Currentsierra health and lifePolicy 2026D0068R

Denosumab Medical Benefit Drug Policy

Defines coverage, preferred products, preferred-product substitution criteria, diagnosis-specific medical necessity criteria (postmenopausal osteoporosis, high fracture risk, glucocorticoid-induced osteoporosis), reauthorization limits, non-covered/unproven indications, and applicable HCPCS/CPT/ICD-10 codes for denosumab products for non-oncology uses.

Policy Summary

Payersierra health and life

PolicyDenosumab Medical Benefit Drug Policy

Policy CodePolicy 2026D0068R

Change TypeProduct list, preferred product criteria, Review at Launch

Effective DateJan 1, 2026

Next Review Date

Key ActionRequire members on non-preferred denosumab to switch to Prolia or Stoboclo unless Preferred Product Criteria are met (document trial/failure or intolerance with physician attestation).

POLICY UPDATE CHANGES

Bildyos, Bosaya, Conexxence, Enoby, and Ospomyv added to Review at Launch program listing.

Preferred products identified as Prolia and Stoboclo; Jubbonti typically excluded but may have coverage reviews per law or plan.

Added reference link to Medical Benefit Drug Policies including Maximum Dosage and Frequency, Medical Benefit Therapeutic Equivalent Medications - Excluded Drugs, Oncology Medication Clinical Coverage, Provider Administered Drugs - Site of Care.

Removed reference link to the Medical Benefit Drug Policy 'Review at Launch for New to Market Medications' for Jubbonti and Stoboclo.

Revised list of applicable denosumab products for non-oncology conditions: added 'any FDA-approved denosumab product not listed' and removed Osenvelt, Xgeva, and Wyost from the list.

Added language indicating Bildyos, Bosaya, Conexxence, Enoby, and Ospomyv have been added to the Review at Launch program and some members may not be eligible for coverage at this time.

In order to continue coverage, members already on Jubbonti or other non-preferred denosumab products will be required to change therapy to Prolia or Stoboclo unless they meet Preferred Product Criteria.

Preferred Product Criteria defined (trial and attestation pathways) for non-preferred denosumab products.

Policy language standardized to 'denosumab' and wording softened for some indications

Removed language indicating Jubbonti, Prolia, and Stoboclo are proven and medically necessary for androgen deprivation therapy and adjuvant aromatase inhibitor therapy, and removed prior lists of indications for Osenvelt, Wyost, and Xgeva.

Updated Clinical Evidence, FDA, CMS, and References sections to reflect the most current information; archived previous policy version 2025D0068Q.

Coverage Summary

This policy covers FDA‑approved denosumab products for non‑oncology indications, specifically treatment of postmenopausal osteoporosis and glucocorticoid‑induced osteoporosis, and defines preferred product status and substitution requirements. Prolia and Stoboclo are identified as the preferred denosumab products; Jubbonti is typically excluded (coverage reviews may apply if required by law or the benefit plan). Some denosumab biosimilars and other FDA‑approved denosumab products are included in the Review at Launch program (Bildyos, Bosaya, Conexxence, Enoby, Ospomyv listed) and some members may not be eligible for coverage pending review. The policy requires switching members on non‑preferred products to preferred products unless they meet Preferred Product Criteria, and authorization is limited to no more than 12 months per authorization threshold.

Preferred Product Criteria (Non-Preferred Product Overrides)

Preferred Product Criteria

ONE of the following (trial + attestation)
- History of a trial of adequate dose and duration of Prolia or 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 or Stoboclo.
ONE of the following (intolerance/contraindication)
- History of intolerance, contraindication, or adverse event to Prolia or Stoboclo.
- 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.

Treatment with Jubbonti or other non-preferred denosumab products is medically necessary when

ONE of the following (trial + attestation)
- History of a trial of adequate dose and duration of Prolia or 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 or Stoboclo.
ONE of the following (intolerance/contraindication)
- History of intolerance, contraindication, or adverse event to Prolia or Stoboclo.
- 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.

