Modifiedsierra health and lifePolicy 2026D0068S

Denosumab (Prolia, biosimilars) medical benefit drug policy — non-oncology coverage criteria

Defines medical necessity, preferred product rules, diagnosis-specific coverage criteria, and applicable billing codes for denosumab products for non-oncology indications for UnitedHealthcare Commercial members (Sierra Health and Life). Affects providers requesting authorization for denosumab formulations including branded and biosimilar products.

Policy Summary

Payersierra health and life

PolicyDenosumab (Prolia, biosimilars) medical benefit drug policy — non-oncology coverage criteria

Policy CodePolicy 2026D0068S

Change TypePreferred product criteria revisedcoding updates

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document prior trials of both Prolia and Stoboclo (or documented intolerance/contraindication) plus physician attestation when requesting a non-preferred denosumab.

SourceLink

POLICY UPDATE CHANGES

Preferred product criteria changed to require prior trial of Prolia and Stoboclo (both) rather than Prolia or Stoboclo (either).

Physician attestation requirement revised to compare expected superiority against Prolia and Stoboclo (both) rather than Prolia or Stoboclo (either).

Intolerance/contraindication criterion revised to require history of intolerance, contraindication, or adverse event to Prolia and Stoboclo (both).

HCPCS codes Q5158, Q5159, Q5161, and Q5162 were added; descriptions for Q5136 and Q5157 were revised.

2Preferred products

12 monthsMax authorization

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Coverage Criteria for Denosumab

Preferred Product Criteria

Treatment with Jubbonti or other non-preferred denosumab products is medically necessary when ONE of the following paired conditions is met:

Preferred product exception paths

Path A: Trial and physician attestation: History of a trial of adequate dose and duration of Prolia and Stoboclo resulting in minimal clinical response; AND physician attests that the clinical response would be expected to be superior with Jubbonti or other non-preferred denosumab product compared with Prolia and Stoboclo.
Prior trial must include BOTH preferred products (Prolia and Stoboclo).
Path B: Intolerance/contraindication and physician attestation: History of intolerance, contraindication, or adverse event to Prolia and Stoboclo; AND physician attests that the same intolerance/contraindication/adverse event would not be expected to occur with Jubbonti or other non-preferred denosumab product.
Intolerance/contraindication must be documented for BOTH Prolia and Stoboclo.

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Diagnosis-Specific Criteria

Denosumab is covered when ALL of the following are met for the specified indication:

Initial Therapy - Osteoporosis: Diagnosis of osteoporosis; AND patient is at high risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors for fracture, or failed/intolerant to other available osteoporosis therapy); AND dosing is in accordance with FDA-approved labeling; AND authorization is for no more than 12 months.

Reauthorization - Osteoporosis: Documentation of positive clinical response to therapy; AND dosing is in accordance with FDA-approved labeling; AND authorization is for no more than 12 months.

Initial Therapy - Glucocorticoid-induced Osteoporosis: Diagnosis of glucocorticoid-induced osteoporosis; AND patient is at high risk for fracture (examples as above); AND dosing is in accordance with FDA-approved labeling; AND authorization is for no more than 12 months.

Reauthorization - Glucocorticoid-induced Osteoporosis:

Unproven/Not Supported Indications

Denosumab is considered unproven (not supported by this policy) for the following indications:

Unproven Indications: Combination therapy with intravenous bisphosphonates; Hyperparathyroidism; Immobilization hypercalcemia; Osteogenesis imperfecta; Osteopenia.

These indications are listed as unproven in the policy.

Medical necessity for denosumab

Covered when documentation supports an osteoporosis diagnosis or related pathological fracture and clinical rationale for denosumab therapy

Primary coverage criteria: Member has diagnosis of osteoporosis or pathological fracture (see listed ICD-10 codes) AND one of the following: DXA T-score ≤ -2.5 OR presence of fragility/pathological fracture OR FRAX 10-year probability meeting US thresholds (major osteoporotic fracture ≥20% or hip fracture ≥3%).DXA T-score ≤ -2.5; FRAX major ≥20% or hip ≥3%

Clinical documentation (DXA, FRAX, or fracture history) required; denosumab mechanism (RANKL inhibition) supports use to reduce bone resorption.

FDA-labeled Indications

Covered when consistent with FDA indications and clinical trial-supported uses:

FDA-indicated uses: Treatment of postmenopausal women with osteoporosis at high risk for fracture; increase bone mass in men with osteoporosis at high risk for fracture; treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture; increase bone mass in men receiving androgen deprivation therapy for nonmetastatic prostate cancer; increase bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer.

Based on FDA prescribing information for Prolia, Jubbonti, and Stoboclo.

