Bone Modifiers - Denosumab Products (Prolia)
Sign up for Cigna Policy IP0331 alerts
Get alerted when Policy IP0331 changes without checking for updates manually.
Defines prior authorization, medical necessity criteria, dosing, indications, and exclusions for denosumab products (Prolia and biosimilars) for Cigna-administered health benefit plans.
Added Treatment of Bone Loss in Patients with Prostate Cancer Receiving Androgen Deprivation Therapy as a new condition of approval with dosing.
Added Increase Bone Mineral Density in Patients with Breast Cancer as a new condition of approval with dosing.
Policy title updated to 'Bone Modifiers - Denosumab Products (Prolia)' and biosimilars Jubbonti and Stoboclo were added with the same criteria as Prolia.
Removed documentation requirements throughout the policy.
Added HCPCS code Q5157 effective 10/01/2025 and updated descriptions for C9399, J3490 & J3590 to indicate they are effective until 09/30/2025.
Clarified that the oral bisphosphonate or oral bisphosphonate-containing prerequisite trial should be for 12 months and added examples of inadequate efficacy and intolerance.
Coverage Criteria
1. Bone loss in breast cancer patients receiving aromatase inhibitors (FDA-approved)
Covered when ALL of the following are met
Dosing: 60 mg subcutaneously once every 6 months; Approve for 1 year.
2. Bone loss in nonmetastatic prostate cancer receiving androgen deprivation therapy (FDA-approved)
Covered when ALL of the following are met
Dosing: 60 mg subcutaneously once every 6 months; Approve for 1 year.
3. Glucocorticoid-induced osteoporosis — treatment (FDA-approved)
Covered when ALL of the following are met
Dosing: 60 mg subcutaneously once every 6 months; Approve for 1 year.
4. Osteoporosis treatment — postmenopausal (FDA-approved)
Covered when BOTH of the following are met
Dosing: 60 mg subcutaneously once every 6 months; Approve for 1 year.
5. Osteoporosis treatment in men (FDA-approved)
Covered when BOTH of the following are met
Dosing: 60 mg subcutaneously once every 6 months; Approve for 1 year.
6. Treatment of bone loss in prostate cancer receiving ADT (alternate listing)
Covered when the patient is receiving androgen deprivation therapy
Dosing: 60 mg subcutaneously once every 6 months; Approve for 1 year.
7. Increase bone mineral density in patients with breast cancer
Covered when ONE of the following is met
Dosing: 60 mg subcutaneously once every 6 months; Approve for 1 year.
8. Not Medically Necessary Uses
Denosumab products are considered not medically necessary for the following uses unless specific policy criteria are met elsewhere in the policy:
Calcium and/or vitamin D supplements are allowed in combination.
9. Added Covered Indications
Newly added conditions considered medically necessary when full policy criteria are met:
Examples of androgen deprivation therapy were added.
Examples of aromatase inhibitor therapy were added.
Use of denosumab products (Prolia and biosimilars) concurrently with other osteoporosis agents is considered not medically necessary. Examples of agents that should NOT be administered together with denosumab products include teriparatide (Forteo), abaloparatide (Tymlos), oral bisphosphonates (e.g., alendronate, risedronate, ibandronate), intravenous bisphosphonates (e.g., zoledronic acid [Reclast], IV ibandronate), calcitonin nasal spray (Miacalcin/Fortical), and romosozumab (Evenity). Calcium and/or vitamin D supplementation may be used in combination with denosumab products.
Giant cell tumor of bone is treated with a higher-dose denosumab product (Xgeva) using dosing regimens distinct from Prolia. Use of Prolia or its biosimilars at Prolia dosing for giant cell tumor of bone is not covered; Xgeva (and its biosimilars where indicated) is the product studied and indicated for unresectable giant cell tumor of bone or when surgery would cause severe morbidity.
Operationally, denosumab products (Prolia and biosimilars) are not covered when used concurrently with other osteoporosis medications, and Prolia dosing should not be used to treat giant cell tumor of bone because the GCT-B indication was studied with and is indicated for Xgeva. Additionally, denosumab products are not indicated for osteoporosis prevention and therefore are not covered for prevention-only use.
Any use of denosumab products (Prolia and biosimilars) for indications other than those explicitly listed as covered in this policy is considered not medically necessary. This includes, but is not limited to, concurrent combination therapy with other osteoporosis agents as described in the policy.
