CurrentAdvanced HealthPolicy N/A

Denosumab (Prolia) Drug Use Criteria

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This policy governs prior authorization and renewal of Prolia (denosumab) for osteoporosis and selected cancer-treatment-related bone loss indications. Coverage is limited to members meeting specified fracture-risk, alternative-treatment, biosimilar-preference, clinical-benefit, and monitoring requirements.

Policy Summary

PayerAdvanced Health

PolicyDenosumab (Prolia) Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewOct 8, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document an eligible indication, required alternative-treatment steps, and preferred-biosimilar failure or adverse reaction before requesting Prolia.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsMaximum approval period

7.5 mg/dayGlucocorticoid threshold

≤ -3.0T-score threshold without fractures

>30% / >4.5%FRAX thresholds

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CurrentAdvanced HealthPolicy N/A

Denosumab (Prolia) Drug Use Criteria

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Policy Summary

PayerAdvanced Health

PolicyDenosumab (Prolia) Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewOct 8, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document an eligible indication, required alternative-treatment steps, and preferred-biosimilar failure or adverse reaction before requesting Prolia.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsMaximum approval period

7.5 mg/dayGlucocorticoid threshold

≤ -3.0T-score threshold without fractures

>30% / >4.5%FRAX thresholds

Preferred biosimilar

Coverage Criteria

Post-menopausal osteoporosis

Covered initial therapy when the member meets the post-menopausal osteoporosis pathway and completes the required authorization steps.

Qualifying osteoporosis circumstance
- Radiographic fracture pathway: Member has radiographic evidence of an osteoporotic fracture while compliant with an oral bisphosphonate.Oral bisphosphonate use ≥12 months
- Very-high-risk intolerance pathway
  - Very high fracture risk: Member is at very high risk of fracture as defined in Table 1.See Very High Risk of Fracture criteria
  - Oral bisphosphonate intolerance or contraindication
    Member has a documented adverse event with an oral bisphosphonate despite proper administration.
    Member has a contraindication to oral bisphosphonates, including previous hypersensitivity, esophageal abnormality, hypocalcemia, inability to stand or sit upright for 30 minutes, or history of bariatric surgery.

Glucocorticoid-induced osteoporosis

Covered initial therapy when the member meets the glucocorticoid-induced osteoporosis pathway and completes the required authorization steps.

Member has glucocorticoid-induced osteoporosis and is receiving prednisone 7.5 mg per day or equivalent.Prednisone ≥7.5 mg/day equivalent for ≥6 months
Qualifying glucocorticoid osteoporosis circumstance
- Radiographic fracture pathway: Member has radiographic evidence of an osteoporotic fracture while compliant with an oral bisphosphonate.Oral bisphosphonate use ≥12 months
- High-risk intolerance pathway
  - Member is at high risk of fracture.

Cancer-treatment-related and male osteoporosis

Covered initial therapy when the member has an eligible diagnosis, very high fracture risk, and meets the required alternative-treatment sequence.

Cancer-treatment-related or male osteoporosis

Eligible diagnosis or treatment circumstance
- Member has non-metastatic prostate cancer and is receiving androgen deprivation therapy.
- Member has breast cancer and is receiving adjuvant aromatase inhibitor therapy.
- Member is male with osteoporosis.
Very high fracture risk: Member is at very high risk of fracture as defined in Table 1.See Very High Risk of Fracture criteria

Very high risk of fracture

Very high risk of fracture is established when the member meets any one of the following conditions.

Very high fracture risk definition

Member has multiple fragility fractures.
Member has a T-score of -2.0 or less and a fragility fracture.T-score ≤ -2.0 plus fragility fracture
Member has a T-score of -3.0 or less without fractures.T-score ≤ -3.0
Member has sustained fractures while receiving approved osteoporosis therapy.

Continuation therapy

Covered renewal when all continuation requirements are met.

Continued clinical benefit
- Bone mineral density is stable or improved with Prolia.
- Member has had no new osteoporotic fractures.
Monitoring and adherence
- Member is adherent to calcium and vitamin D supplementation.
- Member completes regular laboratory monitoring.

Off-label use is not a covered benefit of OHP. Prolia requests must meet one of the policy’s covered indications and associated clinical criteria.

For the applicable pathway, the member must have tried and failed or have a contraindication to zoledronic acid (Zometa), the preferred least-cost alternative, before Prolia can be approved.

Before Prolia is approved, the member must have documented treatment failure or an adverse reaction to preferred Jubbonti (denosumab-bbdz).

Authorization and Documentation Requirements

Prior Authorization

Initial Prolia Authorization Required

Prior authorization is required for initial Prolia therapy. Coverage may be considered when the member meets a qualifying clinical pathway, fracture-risk requirement, and applicable prerequisite-therapy requirements.

