UnitedHealthcare denosumab Coverage Update

Coverage Criteria — Denosumab (non-oncology indications)

Initial Therapy - Postmenopausal Osteoporosis

Covered when ALL of the following are met for postmenopausal osteoporosis:

Postmenopausal osteoporosis initial therapy: Diagnosis of osteoporosis; 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); dosing is in accordance with FDA-approved labeling; authorization limited to no more than 12 months.

Reauthorization - Postmenopausal Osteoporosis

Reauthorization/Continuation of Care Criteria for osteoporosis:

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

Initial Therapy - Glucocorticoid-Induced Osteoporosis

Covered when ALL of the following are met for glucocorticoid-induced osteoporosis:

Glucocorticoid-induced osteoporosis initial therapy: Diagnosis of glucocorticoid-induced osteoporosis; 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); dosing is in accordance with FDA-approved labeling; authorization limited to no more than 12 months.

Reauthorization - Glucocorticoid-Induced Osteoporosis

Reauthorization/Continuation of Care Criteria for glucocorticoid-induced osteoporosis:

Glucocorticoid-induced osteoporosis continuation: Documentation of positive clinical response to therapy; dosing is in accordance with FDA-approved labeling; authorization limited to no more than 12 months.

Preferred Product Exception Criteria

Preferred Product Criteria for use of non-preferred denosumab (e.g., Jubbonti):

Non-preferred product approval pathways: Either (1) both: history of a trial of adequate dose and duration of Prolia or Stoboclo resulting in minimal clinical response; and physician attests clinical response would be expected to be superior with the non-preferred denosumab product than experienced with Prolia or Stoboclo; OR (2) both: history of intolerance, contraindication, or adverse event to Prolia or Stoboclo; and physician attests the same intolerance/contraindication/adverse event would not be expected to occur with the non-preferred denosumab product.

Physician attestation required.

Preferred Product Criteria

Preferred Product Criteria — denosumab (non-oncology indications)

Trial plus attestation: Both of the following: history of a trial of adequate dose and duration of Prolia or Stoboclo resulting in minimal clinical response; and physician attests that clinical response would be expected to be superior with Jubbonti or other non-preferred denosumab product than experienced with Prolia or Stoboclo.
Intolerance/contraindication plus attestation: Both of the following: history of intolerance, contraindication, or adverse event to Prolia or Stoboclo; and physician attests that the same intolerance, contraindication, or adverse event would not be expected to occur with Jubbonti or other non-preferred denosumab product.

The policy specifies that denosumab is unproven for several indications outside the covered osteoporosis uses. Specifically, denosumab is considered unproven for: combination therapy with intravenous bisphosphonates, hyperparathyroidism, immobilization hypercalcemia, osteogenesis imperfecta, and osteopenia. These uses are not supported as medically necessary under this policy.

Policy language was standardized to use the generic term denosumab rather than listing multiple brand-specific proven indications. Previously included statements that certain brands (for example, Jubbonti, Prolia, Stoboclo, Osenvelt, Wyost, and Xgeva) were proven and medically necessary for a number of oncology and non-oncology indications were removed from the policy and archived in the Policy History.

Consistent with the exclusions, the policy states explicitly that denosumab is not medically necessary (unproven) for the following indications: combination therapy with intravenous bisphosphonates, hyperparathyroidism, immobilization hypercalcemia, osteogenesis imperfecta, and osteopenia. The Policy History further clarifies that previous brand-specific listings were removed and the language was revised to indicate the class-level statement that denosumab is unproven for the listed indications.

The previous policy versions included explicit, brand-specific lists of unproven or not medically necessary indications for certain denosumab products (for example, denosumab-bbdz and denosumab-bmwo). Those historical listings — which named indications such as bone loss associated with hormone-ablation therapy (other than aromatase inhibitors), cancer pain, central giant cell granuloma, hyperparathyroidism, immobilization hypercalcemia, osteogenesis imperfecta, and osteopenia — were removed during this revision and are recorded in the Policy History.

Coding — HCPCS and ICD-10

Denosumab HCPCS CodesHCPCS

J0897	Injection, denosumab, 1 mg. Brand Name = Prolia.
Q5136	Injection, denosumab (jubbonti/wyost), biosimilar, 1 mg. Brand Name = Jubbonti.
Q5157	Injection, denosumab (stoboclo/osenvelt), biosimilar, 1 mg. Brand Name = Stoboclo.

Applicable ICD-10 Codes (excerpt shown)ICD-10

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.

