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    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsCareSource Georgia Prolia Coverage Update | OpenPa…
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    CurrentCareSource GeorgiaPolicy GA-MED-P-366579

    Prolia (denosumab) Coverage Criteria

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    Georgia Medicaid medical prior authorization and renewal requirements for Prolia (denosumab) used for osteoporosis, glucocorticoid-induced osteoporosis, and cancer-treatment-related bone loss.

    Policy Summary
    PayerCareSource Georgia
    PolicyProlia (denosumab) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeRevised
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit medical prior authorization documentation showing the applicable diagnosis, fracture-risk or BMD findings, prior bisphosphonate response or trial, and requested dose and quantity.
    SourceLink
    POLICY UPDATE CHANGES

    The glucocorticoid-induced osteoporosis criteria were revised to use prednisone-equivalent exposure of at least 2.5 mg daily for more than 3 months and to add moderate-, high-, and very-high-fracture-risk pathways.

    Renewal criteria were updated to require documentation of positive clinical response, including stable or increased BMD or no new fractures or vertebral fracture progression.

    The policy added a very-high-fracture-risk pathway for postmenopausal women with osteoporosis.

    The breast-cancer bone-loss section was revised to specify postmenopausal status and update the high-risk definition.

    60 mgAllowed dose
    6 monthsDosing interval

    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.

    12 monthsAuthorization period
    5Coverage sections
    12 monthsBisphosphonate trial

    Coverage Criteria

    Osteoporosis in Postmenopausal Women — Initial Authorization

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Member is a postmenopausal woman.

    • ONE of the following osteoporosis criteria

      • Bone mineral density (BMD) T-score of -2.5 or below in the lumbar spine, femoral neck, total proximal femur, or 1/3 radius.
      • Low-trauma spine or hip fracture, regardless of BMD.
      • Osteopenia (T-score between -1 and -2.5) with a fragility fracture of the proximal humerus, pelvis, or distal forearm.
      • Osteopenia (T-score between -1 and -2.5) with FRAX fracture probability of at least 20% for major osteoporotic fracture or at least 3% for hip fracture.

    • ONE of the following treatment-history or fracture-risk criteria

      • Inadequate response to at least 12 months of an oral bisphosphonate, such as alendronate or risedronate, or an IV bisphosphonate, such as zoledronic acid (Reclast) or ibandronate.

      • ALL of the following

        • Member has very high fracture risk, such as multiple fractures, very low T-score (-3.0 or below), T-score -2.5 or below plus fractures, fractures while taking an osteoporosis drug, FRAX greater than 30% for major osteoporotic fracture, or FRAX greater than 4.5% for hip fracture.
        • Member has had a trial of zoledronic acid.
    • Dosage and quantity limit: 60 mg subcutaneously every 6 months (one 1-mL syringe per 6 months).

    Postmenopausal Osteoporosis — Continuation Authorization

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Chart notes have been provided showing a positive clinical response, such as stable or increased BMD, no evidence of new fractures, or no vertebral fracture progression.
    • If criteria are met, authorization may be approved for an additional 12 months.

    Osteoporosis in Men — Initial Authorization

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Member is a male 18 years of age or older.
    • Medication is being used to treat osteoporosis.

    • ONE of the following high-fracture-risk criteria

      • Hip or vertebral fracture without major trauma.
      • BMD of the spine, femoral neck, and/or total hip is 2.5 standard deviations or more below the mean of normal young white males (T-score -2.5 or less).
      • T-score between -1.0 and -2.5 in the spine, femoral neck, or total hip, plus a 10-year risk of any fracture of at least 20% or a 10-year risk of hip fracture of at least 3% using FRAX.

    Male Osteoporosis — Continuation Authorization

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Chart notes have been provided showing a positive clinical response, such as stable or increased BMD, no evidence of new fractures, or no vertebral fracture progression.
    • If criteria are met, authorization may be approved for an additional 12 months.