Post-menopausal osteoporosis with an osteoporotic fracture despite at least 12 months of compliant oral bisphosphonate therapy, or very high fracture risk plus oral bisphosphonate adverse event or contraindication.
Glucocorticoid-induced osteoporosis with prednisone 7.5 mg/day or equivalent for at least 6 months, an applicable fracture-risk pathway, and oral bisphosphonate adverse event or contraindication.
Non-metastatic prostate cancer receiving androgen-deprivation therapy, breast cancer receiving adjuvant aromatase-inhibitor therapy, or male osteoporosis, with very high fracture risk.
Initial approval, when criteria are met, may be granted for up to 12 months.

Prior Authorization

Renewal Authorization Requirements

For renewal, document continued clinical benefit and confirm that the member remains adherent to supplementation and laboratory monitoring. Renewal approval may be granted for up to 12 months when all requirements are met.

Clinical Background

Prolia (denosumab) is a monoclonal antibody that binds RANK ligand and inhibits osteoclast formation, function, and survival. By reducing bone resorption, it increases bone mass and strength and helps reduce bone loss.

Policy Definitions

FRAX

MeaningFracture Risk Assessment Tool used to estimate fracture probability.

Major osteoporotic fracture thresholdFRAX score greater than 30%.

Hip fracture thresholdFRAX score greater than 4.5%.

T-score

MeaningBone-density measurement used to define very high fracture risk.

With a fragility fractureT-score of -2.0 or less plus a fragility fracture.

Without a fractureT-score of -3.0 or less in the absence of fractures.

Initial Therapy Criteria

Initial indication

Initial Prolia therapy requires one eligible clinical pathway followed by the applicable alternative-treatment and preferred-product requirements.

Eligible initial indication

Post-menopausal osteoporosis pathway is met, including the applicable fracture and oral-bisphosphonate criteria.
Glucocorticoid-induced osteoporosis pathway is met, including prednisone 7.5 mg per day or equivalent for at least 6 months and the applicable fracture-risk and oral-bisphosphonate criteria.Prednisone ≥7.5 mg/day equivalent for ≥6 months
Member has non-metastatic prostate cancer receiving androgen deprivation therapy, breast cancer receiving adjuvant aromatase inhibitor therapy, or male osteoporosis with very high fracture risk.

Zoledronic acid and Jubbonti requirements

Continuation and Renewal Criteria

Renewal criteria

Renewal is available when both continued benefit and monitoring/adherence requirements are met.

Prolia renewal

Continued benefit
- Bone mineral density is stable or improved with Prolia.
- Member has had no new osteoporotic fractures.
Monitoring and adherence
- Member is adherent to calcium and vitamin D supplementation.
- Member completes regular laboratory monitoring.

Required Treatment Sequence

Step	Preferred therapy	Requirement before Prolia
2	Jubbonti (denosumab-bbdz)	Document treatment failure or an adverse reaction to Jubbonti.

Step	Preferred therapy	Requirement before Prolia
1	Zoledronic acid (Zometa)	Document that the member tried and failed or has a contraindication to zoledronic acid.

Preferred Denosumab Biosimilar

Billing Rule

Use preferred denosumab biosimilar before Prolia

Jubbonti (denosumab-bbdz) is the preferred least-cost denosumab biosimilar. Prolia requires documented treatment failure or an adverse reaction to Jubbonti.

Policy Summary

PayerAdvanced Health

PolicyDenosumab (Prolia) Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewOct 8, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document an eligible indication, required alternative-treatment steps, and preferred-biosimilar failure or adverse reaction before requesting Prolia.

SourceLink

On This Page

Oral bisphosphonate intolerance or contraindication

Member has a documented adverse event with an oral bisphosphonate despite proper administration.
Member has a contraindication to oral bisphosphonates, including previous hypersensitivity, esophageal abnormality, hypocalcemia, or inability to stand or sit upright for 30 minutes.

Alternative-treatment requirements

Member has tried and failed or has a contraindication to zoledronic acid (Zometa).
Member has experienced treatment failure or an adverse reaction to preferred Jubbonti (denosumab-bbdz).

Member has sustained fractures while taking medications causing skeletal harm, such as long-term glucocorticoids.

Member has a high risk for falls or a history of injurious falls, very high fracture probability, and a FRAX score greater than 30% for major osteoporotic fracture or greater than 4.5% for hip fracture.FRAX >30% for major osteoporotic fracture or >4.5% for hip fracture

Stable or improved bone mineral density (BMD) or absence of new osteoporotic fractures.
Adherence to calcium and vitamin D supplementation.
Regular laboratory monitoring.

Step Therapy

Zoledronic Acid Prerequisite

Before Prolia is approved for the applicable initial pathways, document that the member has tried and failed zoledronic acid or has a contraindication to it.

