ModifiedUnitedHealthcarePolicy CS2026D0068X

Denosumab products (Medical Benefit Drug Policy)

Defines UnitedHealthcare Community Plan medical benefit coverage, preferred product hierarchy, and medical necessity criteria for denosumab (Prolia/Xgeva and biosimilars) for specified indications affecting providers submitting authorization requests.

Policy Summary

PayerUnitedHealthcare

PolicyDenosumab products (Medical Benefit Drug Policy)

Policy CodePolicy CS2026D0068X

Change TypeAdministrative updates (HCPCS code Q5162removed Louisiana applicability)

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documented diagnosis, prior therapy history (preferred product trials or bisphosphonate failure/contraindication/intolerance), dosing per FDA labeling, and provider attestation of clinical response.

SourceLink

POLICY UPDATE CHANGES

Removed content/language pertaining to the state of Louisiana.

Updated list of applicable HCPCS codes to reflect quarterly edits; replaced C9399, J3490, J3590, and J9999 with Q5162.

Archived previous policy version CS2026D0068W.

4preferred denosumab products

12 moauthorization period (most)

J0897, Q5136, Q5157, Q5158, Q5162HCPCS codes listed

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

distinct covered indications

T-score ≤ -2.5WHO osteoporosis threshold

Coverage and Medical Necessity Criteria

Osteoporosis (postmenopausal/high fracture risk)

Covered when ALL of the following are met

Initial Therapy: Diagnosis of osteoporosis; and one of: BMD T-score ≤ -2.5 at lumbar spine, femoral neck/total hip, or one-third radius; OR history of a qualifying low-trauma fracture (vertebral compression, hip, distal radius, pelvis, proximal humerus); OR BMD T-score between -1.0 and -2.5 AND FRAX 10-year probability meeting US thresholds (major osteoporotic fracture ≥20% or hip fracture ≥3%).see BMD T-score and FRAX thresholds

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Prior therapy: One of: both of the following — history of intolerance to oral bisphosphonate therapy AND history of failure, contraindication, or intolerance to IV bisphosphonate therapy (e.g., pamidronate, zoledronic acid); OR history of failure or contraindication to oral bisphosphonate therapy; OR history of failure, contraindication, or intolerance to IV bisphosphonate therapy.

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Dosing and duration: Dosing is in accordance with FDA-approved labeling (e.g., denosumab 60 mg subcutaneously every 6 months for osteoporosis); authorization is for no more than 12 months.

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Continuation/Reauthorization for osteoporosis and related indications

Covered when ALL of the following are met

Clinical response: Provider attests to a positive clinical response to therapy.

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Dosing is in accordance with FDA-approved labeling for the treated indication.

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Authorization period: Authorization for continuation/reauthorization is for no more than 12 months.

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Prevention of skeletal-related events in multiple myeloma and bone metastases

Covered when ALL of the following are met

Patient age/maturity: Patient is ≥18 years of age or a skeletally mature adolescent.

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Diagnosis of multiple myeloma OR presence of bone metastases secondary to a solid tumor.

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Prognosis: Expected survival of 3 months or greater.

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Prior bisphosphonate: Refractory (within past 30 days), contraindication (including renal insufficiency), or intolerance to IV bisphosphonate therapy (e.g., pamidronate, zoledronic acid).

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Giant cell tumor of bone

Covered when ALL of the following are met

Age/maturity: Patient is ≥18 years of age or a skeletally mature adolescent.

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Diagnosis of localized or metastatic giant cell tumor of bone.

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Disease criteria: Disease is unresectable OR surgical resection is likely to result in severe morbidity.

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Dosing and duration: Dosing per FDA labeling; authorization for no more than 12 months.

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Hypercalcemia of malignancy

Covered when ALL of the following are met

Age/maturity: Patient is ≥18 years of age or a skeletally mature adolescent.

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Diagnosis: Albumin-corrected serum calcium greater than 12.5 mg/dL (3.1 mmol/L) with no pre-existing hypocalcemia (hypercalcemia of malignancy).

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Prior bisphosphonate: Refractory (within past 30 days), contraindication (including renal insufficiency), or intolerance to IV bisphosphonate therapy.

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Dosing and duration: Dosing per FDA labeling; authorization for no more than 12 months.

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Systemic mastocytosis with bone pain (osteopenia/osteoporosis)

Covered when ALL of the following are met

Diagnosis of systemic mastocytosis with bone pain and osteoporosis/osteopenia defined by BMD T-score ≤ -1 at lumbar spine/hip/radius OR history of a qualifying minimal-trauma fracture (vertebral compression, hip, distal radius, pelvis, proximal humerus).

