approvable only when concurrent androgen‑deprivation therapy is in place or after bilateral orchiectomy as specified by indication.
    Common applicationsRequired for initial approval of agents in metastatic and non‑metastatic castration‑sensitive and castration‑resistant settings per individual drug criteria.
    Most actionable requirementEnsure documentation that the member is receiving a GnRH analog/antagonist concurrently or has had bilateral orchiectomy when requesting PA for affected agents.
    BRCA‑mutated (BRCAm)
    Definition

    Initial Therapy Authorization Criteria

    inv-15: Initial therapy approvals

    Initial approvals follow indication-specific criteria below.

    See individual drug criteria: Approval contingent on indication-specific criteria and, for many agents, concurrent GnRH therapy or prior bilateral orchiectomy as specified in the drug sections.

    Step Therapy and Preferred Agent Guidance

    StepRequirement
    1Refer to the Preferred Drug List (PDL) to determine preferred agents; non-preferred agents require prior authorization and may require a written letter of medical necessity when requested.

    Quantity Limits and Restrictions

    Quantity Level Limits (QLL) — reference
    ReferenceQuantity Level Limit (QLL) details are maintained on the MMIS website: www.mmis.georgia.gov/portal under Pharmacy > Other Documents > most recent QLL list.
    Policy instructionFollow the QLL list for drug‑specific monthly quantity limits that may affect PA approvals and dispensing.
    Where to checkAccess the current QLL via the Georgia MMIS portal for up‑to‑date limits before submitting PA requests.

    Site of Care

    Note

    Outpatient/home dispensing

    These oral prostate oncology agents are dispensed via outpatient pharmacy and are considered outpatient/home site-of-care medications.

    Background

    This policy establishes prior authorization criteria for specified oral therapies used across prostate cancer disease states, including non‑metastatic castration‑resistant prostate cancer (nmCRPC), metastatic castration‑sensitive prostate cancer (mCSPC/CSPC), metastatic castration‑resistant prostate cancer (mCRPC/CRPC), metastatic castration‑naïve disease, and other forms of advanced prostate cancer. Several agents require concurrent androgen‑deprivation therapy (a gonadotropin‑releasing hormone analog or antagonist) or prior bilateral orchiectomy as specified in the individual drug criteria.

    Policy Summary
    PayerGeorgia Department of Community Health
    PolicyOral oncology drugs for prostate cancer prior authorization (Georgia Medicaid Fee-for-Service)
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization from OptumRx (call 1-866-525-5827) for listed oral prostate oncology agents; submit letter of medical necessity when non-preferred abiraterone products are requested.
    SourceLink
    On This Page
    Coverage Criteria for Oral Prostate Oncology AgentsProvider Actions and Prior AuthorizationDefinitions and TermsInitial Therapy Authorization CriteriaStep Therapy and Preferred Agent GuidanceQuantity Limits and RestrictionsSite of CareBackground

    Refer to the Georgia Preferred Drug List (PDL) and the current Quantity Level Limits (QLL) when selecting agents; preferred status and QLL restrictions may affect prior authorization decisions and approval.

    Documentation Required

    Submit letter of medical necessity for non‑preferred abiraterone

    When prescribing non-preferred abiraterone products (Zytiga 500 mg or Yonsa 125 mg), the prescriber must submit a written letter of medical necessity explaining why the preferred product, Zytiga 250 mg, is not appropriate for the member; for Zytiga overall the prescriber must submit a written letter of medical necessity when requested for the 250 mg preferred product.

    • Applies to Zytiga 500 mg and non-preferred Yonsa 125 mg — written letter of medical necessity required.
    • For Zytiga 250 mg the prescriber must submit a written letter of medical necessity stating reasons the preferred product is not appropriate when requested.
    A genetic mutation in BRCA genes (BRCA‑mutated, BRCAm).
    Specific useRequired for Akeega (niraparib/abiraterone) approval in metastatic castration‑sensitive prostate cancer (mCSPC) or metastatic castration‑resistant prostate cancer (mCRPC).
    Concomitant therapyAkeega approval requires use in combination with prednisone and concurrent GnRH therapy or prior bilateral orchiectomy.
    Documentation tipInclude genetic testing result indicating BRCA mutation when submitting PA for Akeega.