    Glucocorticoid-Induced Osteoporosis — Initial Authorization

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Member is at least 18 years of age.
    • Medication is being used for glucocorticoid-induced osteoporosis.
    • Member is initiating or continuing systemic glucocorticoids equivalent to at least 2.5 mg/day of prednisone and will remain on therapy for more than 3 months.

    • ONE of the following fracture-risk criteria

      • Moderate risk; age 40 years or older

        • ANY of the following

    Glucocorticoid-Induced Osteoporosis — Continuation Authorization

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Chart notes have been provided showing a positive clinical response, such as stable or increased BMD, no evidence of new fractures, or no vertebral fracture progression.

    • ONE of the following

      • Member is continuing glucocorticoid therapy.
      • Member remains at very high or high fracture risk with BMD T-score -2.5 or less.
      • Member has a fragility fracture occurring after at least 12 months of therapy.
    • If criteria are met, authorization may be approved for an additional 12 months.

    Bone Loss From Androgen Deprivation Therapy — Initial Authorization

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Member is a male 18 years of age or older.
    • Member has a diagnosis of non-metastatic prostate cancer.
    • Member is receiving androgen deprivation therapy, such as goserelin, leuprolide, or degarelix.

    • ONE of the following high-fracture-risk criteria

      • T-score less than -2.5 (osteoporosis) in the femoral neck, total hip, or lumbar spine.
      • Prior fragility fracture(s).

    Prostate-Cancer Bone Loss — Continuation Authorization

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Member continues to be at high risk for fracture due to androgen deprivation therapy.
    • Chart notes have been provided showing a positive clinical response, such as stable or increased BMD, no evidence of new fractures, or no vertebral fracture progression.
    • If criteria are met, authorization may be approved for an additional 12 months.

    Bone Loss From Aromatase Inhibitor Therapy — Initial Authorization

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Member is a postmenopausal female.
    • Member has a diagnosis of breast cancer.
    • Member is currently receiving an adjuvant aromatase inhibitor, such as anastrozole or letrozole.

    • ONE of the following high-fracture-risk criteria

      • T-score less than -2.0 in the femoral neck, total hip, or lumbar spine.
      • At least two of the following risk factors: prior fragility fracture(s), parental hip fracture, diabetes, two or more falls in the past year, rheumatoid arthritis, BMI less than 20, current smoking, more than two alcoholic drinks per day, or glucocorticoid use greater than 7.5 mg/day for more than 3 months.

    Breast-Cancer Bone Loss — Continuation Authorization

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Member continues to be at high risk for fracture due to receiving aromatase inhibitor therapy.
    • Chart notes have been provided showing a positive clinical response, such as stable or increased BMD, no evidence of new fractures, or no vertebral fracture progression.
    • If criteria are met, authorization may be approved for an additional 12 months.

    CareSource considers Prolia (denosumab) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.

    Prolia (denosumab) is not medically necessary for unlisted conditions or indications not otherwise specified in this policy.

    Clinical Thresholds and Risk Definitions

    Postmenopausal Osteoporosis BMD
    BMD thresholdT-score -2.5 or below
    Qualifying sitesLumbar spine, femoral neck, total proximal femur, or 1/3 radius
    UseEvidence of osteoporosis for postmenopausal women
    Postmenopausal Osteopenia FRAX
    BMD rangeT-score between -1 and -2.5
    Major osteoporotic fracture riskFRAX probability ≥20%
    Hip fracture riskFRAX probability ≥3%

    Authorization and Documentation Requirements

    Prior Authorization

    Medical Prior Authorization Required

    Medical prior authorization is required for Prolia (denosumab). Initial approval requires the member to meet the applicable indication-specific criteria, including the required fracture-risk assessment and prior bisphosphonate therapy or applicable exception.

    • Approved dose and quantity limit: 60 mg subcutaneously every 6 months (1 syringe [1 mL] per 6 months).
    • When initial criteria are met, authorization is approved for 12 months.
    Step Therapy

    Postmenopausal Osteoporosis: Bisphosphonate Step

    For postmenopausal osteoporosis, document an inadequate response to at least 12 months of an oral bisphosphonate (such as alendronate or risedronate) or an IV bisphosphonate (such as zoledronic acid or ibandronate).

