Currentblue cross blue shield - tennesseePolicy N/A

Denosumab (Prolia and biosimilars) — Coverage Criteria

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Covers medical necessity, authorization criteria, continuation rules, quantity limits, and documentation requirements for denosumab products (Prolia and biosimilars) for osteoporosis, glucocorticoid-induced bone loss, and treatment-related bone loss in prostate and breast cancer patients. Applies to members and providers under the payer's plan.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyDenosumab (Prolia and biosimilars) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 30, 2026

Last ReviewJun 30, 2026

Next Review DateJun 30, 2026

Key ActionSubmit prior authorization documentation to support indication-specific criteria for a 12-month authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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Currentblue cross blue shield - tennesseePolicy N/A

Denosumab (Prolia and biosimilars) — Coverage Criteria

Customize your policy alerts

Sign up for all blue cross blue shield - tennessee policy alerts

Know when blue cross blue shield - tennessee releases new policies or updates existing guidance.

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Policy Summary

Payerblue cross blue shield - tennessee

PolicyDenosumab (Prolia and biosimilars) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 30, 2026

Last ReviewJun 30, 2026

Next Review DateJun 30, 2026

Key ActionSubmit prior authorization documentation to support indication-specific criteria for a 12-month authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Coverage Criteria for Denosumab Products

Initial therapy — Postmenopausal Osteoporosis

Authorization of 12 months may be granted to postmenopausal members with osteoporosis when EITHER of the following criteria is met:

ANY of the following

Member has a pre-treatment T-score less than or equal to -2.5.
- ANY of the following
  - Member has a history of fragility fractures (e.g., low trauma fracture from force similar to a fall from standing position).
  - Member has indicators of very high fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T-scores [less than or equal to -3], or increased fall risk).
  - Member has failed prior treatment with or is intolerant to previous injectable osteoporosis therapy (e.g., zoledronic acid [Reclast], teriparatide [Forteo], abaloparatide [Tymlos]).
  - Member has had an oral bisphosphonate trial of at least 1-year duration or there is a clinical reason to avoid treatment with an oral bisphosphonate (see Appendix A).

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Initial therapy — Osteoporosis in Men

Authorization of 12 months may be granted to male members with osteoporosis when EITHER of the following criteria is met:

ANY of the following

- ALL of the following
  - Member has a history of an osteoporotic vertebral or hip fracture.
  - Member has a pre-treatment T-score less than or equal to -2.5 OR member has osteopenia (pre-treatment T-score greater than -2.5 and less than -1) with a high pre-treatment FRAX fracture probability (see Appendix B).
Member has had an oral or injectable bisphosphonate trial of at least 1-year duration OR there is a clinical reason to avoid treatment with a bisphosphonate (see Appendix A).

Initial therapy — Glucocorticoid-Induced Osteoporosis

Authorization of 12 months may be granted for members with glucocorticoid-induced osteoporosis when ALL of the following criteria are met:

ALL of the following

Member has had an oral or injectable bisphosphonate trial of at least 1-year duration OR there is a clinical reason to avoid treatment with a bisphosphonate (see Appendix A).
Member is currently receiving or will be initiating glucocorticoid therapy at an equivalent prednisone dose of ≥ 2.5 mg/day for ≥ 3 months.
- ANY of the following
  - Member has a history of a fragility fracture (e.g., low trauma fracture from force similar to a fall from standing position).
  - Member has a pre-treatment T-score less than or equal to -2.5.

Initial therapy — Prostate and Breast Cancer indications

Authorization of 12 months may be granted to members receiving specified systemic therapy for cancer-related bone loss:

ANY of the following

Prostate cancer: Member is receiving androgen deprivation therapy (ADT) for prostate cancer.
Breast cancer: Member is receiving adjuvant aromatase inhibition therapy for breast cancer to maintain or improve bone mineral density and reduce risk of fractures.

Products, Definitions, and Key Thresholds

High FRAX fracture probability — 10-year major fracture risk ≥ 20% or hip fracture risk ≥ 3%

High FRAX fracture probability10-year major osteoporotic fracture risk ≥ 20% OR hip fracture risk ≥ 3%

Glucocorticoid exposure — Equivalent prednisone dose of ≥ 2.5 mg/day for ≥ 3 months (with higher-dose adjustment noted in Appendix B)

Glucocorticoid exposureEquivalent prednisone dose of ≥ 2.5 mg/day for ≥ 3 months (with higher-dose adjustment noted in Appendix B)

FRAX high-risk thresholds — 10-year major osteoporotic fracture risk ≥ 20% or hip fracture risk ≥ 3%; adjust by multipliers for glucocorticoid use (>7.5 mg/day)

FRAX high-risk thresholds10-year major osteoporotic fracture risk ≥ 20% OR hip fracture risk ≥ 3%; adjust by multipliers for glucocorticoid use (>7.5 mg/day): multiply major fracture risk by 1.15 and hip fracture risk by 1.2

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior authorization: 12‑month approvals when criteria met

Authorization of up to 12 months may be granted when indication-specific criteria are met (see coverage criteria for postmenopausal osteoporosis, osteoporosis in men, glucocorticoid‑induced osteoporosis, and cancer‑related bone loss during ADT or aromatase inhibitor therapy).