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Prior bisphosphonate: Refractory (within past 30 days), contraindication (including renal insufficiency), or intolerance to IV bisphosphonate therapy (e.g., pamidronate, zoledronic acid).

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Dosing and duration: Dosing per FDA labeling; authorization for no more than 12 months.

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Initial Therapy

Covered when ALL of the following are met

Initial Therapy: Diagnosis of systemic mastocytosis; AND presence of bone pain; AND osteoporosis/osteopenia defined by BMD T-score ≤ -1 at lumbar spine/hip/one-third radius OR history of a qualifying minimal-trauma fracture (vertebral compression, hip, distal radius, pelvis, proximal humerus); AND refractory to, contraindicated for, or intolerant of IV bisphosphonate therapy within the past 30 days (e.g., pamidronate, zoledronic acid); AND dosing per FDA labeling; AND authorization limited to no more than 12 months.

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Reauthorization/Continuation of Care

Covered for continuation when ALL of the following are met

Reauthorization: Provider attests to a positive clinical response; AND dosing is in accordance with FDA-approved labeling for the indication; AND authorization is for no more than 12 months.

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Osteoporosis diagnosis (clinical)

Covered when ALL of the following diagnostic conditions are met or documented:

Osteoporosis diagnostic criteria

Options: Fragility fracture OR T-score ≤ -2.5 OR (T-score between -1.0 and -2.5 AND FRAX threshold exceeded)
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Covered Indications

Covered when the following indication-specific criteria are met (aligning with FDA approvals and NCCN guidance):

Indications: Denosumab or indicated biosimilars for any of the following as supported by FDA labeling or NCCN guidance: (1) Postmenopausal women with osteoporosis at high risk for fracture; (2) Men with osteoporosis at high risk for fracture; (3) Glucocorticoid-induced osteoporosis in patients at high risk receiving prednisone-equivalent doses (see glucocorticoid thresholds); (4) Men receiving androgen-deprivation therapy for nonmetastatic prostate cancer to increase bone mass; (5) Women receiving adjuvant aromatase inhibitor therapy to increase bone mass; (6) Prevention of skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors (specific denosumab products); (7) Treatment of unresectable or morbid giant cell tumor of bone in skeletally mature patients; (8) Treatment of hypercalcemia of malignancy refractory to bisphosphonates.

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SRE Prevention (Oncology)

Cancer-related SRE prevention and evidence summary

SRE prevention: For patients with bone metastases or multiple myeloma, denosumab 120 mg monthly demonstrated noninferiority to zoledronic acid for time to first on-study skeletal-related event and in some analyses delayed time to first SRE compared with zoledronic acid; consider expected survival and renal function when selecting agent. Hypocalcemia is observed more frequently with denosumab; zoledronic acid is associated with renal adverse events.

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Osteoporosis Evidence

Osteoporosis comparator evidence

Osteoporosis efficacy: Randomized trials demonstrate denosumab 60 mg subcutaneously every 6 months increases BMD more than alendronate and risedronate and reduced vertebral, nonvertebral, and hip fracture risk in postmenopausal women; denosumab was noninferior and in some analyses superior to comparators for BMD outcomes in glucocorticoid-induced osteoporosis. Consider prior bisphosphonate use or intolerance when choosing therapy.

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This Medical Benefit Drug Policy does not apply to the states listed in the Application section. Specifically, this policy is not applicable to Florida, Indiana, Kansas, Ohio, and Pennsylvania; providers in those states should refer to the state-specific Medicaid clinical policy or state guidance noted in the Application. (See the policy Application for state‑specific instructions.)

The policy designates several indications and, conversely, explicitly lists uses that are unproven and not medically necessary. Denosumab products (including the listed biosimilars) are considered not medically necessary for combination therapy with intravenous bisphosphonates. Other listed unproven indications include bone loss associated with hormone‑ablation therapy (other than aromatase inhibitors), cancer pain, central giant cell granuloma, hyper‑parathyroidism, immobilization hypercalcemia, osteogenesis imperfecta, and osteopenia. Requests for combination use with IV bisphosphonates should be denied absent robust supporting clinical justification documented in the medical record.

Per World Health Organization guidance cited in the Background, a diagnosis of osteoporosis requires that other causes of low bone mineral density be excluded. The WHO‑based diagnostic framework requires either a qualifying fragility fracture, a DXA T‑score of ≤ -2.5 at prespecified sites, or a T‑score between -1.0 and -2.5 with an elevated FRAX meeting country‑specific thresholds. Providers must document evaluation for alternative metabolic bone disorders or other causes of low BMD prior to assigning an osteoporosis diagnosis for coverage purposes.