Supporting Clinical Evidence

Clinical evidence supporting efficacy:

Key trial findings: Denosumab increased BMD versus alendronate and showed reduced risk of subsequent osteoporotic fractures in FREEDOM and its extension; trials in men demonstrated increases in BMD and acceptable safety over 12–24 months.60 mg Q6M

See FREEDOM analyses and randomized phase 3 trials cited in the policy.

For oncology indications, refer to the Medical Benefit Drug Policy titled Oncology Medication Clinical Coverage and the NCCN Drugs & Biologics Compendium. This denosumab policy addresses non-oncology uses only and does not define coverage criteria for oncology therapy; oncology-related requests should be evaluated under the referenced oncology policy and compendia.

This policy segment does not list explicit broad exclusions beyond the stated scope; specific contraindications or exclusions referenced in product labeling are addressed by individual prescribing information and may be considered during medical review.

Coverage for experimental, investigational, or other unproven treatments may be permitted only when the member-specific benefit plan or applicable state mandates require it. Review the member's certificate of coverage and any state-specific mandates to determine whether an otherwise unproven use may be authorized.

Use of denosumab for indications listed as unproven in this policy — for example, combination therapy with intravenous bisphosphonates, hyperparathyroidism, immobilization hypercalcemia, osteogenesis imperfecta, and osteopenia — is not supported by this policy and will generally be considered not medically necessary unless the member's benefit or applicable mandate dictates otherwise.

Absence of supporting diagnostic documentation (such as an applicable ICD-10 diagnosis from the M80.*, M81.*, Z78.*, or Z79.* groups) or absence of required clinical data (e.g., DXA T-score, FRAX probability, fragility fracture history) may result in the request being deemed not medically necessary due to insufficient documentation to support denosumab therapy.

FDA approval is provided for informational context only. FDA approval alone is not a basis for coverage; authorization requires that the member also meet the policy's clinical criteria and documentation requirements to establish medical necessity.

Applicable Billing and Diagnosis Codes

Applicable HCPCS CodesHCPCS

J0897	Injection, denosumab, 1 mg. Brand Name = Prolia.
Q5136	Injection, denosumab-bbdz (jubbonti/wyost), biosimilar, 1 mg. Brand Name = Jubbonti.
Q5157	Injection, denosumab-bmwo (stoboclo/osenvelt), biosimilar, 1 mg. Brand Name = Stoboclo.
Q5158	Injection, denosumab-bnht (bomyntra/conexxence), biosimilar, 1 mg. Brand Name = Conexxence.
Q5159	Injection, denosumab-dssb (ospomyv/xbryk), biosimilar, 1 mg. Brand Name = Ospomyv.
Q5161	Injection, denosumab-kyqq (aukelso/bosaya), biosimilar, 1 mg. Brand Name = Bosaya.
Q5162	Injection, denosumab-nxxp (bildyos/bilprevda), biosimilar, 1 mg. Brand Name = Bildyos.

Applicable ICD-10 CodesICD-10

M80.*

Multiple ICD-10 codes for age-related osteoporosis with current pathological fracture (various sites and encounter types) as listed in the policy.

Applicable ICD-10 Codes (selected examples from long list)ICD-10

M80.051A	Age-related osteoporosis with current pathological fracture, right femur, initial encounter for fracture
M80.051D	Age-related osteoporosis with current pathological fracture, right femur, subsequent encounter for fracture with routine healing
M80.051G	Age-related osteoporosis with current pathological fracture, right femur, subsequent encounter for fracture with delayed healing
M80.051K	Age-related osteoporosis with current pathological fracture, right femur, subsequent encounter for fracture with nonunion
M80.051P	Age-related osteoporosis with current pathological fracture, right femur, subsequent encounter for fracture with malunion
M80.051S	Age-related osteoporosis with current pathological fracture, right femur, sequela
M80.052A	Age-related osteoporosis with current pathological fracture, left femur, initial encounter for fracture
M80.059A	Age-related osteoporosis with current pathological fracture, unspecified femur, initial encounter for fracture
M80.08XA	Age-related osteoporosis with current pathological fracture, vertebra(e), initial encounter for fracture
M80.811A	Other osteoporosis with current pathological fracture, right shoulder, initial encounter for fracture

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Applicable HCPCS Codes (updated)HCPCS

Q5136	Revised description (per policy history)
Q5157	Revised description (per policy history)
Q5158	Added (per policy history)
Q5159	Added (per policy history)
Q5161	Added (per policy history)
Q5162	Added (per policy history)

inv-17: DXA T-score — threshold value used in diagnostic criteria

DXA T-score thresholdT-score ≤ -2.5 defines osteoporosis (WHO diagnostic threshold)

