ModifiedWashington State Health Care AuthorityPolicy 30.04.45-2

Bone Density Regulators - RANKL Inhibitors

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This policy governs Washington Apple Health fee-for-service prior authorization and medical-necessity review for the RANKL inhibitors denosumab (Prolia and Xgeva). It establishes indication-specific clinical criteria, preferred-drug step therapy, reauthorization requirements, dosing limits, and billing information.

Policy Summary

PayerWashington State Health Care Authority

PolicyBone Density Regulators - RANKL Inhibitors

Policy CodePolicy 30.04.45-2

Change TypeModified

Effective DateJun 1, 2025

Next Review DateNot specified

Key ActionFor applicable Prolia indications, document failure, contraindication, or intolerance to at least one preferred Apple Health PDL bisphosphonate, generally after a minimum 12-month trial.

SourceLink

POLICY UPDATE CHANGES

The policy removed the phrase indicating glucocorticoid-induced osteoporosis from the hypercalcemia of malignancy clinical criteria.

Denosumab (Prolia) was removed from the broader Bone Density Regulators policy and denosumab (Xgeva) was moved into the RANKL inhibitor policy.

The policy added indication-specific clinical criteria for denosumab (Xgeva).

The policy updated prior-treatment language for bisphosphonates and added high-fracture-risk requirements.

The policy broke out coverage criteria by indication and updated reauthorization criteria.

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ModifiedWashington State Health Care AuthorityPolicy 30.04.45-2

Bone Density Regulators - RANKL Inhibitors

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Sign up for Washington State Health Care Authority Policy 30.04.45-2 alerts

Get alerted when Policy 30.04.45-2 changes without checking for updates manually.

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Policy Summary

PayerWashington State Health Care Authority

PolicyBone Density Regulators - RANKL Inhibitors

Policy CodePolicy 30.04.45-2

Change TypeModified

Effective DateJun 1, 2025

Next Review DateNot specified

Key ActionFor applicable Prolia indications, document failure, contraindication, or intolerance to at least one preferred Apple Health PDL bisphosphonate, generally after a minimum 12-month trial.

SourceLink

POLICY UPDATE CHANGES

The policy removed the phrase indicating glucocorticoid-induced osteoporosis from the hypercalcemia of malignancy clinical criteria.

Denosumab (Prolia) was removed from the broader Bone Density Regulators policy and denosumab (Xgeva) was moved into the RANKL inhibitor policy.

The policy added indication-specific clinical criteria for denosumab (Xgeva).

The policy updated prior-treatment language for bisphosphonates and added high-fracture-risk requirements.

The policy broke out coverage criteria by indication and updated reauthorization criteria.

2Covered denosumab products

12 monthsTypical initial authorization period

≥20% / ≥3%FRAX major-fracture / hip-fracture thresholds

12 monthsMinimum preferred bisphosphonate trial before Prolia approval

J0897Denosumab injection billing code

Indication-Specific Coverage Criteria

Postmenopausal Osteoporosis — Prolia

Denosumab (Prolia) may be covered when all of the following documented criteria are met:

ALL of the following

Patient is 18 years of age or older.
Diagnosis of osteoporosis.
Patient is a postmenopausal female.
At least ONE of the following fracture-risk categories is met:
- Presence of fragility fractures of the hip or spine, regardless of bone mineral density.
- T-score ≤ -2.5 in the lumbar spine, femoral neck, or total hip.
- T-score between -1 and -2.5 with a history of recent fragility fracture of the proximal humerus, pelvis, or distal forearm.
- T-score between -1 and -2.5 with a FRAX 10-year probability for major fracture ≥20% or hip fracture ≥3%.
Medication will not be used in combination with other bone-density regulators, including bisphosphonates, raloxifene, or Xgeva.
History of at least ONE of the following:
- Treatment with at least one Preferred Apple Health Preferred Drug List (PDL) oral or intravenous bisphosphonate medication has been ineffective, unless all are contraindicated or not tolerated.
  Minimum trial of 12 months.
- Treatment with at least one Preferred Apple Health PDL selective estrogen receptor modulator (SERM) medication has been ineffective, unless all are contraindicated or not tolerated.
  Minimum trial of 24 months.