Non-Medical Necessity Plans / General Diagnosis-Specific Criteria

For Non-Medical Necessity plans, any denosumab product may be approved only if the requirements in the Diagnosis-Specific Criteria section are met.
Diagnosis-Specific Criteria: Denosumab (all products) is indicated for treatment of postmenopausal osteoporosis or to increase bone mass in patients with osteoporosis at high risk for fracture when ALL of the following are met: (1) diagnosis of osteoporosis; (2) 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); (3) dosing consistent with FDA-approved labeling; (4) authorization limited to no more than 12 months for initial therapy.
Reauthorization/Continuation of Care Criteria: Documentation of positive clinical response to therapy; dosing consistent with FDA-approved labeling; authorization for no more than 12 months.
Glucocorticoid-induced osteoporosis: Denosumab is proven when ALL of the following are met: (1) diagnosis of glucocorticoid-induced osteoporosis; (2) patient at high risk for fracture; (3) dosing consistent with FDA-approved labeling; (4) authorization limited to no more than 12 months. Reauthorization requires documentation of positive clinical response and dosing per FDA labeling; authorization for no more than 12 months.

Treatment with Jubbonti or other non-preferred denosumab products is medically necessary when

Preferred Product Criteria (Alternate phrasing)

ONE of the following (trial + attestation)
- History of a trial of adequate dose and duration of Prolia or Stoboclo with minimal clinical response.
- Physician attests that, in their clinical opinion, clinical response would be expected to be superior with Jubbonti or other non-preferred denosumab product compared to Prolia or Stoboclo.
ONE of the following (history of intolerance)
- History of intolerance, contraindication, or adverse event to Prolia or Stoboclo.
- Physician attests that the same intolerance, contraindication, or adverse event would not be expected to occur with Jubbonti or other non-preferred denosumab product.

Initial Therapy / Diagnosis-Specific Criteria

Any approval for a denosumab product is contingent on meeting the policy's Diagnosis‑Specific Criteria. This policy uses the term “denosumab” to refer to all FDA‑approved denosumab products (see Definitions) and coverage for any denosumab product is contingent on the coverage criteria in the Diagnosis‑Specific Criteria section.

Continuation / Reauthorization Criteria

Prior Authorization

Authorization required and limited duration

Authorization for denosumab is granted for up to 12 months. Reauthorization requires documentation of a positive clinical response to therapy and that dosing is in accordance with the U.S. Food and Drug Administration approved labeling.

Unproven / Not Covered Indications

Oncology indications for denosumab are managed under a separate Oncology Medication Clinical Coverage policy and are not covered by this non‑oncology denosumab policy.

Provider Actions

Documentation Required

Physician attestation required for non-preferred product approval

For Jubbonti or other non‑preferred denosumab products, the provider must document either a trial and inadequate response to Prolia or Stoboclo or a history of intolerance/contraindication to Prolia or Stoboclo and include a physician attestation that the intolerance/contraindication would not be expected to occur with the non‑preferred product. This requirement affects the J‑/Q‑codes listed for denosumab products and specifically applies to Q5136 (Jubbonti biosimilar) as an affected code.

Q5136

Step Therapy

Preferred product substitution requirement

Members already on non‑preferred denosumab products will be required to change therapy to the preferred products Prolia or Stoboclo to continue coverage unless they meet the Preferred Product Criteria (trial/failure of Prolia or Stoboclo with physician attestation of superiority, or intolerance/contraindication with physician attestation).