Coverage is limited to indications that align with FDA approvals and guideline‑supported uses. Use of a denosumab product for indications not included in the FDA prescribing information or NCCN‑supported indications listed in this policy (for example, investigational or otherwise unlisted uses) is not supported unless the provider supplies clear, contemporaneous clinical justification demonstrating that the requested use is consistent with the member’s benefit and medical necessity criteria.

Administrative revision: prior policy language that referenced a Louisiana‑specific exclusion has been removed. The policy history documents the removal of the state‑specific Louisiana language; providers should follow the current Application section for remaining state applicability.

Non‑preferred denosumab products (for example, Bomyntra, Conexxence, Osenvelt, Prolia, Stoboclo, Xgeva where designated non‑preferred) are covered only when the Preferred Product Criteria are met. The Preferred Product Criteria require documentation of an adequate trial and inadequate clinical response to specified preferred products (or a documented contraindication or intolerance to all preferred products) together with a physician attestation supporting the medical need for the non‑preferred product. Failure to document these trial/exception pathways may result in non‑coverage.

The policy states that denosumab and its listed biosimilars are unproven and not medically necessary when used in combination with intravenous bisphosphonates. The policy therefore does not support concurrent administration of denosumab with IV bisphosphonates for the prevention or treatment of bone disease; such combinations are listed among the explicitly not medically necessary indications.

The policy requires objective evidence to support an osteoporosis diagnosis. Assigning an osteoporosis or osteopenia diagnostic label without meeting the fragility fracture, DXA (T‑score), or FRAX criteria outlined in the Background is not supported. Providers should ensure documentation of a qualifying fragility fracture, a DXA T‑score meeting the stated thresholds, or an appropriate FRAX calculation before requesting coverage.

Approval for denosumab requires that the patient meet the indication‑specific risk thresholds referenced in the policy. For osteoporosis this includes meeting DXA or FRAX thresholds (e.g., DXA T‑score ≤ -2.5 or T‑score between -1.0 and -2.5 with FRAX major osteoporotic fracture risk ≥ 20% or hip fracture risk ≥ 3%). For glucocorticoid‑induced osteoporosis, patients must meet the glucocorticoid exposure threshold per product labeling (e.g., daily prednisone‑equivalent dosing at or above specified values). Use of denosumab when these indication‑specific thresholds are not met is not supported by the policy unless clear, documented justification is provided.

Billing and Diagnosis Codes

Denosumab HCPCS/Q-codesHCPCS

J0897	Injection, denosumab, 1 mg. Brand Name = Prolia and Xgeva.
Q5136	Injection, denosumab (jubbonti/wyost), biosimilar, 1 mg. Brand Name = Jubbonti and Wyost.
Q5157	Injection, denosumab-bmwo (Stoboclo/Osenvelt), biosimilar, 1 mg. Brand Name = Stoboclo and Osenvelt.
Q5158	Injection, denosumab-bnht (Bomyntra/Conexxence), biosimilar, 1 mg. Brand Name = Bomyntra and Conexxence.
Q5162	Injection, denosumab-nxxp (bildyos/bilprevda), biosimilar, 1 mg. Brand Name = Bildyos and Bilprevda.

Diagnosis codes (examples; policy lists many M80.* fracture codes)ICD-10

C61	Malignant neoplasm of prostate.
C79.81	Secondary malignant neoplasm of breast.
M80.00XA	Age-related osteoporosis with current pathological fracture, unspecified site, initial encounter for fracture.
M80.00XD	Age-related osteoporosis with current pathological fracture, unspecified site, subsequent encounter for fracture with routine healing.
M80.00XG	Age-related osteoporosis with current pathological fracture, unspecified site, subsequent encounter for fracture with delayed healing.
M80.00XK	Age-related osteoporosis with current pathological fracture, unspecified site, subsequent encounter for fracture with nonunion.
M80.00XP	Age-related osteoporosis with current pathological fracture, unspecified site, subsequent encounter for fracture with malunion.
M80.00XS	Age-related osteoporosis with current pathological fracture, unspecified site, sequela.

Osteoporosis with current pathological fracture (examples)ICD-10Covered

M80.061K	Age-related osteoporosis with current pathological fracture, right lower leg, subsequent encounter for fracture with nonunion
M80.061P	Age-related osteoporosis with current pathological fracture, right lower leg, subsequent encounter for fracture with malunion
M80.061S	Age-related osteoporosis with current pathological fracture, right lower leg, sequela
M80.062A	Age-related osteoporosis with current pathological fracture, left lower leg, initial encounter for fracture
M80.062D	Age-related osteoporosis with current pathological fracture, left lower leg, subsequent encounter for fracture with routine healing
M80.062G	Age-related osteoporosis with current pathological fracture, left lower leg, subsequent encounter for fracture with delayed healing
M80.062K	Age-related osteoporosis with current pathological fracture, left lower leg, subsequent encounter for fracture with nonunion
M80.062P	Age-related osteoporosis with current pathological fracture, left lower leg, subsequent encounter for fracture with malunion
M80.062S	Age-related osteoporosis with current pathological fracture, left lower leg, sequela
M80.069A	Age-related osteoporosis with current pathological fracture, unspecified lower leg, initial encounter for fracture