    • Exception/pathway for very high fracture risk: document multiple fractures, a very low T-score (≤ -3.0), T-score ≤ -2.5 plus fractures, fracture while taking osteoporosis medication, or FRAX risk >30% for major osteoporotic fracture or ≥4.5% for hip fracture, and a trial of zoledronic acid.

    Clinical Background

    Prolia (denosumab) is a monoclonal antibody that inhibits RANK ligand (RANKL). Coverage is provided for osteoporosis and treatment-related bone loss when fracture risk is sufficiently high and the member meets the applicable clinical, prior-treatment, and response requirements. Covered settings include postmenopausal osteoporosis, osteoporosis in men, glucocorticoid-induced osteoporosis, androgen-deprivation-therapy-related bone loss in nonmetastatic prostate cancer, and aromatase-inhibitor-related bone loss in postmenopausal breast cancer.

    Initial Therapy Criteria

    Initial Postmenopausal Osteoporosis — Required Conditions and Alternative Pathways

    Covered for initial authorization when ALL of the following are met.

    All required conditions

    • Member is a postmenopausal woman.

    • ONE qualifying diagnosis pathway

      • BMD or fracture pathway

        • BMD T-score is -2.5 or below in the lumbar spine, femoral neck, total proximal femur, or 1/3 radius.
        • Low-trauma spine or hip fracture, regardless of BMD.

      • Osteopenia pathway

    Continuation and Renewal Criteria

    Renewal Requirements Across Indications

    Covered for reauthorization when ALL of the following are met.

    Renewal requirements

    • Chart notes document positive clinical response, such as stable or increased BMD, no evidence of new fractures, or no vertebral fracture progression.

    • Applicable continued exposure or persistent-risk condition

      • Indication-specific continued exposure

        • For glucocorticoid-induced osteoporosis, member is continuing glucocorticoid therapy.
        • For prostate-cancer bone loss, member continues to be at high risk for fracture due to androgen deprivation therapy.

    Required Bisphosphonate Therapy

    IndicationRequired bisphosphonate stepDurationException or additional requirement
    Postmenopausal osteoporosisInadequate response to an oral bisphosphonate such as alendronate or risedronate, or an IV bisphosphonate such as zoledronic acid or ibandronateAt least 12 monthsMembers at very high fracture risk must also have a trial of zoledronic acid
    IndicationRequired bisphosphonate stepDurationException
    Osteoporosis in menInadequate response to an oral bisphosphonate such as alendronate or risedronate, or an IV bisphosphonate such as zoledronic acidAt least 12 monthsRequirement does not apply when the bisphosphonate was not tolerated or is contraindicated
    Indication and risk pathwayRequired bisphosphonate stepDurationException
    Glucocorticoid-induced osteoporosis — moderate fracture riskInadequate response to a bisphosphonateAt least 12 monthsApplies to moderate-risk pathways; high- and very-high-risk pathways are not subject to this listed step requirement
    IndicationRequired bisphosphonate stepDurationException
    Prostate-cancer or breast-cancer treatment-related bone lossInadequate response to an oral bisphosphonate such as alendronate or risedronate, or an IV bisphosphonate such as zoledronic acid12 monthsRequirement does not apply when the bisphosphonate was not tolerated or is contraindicated