Document treatment failure or intolerance with zoledronic acid (Zometa), including relevant clinical details.
If there has been no trial, failure, or contraindication, direct the member to the preferred least-costly alternative, zoledronic acid.

Step Therapy

Preferred Biosimilar Prerequisite

For applicable initial requests, document treatment failure or an adverse reaction to the preferred biosimilar Jubbonti (denosumab-bbdz) before requesting Prolia.

If the member has not failed or had an adverse reaction to Jubbonti, change treatment to the preferred least-costly biosimilar.
Document the specific treatment failure or adverse reaction and its clinical impact.

Documentation Required

Initial Clinical Documentation

Submit clinical documentation supporting the qualifying diagnosis, fracture risk, relevant fracture or imaging history, adherence, and prior treatment history.

Identify the applicable diagnosis: post-menopausal osteoporosis, glucocorticoid-induced osteoporosis, non-metastatic prostate cancer receiving ADT, breast cancer receiving adjuvant AI therapy, or male osteoporosis.
For glucocorticoid-induced osteoporosis, document prednisone 7.5 mg/day or equivalent for at least 6 months.
Provide radiographic evidence of an osteoporotic fracture when required and document compliance with oral bisphosphonate therapy for at least 12 months.
Document very high fracture risk, as applicable: multiple fragility fractures; T-score ≤ -2.0 with a fragility fracture; T-score ≤ -3.0 without fracture; fracture while on approved osteoporosis therapy; fracture while taking medications causing skeletal harm; or high fall risk/injurious falls with FRAX probability >30% for major osteoporotic fracture or >4.5% for hip fracture.
Document oral bisphosphonate adverse events despite proper administration or a contraindication, such as hypersensitivity, esophageal abnormality, hypocalcemia, inability to remain upright for 30 minutes, or history of bariatric surgery.

Documentation Required

Preferred-Alternative Documentation

Include complete evidence supporting failure, intolerance, or contraindication to both preferred alternatives when those prerequisites apply.

For zoledronic acid, document the trial and treatment failure, intolerance, or contraindication.
For Jubbonti (denosumab-bbdz), document treatment failure or adverse reaction, including the drug exposure and clinical outcome.
A request lacking the required preferred-alternative documentation may be denied or redirected to the preferred therapy.

Documentation Required

Renewal Clinical Documentation

For continued Prolia coverage, document that the member continues to benefit from treatment and has not developed a new osteoporotic fracture.

Provide follow-up BMD results showing stability or improvement, when available.
Document absence of new osteoporotic fractures or explain any fracture-related reassessment.

Denial Risk

Initial Criteria Not Met

Deny the initial request when the member does not meet the qualifying diagnosis or fracture-risk criteria, or when required prerequisite therapies have not been addressed.

No qualifying diagnosis or indication is documented.
Required radiographic fracture, osteoporosis, glucocorticoid exposure, or very-high-fracture-risk evidence is absent.
The member has not tried and failed or does not have a contraindication to zoledronic acid.
The member has not experienced treatment failure or an adverse reaction to preferred biosimilar Jubbonti.

Denial Risk

Uncovered or Off-Label Indication

Prolia is not covered for off-label or otherwise nonqualifying indications under this policy. Requests outside the defined osteoporosis, glucocorticoid-induced osteoporosis, prostate cancer/ADT, breast cancer/adjuvant AI, or male osteoporosis pathways should be denied.

The member must also satisfy the applicable fracture-risk and prerequisite-treatment criteria.
A diagnosis alone does not establish coverage when the required risk or alternative-therapy criteria are not met.

Denial Risk

Renewal Requirements Not Met

Deny renewal when continued benefit has not been demonstrated or when required reassessment, supplementation, or laboratory monitoring is absent.

No stable or improved BMD, no documented continued benefit, or a new osteoporotic fracture without required reassessment.
Nonadherence to calcium and vitamin D supplementation.
Failure to complete regular laboratory monitoring.
Reassessment is required when treatment benefit is not demonstrated.

Fragility fracture

MeaningFracture resulting from a low-trauma event.

Very-high-risk markerA fragility fracture combined with a T-score of -2.0 or less establishes a very-high-fracture-risk pathway.

Multiple fracturesMultiple fragility fractures are independently listed as a very-high-fracture-risk condition.

For the cancer-treatment-related and male osteoporosis pathway, all of the following are required.

Alternative and preferred-product requirements

Member is at very high risk of fracture as defined in Table 1.See Very High Risk of Fracture criteria
Member has tried and failed or has a contraindication to zoledronic acid (Zometa), the preferred least-cost alternative.
Member has experienced treatment failure or an adverse reaction to preferred Jubbonti (denosumab-bbdz).