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Other applicable diagnoses and metastatic/neoplasm codesICD-10Covered

M81.0	Age-related osteoporosis without current pathological fracture
M81.8	Other osteoporosis without current pathological fracture
Z79.52	Long-term (current) use of systemic steroids
Z79.811	Long-term (current) use of aromatase inhibitors
Z79.818	Long-term (current) use of other agents affecting estrogen receptors and estrogen levels
Z87.310	Personal history of (healed) osteoporosis fracture
C61	Malignant neoplasm of prostate
C79.51	Secondary malignant neoplasm of bone
C90.00	Multiple myeloma not having achieved remission
D47.02	Systemic mastocytosis

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Applicable ICD-10 Diagnosis CodesICD-10

C79.63	Secondary malignant neoplasm of bilateral ovaries.
C79.70	Secondary malignant neoplasm of unspecified adrenal gland.
C79.71	Secondary malignant neoplasm of right adrenal gland.
C79.72	Secondary malignant neoplasm of left adrenal gland.
C79.81	Secondary malignant neoplasm of breast.
C79.82	Secondary malignant neoplasm of genital organs.
C79.89	Secondary malignant neoplasm of other specified sites.
C79.9	Secondary malignant neoplasm of unspecified site.
C90.00	Multiple myeloma not having achieved remission.
C90.02	Multiple myeloma in relapse.

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Applicable HCPCS CodesHCPCSCovered

Q5162

Notified replacement HCPCS code for denosumab and related products (replaces C9399, J3490, J3590, J9999)

inv-28: BMD T-score — diagnostic thresholds

BMD T-score (osteoporosis)T-score ≤ -2.5 at lumbar spine (≥2 vertebral bodies), femoral neck/total hip, or one‑third radius

BMD range with elevated FRAXBMD T-score between -1.0 and -2.5 combined with FRAX 10‑year major fracture ≥20% or hip fracture ≥3%

Measurement methodDXA (dual‑energy x‑ray absorptiometry) at lumbar spine, hip, or one‑third radius

inv-29: FRAX 10-year fracture probability

FRAX major osteoporotic fracture10‑year probability ≥ 20%

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for denosumab products and listed biosimilars for indications described in this policy. Authorization is generally granted for no more than 12 months and reauthorization requires documentation of ongoing clinical benefit and adherence to FDA‑approved dosing.

Approval duration: up to 12 months for initial authorization and reauthorization (when criteria met).
UnitedHealthcare may use third‑party tools (e.g., InterQual) to assist in administering benefit criteria.

Prior Authorization

Prior authorization: indication confirmation

Prior authorization requests must confirm the diagnosis aligns with an FDA‑approved or guideline‑supported indication (e.g., osteoporosis, glucocorticoid‑induced osteoporosis, bone loss with ADT/aromatase inhibitors, prevention of skeletal‑related events in malignancy, giant cell tumor of bone, hypercalcemia of malignancy, systemic mastocytosis) and include clinical information supporting the indication (see required documentation bullets).

Provider must attest that the diagnosis matches an FDA‑approved or guideline‑supported indication.

Initial Authorization and Preferred Product Requirements

Preferred product exception paths

Covered when ALL of the following are met

Non-preferred override path 1: History of a trial of adequate dose and duration with both specified preferred products (e.g., Bildyos and Jubbonti OR Bilprevda and Wyost per the product group) resulting in minimal clinical response, PLUS physician attestation that clinical response would be expected to be superior with the non-preferred product.

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Non-preferred override path 2: History of contraindication, intolerance, or adverse event to both preferred products with physician attestation that the same contraindication/intolerance/adverse event would not be expected to occur with the requested non-preferred product.

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Initial Therapy

Covered when ALL of the following are met

Reauthorization and Ongoing Therapy

Reauthorization/Continuation

Reauthorization requires provider attestation of positive clinical response and continued dosing per FDA labeling; approvals are typically for no more than 12 months.

Provider attestation: Provider must attest to a positive clinical response for continuation/reauthorization requests.

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Dosing must follow FDA-approved labeling for the relevant indication.

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Authorization period: Authorization for continuation/reauthorization is for up to 12 months.