    Dose and Quantity Limits

    Prolia (denosumab) Quantity Limit
    Dose60 mg
    RouteSubcutaneous
    Administration frequencyEvery 6 months
    Quantity limit1 syringe (1 mL) per 6 months
    Policy Summary
    PayerCareSource Georgia
    PolicyProlia (denosumab) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeRevised
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit medical prior authorization documentation showing the applicable diagnosis, fracture-risk or BMD findings, prior bisphosphonate response or trial, and requested dose and quantity.
    SourceLink
    On This Page
    Coverage CriteriaClinical Thresholds and Risk DefinitionsAuthorization and Documentation RequirementsClinical BackgroundInitial Therapy CriteriaContinuation and Renewal CriteriaRequired Bisphosphonate TherapyDose and Quantity Limits
  1. Member has had an inadequate response to at least 12 months of an oral bisphosphonate, such as alendronate or risedronate, or an IV bisphosphonate, such as zoledronic acid (Reclast), unless not tolerated or contraindicated.
  2. Dosage and quantity limit: 60 mg subcutaneously every 6 months (one 1-mL syringe per 6 months).
    3. FRAX 10-year risk of major osteoporotic fracture is 10% to 19%.
  3. FRAX 10-year risk of hip fracture is greater than 1% and less than 3%.
  4. BMD T-score is between -1 and -2.4.
  5. Inadequate response to at least 12 months of a bisphosphonate.

  6. Moderate risk; age younger than 40 years

    • Glucocorticoid dose is at least 7.5 mg/day for 6 months or longer, and BMD Z-score is less than -3 or there has been significant BMD loss greater than the least significant change of DXA.
    • Inadequate response to at least 12 months of a bisphosphonate.
  7. High fracture risk: age 40 years or older and BMD T-score is -2.5 or less but greater than -3.5, or FRAX 10-year risk of major osteoporotic fracture is 20% to 29% or hip fracture is 3% to 4.4%.
  8. Very high fracture risk: prior osteoporotic fracture, BMD T-score -3.5 or less, FRAX 10-year risk of major osteoporotic fracture of at least 30% or hip fracture of at least 4.5%, glucocorticoid dose of at least 30 mg/day for more than 30 days, or cumulative glucocorticoid exposure of at least 5 g/year.
  9. Dosage and quantity limit: 60 mg subcutaneously every 6 months (one 1-mL syringe per 6 months).
  10. FRAX score of at least 20% for major osteoporotic fracture or at least 3% for hip fracture.
  11. Member has had an inadequate response to 12 months of an oral bisphosphonate, such as alendronate or risedronate, or an IV bisphosphonate, such as zoledronic acid (Reclast), unless not tolerated or contraindicated.
  12. Dosage and quantity limit: 60 mg subcutaneously every 6 months (one 1-mL syringe per 6 months).