Summary of coverage exclusions: denosumab products (Prolia and biosimilars) are not covered for concurrent use with other osteoporosis medications (examples: teriparatide, abaloparatide, oral or IV bisphosphonates, calcitonin nasal spray, romosozumab), for treatment of giant cell tumor of bone using Prolia dosing (Xgeva is the indicated product), and for use solely for osteoporosis prevention.
Initial Therapy Criteria
inv-34: Initial therapy — glucocorticoid-induced osteoporosis
Initial therapy rules for glucocorticoid-induced osteoporosis
Dosing: 60 mg subcutaneously once every 6 months; Approve for 1 year.
inv-35: Initial Therapy Prerequisites
Initial therapy prerequisite updates
Zoledronic acid IV infusion was added as a prerequisite option in some indications per revisions.
Continuation of Therapy
inv-36: Continuation of therapy
Extended approvals are allowed if the patient continues to meet the Criteria and Dosing
Approvals are provided for 1 year.
inv-37: Continuation / Prerequisite Requirements
Continuation and prerequisite trial clarifications in selected revisions
Zoledronic acid IV infusion was added as a prerequisite option in some indications; IV bisphosphonates were removed as prerequisite options in other places per revisions.
Step Therapy Requirements
| Step requirement | Coverage label |
|---|---|
| Patient must have tried or be unable to take oral or IV bisphosphonates per indication-specific criteria (examples include prior trial of zoledronic acid IV, trial of ≥1 oral bisphosphonate with documented inadequate efficacy after a 12-month trial, significant intolerance to oral bisphosphonates, inability to swallow or remain upright, or severe renal impairment with evaluation for CKD-MBD). | |
| Coverage requires meeting the bisphosphonate step requirement as described; denosumab is covered with criteria met. |
| Prerequisite trial | Coverage label |
|---|---|
| Trial of an oral bisphosphonate or an oral bisphosphonate–containing product for 12 months is required in applicable indications unless there is documented inadequate efficacy or significant intolerance (examples of inadequate efficacy include ongoing significant BMD loss, lack of BMD increase, or occurrence of an osteoporotic/fragility fracture; examples of intolerance include severe GI or musculoskeletal adverse events). | |
| Coverage requires fulfillment of the 12-month oral bisphosphonate prerequisite when applicable; denosumab is covered if prerequisite met or appropriate exception documented. |
Coding
| J0897 | Injection, denosumab, 1 mg (example HCPCS used commonly for Prolia) |
| C9399 | Unclassified drugs or biologicals (Effective until 09/30/2025) |
| J0897 | Injection, denosumab, 1 mg |
| J3490 | Unclassified drugs (Effective until 09/30/2025) |
| J3590 | Unclassified drugs or biologicals (Effective until 09/30/2025) |
| Q5136 | Injection, denosumab-bbdz (jubbonti/wyost), biosimilar, 1 mg |
| Q5157 | Injection, denosumab-bmwo (stoboclo/osenvelt), biosimilar, 1 mg (Effective Date 10/01/2025) |
Provider Actions & Authorization
Prior Authorization Recommended
Prior Authorization is recommended for medical benefit coverage of denosumab products (Prolia and biosimilars). Approvals are granted for 1 year when the patient meets the policy Criteria and Dosing. Requests for doses outside the dosing documented in this policy will be reviewed case-by-case by a clinician (Medical Director or Pharmacist).
- All approvals provided for 1 year in duration
- Out-of-range doses considered case-by-case by clinician
Codes Requiring Authorization
Prior authorization is required for denosumab products billed with the listed HCPCS/NDC-like codes. Note that certain miscellaneous/unclassified codes are effective only through 09/30/2025; a new HCPCS (Q5157) becomes effective 10/01/2025.
Step Requirements vs Bisphosphonates
For many indications (including glucocorticoid-induced osteoporosis, postmenopausal osteoporosis, and osteoporosis in men), patients must have tried or be unable to take oral or IV bisphosphonates before denosumab is approved. The policy specifies acceptable prerequisite options and exceptions.
- Prerequisite options include zoledronic acid intravenous infusion (Reclast) where specified, or at least one oral bisphosphonate or oral bisphosphonate-containing product
- Patients must have tried or be unable to take oral/IV bisphosphonates as detailed in indication-specific criteria
Prerequisite Bisphosphonate Trial
Prerequisite oral bisphosphonate trial requirements have been clarified to specify a 12-month trial duration. Examples of inadequate efficacy (e.g., ongoing significant BMD loss, lack of BMD increase, or occurrence of osteoporotic/fragility fracture) and examples of significant intolerance (e.g., severe GI or musculoskeletal adverse events) were added.