Glucocorticoid-Induced Osteoporosis — Prolia

Denosumab (Prolia) may be covered when all of the following documented criteria are met:

ALL of the following

Patient is 18 years of age or older.
Diagnosis of bone loss or osteoporosis.
Patient is receiving glucocorticoid therapy at a daily dosage equivalent to ≥7.5 mg of prednisone and is expected to remain on glucocorticoid therapy for at least 6 months.
At least ONE of the following fracture-risk categories is met:
- Presence of fragility fractures of the hip or spine, regardless of bone mineral density.
- T-score ≤ -2.5 in the lumbar spine, femoral neck, or total hip.

Prostate-Cancer Treatment-Related Bone Loss — Prolia

Denosumab (Prolia) may be covered when all of the following documented criteria are met:

ALL of the following

Patient is 18 years of age or older.
Patient has a diagnosis of bone loss or osteoporosis indicated by one or more of the following:
At least ONE of the following fracture-risk categories is met:
- Presence of fragility fractures of the hip or spine, regardless of bone mineral density.
- T-score ≤ -2.5 in the lumbar spine, femoral neck, or total hip.
- T-score between -1 and -2.5 with a history of recent fragility fracture of the proximal humerus, pelvis, or distal forearm.

Breast-Cancer Treatment-Related Bone Loss — Prolia

Denosumab (Prolia) may be covered when all of the following documented criteria are met:

ALL of the following

Patient is 18 years of age or older.
Patient has a diagnosis of bone loss or osteoporosis indicated by at least ONE of the following:
- Presence of fragility fractures of the hip or spine, regardless of bone mineral density.
- T-score ≤ -2.5 in the lumbar spine, femoral neck, or total hip.
- T-score between -1 and -2.5 with a history of recent fragility fracture of the proximal humerus, pelvis, or distal forearm.
- T-score between -1 and -2.5 with a FRAX 10-year probability for major fracture ≥20% or hip fracture ≥3%.

Multiple Myeloma and Bone Metastases — Xgeva

Denosumab (Xgeva) may be covered when all of the following documented criteria are met:

ALL of the following

Patient is 18 years of age or older.
Patient has ONE of the following:
- Diagnosis of multiple myeloma with skeletal-related events, including radiation to bone, pathologic fracture, surgery to bone, or spinal cord compression.
- Bone metastases from a solid tumor, including metastatic breast cancer, metastatic castration-resistant prostate cancer, or metastatic lung cancer.
History of failure, contraindication, or intolerance to zoledronic acid.

Giant Cell Tumor of Bone — Xgeva

Denosumab (Xgeva) may be covered when all of the following documented criteria are met:

ALL of the following

Patient is 12 years of age or older and skeletally mature.
Diagnosis of giant cell tumor of the bone.
At least ONE of the following disease characteristics is present:
- Disease is unresectable or surgical resection is likely to result in severe morbidity.
- Disease is recurrent or metastatic.
Medication will not be used in combination with denosumab.

Hypercalcemia of Malignancy — Xgeva

Denosumab (Xgeva) may be covered when all of the following documented criteria are met:

ALL of the following

Patient is 18 years of age or older.
Diagnosis of hypercalcemia of malignancy.
Baseline corrected serum calcium >12.5 mg/dL.>12.5 mg/dL
Treatment with at least one Preferred Apple Health PDL oral or intravenous bisphosphonate medication has been ineffective, unless all are contraindicated or not tolerated.
Minimum trial of 12 months.
Medication will not be used in combination with denosumab (Prolia).

Reauthorization

Reauthorization may be approved for 12 months when all applicable ongoing criteria and documentation requirements for the indication continue to be met.

Applicable reauthorization pathway:

Postmenopausal osteoporosis — Prolia
- The prohibition on combination use with other bone-density regulators continues to be met.
- Documentation demonstrates disease stability or a positive clinical response, such as no fragility fracture and bone mineral density improving or remaining stable.
Glucocorticoid-induced osteoporosis — Prolia
- Patient has not suffered a fragility fracture while on treatment.
- The prohibition on combination use with other bone-density regulators continues to be met.

Coverage is not authorized when Prolia or Xgeva is used in combination with other bone-density regulators, including bisphosphonates or raloxifene, or when Prolia and Xgeva are used together as specified in the indication-specific criteria.