  13. ALL of the following

    • T-score less than -1.0.
    • At least one of the risk factors listed above.
  14. Member has had an inadequate response to 12 months of an oral bisphosphonate, such as alendronate or risedronate, or an IV bisphosphonate, such as zoledronic acid (Reclast), unless not tolerated or contraindicated.
  15. Dosage and quantity limit: 60 mg subcutaneously every 6 months (one 1-mL syringe per 6 months).
    16. Very-High-Risk Postmenopausal Osteoporosis
    Very low BMDT-score -3.0 or below
    Major osteoporotic fracture riskFRAX probability >30%
    Hip fracture riskFRAX probability 4.5%
    Male Osteoporosis BMD
    BMD thresholdT-score -2.5 or less
    Qualifying sitesSpine, femoral neck, or total hip
    PopulationMen age 18 years or older
    Male Osteoporosis FRAX
    Any-fracture risk10-year FRAX risk ≥20%
    Hip fracture risk10-year FRAX risk ≥3%
    BMD range associated with FRAX pathwayT-score between -1.0 and -2.5 in the spine, femoral neck, or total hip
    Glucocorticoid Exposure
    Medication exposureSystemic glucocorticoids equivalent to prednisone 2.5 mg/day or greater
    Required durationMore than 3 months
    Applicable conditionGlucocorticoid-induced osteoporosis
    Moderate Glucocorticoid Fracture Risk
    Age 40 years or greaterFRAX 10-year major osteoporotic fracture risk 10 to 19%, hip risk >1% to <3%, or BMD T-score between -1 and 2.4
    Age under 40 yearsGlucocorticoid exposure of 7.5 mg/day or greater for 6 months or longer, plus BMD Z-score less than -3 or significant DXA BMD loss
    Additional requirementModerate-risk pathways require an inadequate response to at least 12 months of a bisphosphonate
    High Glucocorticoid Fracture Risk
    BMD criterionAge 40 years or greater with BMD T-score ≤-2.5 but >-3.5
    Major osteoporotic fracture riskFRAX 10-year risk 20 to 29%
    Hip fracture riskFRAX 10-year risk 3 to 4.4%
    Very-High Glucocorticoid Fracture Risk
    Fracture or BMD criterionPrior osteoporotic fracture or BMD T-score -3.5 or less
    FRAX criterion10-year major osteoporotic fracture risk ≥30% or hip fracture risk ≥4.5%
    Glucocorticoid exposure criterion30 mg/day or greater for more than 30 days, or cumulative exposure of 5 g/year or more
    Prostate-Cancer Bone-Loss Risk
    BMD criterionT-score less than -2.5 in the femoral neck, total hip, or lumbar spine
    Fracture criterionPrior fragility fracture(s)
    FRAX criteriaFRAX ≥20% for major osteoporotic fracture or ≥3% for hip fracture
    Breast-Cancer Bone-Loss BMD
    BMD thresholdT-score < -2.0
    Qualifying sitesFemoral neck, total hip, or lumbar spine
    Applicable populationPostmenopausal women receiving an adjuvant aromatase inhibitor for breast cancer
    Breast-Cancer Bone-Loss Risk Factors
    Required number of factorsAt least two risk factors
    Risk factorsPrior fragility fracture(s); parental hip fracture; diabetes; 2 or more falls in the past year; rheumatoid arthritis; BMI <20; current smoking; more than 2 alcoholic drinks per day; or glucocorticoid use greater than 7.5 mg/day for more than 3 months
    Applicable populationPostmenopausal women receiving an adjuvant aromatase inhibitor for breast cancer
    Breast-Cancer Bone-Loss Combined Risk
    BMD thresholdT-score <1.0
    Additional requirementAt least one listed breast-cancer bone-loss risk factor
    Risk-factor examplesPrior fragility fracture, parental hip fracture, diabetes, falls, rheumatoid arthritis, BMI <20, current smoking, alcohol use, or glucocorticoid use
  16. The member must also meet the applicable postmenopausal osteoporosis diagnostic criteria, including qualifying BMD, low-trauma fracture, osteopenia with specified fragility fracture, or osteopenia with qualifying FRAX risk.
    17. Step Therapy

    Male Osteoporosis: Bisphosphonate Step

    For male osteoporosis, document an inadequate response to at least 12 months of an oral bisphosphonate (such as alendronate or risedronate) or an IV bisphosphonate (such as zoledronic acid).

    • The bisphosphonate requirement may be waived when the medication was not tolerated or is contraindicated.
    • The member must be male, age 18 or older, have osteoporosis, and be at high risk for fracture based on qualifying hip or vertebral fracture, BMD, or FRAX findings.
    Step Therapy

    Glucocorticoid Osteoporosis: Bisphosphonate Step

    For glucocorticoid-induced osteoporosis, the bisphosphonate step applies to the moderate-fracture-risk pathways. Document an inadequate response to at least 12 months of a bisphosphonate when the member meets the applicable moderate-risk criteria.

    • Age 40 or older: document FRAX major osteoporotic fracture risk of 10%–19%, hip risk >1% to <3%, or BMD T-score between -1.0 and 2.4, together with inadequate response to at least 12 months of a bisphosphonate.
    • Age younger than 40: document glucocorticoid exposure of at least 7.5 mg/day for 6 months or longer plus BMD Z-score less than -3 or significant BMD loss, together with inadequate response to at least 12 months of a bisphosphonate.
    • The member must be at least 18, be initiating or continuing systemic glucocorticoids equivalent to ≥2.5 mg/day prednisone for more than 3 months, and meet the applicable risk pathway. High- and very-high-risk pathways do not state this moderate-risk bisphosphonate step.
    Step Therapy

    Cancer-Treatment Bone Loss: Bisphosphonate Step

    For cancer-treatment bone loss, document an inadequate response to 12 months of an oral bisphosphonate (such as alendronate or risedronate) or an IV bisphosphonate (such as zoledronic acid), unless the bisphosphonate was not tolerated or is contraindicated.