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Reauthorization/Continuation

Covered when ALL of the following are met

Step Therapy and Prior Treatment Requirements

Requirement	What to document / provider action
Documentation of trial or contraindication to preferred products
Record of specific preferred products tried (e.g., Bildyos and Jubbonti OR Bilprevda and Wyost) with adequate dose and duration and documentation of minimal clinical response
Or documentation of contraindication/intolerance/adverse event to both preferred products with physician attestation that the same issue would not be expected with the non-preferred product
Physician attestation that clinical response would be superior with the requested non-preferred product compared with preferred products (when applicable)
If applicable, documentation that patient has not had loss of favorable response after established maintenance therapy with preferred product(s)

Requirement	Details / Evidence required
Failure, intolerance, or contraindication to IV bisphosphonate therapy
Document that patient is refractory within the past 30 days, intolerant of, or has a contraindication (including renal insufficiency) to intravenous bisphosphonate(s) such as pamidronate or zoledronic acid
Dosing per FDA labeling
Authorization duration
Authorization limited to no more than 12 months when criteria met

Consideration	How it affects authorization for osteoporosis
Prior bisphosphonate use (oral)
Consider history of oral bisphosphonate therapy (e.g., alendronate, risedronate) including adequacy of dose/duration and response; trials or intolerance may influence choice to authorize denosumab for osteoporosis (Brown et al. compared denosumab vs alendronate)
Glucocorticoid-induced osteoporosis context
For patients with glucocorticoid-induced osteoporosis, trials versus risedronate are relevant; denosumab 60 mg Q6M was compared with risedronate in patients receiving ≥7.5 mg prednisone-equivalent (Saag et al.)
Document contraindication or intolerance to bisphosphonates when applicable
If oral or IV bisphosphonate therapy is contraindicated or not tolerated, document the contraindication/intolerance to support denosumab authorization

Dosing Frequency and Quantity Limits

inv-79: Denosumab dosing per FDA labeling

Denosumab osteoporosis dosing (Prolia)60 mg subcutaneously every 6 months (per FDA labeling)

Denosumab SRE prevention dosing (Xgeva)120 mg subcutaneously every month for prevention of skeletal‑related events

ApplicabilityDosing and indication depend on specific denosumab product labeling

Administration Setting Guidance

Note

Follow indication-specific dosing and site-of-care guidance

Dosing and administration differ by indication (e.g., 60 mg subcutaneously every 6 months for osteoporosis versus 120 mg monthly for SRE prevention); the drug can be administered in office or infusion clinic depending on local practice.

Note

Refer to policy and contractual terms for infusion center site-of-care

Infusion center site-of-care guidance is not specified in this section; follow federal/state/contractual requirements and the main Medical Benefit Drug Policy text for site-of-care decisions.

Preferred Products and Biosimilar Notes

Billing Rule

Preferred denosumab products require meeting diagnosis-specific criteria

Preferred denosumab products are Bildyos, Bilprevda, Jubbonti, and Wyost; coverage for these products is contingent on meeting the diagnosis-specific criteria in this policy.

Billing Rule

Use listed HCPCS/Q-codes for denosumab/biosimilars on claims

HCPCS/Q-codes for denosumab and biosimilars are listed in the policy (e.g., J0897, Q5136, Q5157, Q5158, Q5162); include the appropriate code when submitting claims.

J0897 = Injection, denosumab, 1 mg (Prolia/Xgeva)
Q5136, Q5157, Q5158, Q5162 = biosimilar denosumab Q-codes

Background and Clinical Context

Denosumab products are monoclonal antibodies that inhibit RANK ligand and are indicated for several bone disorders. They are used to treat osteoporosis, increase bone mass in high‑risk patients (including men on androgen‑deprivation therapy and women on aromatase inhibitors), prevent skeletal‑related events in patients with bone metastases or multiple myeloma, treat unresectable giant cell tumor of bone in skeletally mature patients, and manage hypercalcemia of malignancy refractory to bisphosphonates. Many covered indications require prior failure, intolerance, or contraindication to bisphosphonate therapy or adherence to product‑specific dosing schedules.

Key Definitions

inv-61: Skeletally mature adolescent

Skeletally mature adolescent definitionDefined as having at least one mature long bone (e.g., closed epiphyseal growth plate of the humerus)

Age alternativeUsed as an alternative to ≥18 years for certain oncology/giant cell tumor indications

RelevanceDetermines eligibility for indications that include skeletally mature adolescents

inv-62: Hypercalcemia of malignancy

Hypercalcemia of malignancy definitionAlbumin‑corrected serum calcium > 12.5 mg/dL (3.1 mmol/L) with no pre‑existing hypocalcemia

ContextCriterion for denosumab therapy for hypercalcemia of malignancy when refractory/contraindicated to IV bisphosphonates

Policy Changes and Revision Notes

04/01/2026policy_updateLatest

Removed Louisiana-specific language from the policy, updated applicable HCPCS codes replacing miscellaneous codes with Q5162, and archived the prior policy version CS2026D0068W.