Initial Therapy by Product and Indication

Prolia Initial Therapy — Postmenopausal Osteoporosis

Prolia is covered for postmenopausal osteoporosis when all of the following documented criteria are met:

Initial therapy — postmenopausal osteoporosis

Patient is at least 18 years of age, has osteoporosis, and is a postmenopausal female.
Qualifying fracture risk
- Fragility fracture of the hip or spine, regardless of bone mineral density.
- T-score is ≤ -2.5 at the lumbar spine, femoral neck, or total hip.
- T-score is between -1 and -2.5 with a recent fragility fracture of the proximal humerus, pelvis, or distal forearm.

Continuation and Reauthorization

Denosumab Continuation Therapy

Denosumab may be reauthorized when all of the following applicable continuation criteria are met:

Continuation therapy

The applicable ongoing treatment and noncombination criteria continue to be met.
Documentation demonstrates disease stability or a positive clinical response.
Acceptable evidence of stability or response
- No fragility fracture while on treatment.
- Bone mineral density continues to improve or remains stable.

Required Prior Treatment

Step	Applies before	Required prior treatment	When requirement is satisfied
1	Applicable Prolia indications	Try at least one preferred Apple Health PDL oral or intravenous bisphosphonate for a minimum of 12 months.	The bisphosphonate was ineffective, or all applicable agents are contraindicated or not tolerated.

Step	Applies before	Required prior treatment	When requirement is satisfied
2	Prolia for postmenopausal osteoporosis	Try at least one preferred Apple Health PDL selective estrogen receptor modulator (SERM) for a minimum of 24 months.	The SERM was ineffective, or all applicable agents are contraindicated or not tolerated.

Step	Applies before	Required prior treatment	When requirement is satisfied
1	Xgeva for multiple myeloma or bone metastases from solid tumors	Document prior treatment with zoledronic acid.	Zoledronic acid failure, contraindication, or intolerance is documented.

Product-Specific Quantity Limits

Quantity limit

ProductDenosumab (Prolia)

Quantity limit1 mL every 168 days

Dosage form60 mg/1 mL prefilled syringe

Quantity limit

ProductDenosumab (Xgeva)

IndicationGiant cell tumor of bone

Loading quantity5.1 mL per 28 days, with additional 120 mg doses on Days 8 and 15 of the first month of therapy

Billing and Clinical Thresholds

Denosumab billing codeHCPCS

J0897

Injection, denosumab, 1 mg

Bone mineral density T-score

Osteoporotic T-score≤ -2.5 at the lumbar spine, femoral neck, or total hip

Osteopenic T-score with fractureBetween -1.0 and -2.5 with a recent fragility fracture of the proximal humerus, pelvis, or distal forearm

Hip or vertebral fractureA hip or vertebral fragility fracture qualifies regardless of bone mineral density

T-score measurement sitesLumbar spine, femoral neck, or total hip

FRAX risk

Major fracture risk≥20% 10-year probability for a major fracture

Prior Authorization and Documentation Requirements

Prior Authorization

Medical-Necessity Review

Denosumab (Prolia or Xgeva) may be considered medically necessary only when the applicable clinical-policy criteria are documented. If all criteria are not met, the clinical reviewer may determine medical necessity and approve the request case by case, including use of reauthorization criteria for a patient established on therapy who is new to Apple Health.

Prior Authorization

Preferred-List Prior Authorization

New-to-market and other non-preferred agents on the Apple Health Preferred Drug List (AHPDL) require prior authorization. Document the applicable preferred alternatives and the required inadequate response, severe adverse reaction, contraindication, or intolerance before requesting a non-preferred agent.

Review the current AHPDL at https://www.hca.wa.gov/assets/billers-and-providers/applehealth-preferred-drug-list.xlsx.
New indications approved by the FDA are reviewed for medical necessity case by case.

Clinical Background

Osteoporosis is characterized by decreased bone mass and increased fracture risk, particularly at the spine, hip, and wrist. Findings associated with high fracture risk include a qualifying fragility fracture, low bone-mineral-density T-score, elevated FRAX risk, or long-term glucocorticoid exposure.