    • Prostate cancer pathway: male age 18 or older with nonmetastatic prostate cancer receiving androgen deprivation therapy and high fracture risk.
    • Breast cancer pathway: postmenopausal female with breast cancer receiving an adjuvant aromatase inhibitor and high fracture risk.
    • Approved dose and quantity limit for either pathway: 60 mg subcutaneously every 6 months (1 syringe [1 mL] per 6 months); initial approval is for 12 months when criteria are met.
    Documentation Required

    Renewal Requires Positive Clinical Response

    For renewal, submit chart notes demonstrating a positive clinical response. When the applicable continuation criteria are met, authorization is approved for an additional 12 months.

    • Positive response may include stable or increased BMD, no new fractures, or no vertebral fracture progression.
    • For glucocorticoid-induced osteoporosis, also document continued glucocorticoid therapy or that the member remains at high or very high fracture risk, including BMD T-score ≤ -2.5 or a fragility fracture after at least 12 months of therapy.
    • For prostate cancer bone loss, document continued high fracture risk due to androgen deprivation therapy. For breast cancer bone loss, document continued high fracture risk due to aromatase inhibitor therapy.
    Documentation Required

    Initial Authorization Documentation

    Initial authorization requests must include indication-specific clinical documentation supporting the diagnosis, fracture risk, required treatment history, and dose.

    • Postmenopausal osteoporosis: submit BMD, fracture, osteopenia/fragility-fracture, or FRAX documentation; prior bisphosphonate treatment and response; or documentation supporting the very-high-risk pathway and zoledronic acid trial.
    • Male osteoporosis: submit age, diagnosis, qualifying fracture-risk findings, and oral or IV bisphosphonate history, including intolerance or contraindication when applicable.
    • Glucocorticoid-induced osteoporosis: submit age, glucocorticoid drug and dose, expected duration, BMD/FRAX or fracture-risk findings, and bisphosphonate history for moderate-risk pathways.
    • Cancer-treatment bone loss: submit cancer diagnosis, relevant therapy, fracture-risk findings, and prior bisphosphonate treatment or documented intolerance/contraindication.
    • Include the requested regimen of 60 mg subcutaneously every 6 months.
    Denial Risk

    Unlisted Indications Are Not Medically Necessary

    Prolia is not medically necessary for treatment of conditions or indications not listed in this policy. For another indication, refer to the Off-Label policy.

    • Submit the applicable listed indication and supporting clinical records with every request.
    Denial Risk

    Failure to Meet Criteria May Result in Denial

    Requests may be denied when indication-specific medical-necessity criteria, required bisphosphonate step therapy or exception, fracture-risk findings, or supporting documentation are not satisfied.

    • Ensure the submitted records support the member's diagnosis, age/sex and treatment indication, BMD/fracture/FRAX risk, prior therapy or contraindication/intolerance, dose and quantity, and renewal response when applicable.
    • An unlisted indication should be directed to the Off-Label policy rather than submitted under this policy.
  17. T-score is between -1 and -2.5 with a fragility fracture of the proximal humerus, pelvis, or distal forearm.
  18. T-score is between -1 and -2.5 with FRAX probability of at least 20% for major osteoporotic fracture or at least 3% for hip fracture.

  19. ONE treatment pathway

    • Inadequate response to at least 12 months of an oral or IV bisphosphonate.
    • Very high fracture risk, including multiple fractures, T-score -3.0 or below, T-score -2.5 or below plus fractures, fractures while taking an osteoporosis drug, FRAX greater than 30% for major osteoporotic fracture or 4.5% for hip fracture, and a trial of zoledronic acid.

    20. Initial Male Osteoporosis — Required Conditions

    Covered for initial authorization when ALL of the following are met.

