CurrentCareSourcePolicy N/A

Denosumab products (Prolia and biosimilar) coverage for osteoporosis and bone loss indications

This policy defines prior authorization criteria and coverage conditions for denosumab products (Prolia and its biosimilar Jubbonti) for treatment of osteoporosis, glucocorticoid-induced osteoporosis, and bone loss related to breast and prostate cancer. It applies to medical-benefit coverage review for members whose plans use this CareSource policy (national—no states specified).

Policy Summary

PayerCareSource

PolicyDenosumab products (Prolia and biosimilar) coverage for osteoporosis and bone loss indications

Policy CodePolicy N/A

Change TypeTerminology updates and additions (Jubbonti added, criteria reorganized)

Effective Date10/23/2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of prior bisphosphonate trials or clinical reasons for not using them, and document CKD‑MBD evaluation for patients with severe renal impairment.

SourceLink

POLICY UPDATE CHANGES

Jubbonti (denosumab-bbdz) was added to the policy with the same criteria as Prolia and the policy name was changed to denote denosumab products.

Wording throughout the policy was changed from 'Prolia' to 'denosumab products (Prolia, biosimilar)'.

Glucocorticoid-induced osteoporosis, postmenopausal osteoporosis, and osteoporosis in men: criteria regarding exceptions for prior bisphosphonate trial were reorganized and the requirement to evaluate for CKD-MBD in severe renal impairment added.

Treatment of bone loss in patients with prostate cancer receiving androgen deprivation therapy and increase BMD in patients with breast cancer were added to 'Other Uses with Supportive Evidence' with dosing.

60 mgStandard dose every 6 months

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Default approval duration

4Primary FDA‑approved indication groups covered

Boxed WarningHypocalcemia risk in advanced CKD/CKD‑MBD

Authorization Criteria for Denosumab Products

FDA‑Approved Indications — Breast Cancer (Bone Loss during Aromatase Inhibitor Therapy)

Approve 60 mg SC every 6 months when ALL of the following are met:

ALL of the following

Patient has breast cancer that is not metastatic to bone
Patient is receiving aromatase inhibitor therapy (examples: anastrozole, letrozole, exemestane)

FDA‑Approved Indications — Prostate Cancer (Bone Loss during Androgen Deprivation Therapy)

Approve 60 mg SC every 6 months for 1 year when ALL of the following are met:

ALL of the following

Patient has prostate cancer that is not metastatic to bone
ONE of:
- Patient is receiving androgen deprivation therapy (examples: leuprolide, triptorelin, goserelin, relugolix)
- Patient has undergone bilateral orchiectomy

FDA‑Approved Indications — Glucocorticoid‑Induced Osteoporosis (Treatment)

Approve 60 mg SC every 6 months for 1 year when ALL of the following are met:

ALL of the following

Patient is initiating or continuing systemic glucocorticoids (daily prednisone equivalent >= 7.5 mg) and expected to remain on glucocorticoids for at least 6 months>= 7.5 mg prednisone daily for >= 6 months
ONE of:
- Patient has tried zoledronic acid IV (Reclast)
- Patient has tried at least one oral bisphosphonate and meets ONE of the following:
  - According to the prescriber, patient experienced inadequate efficacy after a trial of 12 months (examples: continued BMD loss, lack of BMD increase, or osteoporotic/fragility fracture)

FDA‑Approved Indications — Osteoporosis Treatment (Postmenopausal Women)

Approve 60 mg SC every 6 months when ALL of the following are met:

ALL of the following

ONE of:
- T-score (current or any time in the past) <= -2.5 at lumbar spine, femoral neck, total hip, and/or 33% radius<= -2.5
- Patient has had an osteoporotic fracture or fragility fracture
- Both:
  - Patient has low bone mass (T-score between -1.0 and -2.5)

FDA‑Approved Indications — Osteoporosis Treatment (Men)

Approve 60 mg SC every 6 months for 1 year when ALL of the following are met:

ALL of the following

ONE of:
- T-score (current or any time in the past) <= -2.5 at lumbar spine, femoral neck, total hip, and/or 33% radius<= -2.5
- Patient has had an osteoporotic fracture or fragility fracture
- Both:
  - Patient has low bone mass (T-score between -1.0 and -2.5)

Other Uses with Supportive Evidence

Coverage considered (approve 60 mg SC every 6 months for 1 year) when specified conditions are met:

