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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAlaska Medicaid leuprolide acetate Coverage | Open…
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    CurrentAlaska MedicaidPolicy N/A

    Leuprolide acetate injection (Lupron, Eligard) coverage

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    Defines Alaska Medicaid coverage criteria and approval terms for leuprolide acetate injectable products (Lupron, Lupron Depot-Ped, Lupron Depot, Eligard) for pharmacy dispensing. Applies to Alaska Medicaid beneficiaries receiving these drugs.

    Policy Summary
    PayerAlaska Medicaid
    PolicyLeuprolide acetate injection (Lupron, Eligard) coverage
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateOct 4, 2009
    Last ReviewOct 4, 2009
    Next Review DateOct 4, 2009
    Key ActionObtain prior authorization; approvals may be granted up to 1 year when patient meets one of the listed indications.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    1 yearmaximum approval duration
    3covered indications
    multipleformulations listed

    Coverage Criteria for Leuprolide Acetate

    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.

    Indication-based coverage

    Covered when ANY of the following patient-specific conditions are met:

    Indication criteria: 1) The patient is a child being treated for central precocious puberty; OR 2) The patient is a woman being treated for endometriosis or uterine leiomyomata; OR 3) The patient is a man being treated for advanced prostatic cancer.

    Each indication is sufficient for approval per policy.

    This policy defines coverage for leuprolide acetate injectable products only when the patient meets one of the specific clinical indications listed in the CRITERIA FOR APPROVAL. Covered indications are limited to: (1) a child being treated for central precocious puberty; (2) a woman being treated for endometriosis or uterine leiomyomata; or (3) a man being treated for advanced prostatic cancer. These three indications constitute the scope of approved use under this policy for Alaska Medicaid beneficiaries receiving leuprolide acetate products.

    Diagnoses or indications other than the three listed above are not described as approved in this document and therefore do not meet the policy's stated criteria for coverage.

    Initial Therapy Requirements

    Initial therapy

    Initial approval: Initial authorization granted when the patient meets one of the listed indications.1 year

    No additional initiation requirements specified in document; initial approval duration up to 1 year.

    Continuation / Length of Approval

    Length of approval

    Duration and continuation therapy criteria:

    Approval length: All criteria may be approved for up to 1 year.1 year

    Renewal/continuation requires documentation that the patient continues to meet the same indication criteria.

    Provider Actions and Requirements

    Prior Authorization

    Prior authorization required; approval up to 1 year

    Prior authorization is required for leuprolide acetate injectable products; when the patient meets one of the listed clinical indications the request may be approved for up to 1 year.

    Step Therapy

    No step therapy or formulary preference specified

    No step therapy requirements or preferred/non‑preferred medication distinctions are specified in this policy.

    Documentation Required

    Provide documentation showing the patient meets a listed indication

    Submit clinical documentation that demonstrates the patient meets one of the approved indications: central precocious puberty (child), endometriosis or uterine leiomyomata (woman), or advanced prostatic cancer (man).

    • Documentation should support which of the listed indication criteria applies to the patient.
    • Include relevant diagnosis and clinical notes that correspond to the criteria for approval.
    Denial Risk

    Denial risk if indication criteria not met

    Requests that do not meet one of the listed indication criteria (central precocious puberty in children; endometriosis or uterine leiomyomata in women; advanced prostatic cancer in men) would not meet the stated criteria for approval and may be denied.

    Key Terms and Definitions

    central precocious puberty — definition / explanation
    DefinitionCentral precocious puberty: early onset of puberty in children; Lupron Depot-Ped is indicated for treatment of children with central precocious puberty.
    Covered populationChildren diagnosed with central precocious puberty (approval granted when this indication is documented).
    Related productLupron Depot-Ped (listed depot formulations for pediatric use).
    palliative treatment (advanced prostate cancer) — definition / explanation
    DefinitionPalliative treatment (advanced prostate cancer): therapy intended for symptom control in men with advanced prostatic (prostate) cancer; Lupron Depot and Eligard are indicated for palliative treatment of advanced prostate cancer.
    Covered populationMen with advanced prostatic cancer when treatment is for palliative intent (symptom control).
    Related productsLupron Depot and Eligard are the depot formulations indicated for palliative treatment of advanced prostate cancer.

    Background

    Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist formulated in multiple depot presentations and dosage strengths for injection. In clinical practice it is used to suppress sex-hormone production for conditions such as central precocious puberty in children, endometriosis and uterine leiomyomata in women, and as palliative therapy for advanced prostatic cancer in men. This policy applies to dispensing of these leuprolide acetate products through the pharmacy for Alaska Medicaid beneficiaries when one of the covered indications is met.

    Step Therapy / Formulary Designation

    StepPreferred MedicationNon-Preferred Medication
    Step 0NANA

    Site of Care / Dispensing

    Note

    Pharmacy dispensing; site-of-care not specified

    Leuprolide acetate products in this policy are listed for pharmacy dispensing; the document does not specify particular infusion center or other administration site requirements.

    Coding (if applicable)

    Preferred Medicationmixed
    NANA
    Non-Preferred Medicationmixed
    NANA

    Revision History

    2009-10-04policy_revisionLatest

    Policy last revised and reviewed on 2009-10-04; criteria list and approval length (up to 1 year) published in this revision.

    Policy Summary
    PayerAlaska Medicaid
    PolicyLeuprolide acetate injection (Lupron, Eligard) coverage
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateOct 4, 2009
    Last ReviewOct 4, 2009
    Next Review DateOct 4, 2009
    Key ActionObtain prior authorization; approvals may be granted up to 1 year when patient meets one of the listed indications.
    SourceLink
    On This Page
    Coverage Criteria for Leuprolide AcetateInitial Therapy RequirementsContinuation / Length of ApprovalProvider Actions and RequirementsKey Terms and DefinitionsBackgroundStep Therapy / Formulary DesignationSite of Care / DispensingCoding (if applicable)Revision History