DXA measurement sitesLumbar spine, femoral neck, total hip, or one-third radius used for T-score assessment

Osteopenia range (context)T-score between -1.0 and -2.5 indicates osteopenia

inv-18: FRAX 10-year probability — thresholds supporting clinical diagnosis

FRAX major osteoporotic fracture thresholdFRAX 10-year probability ≥ 20% (major osteoporotic fracture)

FRAX hip fracture threshold

Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization required for non-preferred denosumab products (e.g., Jubbonti and other non-preferred denosumab). Requests for coverage must document trials of preferred products and meet the Diagnosis-Specific Criteria. Coverage for Prolia and Stoboclo is contingent on meeting the Diagnosis‑Specific Criteria; members already receiving a non-preferred product may be required to change to a preferred product unless they meet the exceptions below.

Prior authorization required when billing non-preferred denosumab for osteoporosis or related pathological fracture.
Authorization limited to a maximum of 12 months per approval period for initial and reauthorization requests.

Denial Risk

Non-preferred Product Denial Risk

Requests for non-preferred denosumab that do not document required trials of Prolia and Stoboclo or the physician attestation described in Preferred Product Criteria are at high risk for denial.

Initial Therapy Criteria and Evidence

Initial Therapy Criteria

Initial therapy coverage conditions

Initial Therapy - Osteoporosis: Diagnosis of osteoporosis; patient is at high risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors, or failed/intolerant to other available osteoporosis therapy); dosing is in accordance with FDA-approved labeling; authorization up to 12 months.

Denosumab refers to all denosumab products; dosing per labeling.

Initial Therapy - Glucocorticoid-induced Osteoporosis: Diagnosis of glucocorticoid-induced osteoporosis; patient is at high risk for fracture; dosing is in accordance with FDA-approved labeling; authorization up to 12 months.

Initial therapy

Initiation criteria

Initiation:

Reauthorization and Continuation of Care

Reauthorization / Continuation of Care

Reauthorization requires documentation

Reauthorization/Continuation: Documentation of positive clinical response to therapy; dosing is in accordance with FDA-approved labeling; authorization limited to no more than 12 months.

Clinical documentation must be provided at reauthorization to demonstrate benefit.

Continuation therapy

Continuation supported when initial clinical benefit and ongoing indication persist.

Continuation criteria: Ongoing treatment with denosumab or biosimilar may continue if member has prior approval and clinical response/stability; clinical documentation should demonstrate ongoing need (e.g., fragility fracture prevention, continued low BMD, or fracture history).

Document prior authorization and evidence of response where required.

Step Therapy Requirements

Requirement	Description	Coverage Label
Physician attestation of superiority
Physician attests that, in their clinical opinion, the clinical response would be expected to be superior with the requested non-preferred denosumab (e.g., Jubbonti) than experienced with Prolia and Stoboclo.
Coverage contingent on attestation

Requirement	Description	Coverage Label
Physician attestation re: intolerance/contraindication
Physician attests that the same intolerance, contraindication, or adverse event would not be expected to occur with the requested non-preferred denosumab (e.g., Jubbonti) compared to Prolia and Stoboclo.
Coverage contingent on attestation

Step-Therapy Requirement	Description	Coverage Label
Prior step-therapy specified
No explicit prior step-therapy requirements are described in this segment of the policy (diagnosis-specific criteria and general authorization rules apply).
Neutral

Step-Therapy Requirement	Description	Coverage Label
Prior trial or intolerance to preferred denosumab products
Approval of a non-preferred denosumab requires history of trial of adequate dose and duration of both Prolia and Stoboclo with minimal clinical response, or history of intolerance/contraindication/adverse event to both Prolia and Stoboclo, supported by physician attestation as specified in policy.
Coverage contingent on prior trials/intolerance

Quantity and Dosing Limits

inv-51: Denosumab dosing — 60 mg (trial dosing used in Prolia studies)

Trial dosing used in Prolia studiesDenosumab 60 mg subcutaneously every 6 months (Q6M)

Route of administrationSubcutaneous injection

Efficacy endpoint context60 mg Q6M produced significant BMD increases vs comparator in phase 3 trials

Site of Care and Medicare Considerations

Note

Site of care not specified in this policy segment

The policy segment does not specify a site‑of‑care restriction; site‑of‑care requirements are not specified here and should be confirmed elsewhere if needed.

Note

Medicare site‑of‑care and Part B considerations

For Medicare members, outpatient injectable denosumab furnished 'incident to' a physician's service may be covered under Part B; check the member's benefit and applicable Medicare rules.

Medicare Advantage members should also be checked for Part B Step Therapy Program applicability.

