Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAdvanced Health Xgeva Prior Auth Coverage | OpenPa…
    Ask Trek AI about this page
    CurrentAdvanced HealthPolicy N/A

    Denosumab (Xgeva) Drug Use Criteria

    Customize your policy alerts

    Sign up for all advancedhealth policy alerts

    Know when advancedhealth releases new policies or updates existing guidance.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    This policy governs prior authorization for Xgeva (denosumab) for members with specified malignancy-related bone conditions, giant cell tumor of bone, or hypercalcemia of malignancy. It establishes initial-therapy alternatives, preferred biosimilar requirements, approval duration, and renewal criteria.

    Policy Summary
    PayerAdvanced Health
    PolicyDenosumab (Xgeva) Drug Use Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective Date10/01/2025
    Last ReviewOct 8, 2025
    Next Review DateN/A
    Key ActionDocument a covered indication, required alternative-therapy trial or qualifying contraindication, and treatment failure or adverse reaction to preferred Wyost for initial Xgeva requests.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    3Covered clinical indication pathways
    12 monthsMaximum initial approval period
    12 monthsMaximum renewal approval period
    WyostPreferred denosumab biosimilar

    Coverage Criteria

    Policy Summary
    PayerAdvanced Health
    PolicyDenosumab (Xgeva) Drug Use Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective Date10/01/2025
    Last ReviewOct 8, 2025
    Next Review DateN/A
    Key ActionDocument a covered indication, required alternative-therapy trial or qualifying contraindication, and treatment failure or adverse reaction to preferred Wyost for initial Xgeva requests.
    SourceLink
    On This Page
    Coverage CriteriaProvider Actions and Authorization RequirementsBackgroundDefinitionsInitial Xgeva AuthorizationXgeva RenewalStep Therapy RequirementsApproval DurationPreferred Biosimilar

    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.

    Initial Therapy

    Covered when the member meets one covered indication pathway, satisfies the applicable alternative-therapy requirement, and has treatment failure or an adverse reaction to preferred Wyost.

    Initial therapy eligibility

    • Covered indication pathway

      • Bone metastases or multiple myeloma: The member has bone metastases from a solid tumor or multiple myeloma, and zoledronic acid has been trialed or there is a contraindication to zoledronic acid that is not a contraindication to denosumab.
      • Giant cell tumor of bone: The member has giant cell tumor of bone that is unresectable or for which surgical resection is likely to result in severe morbidity.
      • Hypercalcemia of malignancy: The member has hypercalcemia of malignancy, and a bisphosphonate such as zoledronic acid or pamidronate has been trialed or there is a contraindication to either medication.
    • Preferred biosimilar requirement: The member has had treatment failure or an adverse reaction to preferred Wyost (denosumab-bbdz).

    Continuation Therapy

    Covered for renewal when the patient continues to receive clinical benefit from therapy.

    Continued clinical benefit: The patient continues to receive clinical benefit, including stable or improved bone lesions, maintained normocalcemia, or prevention of new skeletal events.

    Approve for up to 12 months. If clinical benefit is not continued, reassessment is needed.

    Off-label use of Xgeva outside the covered indication pathways is excluded because it is not a covered benefit. Covered pathways include bone metastases from solid tumors or multiple myeloma, unresectable giant cell tumor of bone or tumor for which resection is likely to result in severe morbidity, and hypercalcemia of malignancy.

    For bone metastases from solid tumors or multiple myeloma, Xgeva is not medically necessary unless zoledronic acid (Zometa) has been trialed or the member has a contraindication to zoledronic acid that is not also a contraindication to denosumab.

    For hypercalcemia of malignancy, Xgeva is not medically necessary unless a bisphosphonate, such as zoledronic acid (Zometa) or pamidronate (Aredia), has been trialed or the member has a contraindication to either medication.

    Xgeva is not medically necessary when the member has not experienced treatment failure or an adverse reaction to preferred Wyost (denosumab-bbdz). Wyost must be used before Xgeva unless this requirement has been satisfied.

    Provider Actions and Authorization Requirements

    Prior Authorization

    Initial Authorization Requirements

    Obtain prior authorization and document a covered indication, the applicable treatment trial or qualifying contraindication, and treatment failure or adverse reaction to preferred Wyost (denosumab-bbdz). Covered indications include bone metastases from solid tumors or multiple myeloma, unresectable giant cell tumor of bone or tumor where resection would likely cause severe morbidity, and hypercalcemia of malignancy.

    Documentation Required

    Renewal Authorization Requirements

    For renewal, document that the member continues to receive clinical benefit from Xgeva. Approval may continue for up to 12 months when disease findings remain stable or improve.

    • Examples include stable or improved bone lesions, maintained normocalcemia, or prevention of new skeletal events.
    Step Therapy

    Zoledronic Acid Before Xgeva

    Before Xgeva for bone metastases from solid tumors or multiple myeloma, document a trial of zoledronic acid (Zometa), unless there is a contraindication to zoledronic acid that is not a contraindication to denosumab.

    • If the trial or qualifying contraindication is not documented, the request may be denied.
    • Use the preferred least costly alternative, zoledronic acid (Zometa), when appropriate.
    Step Therapy

    Bisphosphonate Before Xgeva

    Before Xgeva for hypercalcemia of malignancy, document a trial of a bisphosphonate such as zoledronic acid (Zometa) or pamidronate (Aredia), unless there is a contraindication to either agent.