Applicable ICD-10 Codes (excerpt)ICD-10

M80.041S	Age-related osteoporosis with current pathological fracture, right hand, sequela.
M80.042A	Age-related osteoporosis with current pathological fracture, left hand, initial encounter for fracture.
M80.042D	Age-related osteoporosis with current pathological fracture, left hand, subsequent encounter for fracture with routine healing.
M80.042G	Age-related osteoporosis with current pathological fracture, left hand, subsequent encounter for fracture with delayed healing.
M80.042K	Age-related osteoporosis with current pathological fracture, left hand, subsequent encounter for fracture with nonunion.
M80.042P	Age-related osteoporosis with current pathological fracture, left hand, subsequent encounter for fracture with malunion.
M80.042S	Age-related osteoporosis with current pathological fracture, left hand, sequela.
M80.049A	Age-related osteoporosis with current pathological fracture, unspecified hand, initial encounter for fracture.

Applicable ICD-10 Codes (continued)ICD-10

M80.049D	Age-related osteoporosis with current pathological fracture, unspecified hand, subsequent encounter for fracture with routine healing.
M80.049G	Age-related osteoporosis with current pathological fracture, unspecified hand, subsequent encounter for fracture with delayed healing.
M80.049K	Age-related osteoporosis with current pathological fracture, unspecified hand, subsequent encounter for fracture with nonunion.
M80.049P	Age-related osteoporosis with current pathological fracture, unspecified hand, subsequent encounter for fracture with malunion.
M80.049S	Age-related osteoporosis with current pathological fracture, unspecified hand, sequela.
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.

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Applicable ICD-10 CodesICD-10

M80.869K	Other osteoporosis with current pathological fracture, unspecified lower leg, subsequent encounter for fracture with nonunion.
M80.869P	Other osteoporosis with current pathological fracture, unspecified lower leg, subsequent encounter for fracture with malunion.
M80.869S	Other osteoporosis with current pathological fracture, unspecified lower leg, sequela.
M80.871A	Other osteoporosis with current pathological fracture, right ankle and foot, initial encounter for fracture.
M80.871D	Other osteoporosis with current pathological fracture, right ankle and foot, subsequent encounter for fracture with routine healing.
M80.871G	Other osteoporosis with current pathological fracture, right ankle and foot, subsequent encounter for fracture with delayed healing.
M80.871K	Other osteoporosis with current pathological fracture, right ankle and foot, subsequent encounter for fracture with nonunion.
M80.871P	Other osteoporosis with current pathological fracture, right ankle and foot, subsequent encounter for fracture with malunion.
M80.871S	Other osteoporosis with current pathological fracture, right ankle and foot, sequela.
M80.872A	Other osteoporosis with current pathological fracture, left ankle and foot, initial encounter for fracture.

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Authorization duration — authorization limit

Authorization limitAuthorization is for no more than 12 months for both initial therapy and reauthorization/continuation of care.

Applies to indicationsAuthorization duration applies to postmenopausal osteoporosis and glucocorticoid‑induced osteoporosis when criteria are met.

Dosing requirementApproval contingent on dosing in accordance with US FDA‑approved labeling.

DXA T-score threshold — T-score criteria for osteoporosis/osteopenia

Osteoporosis thresholdT‑score ≤ -2.5 SD defines osteoporosis (when other causes of low BMD are ruled out).

Provider Actions — Authorization, Documentation, Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for denosumab products. Initial approvals are limited to no more than 12 months; reauthorization/continuation approvals are also granted for no more than 12 months at a time.

Authorization duration: ≤12 months for initial and continuation therapy
Prior authorization required — verify member-specific benefits before submission

Denial Risk

Preferred-Product Transition and Coverage Risk

Prolia and Stoboclo are the preferred denosumab products. Members already receiving non-preferred denosumab (e.g., Jubbonti or other non-preferred products) may be required to transition to Prolia or Stoboclo to continue coverage unless they meet the Preferred Product Criteria. Remaining on a non-preferred product without meeting criteria may result in denial or loss of coverage.

Initial Therapy Requirements

Initial Therapy

Initial therapy requirements for covered non‑oncology indications:

Initial Therapy (umbrella): Diagnosis of osteoporosis or glucocorticoid-induced osteoporosis as applicable; patient at high risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors for fracture, or failed/intolerant to other available osteoporosis therapy); dosing per FDA-approved labeling; authorization for no more than 12 months.