Applicable Codes

Denosumab J-codes / Q-codes (drug administration)HCPCSCovered

J0897	Injection, denosumab, 1 mg (Prolia)
Q5136	Injection, denosumab (Jubbonti), biosimilar, 1 mg
Q5157	Injection, denosumab (Stoboclo), biosimilar, 1 mg

Applicable ICD-10 Diagnosis Codes (osteoporosis and related fractures)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
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
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

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Applicable ICD-10 Diagnosis Codes (additional / covered)ICD-10Covered

M80.011A	Age-related osteoporosis with current pathological fracture, right shoulder, initial encounter for fracture
M80.011D	Age-related osteoporosis with current pathological fracture, right shoulder, subsequent encounter for fracture with routine healing
M80.011G	Age-related osteoporosis with current pathological fracture, right shoulder, subsequent encounter for fracture with delayed healing
M80.011K	Age-related osteoporosis with current pathological fracture, right shoulder, subsequent encounter for fracture with nonunion
M80.011P	Age-related osteoporosis with current pathological fracture, right shoulder, subsequent encounter for fracture with malunion
M80.011S	Age-related osteoporosis with current pathological fracture, right shoulder, sequela
M80.012A	Age-related osteoporosis with current pathological fracture, left shoulder, initial encounter for fracture
M80.012D	Age-related osteoporosis with current pathological fracture, left shoulder, subsequent encounter for fracture with routine healing
M80.022A	Age-related osteoporosis with current pathological fracture, right humerus, initial encounter for fracture
M80.022D	Age-related osteoporosis with current pathological fracture, right humerus, subsequent encounter for fracture with routine healing

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Definitions & Thresholds

Definitions: Denosumab — Refers to all denosumab products (Prolia, Stoboclo, Jubbonti, and other FDA‑approved denosumab products). Denosumab (FDA‑approved products) — Refers to all FDA‑approved denosumab products (includes biosimilars and branded products) for non‑oncology indications per this policy. Review at Launch program — Program for new‑to‑market medications where some members may not be eligible for coverage until review.

Thresholds

Authorization durationAuthorization is for no more than 12 months

FRAX 10-year probabilityMajor osteoporotic fracture >= 20% OR Hip fracture >= 3%

DXA T-score diagnostic thresholdT-score <= -2.5 for osteoporosis; T-score between -1.0 and -2.5 for osteopenia

Clinical Evidence

8.0%ADAMO: cumulative 24-month lumbar spine BMD gain with long-term denosumab (8.0%)

5.7%Orwoll: lumbar spine BMD increase at 12 months with denosumab (5.7%)

Key clinical evidence cited includes the FREEDOM and FREEDOM Extension analyses showing denosumab decreased the risk of subsequent osteoporotic fractures; the phase 3 trial by Brown JP demonstrating greater BMD increases with denosumab versus alendronate at 12 months with a similar safety profile; and the ADAMO/Orwoll studies showing denosumab increased BMD in men with low BMD and was well tolerated. FDA‑approved labeling and these trial findings inform the Diagnosis‑Specific Criteria and the reauthorization requirements in the policy.

Policy Background

Background: This policy applies to FDA‑approved denosumab products for non‑oncology uses — primarily postmenopausal osteoporosis and glucocorticoid‑induced osteoporosis — and references preferred product status (Prolia and Stoboclo) and that Jubbonti is typically excluded. Biosimilars and other FDA‑approved denosumab products are addressed; several new denosumab products (Bildyos, Bosaya, Conexxence, Enoby, Ospomyv) have been added to the Review at Launch program and some members may not be eligible for coverage pending review. Members already receiving non‑preferred denosumab products will be required to change therapy to preferred products unless they meet the Preferred Product Criteria. Oncology indications are handled under a separate oncology medication policy.

Revision History

01/01/2026effective_dateLatest

Effective date 01/01/2026. Policy revision includes multiple changes (is_material true overall).

added

Bildyos, Bosaya, Conexxence, Enoby, and Ospomyv added to the Review at Launch program; some members may not be eligible for coverage pending Review at Launch (is_material true).

clarified

Preferred products identified as Prolia and Stoboclo; Jubbonti typically excluded but coverage reviews may occur if required by law or benefit plan.