ModifiedMass General Brigham Health PlanPolicy N/A

Denosumab (Prolia, Xgeva) prior authorization and coverage

Defines prior authorization, coverage criteria, and limits for denosumab products Prolia and Xgeva for Mass General Brigham Health Plan members across medical and pharmacy benefits. Applies to providers requesting authorization for denosumab for osteoporosis, cancer-related bone conditions, and other labeled uses.

Policy Summary

PayerMass General Brigham Health Plan

PolicyDenosumab (Prolia, Xgeva) prior authorization and coverage

Policy CodePolicy N/A

Change TypeApproval duration for Prolia updated to 24 monthscriteria consolidated and switched to Custom criteria

Effective DateSep 1, 2022

Next Review DateN/A

Key ActionSubmit supporting chart notes or medical records showing fracture history, T-score, and FRAX probability to initiate prior authorization.

SourceLink

POLICY UPDATE CHANGES

Approval duration for Prolia was updated to 24 months.

Prolia and Xgeva criteria were combined into a single document.

Policy switched from CVS Standard to Custom criteria.

24 monthsProlia approval duration

12 monthsXgeva approval duration

2 monthsHypercalcemia initial auth

Prior authorization requiredPA required

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MOF ≥20% / Hip ≥3%FRAX thresholds

×1.15 / ×1.2FRAX glucocorticoid adj

Coverage Criteria for Denosumab (Prolia, Xgeva)

Postmenopausal osteoporosis (Initial authorization)

Authorization may be granted when ALL of the following drug-specific criteria are met and documentation is provided:

History of fragility fracture: Member has a history of fragility fractures

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T-score and FRAX pre-treatment criteria: Pre-treatment T-score > -2.5 and < -1 with a high pre-treatment FRAX fracture probability OR low T-score (<= -3) or increased fall risk; alternatively a pre-treatment T-score <= -2.5T-score and FRAX per Appendix B

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Prior therapy or contraindication: Member has had an oral bisphosphonate trial of at least 1 year OR there is a clinical reason to avoid oral bisphosphonate therapy OR member has failed or is intolerant to prior injectable osteoporosis therapy1 year bisphosphonate trial

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Osteoporosis in men

Authorization may be granted when BOTH of the following are met:

Fracture history: Member has a history of an osteoporotic vertebral or hip fracture

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T-score/FRAX: Pre-treatment T-score <= -2.5 OR osteopenia (pre-treatment T-score > -2.5 and < -1) with a high pre-treatment FRAX fracture probabilityPer Appendix B

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Prior therapy or contraindication: Member has had an oral OR injectable bisphosphonate trial of at least 1 year OR there is a clinical reason to avoid treatment with a bisphosphonate1 year trial

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Glucocorticoid-induced osteoporosis

Authorization may be granted when member meets duration/dose and one of the listed bone-risk criteria and prior therapy conditions:

Glucocorticoid exposure: Member is currently receiving or will be initiating glucocorticoid therapy at an equivalent prednisone dose of >= 2.5 mg/day for >= 3 months>= 2.5 mg/day for >= 3 months

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Bone-risk criteria: Member has a history of fragility fracture OR pre-treatment T-score <= -2.5 OR osteopenia (pre-treatment T-score > -2.5 and < -1) with a high pre-treatment FRAX fracture probabilityPer Appendix B

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Prior therapy or contraindication: Member has had an oral OR injectable bisphosphonate trial of at least 1 year OR there is a clinical reason to avoid bisphosphonate therapy

Breast cancer (adjuvant aromatase inhibitor therapy)

Adjuvant aromatase inhibitor therapy: Authorization may be granted to members who are receiving adjuvant aromatase inhibition therapy for breast cancer

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Prostate cancer (androgen deprivation therapy)

Androgen deprivation therapy: Authorization may be granted to members who are receiving androgen deprivation therapy for prostate cancer

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Multiple myeloma

Prevention of SREs: Authorization may be granted for prevention of skeletal-related events in members with multiple myeloma

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Bone metastases

Authorization may be granted when ONE of the following are met:

Palliative care for bone metastases: As palliative care for bone metastases from thyroid carcinoma

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Giant cell tumor of bone

Giant cell tumor of bone: Authorization of 12 months may be granted for treatment of giant cell tumor of bone12 months authorization

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Hypercalcemia of malignancy

Hypercalcemia refractory to IV bisphosphonate: Initial authorization of 2 months may be granted for treatment of hypercalcemia of malignancy refractory to IV bisphosphonate therapy OR when there is a clinical reason to avoid IV bisphosphonate therapy2 months authorization

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Systemic mastocytosis

Second-line for osteopenia/osteoporosis: Authorization of 12 months may be granted for second-line therapy in members with systemic mastocytosis who have not responded to bisphosphonates or are not candidates for bisphosphonates because of renal insufficiency12 months authorization

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Continuation of therapy (Reauthorization)

