CurrentUnitedHealthcarePolicy 2026D0068S

Denosumab products for non-oncology indications (osteoporosis, glucocorticoid‑induced osteoporosis)

UnitedHealthcare medical benefit drug policy governing coverage, preferred product rules, and diagnosis-specific medical necessity criteria for denosumab products (Prolia, Stoboclo, Jubbonti and biosimilars) for non-oncology indications; includes applicable HCPCS and ICD-10 codes. Part 1 of 2.

Policy Summary

PayerUnitedHealthcare

PolicyDenosumab products for non-oncology indications (osteoporosis, glucocorticoid‑induced osteoporosis)

Policy CodePolicy 2026D0068S

Change TypeRevised criteria; HCPCS additions

Effective DateApr 1, 2026

Next Review Date

Key ActionAuthorization requests must document diagnosis, high fracture risk status or failure/intolerance to other osteoporosis therapy, dosing per FDA labeling, and (for non-preferred products) prior trial of Prolia and Stoboclo or documentation of intolerance/contraindication and physician attestation as specified.

POLICY UPDATE CHANGES

Preferred product criteria revised to require trial/intolerance to Prolia AND Stoboclo (previously OR) for coverage of non-preferred denosumab products.

Applicable HCPCS codes Q5158, Q5159, Q5161, and Q5162 were added to the applicable codes list.

2Proven indications (osteoporosis, glucocorticoid-induced)

5Unproven indications listed

7Denosumab HCPCS/Q-codes listed

HCPCS codes added/updated 04/01/2026

40+ICD-10 fracture codes listed (examples)

Coverage Summary & Scope

This UnitedHealthcare Medical Benefit Drug Policy covers denosumab products for non-oncology indications and governs coverage, preferred product rules, and diagnosis‑specific medical necessity criteria for therapies such as Prolia and Stoboclo (preferred) and non‑preferred products including Jubbonti and other denosumab biosimilars. Coverage for Prolia and Stoboclo is provided when the Diagnosis‑Specific Criteria are met; coverage for Jubbonti or other non‑preferred denosumab products requires meeting the Preferred Product Criteria (which now requires prior trial/failure or intolerance to both Prolia and Stoboclo or physician attestation as specified). For oncology indications, this policy directs readers to a separate Oncology Medication Clinical Coverage policy. New biosimilars such as Bildyos, Bosaya, Conexxence, Enoby, and Ospomyv are enrolled in UnitedHealthcare’s Review at Launch program and may be subject to limited coverage until reviewed.

Authorization duration

Authorization durationno more than 12 months

Policy number2026D0068S

Effective dateApril 1, 2026

Initial Therapy Criteria (Non-preferred denosumab / Diagnosis-specific)

Preferred Product Criteria (Non-preferred denosumab: Jubbonti or other non-preferred products)

Treatment with Jubbonti or other non-preferred denosumab products is medically necessary for the indications specified in this policy when one of the following branches is met.

ANY of the following

Trial + anticipated superior response
- History of a trial of adequate dose and duration of Prolia and Stoboclo, resulting in minimal clinical response.
- Physician attests that, in their clinical opinion, the clinical response would be expected to be superior with Jubbonti or other non-preferred denosumab product than experienced with Prolia and Stoboclo.
Intolerance/contraindication/adverse event
- History of intolerance, contraindication, or adverse event to Prolia and Stoboclo.

Reauthorization / Continuation Therapy Criteria

Reauthorization / Continuation of Care: Postmenopausal osteoporosis

Reauthorization is proven when ALL of the following are met:

ALL of the following

Positive clinical response: Documentation of positive clinical response to therapy
Dosing is in accordance with the United States Food and Drug Administration approved labeling
Authorization duration: Authorization is for no more than 12 months

Reauthorization / Continuation of Care: Glucocorticoid-induced osteoporosis

Reauthorization is proven when ALL of the following are met:

Unproven or Not Covered Indications

Unproven / Not covered indications

Denosumab is unproven for the following indications:

ANY of the following

Combination therapy with intravenous bisphosphonates
Hyperparathyroidism
Immobilization hypercalcemia
Osteogenesis imperfecta
Osteopenia

Applicable Codes

HCPCS - Denosumab products and biosimilarsHCPCSCovered

J0897	Injection, denosumab, 1 mg (Prolia)
Q5136	Injection, denosumab-bbdz (Jubbonti), biosimilar, 1 mg
Q5157	Injection, denosumab-bmwo (Stoboclo), biosimilar, 1 mg
Q5158	Injection, denosumab-bnht (Conexxence), biosimilar, 1 mg
Q5159	Injection, denosumab-dssb (Ospomyv), biosimilar, 1 mg
Q5161	Injection, denosumab-kyqq (Bosaya), biosimilar, 1 mg
Q5162	Injection, denosumab-nxxp (Bildyos), biosimilar, 1 mg

Applicable ICD-10 diagnosis codes (examples)ICD-10

M80.0AXA	Age-related osteoporosis with current pathological fracture, other site, initial encounter for fracture
M80.0AXD	Age-related osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with routine healing
M80.0AXG	Age-related osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with delayed healing
M80.0AXK	Age-related osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with nonunion
M80.0AXP	Age-related osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with malunion
M80.0AXS	Age-related osteoporosis with current pathological fracture, other site, sequela
M80.0B1A	Age-related osteoporosis with current pathological fracture, right pelvis, initial encounter for fracture
M80.0B1D	Age-related osteoporosis with current pathological fracture, right pelvis, subsequent encounter for fracture with routine healing
M80.011A	Age-related osteoporosis with current pathological fracture, right shoulder, initial encounter for fracture
M80.019A	Age-related osteoporosis with current pathological fracture, left shoulder, initial encounter for fracture (example)

