Prolia (denosumab) Prior Authorization Guide: Navigating Access Across Major U.S. Payers

Prolia® (denosumab) is a monoclonal antibody administered via subcutaneous injection every six months, primarily used to treat osteoporosis in postmenopausal women and men at high risk for fracture. It is also indicated for bone loss associated with certain cancer therapies. Given its classification as a specialty drug, Prolia typically requires prior authorization (PA) across most insurance plans. This guide provides an overview of PA requirements and considerations across major U.S. payers.EmblemHealth

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Coding & Billing Essentials

• HCPCS Code: J0897 (Injection, denosumab, 1 mg)

• NDC: 55513-0710-01 (Prolia 60 mg/mL single-dose prefilled syringe)

• Administration: Subcutaneous injection every 6 months

• Typical Use Cases:

  • Postmenopausal osteoporosis

  • Glucocorticoid-induced osteoporosis

  • Bone loss due to androgen deprivation therapy (ADT) or aromatase inhibitor therapyAetna Better Health+1EmblemHealth+1

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Prior Authorization Criteria by Major Payers

Aetna

• Commercial & Medicare:

  • Requires PA for all indications.

  • Approval duration: 12 months.

  • Criteria:

    • Diagnosis of osteoporosis with high fracture risk (e.g., T-score ≤ -2.5, history of osteoporotic fracture, or high FRAX score).

    • For male patients: history of osteoporotic fracture or high FRAX score with osteopenia.

    • For cancer-related bone loss: inability to use bisphosphonates due to contraindications or intolerance.

  • Quantity Limits: 1 syringe (60 mg) per 6 months. Louisiana Blue+17BlueShieldCA+17EmblemHealth+17Aetna Better Health+1Louisiana Department of Health+1

UnitedHealthcare (UHC)

• Commercial Plans:

  • PA required for Prolia.

  • Criteria:

    • Diagnosis of osteoporosis with high fracture risk.

    • Failure or intolerance to other osteoporosis therapies.

    • Dosing aligns with FDA-approved labeling.

  • Approval Duration: Up to 12 months. UHC Provider+7ConnectiCare+7UHC Provider+7Aetna+3UHCprovider.com+3MVP Health Care+3

Cigna

• Coverage:

  • PA required for Prolia.

  • Criteria:

    • Diagnosis of osteoporosis with high fracture risk.

    • History of osteoporotic fracture or T-score ≤ -2.5.

    • For cancer-related bone loss: patient receiving ADT or aromatase inhibitors with high fracture risk.

  • Approval Duration: Typically 12 months.

Blue Cross Blue Shield (BCBS)

• General Policies:

  • PA required for Prolia across most BCBS plans.

  • Criteria:

    • Diagnosis of osteoporosis with high fracture risk.

    • T-score ≤ -2.5 or history of osteoporotic fracture.

    • For cancer-related bone loss: patient undergoing ADT or aromatase inhibitor therapy.

  • Approval Duration: Varies by plan; commonly 12 months.

Medicare

• Coverage:

  • Prolia is covered under Medicare Part B when administered in a clinical setting.

  • Criteria:

    • Diagnosis of osteoporosis with high fracture risk.

    • Documentation of medical necessity, including T-score and fracture history.

    • Self-administration is not covered; must be administered by a healthcare professional.

  • PA Requirements: May vary by Medicare Advantage plans; traditional Medicare typically does not require PA but requires documentation for medical necessity. Providers+21Federal Health Group+21Medicare Plan Options+21

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Key Considerations for Providers

• Documentation: Ensure comprehensive documentation, including T-scores, fracture history, and previous osteoporosis treatments, to support PA requests.

• Administration Setting: Prolia must be administered by a healthcare professional; self-administration is not covered under Medicare.

• Monitoring: Monitor calcium levels before and during treatment, especially in patients with renal impairment.

• Transition of Care: If discontinuing Prolia, consider alternative osteoporosis treatments to mitigate rebound fracture risk.Prolia HCP+23BlueShieldCA+23BlueCross BlueShield of Tennessee+23Medicare Plan OptionsProlia HCP+2AAPC+2Prolia HCP+2PrintFriendly+1Prolia HCP+1

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Summary

Prolia is a widely used treatment for osteoporosis and cancer-related bone loss, but access requires navigating varying PA requirements across payers. Understanding each payer's criteria and ensuring thorough documentation can facilitate approval and timely patient care.

For assistance with specific payer requirements or to access PA forms, please refer to the respective payer's provider portal or contact their provider services.