    • If the trial or qualifying contraindication is not documented, the request may be denied.
    • Use zoledronic acid (Zometa) or pamidronate (Aredia) as the preferred least costly alternative when appropriate.
    Step Therapy

    Preferred Biosimilar Step

    After applicable clinical indication criteria are met, document treatment failure or an adverse reaction to preferred Wyost (denosumab-bbdz) before requesting Xgeva.

    • Approval may be granted for up to 12 months when failure or adverse reaction to Wyost is documented.
    Denial Risk

    No Zoledronic Acid Trial or Qualifying Contraindication

    Requests for Xgeva for bone metastases from solid tumors or multiple myeloma may be denied when zoledronic acid has not been trialed and no qualifying contraindication is documented.

    • Document a zoledronic acid (Zometa) trial or a contraindication to zoledronic acid that is not a contraindication to denosumab.
    Denial Risk

    No Bisphosphonate Trial or Qualifying Contraindication

    Requests for Xgeva for hypercalcemia of malignancy may be denied when neither zoledronic acid nor pamidronate has been trialed and no qualifying contraindication is documented.

    • Document a trial of zoledronic acid (Zometa) or pamidronate (Aredia), or a contraindication to either agent.
    Denial Risk

    Off-Label Use

    Use of Xgeva outside the listed covered indications is not a covered benefit of Advanced Health.

    • Covered indications include bone metastases from solid tumors or multiple myeloma, qualifying giant cell tumor of bone, and hypercalcemia of malignancy.
    Denial Risk

    Preferred Biosimilar Not Tried

    Initial Xgeva requests may be denied when the member has not tried preferred Wyost (denosumab-bbdz) and there is no documented treatment failure or adverse reaction after clinical indication criteria are met.

    • Change to the preferred least costly biosimilar, Wyost, when clinically appropriate.
    Denial Risk

    No Ongoing Clinical Benefit

    Renewal requests may be denied when the member is not continuing to receive clinical benefit from Xgeva. Reassessment is required before continued authorization.

    • Document stable or improved bone lesions, maintained normocalcemia, prevention of new skeletal events, or another ongoing clinical benefit.

    Background

    Xgeva (denosumab) is a monoclonal antibody that binds to and inhibits RANK ligand (RANKL), a key mediator of osteoclast formation, function, and survival. By reducing osteoclast activity and bone resorption, Xgeva helps prevent skeletal-related events associated with bone metastases and is used for covered indications including bone metastases, giant cell tumor of bone, and malignancy-related hypercalcemia.

    Definitions

    Xgeva Mechanism of Action
    DrugXgeva (denosumab)
    MechanismMonoclonal antibody that binds to and inhibits RANK ligand (RANKL)
    EffectReduces osteoclast formation, function, and survival, thereby reducing bone resorption

    Initial Xgeva Authorization

    Initial Xgeva Authorization

    Initial Xgeva authorization requires a covered indication, the applicable alternative-therapy trial or qualifying contraindication, and failure or an adverse reaction to preferred Wyost.

    Initial Xgeva eligibility

    • Covered indication pathway

      • Bone metastases or multiple myeloma

        • Zoledronic acid requirement: Zoledronic acid was trialed, or the member has a contraindication to zoledronic acid that is not a contraindication to denosumab.
      • Giant cell tumor of bone: The member has giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

      • Hypercalcemia of malignancy

        • Bisphosphonate requirement: Zoledronic acid or pamidronate was trialed, or the member has a contraindication to either medication.
    • Preferred biosimilar requirement: The member has had treatment failure or an adverse reaction to preferred Wyost (denosumab-bbdz).

    Xgeva Renewal

    Xgeva Renewal

    Renewal coverage requires documentation that clinical benefit continues.

    Renewal eligibility: The patient continues to receive clinical benefit, including stable or improved bone lesions, maintained normocalcemia, or prevention of new skeletal events.

    Approve for up to 12 months; if benefit is not continued, reassessment is needed.

    Step Therapy Requirements

    StepRequirementCoverage status
    1Use preferred Wyost (denosumab-bbdz) before Xgeva. Xgeva requires treatment failure or an adverse reaction to Wyost.Covered after requirement is met
    StepIndicationRequirementCoverage status
    1Bone metastases from solid tumors or multiple myelomaTrial zoledronic acid (Zometa), or document a contraindication to zoledronic acid that is not a contraindication to denosumab.Covered after requirement is met
    StepIndicationRequirementCoverage status
    1Hypercalcemia of malignancyTrial a bisphosphonate such as zoledronic acid (Zometa) or pamidronate (Aredia), or document a contraindication to either medication.Covered after requirement is met

    Approval Duration

    Initial Approval
    Authorization typeInitial request
    Approval durationUp to 12 months
    Approval conditionThe member must meet the applicable coverage criteria, including a covered indication and treatment failure or an adverse reaction to preferred Wyost (denosumab-bbdz)
    Renewal Approval
    Authorization typeRenewal request
    Approval durationUp to 12 months
    Renewal conditionThe patient must continue to receive clinical benefit, such as stable or improved bone lesions, maintained normocalcemia, or prevention of new skeletal events

    Preferred Biosimilar

    Billing Rule

    Wyost is preferred over Xgeva

    Wyost (denosumab-bbdz) is the preferred least costly denosumab biosimilar. Xgeva requires treatment failure or an adverse reaction to Wyost after the applicable clinical indication criteria are met.

    • Use Wyost before Xgeva when clinically appropriate.
    • Document treatment failure or an adverse reaction to Wyost for an Xgeva request.