Reauthorization requires evidence of clinical benefit and absence of significant adverse events. Resubmission by prescriber required when ONE of the following is met:

Clinical benefit (radiography): Member has experienced clinical benefit (e.g., no new fracture seen on radiography) and has not experienced clinically significant adverse events during therapy

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Clinical benefit (bone mass measurement): Member has experienced clinical benefit as evidenced by bone mass measurement showing improvement or stabilization in T-score compared with previous measurement and no adverse effects

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FRAX-based indication

Covered when FRAX indicates high fracture probability as defined below

High FRAX fracture probability: 10-year major osteoporotic fracture risk >= 20% OR hip fracture risk >= 3%MOF >=20% OR Hip >=3%

Apply glucocorticoid adjustment (multiply MOF by 1.15 and hip by 1.2) if glucocorticoid dose > 7.5 mg/day prednisone equivalent

Authorization is not available when the product was obtained as samples or through the manufacturer’s patient assistance programs. For members currently receiving treatment with Prolia or Xgeva, authorization may be granted only when the criteria in this policy are met and appropriate documentation is provided; products obtained as samples or via patient assistance are explicitly excluded from authorization consideration.

No additional authorization exclusions or special-case exclusions are specified in the cited portions of the document beyond those already stated; refer to the full policy for any other operational exclusions added elsewhere in the record.

The provided portions of the policy do not include explicit statements labeled "not medically necessary." Instead, coverage determinations are conditional: denosumab is covered only when the specific clinical criteria and documentation requirements listed in this policy are met.

Use of denosumab when the patient’s FRAX estimate does not meet the policy’s high FRAX fracture probability thresholds would not satisfy the FRAX-based coverage indication. The policy defines high FRAX fracture probability as a 10‑year major osteoporotic fracture risk ≥ 20% or hip fracture risk ≥ 3%, with specified multipliers applied when glucocorticoid dose exceeds 7.5 mg/day (prednisone equivalent). Requests with FRAX values below these thresholds are at risk for denial under the FRAX-based criterion.

FRAX Thresholds and Definitions

High FRAX fracture probability thresholds

10-year major osteoporotic fracture threshold≥ 20%

10-year hip fracture threshold≥ 3%

Glucocorticoid adjustment — MOFMultiply FRAX MOF estimate by 1.15 when prednisone-equivalent > 7.5 mg/day

Glucocorticoid adjustment — hipMultiply FRAX hip fracture estimate by 1.2 when prednisone-equivalent > 7.5 mg/day

FRAX thresholds

Major osteoporotic fracture (MOF) threshold10-year MOF ≥ 20%

Hip fracture threshold

Provider Actions, Documentation, and Operational Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Prolia (denosumab) and Xgeva (denosumab). These products are designated specialty and must be filled at a contracted specialty pharmacy when applicable. Submit supporting chart notes or medical records showing history of fractures, pre-treatment T-score, and FRAX 10-year fracture probabilities as applicable.

Specialty fill required at contracted specialty pharmacy for designated specialty medications.
Contact (Medical & Specialty Medications): Phone: 877-519-1908 • Fax: 855-540-3693
Non-Specialty Medications contact (All Plans): Phone: 800-711-4555 • Fax: 844-403-1029

Denial Risk

Failure to meet drug-specific criteria may result in denial

Authorization may be denied if the member is not currently receiving Prolia/Xgeva (except when product was obtained as samples or via manufacturer patient assistance) and the request does not meet drug-specific criteria. Ensure documentation demonstrates fulfillment of the applicable coverage criteria to avoid denial.

Background — Denosumab Products

Denosumab is a monoclonal antibody available as Prolia and Xgeva with distinct indications addressed in this policy. The policy combines Prolia and Xgeva into a single document and requires prior authorization for both products; Prolia approvals were updated to a 24‑month duration per the review history. The policy outlines covered clinical situations including postmenopausal osteoporosis, osteoporosis in men, glucocorticoid‑induced osteoporosis, adjuvant settings for breast and prostate cancer, prevention of skeletal‑related events in multiple myeloma and bone metastases, treatment of giant cell tumor of bone, hypercalcemia of malignancy, and second‑line use in systemic mastocytosis.

Definitions and Key Terms

Clinical reasons to avoid bisphosphonate therapy

Renal insufficiency (CrCl)Creatinine clearance < 35 mL/min

Acute renal impairment (IV)Acute renal impairment—reason to avoid IV bisphosphonates

History of intolerance to IV bisphosphonateDocumented intolerance to IV bisphosphonates

Active upper GI conditionsDysphagia, gastritis, duodenitis, erosive esophagitis, or ulcers—reasons to avoid oral bisphosphonates

Inability to comply with oral dosing requirementsInability to stand/sit upright 30–60 minutes or to delay food/medication intake—reason to avoid oral bisphosphonates

High FRAX fracture probability

Policy Summary

PayerMass General Brigham Health Plan

PolicyDenosumab (Prolia, Xgeva) prior authorization and coverage

Policy CodePolicy N/A

Change TypeApproval duration for Prolia updated to 24 monthscriteria consolidated and switched to Custom criteria

Effective DateSep 1, 2022

Next Review DateN/A

Key ActionSubmit supporting chart notes or medical records showing fracture history, T-score, and FRAX probability to initiate prior authorization.

