CurrentNeighborhood Health Plan of Rhode IslandPolicy 2026-A

Denosumab (Prolia and biosimilars) coverage for osteoporosis and related indications

Defines medical necessity criteria, covered indications, documentation requirements, authorization durations, continuation criteria, and clinical exceptions for denosumab (Prolia and listed biosimilars) across postmenopausal osteoporosis, osteoporosis in men, glucocorticoid-induced osteoporosis, and bone loss related to ADT or aromatase inhibitor therapy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDenosumab (Prolia and biosimilars) coverage for osteoporosis and related indications

Policy CodePolicy 2026-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization (12 months) with chart notes or medical record documentation meeting the policy clinical criteria, including fracture history, pre-treatment T-score, FRAX (if applicable), and documentation supporting ADT or aromatase inhibitor therapy when relevant.

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

5Covered Indications Listed

12Auth Duration (months)

>=1 yrBisphosphonate trial

>=7.5 mg/dayGlucocorticoid dose threshold

Scope: This policy defines medical necessity criteria, required documentation, authorization durations, continuation criteria, and clinical exceptions for denosumab (Prolia and listed biosimilars: Conexxence, Jubbonti, Ospomyv, Stoboclo) across osteoporosis-related indications. Covered indications with clinical criteria include postmenopausal osteoporosis, osteoporosis in men, glucocorticoid-induced osteoporosis, and bone loss associated with androgen deprivation therapy (ADT) or adjuvant aromatase inhibitor therapy.

Coverage stance: Denosumab (Prolia and the listed biosimilars) is covered with clinical criteria—prior authorization for up to 12 months is required and approval is granted only when submitted documentation meets the policy clinical criteria (history of fractures, pre-treatment T-score, FRAX when applicable, bisphosphonate trial or clinical reason to avoid, and for cancer-related indications documentation of ADT or aromatase inhibitor therapy). Compendial cancer-related bone-loss uses (ADT- or aromatase inhibitor–related) are included as covered when documentation supports the therapy.

Quick facts & thresholds

Covered Indications Listed5

Initial/Authorization Duration12 months

Required bisphosphonate trial duration>=1 year

Glucocorticoid dose threshold (prednisone eq.)>=7.5 mg/day

FRAX / T-score thresholdsPre-treatment T-score <= -2.5 (osteoporosis); osteopenia > -2.5 and < -1 with high FRAX (10-year major fracture risk >=20% or hip risk >3%; multiply risk by 1.15 for major fracture and 1.2 for hip fracture if glucocorticoid dose >7.5 mg/day)

Not Medically Necessary / Exclusions

Not Medically Necessary

All other indications not listed above

Not medically necessary: Any indication not FDA-approved or compendial as listed in this policy

All other indications are considered experimental/investigational and not medically necessary

Provider Actions / Prior Authorization

Prior Authorization

Authorization required

Prior authorization (12 months) required for denosumab (Prolia and listed biosimilars). Approval will be granted only when submitted documentation meets the policy clinical criteria. Approval duration: 12 months.

Approval duration: 12 months

Documentation Required

Supporting documentation required

Chart notes or medical record documentation must be submitted showing history of fractures, pre-treatment T-score, and FRAX fracture probability (if applicable). For cancer-related indications, submit chart notes, medical record documentation, or claims history supporting use of androgen deprivation therapy (ADT) or adjuvant aromatase inhibitor therapy as applicable.

Documentation Required

Bisphosphonate trial or clinical reason to avoid

When the policy criteria specify a bisphosphonate trial, documentation is required of at least a 1-year oral or injectable bisphosphonate trial. Alternatively, document a clinical reason to avoid oral bisphosphonate therapy as described in Appendix A (for example, esophageal abnormalities, active upper GI disease, malabsorption, inability to remain upright, renal insufficiency, or prior intolerance).

Background

Background: This policy governs the use of denosumab (Prolia and biosimilars Conexxence, Jubbonti, Ospomyv, and Stoboclo) for osteoporosis-related indications including postmenopausal osteoporosis, osteoporosis in men, glucocorticoid-induced osteoporosis (when receiving or initiating systemic glucocorticoids at prednisone equivalent ≥ 7.5 mg/day and expected ≥ 6 months), and to increase bone mass in patients receiving ADT for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer. The policy requires chart notes or medical record documentation (history of fractures, T-score, FRAX when applicable) and supports compendial cancer-related uses when documentation supports therapy.

Definitions

Fragility fracture definitionLow trauma fracture from force similar to a fall from standing position

High FRAX fracture probability10-year major osteoporosis-related fracture risk >= 20% OR hip fracture risk > 3%; adjust estimated risk by x1.15 for major fracture and x1.2 for hip fracture if glucocorticoid dose >7.5 mg prednisone eq./day

Osteopenia definitionPre-treatment T-score greater than -2.5 and less than -1

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDenosumab (Prolia and biosimilars) coverage for osteoporosis and related indications

Policy CodePolicy 2026-A

Change TypeNo material change

Effective Date

Next Review Date

On This Page

OpenPayer

Denosumab (Prolia and biosimilars) coverage for osteoporosis and related indications

Coverage Summary

Covered Indications / Initial Authorization (12 months)

Continuation of Therapy (12 months)

Compendial Uses (covered when criteria met)

Not Medically Necessary / Exclusions

Applicable Codes

Provider Actions / Prior Authorization

Clinical Evidence

Background

Revision History

Prolia	denosumab (brand)
Conexxence	denosumab-bnht (biosimilar)
Jubbonti	denosumab-bbdz (biosimilar)
Ospomyv	denosumab-dssb (biosimilar)
Stoboclo	denosumab-bmwo (biosimilar)