A high-risk bone-density finding may include a T-score of ≤ -2.5 at the spine, femoral neck, or total hip. In patients with a T-score between -1.0 and -2.5, risk may also be established by a recent qualifying fragility fracture or a 10-year FRAX probability of ≥20% for a major fracture or ≥3% for a hip fracture. Long-term glucocorticoid exposure is defined as treatment equivalent to ≥7.5 mg of prednisone daily. Pharmacologic treatment is used with measures such as adequate calcium and vitamin D, exercise, smoking cessation, fall prevention, and avoidance of heavy alcohol use.

Policy Definitions

High fracture risk

Bone mineral densityT-score ≤ -2.5 at the spine, femoral neck, or total hip

Fracture historyHip or vertebral fracture regardless of bone mineral density

Recent fragility fractureT-score between -1.0 and -2.5 with a recent fracture of the proximal humerus, pelvis, or distal forearm

FRAX findingsT-score between -1.0 and -2.5 with a 10-year risk of at least 20% for any major fracture or at least 3% for hip fracture

Long-term glucocorticoid exposure

Treatment definitionLong-term glucocorticoid treatment

Prednisone-equivalent dose

Policy Summary

PayerWashington State Health Care Authority

PolicyBone Density Regulators - RANKL Inhibitors

Policy CodePolicy 30.04.45-2

Change TypeModified

Effective DateJun 1, 2025

Next Review DateNot specified

Key ActionFor applicable Prolia indications, document failure, contraindication, or intolerance to at least one preferred Apple Health PDL bisphosphonate, generally after a minimum 12-month trial.

SourceLink

On This Page

T-score between -1 and -2.5 with a history of recent fragility fracture of the proximal humerus, pelvis, or distal forearm.

T-score between -1 and -2.5 with a FRAX 10-year probability for major fracture ≥20% or hip fracture ≥3%.

Medication will not be used in combination with other bone-density regulators, including bisphosphonates, raloxifene, or Xgeva.

Treatment with at least one Preferred Apple Health PDL oral or intravenous bisphosphonate medication indicated for glucocorticoid-induced osteoporosis has been ineffective, unless all are contraindicated or not tolerated.

Minimum trial of 12 months.

T-score between -1 and -2.5 with a FRAX 10-year probability for major fracture ≥20% or hip fracture ≥3%.

Patient is currently receiving androgen deprivation therapy (ADT), such as leuprolide, degarelix, or relugolix, for non-metastatic prostate cancer, unless all are contraindicated or not tolerated.

Medication will not be used in combination with denosumab (Xgeva).

Treatment with at least one Preferred Apple Health PDL oral or intravenous bisphosphonate medication has been ineffective, unless all are contraindicated or not tolerated.

Minimum trial of 12 months.

Patient is receiving adjuvant aromatase inhibitor therapy, such as anastrozole, exemestane, or letrozole, for breast cancer, unless all are contraindicated or not tolerated.

Medication will not be used in combination with denosumab (Xgeva).

Treatment with at least one Preferred Apple Health PDL oral or intravenous bisphosphonate medication has been ineffective, unless all are contraindicated or not tolerated.

Minimum trial of 12 months.

Medication will not be used in combination with denosumab (Prolia).

Documentation demonstrates disease stability or a positive clinical response, such as bone mineral density improving or remaining stable.

Prostate-cancer treatment-related bone loss — Prolia

Patient continues to receive androgen deprivation therapy for non-metastatic prostate cancer.
Medication continues not to be used in combination with denosumab (Xgeva).
Documentation demonstrates disease stability or a positive clinical response, such as no fragility fracture and bone mineral density improving or remaining stable.

Breast-cancer treatment-related bone loss — Prolia

Documentation demonstrates disease stability or a positive clinical response, such as no fragility fracture and bone mineral density improving or remaining stable.
Patient continues to meet the applicable non-combination requirement.

Multiple myeloma and bone metastases — Xgeva

Medication continues not to be used in combination with denosumab (Prolia).
Documentation demonstrates disease stability or a positive clinical response, such as no fracture and bone mineral density improving or remaining stable.

Giant cell tumor of bone — Xgeva

Medication continues not to be used in combination with denosumab.
Documentation demonstrates disease stability or a positive clinical response, such as a decrease in tumor size or spread of tumor.