Policy Summary

PayerUnitedHealthcare

PolicyDenosumab products (Medical Benefit Drug Policy)

Policy CodePolicy CS2026D0068X

Change TypeAdministrative updates (HCPCS code Q5162removed Louisiana applicability)

Effective DateApr 1, 2026

Next Review DateN/A

SourceLink

On This Page

Dosing and duration: Dosing per FDA labeling (e.g., 120 mg monthly for SRE prevention); authorization for no more than 12 months.

10‑year probability ≥ 3%

Use with or without BMDFRAX may be used with or without femoral neck BMD to estimate 10‑year fracture risk

inv-30: Glucocorticoid exposure

Glucocorticoid exposure thresholdPrednisone or equivalent ≥ 5 mg/day for ≥ 3 months

ContextCriterion used to define glucocorticoid‑induced osteoporosis initial therapy eligibility

DocumentationDuration and dose should be documented in prior therapy history for authorization

inv-31: Hypercalcemia serum calcium

Hypercalcemia thresholdAlbumin‑corrected serum calcium > 12.5 mg/dL (3.1 mmol/L)

Additional requirementNo pre‑existing hypocalcemia (corrected calcium within normal limits prior to event)

ContextThreshold used to define hypercalcemia of malignancy for denosumab eligibility

inv-32: BMD T-score — ≤ -1

Osteopenia/osteoporosis threshold (systemic mastocytosis section)BMD T‑score ≤ -1 at lumbar spine, hip, or one‑third radius

Alternate qualifying optionHistory of a minimal‑trauma fracture (vertebral compression, hip, distal radius, pelvis, proximal humerus)

Measurement methodBMD measured by DXA at specified sites

inv-33: DXA T-score — T-score ≤ -2.5

DXA osteoporosis thresholdT‑score ≤ -2.5 indicates osteoporosis per WHO criteria

Sites for DXA measurementLumbar spine (≥2 vertebral bodies), femoral neck, total hip, or one‑third radius

Role in coverageDXA T‑score ≤ -2.5 meets diagnostic criterion for denosumab coverage for osteoporosis indications

inv-34: FRAX 10-year probability — Major osteoporotic fracture ≥ 20% or hip fracture ≥ 3%

FRAX major fracture threshold (US)10‑year probability of major osteoporotic fracture ≥ 20%

FRAX hip fracture threshold (US)10‑year probability of hip fracture ≥ 3%

Clinical useUS clinical diagnosis of osteoporosis may be made when FRAX meets these thresholds

inv-35: FRAX 10-year probability — US clinical diagnosis threshold

US clinical diagnosis FRAX thresholdsMajor osteoporotic fracture ≥ 20% or hip fracture ≥ 3% (used to support clinical diagnosis of osteoporosis)

Role relative to DXAFRAX may diagnose osteoporosis in patients with T‑scores between -1.0 and -2.5 when thresholds exceeded

Tool descriptionFRAX estimates 10‑year probability of hip and major osteoporotic fractures

inv-36: DXA T-score — Osteoporosis defined as T-score <= -2.5

WHO definition of osteoporosisOsteoporosis defined as DXA T‑score ≤ -2.5

RequirementOther causes of low BMD should be ruled out before diagnosing osteoporosis

MeasurementDXA at lumbar spine, femoral neck, total hip, or one‑third radius

For systemic mastocytosis, authorization requires documentation of bone pain plus osteoporosis/osteopenia and intolerance/refractoriness to IV bisphosphonates.

Billing Rule

Prior authorization and billing code guidance

Use updated HCPCS and diagnosis codes on authorization requests and claims. Claims for denosumab products should use HCPCS Q5162 for unspecified denosumab and list the product‑specific NDC or HCPCS where applicable. Failure to use correct codes may delay processing.

Updated HCPCS: Q5162 should be used in lieu of legacy miscellaneous J‑codes on claim submissions.
Include applicable ICD‑10 diagnosis codes (see ICD‑10 code guidance) and product drug identifiers (NDC/HCPCS) on the request.

Denial Risk

Claims using listed diagnosis codes that do not meet policy clinical criteria may be denied

Claims submitted with listed diagnosis codes that do not meet the clinical criteria documented in this policy (including required prior therapy, contraindications, or intolerance) may be denied.

Claims using ICD‑10 codes for metastatic disease, multiple myeloma, desmoid tumors, systemic mastocytosis, hypercalcemia, and long‑term steroid/aromatase inhibitor use must be supported by the clinical documentation required by this policy.
Missing or insufficient documentation of prior bisphosphonate failure, contraindication, or intolerance is a common denial risk.