    All required conditions

    • Member is a male 18 years of age or older.
    • Medication is being used to treat osteoporosis.

    • ONE high-fracture-risk pathway

      • Hip or vertebral fracture without major trauma.
      • BMD T-score is -2.5 or less in the spine, femoral neck, or total hip.
      • T-score is between -1.0 and -2.5 in the spine, femoral neck, or total hip and 10-year FRAX risk is at least 20% for any fracture or at least 3% for hip fracture.
    • Inadequate response to at least 12 months of an oral or IV bisphosphonate, unless it was not tolerated or is contraindicated.

    Initial Glucocorticoid-Induced Osteoporosis — Required Conditions and Risk Categories

    Covered for initial authorization when ALL of the following are met.

    All required conditions

    • Member is at least 18 years of age.
    • Medication is being used for glucocorticoid-induced osteoporosis.
    • Member is initiating or continuing systemic glucocorticoids equivalent to at least 2.5 mg/day of prednisone and will remain on therapy for more than 3 months.

    • ONE fracture-risk category

      • Moderate risk

        • ONE moderate-risk age pathway

          • Age 40 years or greater with FRAX 10-year major osteoporotic fracture risk of 10% to 19%, hip risk greater than 1% and less than 3%, or BMD T-score between -1 and 2.4; and inadequate response to at least 12 months of a bisphosphonate.
          • Age under 40 with glucocorticoids of at least 7.5 mg/day for 6 months or longer and BMD Z-score less than -3 or significant DXA BMD loss; and inadequate response to at least 12 months of a bisphosphonate.

      • High risk

        • Age 40 years or greater with BMD T-score -2.5 or less but greater than -3.5.
        • FRAX 10-year major osteoporotic fracture risk of 20% to 29% or hip risk of 3% to 4.4%.

      • Very high risk

        • Prior osteoporotic fracture.
        • BMD T-score -3.5 or less.
        • FRAX 10-year major osteoporotic fracture risk of at least 30% or hip risk of at least 4.5%.
        • Glucocorticoid exposure of at least 30 mg/day for more than 30 days.
        • Cumulative glucocorticoid exposure of at least 5 g/year.

    Initial Prostate-Cancer Bone Loss — Required Conditions

    Covered for initial authorization when ALL of the following are met.

    All required conditions

    • Member is a male 18 years of age or older.
    • Member has nonmetastatic prostate cancer.
    • Member is receiving androgen deprivation therapy.

    • ONE high-fracture-risk pathway

      • T-score is less than -2.5 in the femoral neck, total hip, or lumbar spine.
      • Prior fragility fracture.
      • FRAX score is at least 20% for major osteoporotic fracture or at least 3% for hip fracture.
    • Inadequate response to 12 months of an oral or IV bisphosphonate, unless it was not tolerated or is contraindicated.

    Initial Breast-Cancer Bone Loss — Required Conditions

    Covered for initial authorization when ALL of the following are met.

    All required conditions

    • Member is a postmenopausal female.
    • Member has breast cancer.
    • Member is currently receiving an adjuvant aromatase inhibitor.

    • ONE high-fracture-risk pathway

      • T-score is less than -2.0 in the femoral neck, total hip, or lumbar spine.
      • At least two risk factors are present: prior fragility fracture, parental hip fracture, diabetes, two or more falls in the past year, rheumatoid arthritis, BMI below 20, current smoking, more than two alcoholic drinks per day, or glucocorticoid use greater than 7.5 mg/day for more than 3 months.
      • T-score is less than 1.0 plus one listed risk factor.
    • Inadequate response to 12 months of an oral or IV bisphosphonate, unless it was not tolerated or is contraindicated.
    For breast-cancer bone loss, member continues to be at high risk for fracture due to aromatase inhibitor therapy.

  20. Glucocorticoid persistent-risk pathway

    • Member remains at very high or high fracture risk with BMD T-score -2.5 or less.
    • Member has a fragility fracture occurring after at least 12 months of therapy.
  21. The requested renewal period is an additional 12 months.