Hypercalcemia of malignancy — Xgeva

Medication continues not to be used in combination with denosumab (Prolia).
Documentation demonstrates disease stability or a positive clinical response, such as a decrease in corrected serum calcium.

T-score is between -1 and -2.5 with a FRAX 10-year probability of ≥20% for major fracture or ≥3% for hip fracture.

Medication will not be used in combination with another bone-density regulator, including a bisphosphonate, raloxifene, or Xgeva.

Required preferred-drug history

At least one preferred Apple Health Preferred Drug List oral or intravenous bisphosphonate was ineffective after a minimum trial of 12 months, unless all applicable agents are contraindicated or not tolerated.
At least one preferred Apple Health Preferred Drug List selective estrogen receptor modulator was ineffective after a minimum trial of 24 months, unless all applicable agents are contraindicated or not tolerated.

Prolia Initial Therapy — Treatment-Related Bone Loss

Prolia is covered for specified cancer-treatment-related bone loss when all applicable criteria for the selected indication are met:

Cancer-treatment-related bone loss

Glucocorticoid-induced osteoporosis
- Patient is at least 18 years of age; is receiving glucocorticoid therapy at a daily dose equivalent to at least 7.5 mg of prednisone and is expected to remain on therapy for at least 6 months; meets a qualifying fracture-risk category; will not use Prolia with another bone-density regulator; and has failed at least one preferred Apple Health PDL oral or intravenous bisphosphonate for a minimum of 12 months unless all are contraindicated or not tolerated.
Prostate-cancer treatment-related bone loss
- Patient is at least 18 years of age; has qualifying bone loss or osteoporosis; is receiving androgen-deprivation therapy for non-metastatic prostate cancer; will not use Prolia with Xgeva; and has failed at least one preferred Apple Health PDL oral or intravenous bisphosphonate for a minimum of 12 months unless all are contraindicated or not tolerated.
Breast-cancer treatment-related bone loss
- Patient is at least 18 years of age; has qualifying bone loss or osteoporosis; is receiving adjuvant aromatase-inhibitor therapy for breast cancer; will not use Prolia with Xgeva; and has failed at least one preferred Apple Health PDL oral or intravenous bisphosphonate for a minimum of 12 months unless all are contraindicated or not tolerated.

Tumor size or spread decreases or remains stable, as applicable.

Corrected serum calcium decreases, as applicable for hypercalcemia of malignancy.

Maintenance quantityNot specified in the document excerpt

Quantity limit

ProductDenosumab (Xgeva)

IndicationMultiple myeloma and bone metastases from solid tumors

Quantity limit1.7 mL every 28 days

Dosage form120 mg/1.7 mL vial

≥3% 10-year probability for hip fracture

Applicable T-score rangeBetween -1.0 and -2.5 at the spine, femoral neck, or total hip when paired with qualifying FRAX risk

Glucocorticoid dose

Daily dose≥7.5 mg prednisone-equivalent daily

Expected treatment durationGlucocorticoid therapy expected to continue for at least 6 months

Clinical contextUsed in criteria for glucocorticoid-induced osteoporosis

Hypercalcemia of malignancy

ConditionHypercalcemia of malignancy

Baseline corrected serum calcium>12.5 mg/dL

Measurement timingBaseline corrected serum calcium is required

Step Therapy

Preferred Bisphosphonate Step

For applicable Prolia indications, document that treatment with at least one preferred AHPDL oral or intravenous bisphosphonate was ineffective, unless all applicable preferred bisphosphonates are contraindicated or not tolerated. The minimum required trial is 12 months.

Applies to postmenopausal osteoporosis, glucocorticoid-induced osteoporosis, treatment-related bone loss in men with prostate cancer, treatment-related bone loss in women with breast cancer, and hypercalcemia of malignancy when specified by the clinical criteria.
Document the medication, treatment duration, response, and any contraindication or intolerance.

Step Therapy

Preferred SERM Step

For Prolia requested for postmenopausal osteoporosis, document ineffective treatment with at least one preferred AHPDL selective estrogen receptor modulator (SERM), unless all preferred SERMs are contraindicated or not tolerated. The minimum required trial is 24 months.

Document the preferred SERM, treatment duration, inadequate response, contraindication, or intolerance.