Note

FDA‑indication alignment

Coverage decisions will consider the FDA‑approved indications for each denosumab product and applicable clinical guidelines (e.g., NCCN). FDA approval alone is informational; coverage requires meeting the policy clinical criteria and applicable benefit plan terms.

Ensure the patient’s indication aligns with the specific product’s FDA label (osteoporosis vs. prevention of skeletal‑related events, giant cell tumor of bone, hypercalcemia of malignancy, etc.).
Clinical guideline recommendations (e.g., NCCN for cancer‑related indications and systemic mastocytosis) may be considered when evaluating requests.

Denial Risk

Product‑indication mismatch

Product use that does not match the FDA‑approved indication for the specific denosumab formulation (for example using an osteoporosis‑labeled product for prevention of skeletal‑related events in malignancy, or using an oncology‑labeled product for routine osteoporosis indications) may be non‑covered unless clinical justification is provided and the request meets policy criteria.

Use the product appropriate to the indication: Prolia/Bildyos/Conexxence/Jubbonti/Stoboclo formulations are for osteoporosis-related indications; Xgeva/Bilprevda/Bomyntra/Osenvelt/Wyost are oncology‑labeled for skeletal‑related events, giant cell tumor of bone, and hypercalcemia of malignancy.
Document clinical justification if a product‑indication mismatch is requested (e.g., intolerance to the labeled product and medical rationale for an alternative).

Note

Coverage decisions must reference the federal, state, or contractual benefit requirements

When applying this policy, providers must verify federal, state, and contractual benefit plan requirements because plan‑level terms may differ from the standard policy. In case of conflict, the federal, state, or contractual requirements govern.

Before submitting requests, check the member’s specific benefit plan, state mandates, and any federal program rules that may affect coverage.
UnitedHealthcare reserves the right to modify policies; refer to most current policy version and applicable contractual terms.

Documentation Required

Required clinical documentation

Required clinical documentation must accompany prior authorization requests. Provide clear records that demonstrate the diagnosis, prior therapy history, any contraindications or intolerance, current relevant lab values, bone mineral density results, and the provider attestation supporting the request.

Diagnosis: specific ICD‑10 code that corresponds to the condition being treated (see ICD‑10 code guidance).
Prior therapy: documentation of trials, failures, contraindications, or intolerance to oral and/or IV bisphosphonates when required by the policy (dates, doses, and reason for discontinuation).
Objective data: BMD T‑score(s) with anatomical site and date, or history of qualifying fragility fracture; for hypercalcemia of malignancy include albumin‑corrected serum calcium value.
Provider attestation: statement confirming diagnosis, prior therapy history, rationale for product selection, and expected benefit.
For oncology indications: expected survival ≥ 3 months where required, and documentation of refractory, contraindication, or intolerance to IV bisphosphonates.

Documentation Required

Required Clinical Documentation (additional details)

Additional required clinical details (emphasizing special situations) must be provided for certain indications and to meet step or failure criteria.

Systemic mastocytosis: bone pain plus osteoporosis/osteopenia demonstrated by BMD ≤ -1 or history of minimal‑trauma fracture, and prior refractory/contraindication/intolerance to IV bisphosphonates.
Glucocorticoid‑induced osteoporosis: history of prednisone (or equivalent) ≥ 5 mg/day for ≥ 3 months and BMD or FRAX thresholds as specified; document intolerance or failure to bisphosphonates when applicable.
Oncology indications (metastatic disease/multiple myeloma/hypercalcemia): document metastatic site (ICD‑10), expected survival ≥ 3 months, and refractory/contraindication/intolerance to IV bisphosphonates.

Billing Rule

Use of specific ICD‑10 codes for metastatic disease, multiple myeloma, desmoid tumors, systemic mastocytosis, hypercalcemia, and long‑term steroid/aromatase inhibitor use

Use the specific ICD‑10 codes listed in the policy to support the submitted diagnosis. Commonly used codes include osteoporosis (M80.*, M81.*), age‑related osteoporosis, long‑term steroid use (Z79.52), aromatase inhibitor use (Z79.811), multiple myeloma (C90.*), secondary malignant neoplasm codes (C79.*), systemic mastocytosis (D47.02), desmoid tumors (D48.11x), and hypercalcemia (E83.52).

Include the most specific ICD‑10 code available for the condition being treated (e.g., C79.51 for secondary malignant neoplasm of bone).
Claims using these ICD‑10 codes must be supported by the policy‑required clinical documentation to avoid denials.