ANY of the following

Therapy for patients receiving androgen deprivation therapy (listed as supportive; directs to EviCore if client uses EviCore)
Increase bone mineral density in patients with breast cancer (postmenopausal or premenopausal on estrogen deprivation) per stated subcriteria

Not Recommended for Approval

Denosumab products are not recommended for approval in the following situations:

ANY of the following

Concurrent use with other medications for osteoporosis (examples: teriparatide, abaloparatide, oral or IV bisphosphonates, calcitonin nasal spray, romosozumab). Note: calcium and/or vitamin D supplements are permitted in combination.
Use for indications not listed in the Recommended Authorization Criteria (including prevention of osteoporosis)
Use in giant cell tumor of bone should follow Xgeva dosing—Prolia dosing is not appropriate for that indication.

Relevant Codes for Billing Denosumab Products

HCPCS codes for denosumab products (administration/drug)HCPCS

J0897

Injection, denosumab, 1 mg (commonly used billing code for Prolia/Xgeva dosing conversions)

Prior Authorization and Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for medical‑benefit coverage of denosumab products (HCPCS J0897). All approvals are provided for 1 year in duration. Requests for dosing outside the policy dosing (60 mg subcutaneously every 6 months) will be reviewed on a case‑by‑case basis by a clinician.

HCPCS: J0897
Standard dosing: 60 mg SC every 6 months
Approvals: 1 year; off‑label dosing reviewed case‑by‑case

Documentation Required

Clinical documentation of prior therapies or contraindications

Document in the medical record trials of specified bisphosphonates (oral or IV) or clinical reasons the patient cannot use them. Acceptable documentation includes inadequate efficacy after a 12‑month trial, significant intolerance, inability to swallow, inability to remain upright after administration, or a pre‑existing gastrointestinal condition.

Clinical Background and Safety Considerations

Denosumab products (Prolia and biosimilar Jubbonti) are RANKL inhibitors indicated to increase bone mass and reduce fracture risk in high‑risk patients, including treatment of postmenopausal osteoporosis, osteoporosis in men at high risk, glucocorticoid‑induced osteoporosis, and bone loss in patients with breast or prostate cancer receiving hormone‑deprivation therapies. (See FDA‑approved and supportive indications.)

For the covered indications, the standard dosing is 60 mg subcutaneously every 6 months. Approvals provided under this policy are generally for a 1‑year duration when criteria are met; requests for dosing outside the established 60 mg every 6 months regimen will be reviewed case‑by‑case by a clinician.

There is a Boxed Warning for severe hypocalcemia with denosumab products, with patients who have advanced chronic kidney disease (CKD) and those with chronic kidney disease–mineral and bone disorder (CKD‑MBD) at particular risk. Before initiating denosumab in patients with advanced CKD, evaluate for the presence of CKD‑MBD, and ensure management is supervised by a clinician experienced in CKD‑MBD to mitigate the risk of denosumab‑induced severe hypocalcemia.

Defined Terms

Definitions

High risk of fractureHistory of osteoporotic fracture, multiple fracture risk factors, or failure/intolerance to other available osteoporosis therapy (as determined by prescriber).

Significant intolerance to oral bisphosphonateSevere gastrointestinal‑related adverse events and/or severe musculoskeletal‑related adverse events as reported by the prescriber.

CKD‑MBD evaluationClinical assessment for chronic kidney disease‑mineral and bone disorder to identify and mitigate risk factors for denosumab‑induced hypocalcemia; perform evaluation in patients with severe renal impairment/CKD prior to starting denosumab.

Policy Changes and Material Updates

05/14/2025Selected revision — terminology and product additionLatest

Jubbonti (denosumab-bbdz) was added to the policy with the same criteria as Prolia and wording throughout the policy was changed to refer to denosumab products (Prolia, biosimilar); policy name updated to 'Bone Modifiers Denosumab Products (Prolia)'.

10/23/2024Annual revision — new supportive indications & CKD‑MBD evaluation added

Treatment of bone loss in patients with prostate cancer receiving androgen deprivation therapy and increasing BMD in patients with breast cancer were added to 'Other Uses with Supportive Evidence' with dosing; criteria for severe renal impairment were combined and a requirement to evaluate for chronic kidney disease‑mineral and bone disorder (CKD‑MBD) was added to reduce risk of denosumab‑induced hypocalcemia.