Step Therapy

Zoledronic Acid Step

For Xgeva requested for multiple myeloma with skeletal-related events or bone metastases from solid tumors, document a history of failure, contraindication, or intolerance to zoledronic acid.

The requested indication must be multiple myeloma with skeletal-related events or bone metastases from a solid tumor.
Document the zoledronic-acid treatment history and the reason it failed or could not be used.

Documentation Required

Initial Clinical Documentation

Submit initial clinical documentation sufficient to establish the patient, diagnosis, indication, fracture or disease risk, treatment status, and medication history. Documentation must support every applicable criterion before authorization can be issued.

Patient age and, when applicable, skeletal maturity; diagnosis and requested indication.
For osteoporosis or treatment-related bone loss: fracture history, T-scores, FRAX risk, and applicable glucocorticoid, androgen-deprivation, or aromatase-inhibitor therapy.
For oncology indications: cancer diagnosis, skeletal-related events, metastases, tumor status, or resectability and morbidity details as applicable.
Preferred-drug treatment history, duration, response, contraindications or intolerance, current therapy, and requested product, dose, and schedule.
For hypercalcemia of malignancy: baseline corrected serum calcium and diagnosis.

Documentation Required

Reauthorization Documentation

For reauthorization, document that the applicable continuing criteria remain satisfied and provide evidence of disease stability or a positive clinical response. Requests are generally authorized for 12 months when the reauthorization criteria are met.

Document continued absence of prohibited combination therapy and continued required treatment status.
For Prolia: no fragility fracture and bone mineral density improving or remaining stable, when applicable.
For Xgeva: no fracture, stable or improved tumor status, or decreased corrected serum calcium, according to the indication.

Documentation Required

Calcium Documentation

For Xgeva requested for hypercalcemia of malignancy, document a baseline corrected serum calcium greater than 12.5 mg/dL and provide follow-up corrected serum calcium for reauthorization.

Initial documentation must include diagnosis of hypercalcemia of malignancy and baseline corrected serum calcium > 12.5 mg/dL.
Reauthorization documentation must demonstrate a positive response, such as a decrease in corrected serum calcium.

Prior Authorization

Preferred-Drug Failure Requirement

When requesting a non-preferred or new-to-market agent, document inadequate response or documented intolerance due to a severe adverse reaction or contraindication to the required preferred agents.

Document failure or intolerance to at least two preferred agents when two or more preferred agents are available in the class.
If only one preferred agent is available, document inadequate response to that one preferred agent.

Denial Risk

Indication Criteria Not Met

The request may be denied when the applicable indication, age, disease-risk, treatment-status, or preferred-treatment criteria are not documented or are not met.

Examples include an unsupported diagnosis or indication, age below the applicable minimum, lack of required skeletal maturity, insufficient fracture risk or cancer-related disease criteria, or failure to document the required preferred bisphosphonate, SERM, or zoledronic-acid history.
For Prolia osteoporosis indications, required risk evidence may include qualifying hip or spine fragility fracture, qualifying T-score, qualifying recent fragility fracture with osteopenia, or qualifying FRAX probability.
For Xgeva, the request must match the applicable indication, such as multiple myeloma, bone metastases, giant cell tumor of bone, or hypercalcemia of malignancy.

Denial Risk

Insufficient Reauthorization Evidence

Reauthorization may be denied when ongoing eligibility or clinical response is not established. Submit the required current treatment-status information and objective evidence of stability or positive response for the requested indication.

For Prolia, document continued compliance with the no-combination requirement and disease stability or positive response, such as no fragility fracture and stable or improving bone mineral density.
For Xgeva, document continued applicable criteria and response, such as no fracture, decreased tumor size or spread, or decreased corrected serum calcium.
Missing, outdated, or insufficient clinical response documentation may prevent reauthorization.

Denial Risk

Prohibited Combination Therapy

Do not use denosumab concurrently with another prohibited bone-density regulator or with the other denosumab product. Requests may be denied when concurrent therapy is planned or documented.

Prolia must not be combined with bisphosphonates, raloxifene, or Xgeva.
Xgeva must not be combined with Prolia; applicable criteria also prohibit concurrent use with other specified bone-density regulators.

At least 7.5 mg of prednisone daily

Clinical significanceExposure is recognized as a high-fracture-risk finding