Clinical evidence for initiation

Clinical trial evidence and supporting data for initiation:

Clinical evidence summary: Randomized phase 3 trials demonstrated denosumab 60 mg subcutaneously every 6 months increases bone mineral density versus placebo and versus alendronate, with greater BMD gains and reduction in bone turnover markers; adverse event rates were similar to comparators.

Dose and schedule referenced from trials (60 mg Q6M).

Continuation and Reauthorization Criteria

Continuation Therapy

Reauthorization conditions for continued coverage:

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

Continuation/Transition

Rules when switching from non-preferred to preferred products:

Continuation/transition rule: Members already on Jubbonti or other non-preferred denosumab products will be required to change therapy to Prolia or Stoboclo unless they meet the Preferred Product Criteria.

Physician attestation and documentation of prior trial or intolerance to preferred products required when requesting continuation of non-preferred product.

Step Therapy Requirements

Step	Requirement	Exception(s)
1	Trial of a preferred denosumab product (Prolia or Stoboclo) at an adequate dose and duration with minimal clinical response documented	Documentation of intolerance, contraindication, or adverse event to Prolia or Stoboclo with physician attestation that the same would not be expected with the non-preferred product; or physician attestation that clinical response would be expected to be superior with the non-preferred denosumab

Step	Prior requirement	Approval pathway for non-preferred denosumab
1	Prior trial of Prolia or Stoboclo (adequate dose and duration) with documented minimal clinical response	Approve non-preferred denosumab only if: (A) physician attests clinical response would be superior with the non-preferred product despite prior preferred-product trial; OR (B) documented intolerance/contraindication/adverse event to Prolia or Stoboclo with physician attestation that the same would not be expected with the non-preferred product

Quantity and Dosing Limits

denosumab — dose referenced and quantity limits

Reference doseDenosumab dosing referenced from clinical trials: 60 mg subcutaneous every 6 months (Q6M).

Quantity limit (per policy)Quantity limits reference 60 mg per dosing interval — one 60 mg dose per 6 months as used in trials and FDA labeling.

Dosing basisDosing and quantity limits tied to FDA‑approved labeling and trial regimens (60 mg Q6M).

Site of Care and Administration

Note

Medicare Part B coverage and site-of-care considerations

Medicare Part B coverage and site-of-care considerations apply; refer to member-specific plan documents and applicable CMS LCDs/LCAs for Part B administration and site-of-care rules.

Medicare has no NCD for denosumab; check local LCDs/LCAs and the member's plan for Part B step therapy where applicable.

Biosimilar / Preferred Product Notes

Billing Rule

Prolia (J0897) — non-preferred biosimilar handling

Prolia (J0897) is the reference product; non-preferred biosimilars such as Jubbonti are typically excluded and require meeting Preferred Product Criteria for coverage.

J0897 = Injection, denosumab, 1 mg (Prolia).
Jubbonti (Q5136) is typically excluded from coverage unless criteria are met or required by law/plan.

Billing Rule

Stoboclo (Q5157) — preferred and conditionally covered

Stoboclo (Q5157) is listed as a preferred denosumab product and is covered contingent on meeting the diagnosis‑specific criteria in the policy.

Q5157 = Injection, denosumab (Stoboclo), biosimilar, 1 mg.
Coverage for Stoboclo is subject to the Diagnosis‑Specific Criteria in the policy.

Background

Denosumab is an antiresorptive, monoclonal antibody targeting RANK ligand used to reduce bone resorption and increase bone mass in patients at high risk for fracture. In this policy context, denosumab’s non-oncology role is focused on treatment of osteoporosis, including postmenopausal and glucocorticoid-induced osteoporosis; other potential uses identified in prior versions of the policy have been reviewed and in several cases classified as unproven. Clinical dosing and application should follow FDA labeling and the specific coverage criteria in this policy.

Definitions and Thresholds

High risk for fracture — definition and examples

Definition — high risk for fractureHigh risk for fracture: history of osteoporotic fracture, multiple risk factors for fracture, or failure/intolerance to other available osteoporosis therapy.

Examples — prior fractureHistory of an osteoporotic fragility fracture supports high fracture risk.

Examples — therapy failure/intolerancePatients who have failed or are intolerant to other available osteoporosis therapies are considered at high risk.

Examples — treatment contextsHigh risk definition used for postmenopausal osteoporosis, men with osteoporosis, and glucocorticoid‑induced osteoporosis per FDA indications.

FRAX — fracture risk assessment tool and US thresholds

Tool description

OpenPayer

Denosumab (non-oncology indications) — Medical Benefit Drug Policy