SourceLink

On This Page

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10-year hip fracture risk ≥ 3%

MOF glucocorticoid multiplierMultiply MOF FRAX by 1.15 if glucocorticoids > 7.5 mg/day (prednisone equivalent)

Hip glucocorticoid multiplierMultiply hip FRAX by 1.2 if glucocorticoids > 7.5 mg/day (prednisone equivalent)

High FRAX fracture probability

Definition — high FRAX probability10-year major osteoporotic fracture risk ≥ 20% OR hip fracture risk ≥ 3%

Adjustment for glucocorticoids (MOF)Multiply estimated FRAX MOF score by 1.15 when prednisone-equivalent dose > 7.5 mg/day

Adjustment for glucocorticoids (hip)Multiply estimated FRAX hip score by 1.2 when prednisone-equivalent dose > 7.5 mg/day

High FRAX fracture probability / glucocorticoid adjustment

High FRAX criteria (MOF)10-year major osteoporotic fracture risk ≥ 20%

High FRAX criteria (hip)10-year hip fracture risk ≥ 3%

Glucocorticoid adjustment instructionIf glucocorticoid treatment > 7.5 mg/day (prednisone equivalent), multiply FRAX MOF by 1.15 and FRAX hip by 1.2

Clinical reasons to avoid bisphosphonate therapy

Renal insufficiencyCreatinine clearance < 35 mL/min is listed as a clinical reason to avoid bisphosphonates

Acute renal impairmentAcute renal impairment is a clinical reason to avoid IV bisphosphonate therapy

Intolerance to bisphosphonatesHistory of intolerance to IV or oral bisphosphonates qualifies as a reason to avoid therapy

Upper GI problems and GI malabsorptionActive upper GI problems, anatomic/functional esophageal abnormalities, or documented/potential malabsorption are reasons to avoid oral bisphosphonates

Functional limitations for oral dosingInability to remain upright 30–60 minutes or inability to withhold food/medication timing are reasons to avoid oral bisphosphonates

Authorization may be granted for members currently receiving treatment (excluding samples or manufacturer patient assistance).
If not currently receiving treatment, ALL drug-specific criteria and documentation must be provided for authorization to be considered.

Documentation Required

Required Clinical Documentation

Submit supporting chart notes or medical records indicating history of fragility fractures, pre-treatment T-score, and FRAX fracture probability as applicable to the requested indication. Include documentation of prior bisphosphonate trials or clinical reasons to avoid bisphosphonates when applicable.

Include dates and duration of any bisphosphonate or injectable osteoporosis therapy trials.
Document clinical justification to avoid bisphosphonate therapy when claimed (see Appendix A).
Provide records of current or planned glucocorticoid dosing when relevant.

Note

Prior Authorization Duration

For Prolia approvals, prior authorization duration has been updated to 24 months per the review history when criteria are met.

Approval duration for Prolia: 24 months.

Documentation Required

FRAX Score and Glucocorticoid Adjustment

Document the patient's FRAX 10-year major osteoporotic fracture and hip fracture probabilities. If the patient is receiving glucocorticoid therapy greater than 7.5 mg prednisone equivalent per day, multiply the FRAX major osteoporotic fracture estimate by 1.15 and the hip fracture estimate by 1.2 before applying thresholds.

High FRAX thresholds: 10-year major osteoporotic fracture ≥ 20% OR hip fracture ≥ 3%.
If glucocorticoids > 7.5 mg/day (prednisone equivalent), adjust FRAX: major fracture ×1.15; hip fracture ×1.2.

Denial Risk

FRAX Threshold Not Met

Requests that do not meet the FRAX high fracture probability thresholds (10-year major osteoporotic fracture ≥20% or hip fracture ≥3%) must include clear clinical justification (e.g., history of fragility fracture, very low T-score ≤ -3.0, increased fall risk, or intolerance/failure of bisphosphonate/injectable therapy). Without such justification, authorization is at risk of denial.

FRAX thresholds: major osteoporotic fracture ≥ 20% OR hip fracture ≥ 3%.
Acceptable clinical justifications in lieu of meeting FRAX threshold: documented fragility fracture, T-score ≤ -3.0, increased fall risk, or documented failure/intolerance of prior osteoporosis therapies.

High FRAX fracture probability definition

10-year major osteoporotic fracture risk ≥ 20% OR hip fracture risk ≥ 3%

Apply glucocorticoid multiplier (MOF)Multiply FRAX MOF estimate by 1.15 when prednisone-equivalent dose > 7.5 mg/day

Apply glucocorticoid multiplier (hip)Multiply FRAX hip estimate by 1.2 when prednisone-equivalent dose > 7.5 mg/day