Policy Summary

PayerCareSource

PolicyDenosumab products (Prolia and biosimilar) coverage for osteoporosis and bone loss indications

Policy CodePolicy N/A

Change TypeTerminology updates and additions (Jubbonti added, criteria reorganized)

Effective Date10/23/2024

Next Review DateN/A

SourceLink

On This Page

According to the prescriber, patient experienced significant intolerance to an oral bisphosphonate (examples: severe GI adverse events or severe musculoskeletal adverse events)

Patient cannot take an oral bisphosphonate due to inability to swallow, difficulty remaining upright after administration, or pre-existing esophageal/gastrointestinal condition (examples: esophageal lesions, ulcers, strictures, achalasia)

Patient has severe renal impairment or chronic kidney disease and has been evaluated for chronic kidney disease-mineral and bone disorder (CKD-MBD) to reduce risk of denosumab-induced hypocalcemia; OR patient has had an osteoporotic or fragility fracturecreatinine clearance ≈ 35 mL/min

CKD-MBD evaluation required for severe renal impairment to mitigate hypocalcemia risk

According to the prescriber, patient is at high risk for fracture

High risk defined as history of osteoporotic fracture, multiple risk factors, or failure/intolerance to other therapies

ONE of (trial/failure/intolerance exceptions):

Patient has tried IV ibandronate (Boniva) or zoledronic acid (Reclast)
Patient has tried at least one oral bisphosphonate and meets ONE of the following:
- According to the prescriber, inadequate efficacy after 12 months12 months
- According to the prescriber, significant intolerance to an oral bisphosphonate
Patient cannot take oral bisphosphonates due to swallowing difficulty, inability to remain upright, or pre-existing GI condition
Patient has severe renal impairment or CKD and has been evaluated for CKD-MBD to reduce hypocalcemia risk; OR patient has had an osteoporotic/fragility fracturecreatinine clearance ≈ 35 mL/min
CKD-MBD evaluation required for severe renal impairment to mitigate hypocalcemia risk

According to the prescriber, patient is at high risk for fracture

ONE of (trial/failure/intolerance exceptions):

Patient has tried zoledronic acid IV (Reclast)
Patient has tried at least one oral bisphosphonate and meets ONE of the following:
- According to the prescriber, inadequate efficacy after 12 months12 months
- According to the prescriber, significant intolerance to an oral bisphosphonate
Patient cannot take oral bisphosphonates due to swallowing difficulty, inability to remain upright, or pre-existing GI condition
Patient has severe renal impairment or CKD and has been evaluated for CKD-MBD to reduce hypocalcemia risk; OR patient has had an osteoporotic/fragility fracturecreatinine clearance ≈ 35 mL/min
CKD-MBD evaluation required for severe renal impairment to mitigate hypocalcemia risk

Document trial of at least one oral bisphosphonate or IV zoledronic acid (Reclast)
If trialed: note inadequate efficacy after 12 months (examples: ongoing BMD loss, lack of BMD increase, or osteoporotic/fragility fracture)
If not tolerated or unable to take oral bisphosphonate: document significant intolerance (severe GI or musculoskeletal adverse events), inability to swallow, inability to remain upright, or pre‑existing GI condition (e.g., esophageal lesions, ulcers, strictures, achalasia)

Documentation Required

Evaluation for CKD‑MBD

For patients with severe renal impairment or chronic kidney disease, document an evaluation for chronic kidney disease‑mineral and bone disorder (CKD‑MBD) to reduce the risk of denosumab‑induced hypocalcemia. The policy gives a creatinine clearance example of ≈35 mL/min for severe renal impairment.

Document CKD‑MBD evaluation when patient has severe renal impairment (example: CrCl ≈ 35 mL/min)
Note that CKD‑MBD presence greatly increases hypocalcemia risk and denosumab in these patients should be supervised by a provider experienced in CKD‑MBD management

Denial Risk

Concurrent osteoporosis therapy contraindicated

Requests for concurrent use of denosumab with other osteoporosis medications are not recommended and may be denied.

Concurrent use examples: teriparatide, abaloparatide, oral or IV bisphosphonates, calcitonin nasal spray, romosozumab (Evenity)
Calcium and/or vitamin D supplements are permitted in combination

09/27/2023Annual revision — CKD‑MBD evaluation and wording updates

Exceptions related to trials of bisphosphonates for severe renal impairment/CKD were revised and combined, the phrase 'according to the prescriber' was added, and a requirement to evaluate for CKD‑MBD to reduce Prolia‑induced hypocalcemia risk was included.