1–10 of 104

1/11

HCPCS codes added/updated in revisionHCPCS

Q5136	Injection, denosumab-bbdz (Jubbonti), biosimilar, 1 mg
Q5157	Injection, denosumab-bmwo (Stoboclo), biosimilar, 1 mg
Q5158	Injection, denosumab-bnht (Conexxence), biosimilar, 1 mg
Q5159	Injection, denosumab-dssb (Ospomyv), biosimilar, 1 mg
Q5161	Injection, denosumab-kyqq (Bosaya), biosimilar, 1 mg
Q5162	Injection, denosumab-nxxp (Bildyos), biosimilar, 1 mg

Prior Authorization, Documentation & Step Therapy

Prior Authorization

Prior authorization required for denosumab

Authorization requests must document diagnosis, high fracture risk status or failure/intolerance to other osteoporosis therapy, dosing per FDA labeling, and for non-preferred products, a prior trial of Prolia and Stoboclo or documentation of intolerance/contraindication and physician attestation as specified.

J0897
Q5136
Q5157
Q5158
Q5159
Q5161
Q5162

Documentation Required

Clinical Evidence Summary

0.59FREEDOM extension hazard ratio for subsequent fracture vs placebo (0.43-0.81)

6.7Denosumab exposure-adjusted fracture incidence per 100 subject-years (FREEDOM denosumab)

3.5%Total hip BMD increase at 12 months vs alendronate (3.5% vs 2.6%, p<0.0001)

5.7%Lumbar spine BMD increase at 12 months vs placebo (Orwoll et al)

Key clinical evidence cited at the study level includes the FREEDOM extension post‑hoc fracture incidence analysis (denosumab reduced subsequent fracture risk; HR 0.59 [0.43–0.81]), the Brown JP phase 3 BMD comparison (denosumab produced greater total hip and site‑specific BMD gains versus alendronate at 12 months), the ADAMO trial in men (significant BMD increases and tolerability over 24 months), and Orwoll et al (denosumab increased lumbar spine BMD by 5.7% at 12 months versus placebo with similar adverse event rates). These are summarized as study‑level findings referenced in the policy.

Definitions & Background

Denosumab: term used in this policy to refer to all denosumab products, including branded agents and biosimilars referenced herein. FRAX: the Fracture Risk Assessment Tool that estimates 10‑year probability of hip and major osteoporotic fractures; per U.S. guidance a 10‑year major osteoporotic fracture probability ≥ 20% or a 10‑year hip fracture probability ≥ 3% may indicate an osteoporosis diagnosis. The policy also notes that oncology uses are managed under a separate oncology medication policy and that certain new biosimilars are flagged for the Review at Launch program.

Policy Revision History

04/01/2026policy_revisionLatest

Preferred product criteria revised: language changed to require prior trial or intolerance to BOTH Prolia and Stoboclo (replaced previous 'Prolia or Stoboclo' wording); physician attestation language updated to refer to Prolia AND Stoboclo.

04/01/2026codes_addedLatest

Applicable HCPCS codes Q5158, Q5159, Q5161, and Q5162 were added to the policy's applicable codes list (quarterly edits).

Policy Summary

PayerUnitedHealthcare

PolicyDenosumab products for non-oncology indications (osteoporosis, glucocorticoid‑induced osteoporosis)

Policy CodePolicy 2026D0068S

Change TypeRevised criteria; HCPCS additions

Effective DateApr 1, 2026

Next Review Date

On This Page

Physician attests that, in their clinical opinion, the same intolerance, contraindication, or adverse event would not be expected to occur with Jubbonti or other non-preferred denosumab product.

Diagnosis-Specific Criteria: Postmenopausal osteoporosis / high fracture risk

Denosumab is proven for the treatment of postmenopausal patients with osteoporosis or to increase bone mass in patients with osteoporosis at high risk for fracture when ALL of the following criteria are met:

ALL of the following

Diagnosis of osteoporosis.
Patient is at high risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors for fracture, patients who have failed or are intolerant to other available osteoporosis therapy).
Dosing is in accordance with the United States Food and Drug Administration approved labeling.
Authorization is for no more than 12 months<= 12 months

Diagnosis-Specific Criteria: Glucocorticoid-induced osteoporosis

Denosumab is proven to treat glucocorticoid-induced osteoporosis in patients at high risk for fracture when ALL of the following criteria are met:

ALL of the following

Diagnosis of glucocorticoid-induced osteoporosis.
Patient is at high risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors for fracture, patients who have failed or are intolerant to other available osteoporosis therapy).
Dosing is in accordance with the United States Food and Drug Administration approved labeling.
Authorization is for no more than 12 months<= 12 months

ALL of the following

Positive clinical response: Documentation of positive clinical response to therapy
Dosing is in accordance with the United States Food and Drug Administration approved labeling
Authorization duration: Authorization is for no more than 12 months

Reauthorization documentation

For reauthorization, provide documentation of positive clinical response to therapy and dosing consistent with FDA labeling. Reauthorizations are limited to no more than 12 months.

Step Therapy

Preferred product requirement

Members 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 documenting trial/failure or intolerance and physician attestation.

Q5136
Q5157

Documentation Required

Member-specific benefit verification

Consult the member-specific benefit plan document to determine coverage; the member plan governs in the event of a conflict.

Prior Authorization

Preferred product criteria and prior trial requirement

Coverage for non-preferred denosumab requires documented prior trial of adequate dose and duration and minimal response or intolerance/contraindication to BOTH Prolia and Stoboclo, plus physician attestation.

Documentation Required

Medicare guidance reference

For Medicare members, refer to Local Coverage Determinations/Articles (LCDs/LCAs) for Drugs and Biologicals; Medicare Part B step therapy programs may apply.