Preferred Products and Biosimilar Notes

Billing Rule

Prolia and Stoboclo are preferred products

Prolia and Stoboclo are identified as the preferred denosumab products; coverage for these products is provided when diagnosis‑specific criteria are met.

Billing Rule

Jubbonti is typically non‑preferred/excluded

Jubbonti is typically excluded and treated as non‑preferred; exceptions may be considered only if the Preferred Product Criteria are satisfied.

Billing Rule

Biosimilars recognized; same RANKL mechanism

The policy recognizes denosumab biosimilars; they share the same mechanism and RANKL target as the reference product.

Background

Denosumab and its biosimilars are RANKL inhibitors that reduce osteoclast formation and bone resorption, resulting in increased bone mass and strength. The products have FDA-labeled non-oncology indications including treatment of postmenopausal osteoporosis in women at high risk for fracture, increasing bone mass in men with osteoporosis at high risk for fracture, and treatment of glucocorticoid-induced osteoporosis in patients at high fracture risk. Medical review for coverage requires documentation of an osteoporosis diagnosis or related pathological fracture and demonstration of fracture risk consistent with diagnostic thresholds (for example, DXA T-score ≤ -2.5 or FRAX 10-year probability meeting US thresholds: major osteoporotic fracture ≥ 20% or hip fracture ≥ 3%), as described in the policy.

Definitions and Key Terms

inv-34: Denosumab — policy refers to all denosumab products (branded and biosimilars) collectively as 'denosumab'.

Collective referenceAll denosumab products (branded and biosimilars) are referred to collectively as 'denosumab' within the policy

Includes biosimilarsPolicy scope includes Prolia and denosumab biosimilars (e.g., Jubbonti, Stoboclo, others)

Implication for documentationClinical and authorization criteria apply to any FDA‑approved denosumab product

inv-35: T-score — definition and threshold for osteoporosis (≤ -2.5)

Osteoporosis definition (T-score)T-score ≤ -2.5 (standard deviation below young adult reference) defines osteoporosis

Measurement sitesDiagnosis applies when T-score ≤ -2.5 at lumbar spine, femoral neck, total hip, or one-third radius

Policy Summary

Payersierra health and life

PolicyDenosumab (Prolia, biosimilars) medical benefit drug policy — non-oncology coverage criteria

Policy CodePolicy 2026D0068S

Change TypePreferred product criteria revisedcoding updates

Effective DateApr 1, 2026

Next Review DateN/A

SourceLink

On This Page

Documentation Required

Diagnosis Code Requirement

A supported diagnosis corresponding to the policy’s listed ICD-10 codes must be submitted with the request. Use of denosumab without a matching covered diagnosis may result in denial.

Include the applicable diagnosis code(s) (e.g., osteoporosis or related pathological fracture codes) on the prior authorization and claim.
Requests without a listed, policy-supported diagnosis code may be returned or denied.

Documentation Required

DXA / FRAX Documentation

Document bone mineral density (DXA) results and/or FRAX 10‑year fracture probability consistent with diagnostic thresholds when indicated. The policy follows WHO/FRAX thresholds for osteoporosis/high fracture risk.

Provide DXA T-score (lumbar spine, femoral neck, total hip, or one‑third radius). A T-score ≤ -2.5 supports a diagnosis of osteoporosis.
If DXA T-score is between -1.0 and -2.5, provide FRAX showing 10‑year probability ≥20% for major osteoporotic fracture or ≥3% for hip fracture, or documentation of prior fragility fracture.

Documentation Required

Required Plan‑level Documentation

Coverage determinations must be made in the context of the member-specific benefit plan. When there is any conflict between this policy and the member’s plan or federal/state mandates, the member‑specific benefit plan or applicable mandate governs.

Verify member benefits and any applicable federal or state mandates before approving therapy.
For Medicare Advantage members, review Medicare Part B Step Therapy Programs and applicable LCD/LCA guidance.

Step Therapy

Preferred Product Step Requirement

Coverage for non-preferred denosumab requires prior trial and inadequate response to BOTH Prolia and Stoboclo, or documentation of intolerance/contraindication to BOTH, plus the treating physician’s attestation that clinical response would be superior with the non‑preferred product.

Document prior trials of adequate dose and duration of Prolia and Stoboclo with minimal clinical response, OR document intolerance/contraindication to both.
Include physician attestation that the non-preferred denosumab is expected to provide superior clinical response compared with both Prolia and Stoboclo.

Initial Therapy Evidence

Initial therapy evidence and dosing used in trials

Typical trial dosing: Denosumab 60 mg subcutaneously every 6 months demonstrated significant BMD increases and favorable safety compared with comparators in trials of postmenopausal women and men with low BMD.60 mg Q6M

Used across multiple cited randomized trials (Brown et al, Langdahl et al, Orwoll et al).