Note

Tennessee off‑label coverage: document compendia or literature

This policy complies with Tennessee Code Annotated Section 56‑7‑2352; off‑label uses of FDA‑approved drugs must be supported by a statutorily recognized compendium or published peer‑reviewed literature — providers should document those sources when requesting coverage for off‑label indications.

Step Therapy

Background and Scope

Denosumab (Prolia and listed biosimilars) is indicated for treatment or prevention of bone loss in postmenopausal women and in men with osteoporosis, and for treatment-related bone loss in patients receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer. Coverage under this policy is limited to those FDA-approved indications and recognized compendial uses; other indications are considered experimental/investigational and not medically necessary.

Definitions and Thresholds

High FRAX fracture probability and glucocorticoid adjustments

Definition10-year major osteoporosis-related fracture risk ≥ 20% or hip fracture risk ≥ 3%.

Glucocorticoid adjustmentWhen glucocorticoid daily dose >7.5 mg prednisone equivalent, multiply FRAX major fracture risk by 1.15 and hip fracture risk by 1.2.

ApplicationUsed to determine 'high FRAX' status for coverage decisions across indications (postmenopausal, male osteoporosis, glucocorticoid-induced).

Osteopenia

T-score rangePre-treatment T-score greater than -2.5 and less than -1 (osteopenia).

Role in coverageOsteopenia plus a high pre-treatment FRAX can meet eligibility for postmenopausal women and men when other criteria are present.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyDenosumab (Prolia and biosimilars) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 30, 2026

Last ReviewJun 30, 2026

Next Review DateJun 30, 2026

Key ActionSubmit prior authorization documentation to support indication-specific criteria for a 12-month authorization.

SourceLink

On This Page

Member has osteopenia (pre-treatment T-score greater than -2.5 and less than -1) with a high pre-treatment FRAX fracture probability (see Appendix B).

Renal function thresholdCreatinine clearance <35 mL/min — considered a clinical reason to avoid oral bisphosphonate therapy

Oral administration and posture requirement — must be able to take oral bisphosphonate 30–60 minutes before first food/drink and remain upright for 30–60 minutes

Oral administration and posture requirementMust be able to take oral bisphosphonate 30–60 minutes before first food/drink and remain upright for 30–60 minutes; inability is a reason to avoid oral bisphosphonates

For many indications, the member must have completed an oral or injectable bisphosphonate trial of at least 1 year prior to denosumab unless there is a documented clinical reason to avoid bisphosphonates.

Step Therapy

Document clinical reason to avoid oral bisphosphonate

If an oral bisphosphonate is contraindicated for listed clinical reasons, alternative therapy may be considered — the specific clinical reason to avoid oral bisphosphonate must be documented.

Document the specific clinical condition from Appendix A that supports avoidance (e.g., active upper GI disease, esophageal abnormality, malabsorption, inability to take/get upright for 30–60 minutes, renal insufficiency, or prior intolerance).

Documentation Required

Required documentation: chart notes and supporting evidence

Provide chart notes or medical record documentation to support the requested therapy: for osteoporosis include history of fragility fractures, pre‑treatment T‑score, and FRAX fracture probability; for prostate cancer document androgen deprivation therapy (ADT); for breast cancer document aromatase inhibitor therapy.

Documentation Required

Use recognized compendia for drug/regimen details

Refer to standard reference compendia and drug references for details on regimens, dosing, contraindications, precautions, warnings, and monitoring when supporting off‑label uses or complex chemotherapy-related bone‑loss regimens.

Examples include the NCCN Drugs & Biologics Compendium®, Drugdex, and AHFS Drug Information as cited in the policy references.

Denial Risk

Experimental/investigational exclusions

Indications not listed in this policy (outside FDA‑approved and recognized compendial uses) are considered experimental/investigational and are not medically necessary.

Denial Risk

State mandate compliance may affect coverage

Failure to follow Tennessee mandate requirements for documenting compendial or peer‑reviewed support for off‑label uses may affect coverage determinations under state law.

Referenced in criteriaSpecifically cited in postmenopausal osteoporosis and osteoporosis in men coverage criteria (see initial therapy sections).

High FRAX fracture probability (adjusted)

High FRAX thresholds10-year major osteoporotic fracture risk ≥ 20% or hip fracture risk ≥ 3%.

Adjustment multipliersMultiply calculated FRAX risk by 1.15 for major osteoporotic fracture and by 1.2 for hip fracture when glucocorticoid daily dose >7.5 mg prednisone equivalent.

Calculation sourceFRAX calculation tool available at https://frax.shef.ac.uk/FRAX/ per Appendix B.