Prolia®, Xgeva® (denosumab) prior authorization
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Prior authorization criteria for denosumab products Prolia and Xgeva covering indications, approval and denial conditions, quantity limits, and approval durations for Alaska Medicaid members.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Prolia - Initial Therapy
Covered when ALL of the following are met
inv-02: Xgeva - Indication-specific Criteria
Covered when ALL of the following are met for each indication
Concurrent use of denosumab with another RANK ligand (RANKL) inhibitor is excluded. Requests that propose overlapping therapy with any other RANK ligand inhibitor will be denied.
Use of Prolia or Xgeva when the specified approval criteria are not met is considered not covered / denied. If documentation does not demonstrate that all applicable criteria are satisfied, the request should be declined.
Coding and Limits
| Prolia 60 mg/1 mL | Prolia 60 mg/1 mL single-use prefilled syringe: 1 syringe every 6 months |
| J0897 | Xgeva 120 mg/1.7 mL single-use vial (HCPCS) - Load: 4 vials per 28 days x 1 dose; Maintenance: 1 vial monthly |
Prior Authorization & Provider Requirements
Prolia prior authorization required
Prior authorization required for Prolia (60 mg) — submit documentation that the patient is ≥18 years old, has one of the listed qualifying diagnoses, baseline labs/measurements meeting T‑score or FRAX thresholds, and prior inadequate response or intolerance to at least two traditional osteoporosis therapies (one must be a bisphosphonate).
- Age ≥18 years.
- One of the specified diagnoses (e.g., postmenopausal osteoporosis, glucocorticoid‑induced osteoporosis, decreasing bone mass in men, etc.).
- Baseline objective measure: (a) T‑score between -1.0 and -2.5 at specified sites plus qualifying risk factor, OR (b) FRAX 10‑year major osteoporotic fracture ≥20% or hip ≥3%, OR (c) T‑score ≤ -2.5.
- Inadequate response to or intolerance of ≥2 traditional osteoporosis treatments (oral or IV), including at least one bisphosphonate.
Xgeva prior authorization required
Prior authorization required for Xgeva — submit documentation of the specific indication and supporting clinical details depending on indication: unresectable giant cell tumor of bone in skeletally mature patients; prevention of skeletal‑related events in adults with bone metastases/multiple myeloma; or hypercalcemia of malignancy with albumin‑corrected calcium >12.5 mg/dL and prior bisphosphonate failure/intolerance as applicable.
- For giant cell tumor of bone: patient ≥12 years, diagnosis of GCTB, documented skeletal maturity, and tumor unresectable or surgery likely to cause severe morbidity.
- For prevention of skeletal‑related events: patient ≥18 years with bone metastases or multiple myeloma.
- For hypercalcemia of malignancy: patient ≥18 years with albumin‑corrected calcium >12.5 mg/dL and inadequate response or intolerance to ≥1 bisphosphonate.
Step therapy (Prolia; Xgeva hypercalcemia)
Step therapy required prior to Prolia: provider must document inadequate response to or intolerance of at least two traditional osteoporosis therapies, with at least one being a bisphosphonate.
- Traditional therapies include oral or IV treatments such as alendronate, calcitonin, ibandronate, raloxifene, risedronate, or zoledronic acid.
- For Xgeva used for hypercalcemia of malignancy, document inadequate response to or intolerance of at least one bisphosphonate.
Required documentation for Prolia (baseline labs/measure)
Submit chart notes with baseline objective measures for Prolia requests: either a qualifying T‑score at specified sites with associated risk factor, a FRAX 10‑year probability meeting threshold, or a T‑score ≤ -2.5.
- Acceptable baseline documentation: (a) T‑score between -1.0 and -2.5 at lumbar spine, total hip, femoral neck, or 33% radius plus being on aromatase inhibitor OR androgen deprivation therapy OR history of osteoporotic fracture; (b) FRAX major osteoporotic fracture ≥20% or hip ≥3%; or (c) T‑score ≤ -2.5.
Required documentation for Xgeva
For Xgeva requests, submit documentation of the diagnosis and skeletal maturity when for giant cell tumor of bone, and laboratory evidence when for hypercalcemia of malignancy (albumin‑corrected calcium >12.5 mg/dL); also document prior bisphosphonate failure/intolerance when applicable.
- Giant cell tumor of bone: documentation that patient is ≥12 years and skeletally mature and that tumor is unresectable or surgery would cause severe morbidity.
- Hypercalcemia of malignancy: albumin‑corrected calcium >12.5 mg/dL and prior inadequate response or intolerance to ≥1 bisphosphonate.
Denial triggers and risks
Denial will be issued if approval criteria are not met, if the patient will be taking another RANK ligand inhibitor concurrently, or if pre‑existing hypocalcemia has not been corrected with adequate calcium and vitamin D supplementation.
- Use when approval criteria are not met results in denial.
- Concurrent use with another RANK ligand inhibitor is a denial trigger.
- Uncorrected pre‑existing hypocalcemia despite supplementation is a denial trigger.
Background
Denosumab (Prolia®, Xgeva®) is a RANK ligand (RANKL) inhibitor used to treat conditions related to decreased bone mass and to prevent or manage skeletal complications from oncologic disease. Prolia is indicated for adults with osteoporosis and other bone-loss conditions (including postmenopausal osteoporosis, osteoporosis in men, glucocorticoid‑induced osteoporosis, and bone loss related to cancer therapies) and is subject to age and baseline bone density/FRAX requirements. Xgeva is indicated for prevention of skeletal‑related events in adults with bone metastases or multiple myeloma, treatment of unresectable giant cell tumor of bone in skeletally mature patients, and for hypercalcemia of malignancy refractory to bisphosphonates; Xgeva’s hypercalcemia indication requires an albumin‑corrected calcium > 12.5 mg/dL (3.1 mmol/L).
Definitions
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