Step Therapy

Step considerations vs bisphosphonates and Bisphosphonate Failure/Contraindication Requirement

Step therapy and bisphosphonate failure/contraindication requirements apply for many osteoporosis and oncology‑related denosumab indications. Non‑preferred denosumab products generally require prior trial and inadequate response to specified preferred products or documentation of contraindication/intolerance.

Osteoporosis/glucocorticoid‑induced osteoporosis: document trial and inadequate response to or intolerance/contraindication to oral bisphosphonates; where indicated, failure or contraindication to IV bisphosphonates must be documented.
Oncology indications and systemic mastocytosis: authorization often requires refractory/contraindication/intolerance to IV bisphosphonates (e.g., pamidronate, zoledronic acid).
Failure to document required trials or contraindications may result in non‑coverage or denial.

Initial: Diagnosis of systemic mastocytosis; AND patient has bone pain; AND osteoporosis/osteopenia defined by BMD T-score ≤ -1 at lumbar spine/hip/one-third radius OR history of qualifying minimal-trauma fracture; AND refractory to, contraindicated for, or intolerant of IV bisphosphonate therapy within the past 30 days (e.g., pamidronate, zoledronic acid); AND dosing per FDA labeling; AND authorization limited to no more than 12 months.

Initial Therapy (Osteoporosis)

Covered when ALL of the following are met

Osteoporosis dosing: Denosumab 60 mg subcutaneously every 6 months is the regimen studied and indicated for osteoporosis; follow FDA labeling for administration and monitoring. For glucocorticoid-induced osteoporosis, use in patients receiving the specified glucocorticoid dose/duration per labeling (see thresholds).

chunks 58,62,63

Continuation: Provider attests to positive clinical response; dosing per FDA labeling; authorization for up to 12 months.

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Continuation after on-treatment fracture

Covered when ALL of the following are met

Post-fracture continuation: Evidence from FREEDOM and its extension suggests continuing denosumab after an on-treatment fracture reduces risk of subsequent fractures compared with placebo; continuation may be appropriate absent other contraindications and with provider attestation.

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Select product consistent with indication-specific labeling and codes

Biosimilar and branded denosumab products are listed with HCPCS codes in the policy; product selection should match the indication-specific product labeling (e.g., Prolia labeling for osteoporosis; Xgeva and certain biosimilars for SRE prevention or giant cell tumor).

Authorization noteDosing per FDA labeling; authorization up to 12 months

inv-63: Osteoporosis or osteopenia definition for eligibility

BMD eligibility for systemic mastocytosisBMD T‑score ≤ -1 qualifies as osteoporosis/osteopenia for this indication

Alternate qualifying historyHistory of qualifying minimal‑trauma fracture (vertebral compression, hip, distal radius, pelvis, proximal humerus)

Measurement methodDXA at lumbar spine, hip, or one‑third radius

inv-64: Qualifying fracture history

Qualifying minimal‑trauma fracturesVertebral compression fracture; hip; distal radius; pelvis; proximal humerus

RelevanceThese fracture types satisfy history‑of‑fracture criteria for osteoporosis indications

DocumentationFracture history should be documented in prior authorization request

inv-65: T-score definition

T‑score definitionStandard deviation difference between patient BMD and young adult reference measured by DXA; T‑score ≤ -2.5 indicates osteoporosis

Use in policyT‑score thresholds are primary diagnostic criteria for coverage determinations

Measurement sitesLumbar spine, femoral neck, total hip, one‑third radius

inv-66: FRAX definition

FRAX definitionFracture Risk Assessment Tool estimating 10‑year probability of hip and major osteoporotic fractures, with or without femoral neck BMD

Clinical thresholds (US)Major fracture ≥20% or hip fracture ≥3% used for clinical diagnosis when combined with T‑score between -1 and -2.5

RoleUsed to supplement DXA when deciding osteoporosis diagnosis and treatment eligibility

inv-68: RANKL definition

RANKL definitionReceptor activator of nuclear factor kappa‑B ligand — mediator of osteoclast formation/function and target of denosumab

Mechanism relevanceBlocking RANKL inhibits osteoclast formation, decreasing bone resorption and increasing bone mass

Clinical relevanceRANKL signaling contributes to bone pathology in metastases and giant cell tumor of bone

inv-69: Denosumab — clinical definition

Denosumab descriptionMonoclonal antibody (RANKL inhibitor) used to treat low BMD, osteoporosis related to glucocorticoids or ADT, and to reduce skeletal‑related events in patients with bone metastases

Product differentiationDifferent denosumab products and biosimilars have indication‑specific labeling (e.g., Prolia for osteoporosis; Xgeva and certain biosimilars for SRE prevention)

Clinical actionIncreases bone mass and reduces fracture risk in indicated populations