- Oral bisphosphonate or oral bisphosphonate-containing trial duration: 12 months
- Examples of inadequate efficacy: ongoing/ significant BMD loss, lack of BMD increase, osteoporotic or fragility fracture
- Examples of significant intolerance: severe gastrointestinal or severe musculoskeletal adverse events
Authorization and Documentation Requirements
Prior authorization is recommended and approvals are for 1 year. Dosing, frequency, duration, and site of care should be reasonable and supported by evidence-based literature; receipt of sample product does not satisfy criteria. Documentation requirements were removed operationally from the policy; however, requests may still be reviewed for clinical appropriateness.
- Approvals provided for 1 year
- Out-of-range dosing requests reviewed case-by-case
- Receipt of sample product does not satisfy criteria
Documentation Changes
Documentation requirements were removed throughout the policy as an operational change; clinicians will continue to assess requests against the stated clinical criteria.
- Documentation requirements removed from policy (operational change)
Coding-Based Denial Risk
Claims submitted without a covered diagnosis or procedure code listed in this policy will be denied as not covered. Providers must use the most appropriate codes as of the date of service.
- Claims lacking covered diagnosis/procedure codes will be denied as not covered
- Use most appropriate codes as of the submission effective date
Concurrent Use with Other Osteoporosis Medications
Denosumab products should not be used concurrently with other osteoporosis medications (e.g., teriparatide, abaloparatide, oral or IV bisphosphonates, calcitonin nasal spray, romosozumab). Concurrent use for osteoporosis is considered not medically necessary. This does not exclude use of calcium and/or vitamin D supplements with denosumab.
- Examples of medications not to combine with denosumab: teriparatide (Forteo), abaloparatide (Tymlos), oral bisphosphonates (alendronate, risedronate, ibandronate), IV bisphosphonates (zoledronic acid/Reclast, ibandronate), calcitonin nasal spray (Miacalcin/Fortical), and romosozumab (Evenity)
- Calcium and/or vitamin D supplements may be used in combination with denosumab
Quantity Limits & Dosing
Site of Care
Site of care options
Site of care options include office, infusion center, or home; the site should be reasonable and clinically appropriate and adjusted based on severity and prior response.
- Coding and drug supply codes for infusion center billing are provided elsewhere in the policy.
Site of care coding note (infusion center)
Infusion center is an available site of care; the policy provides coding and drug supply codes for billing denosumab in applicable settings.
Biosimilars
Prolia and biosimilars covered with same criteria
Prolia and listed biosimilars (Jubbonti, Stoboclo) are covered denosumab products and are subject to the same dosing and criteria in this policy.
- Standard dosing for covered indications is 60 mg subcutaneously once every 6 months.
Jubbonti added and covered
Jubbonti (denosumab‑bbdz) was added to the policy and is covered with the same criteria and dosing as Prolia.
Stoboclo added and Q5157 effective 10/01/2025
Stoboclo (denosumab‑bmwo) was added to the policy and is covered with the same criteria and dosing as Prolia; HCPCS Q5157 references this biosimilar and becomes effective 10/01/2025.
- Q5157 (Injection, denosumab‑bmwo) effective date: 10/01/2025.
Definitions
Background
Denosumab products (Prolia and biosimilars) are monoclonal antibody RANKL inhibitors indicated to increase bone mass and reduce fracture risk across multiple settings, including postmenopausal osteoporosis, osteoporosis in men at high fracture risk, bone loss related to androgen deprivation or aromatase inhibitor therapy, and glucocorticoid-induced osteoporosis. The typical Prolia dosing is 60 mg subcutaneously every 6 months with approvals generally granted for 1 year when criteria are met.
Revision History
HCPCS code Q5157 (denosumab biosimilar Stoboclo) added with effective date 10/01/2025; descriptions for C9399, J3490, and J3590 updated to note effectiveness until 09/30/2025.
Policy title updated to 'Bone Modifiers - Denosumab Products (Prolia)'; biosimilars Jubbonti and Stoboclo added and aligned with Prolia criteria; documentation requirements removed; examples of aromatase inhibitor and androgen deprivation therapies added.
Added indications: 'Treatment of Bone Loss in Patients with Prostate Cancer Receiving Androgen Deprivation Therapy' and 'Increase Bone Mineral Density in Patients with Breast Cancer' with dosing; added zoledronic acid IV as a prerequisite option and added oral bisphosphonate-containing products as prerequisite options.
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.