DraftBlue Cross Blue Shield - TennesseePolicy N/A

Denosumab products (Prolia and listed biosimilars) for osteoporosis and cancer-related bone loss — Coverage Criteria

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Policy governs coverage criteria, authorization duration, documentation, and dosing limits for denosumab products (Prolia and listed biosimilars) for osteoporosis, glucocorticoid-induced osteoporosis, and prevention of treatment-related bone loss in prostate and breast cancer. It applies to members of the payer (Blue Cross Blue Shield - Tennessee).

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyDenosumab products (Prolia and listed biosimilars) for osteoporosis and cancer-related bone loss — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 31, 2026

Last ReviewJul 31, 2026

Next Review DateJul 31, 2026

Key ActionSubmit prior authorization with documentation of indication, dosing (60 mg SC every 6 months), and fracture risk (FRAX) or supporting compendia for off-label uses per Tennessee mandate.

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DraftBlue Cross Blue Shield - TennesseePolicy N/A

Denosumab products (Prolia and listed biosimilars) for osteoporosis and cancer-related bone loss — Coverage Criteria

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Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyDenosumab products (Prolia and listed biosimilars) for osteoporosis and cancer-related bone loss — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 31, 2026

Last ReviewJul 31, 2026

Next Review DateJul 31, 2026

Key ActionSubmit prior authorization with documentation of indication, dosing (60 mg SC every 6 months), and fracture risk (FRAX) or supporting compendia for off-label uses per Tennessee mandate.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization duration

60 mgmax dosing regimen

FRAX ≥20%/hip ≥3%high FRAX definition

Tennesseestate mandate

Coverage criteria for denosumab products

Postmenopausal Osteoporosis (Initial)

Covered when ALL of the following are met:

Postmenopausal osteoporosis: Member has a pre-treatment T-score ≤ -2.5 OR member has osteopenia (pre-treatment T-score between -1 and -2.5) with a high pre-treatment FRAX probability, AND meets ANY of the following: history of fragility fracture; indicators of very high fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T-scores ≤ -3, or increased fall risk); inadequate response or intolerance to previous injectable osteoporosis therapy (e.g., zoledronic acid, teriparatide, abaloparatide); inadequate response or intolerance to previous oral bisphosphonate therapy.T-score ≤ -2.5 or osteopenia + high FRAX

Authorization of 12 months may be granted; provide chart notes/medical record documentation or claims history supporting prior medications, fracture history, T-score, and FRAX as applicable.

Osteoporosis in Men (Initial)

Covered when ANY of the following are met:

Osteoporosis in men: Member has a history of an osteoporotic vertebral or hip fracture; OR member has a pre-treatment T-score ≤ -2.5 OR osteopenia (pre-treatment T-score between -1 and -2.5) with a high pre-treatment FRAX probability; OR member has had an inadequate response or intolerance to previous bisphosphonate therapy.T-score ≤ -2.5 or osteopenia + high FRAX

Authorization of 12 months may be granted; provide chart notes/medical record documentation or claims history as applicable.

Glucocorticoid-Induced Osteoporosis (Initial)

Covered when BOTH of the following are met:

Glucocorticoid-induced osteoporosis: Member meets EITHER: member is currently receiving or will be initiating systemic glucocorticoid therapy at an equivalent prednisone dose of ≥ 2.5 mg/day for ≥ 3 months; AND member has had an inadequate response or intolerance to previous bisphosphonate therapy; AND member meets ANY of: history of fragility fracture; osteopenia (pre-treatment T-score between -1 and -2.5) with a high pre-treatment FRAX probability; OR pre-treatment T-score ≤ -2.5.prednisone ≥ 2.5 mg/day for ≥ 3 months; T-score thresholds as specified

Authorization of 12 months may be granted; include documentation of glucocorticoid exposure, prior therapy trials, T-score, and FRAX when applicable.

Prostate Cancer (ADT-related bone loss)

Covered when ALL of the following are met:

Prostate cancer (ADT): Member is receiving androgen deprivation therapy (ADT) for non-metastatic prostate cancer or for treatment-related bone loss and has documentation supporting ADT use (e.g., chart notes or claims history).

Authorization of 12 months may be granted; use is listed as compendial for ADT-related bone loss.

Breast Cancer (AI-related bone loss)

Covered when ALL of the following are met:

Breast cancer (AI): Member is receiving adjuvant aromatase inhibitor (AI) therapy for breast cancer and has documentation supporting AI use (e.g., chart notes or claims history); FDA indication includes increasing bone mass in these patients.

Authorization of 12 months may be granted; compendial uses include postmenopausal breast cancer patients on AI therapy.

Rheumatoid Arthritis (Compendial use)

Covered when ALL of the following are met:

Rheumatoid arthritis: Use is to inhibit progression of bone erosion in members with rheumatoid arthritis with appropriate documentation (chart notes/medical record documentation).

Listed as a compendial use; authorization of 12 months may be granted.

Continuation of Therapy

Covered when EITHER of the following are met for continuation:

Continuation of therapy: Member has received 24 months of therapy or more and meets criteria; OR member has received less than 24 months of therapy and has not experienced clinically significant adverse events during therapy AND has experienced clinical benefit (improvement or stabilization in T-score) AND has not experienced adverse effects.24 months

Authorization of 12 months may be granted for continuation; documentation from prior authorization or medical/pharmacy benefit required.

Covered indications and requirements

Covered when the listed product, dose, route, and indication align with policy and applicable state mandate

Denosumab coverage basics: Product is denosumab (Prolia or listed biosimilars) administered subcutaneously at 60 mg every 6 months.

Supported product names and dosing listed in policy.

Covered indications: Postmenopausal osteoporosis OR osteoporosis in men OR glucocorticoid-induced osteoporosis OR relevant cancer bone-health indications (breast cancer, prostate cancer) as listed in the policy.

Indications enumerated in FDA-approved and compendial sections.

Risk assessment requirement: FRAX should be used to assess fracture risk; high FRAX is defined as 10-year major osteoporotic fracture probability ≥ 20% or hip fracture probability ≥ 3%; apply FRAX glucocorticoid correction when prednisone-equivalent dose > 7.5 mg/day.FRAX thresholds described

FRAX details and glucocorticoid correction provided in the policy.

All indications for denosumab that are not explicitly listed as FDA-approved or compendial uses in this policy are considered experimental/investigational and not medically necessary and therefore are not covered under the criteria outlined in this document.

This policy does not enumerate explicit exclusions beyond those identified as experimental/investigational; coverage of off-label uses must comply with applicable state requirements. Specifically, coverage for off‑label FDA‑approved drug uses is dependent on recognition of the use in statutorily recognized compendia or published peer‑reviewed medical literature as required by Tennessee Code Annotated Section 56‑7‑2352.

Uses of denosumab that are not listed under FDA‑approved indications or supported compendial uses in this policy are considered not medically necessary (i.e., experimental/investigational) and are not eligible for coverage.

The policy does not provide a separate, detailed list of specific Not Medically Necessary conditions; instead, off‑label uses lacking support in recognized compendia or peer‑reviewed literature may be denied. Coverage determinations for such off‑label uses will follow Tennessee statutory guidance requiring compendial or literature support per Tennessee Code Annotated Section 56‑7‑2352.

Products, dosing, and measurable thresholds

Covered productsmixedCovered

Denosumab (Prolia®) and multiple biosimilar/brand names

Listed product names: Prolia; Denosumab-nxxp (Bildyos); Denosumab-mobz (Boncresa); Denosumab-kyqq (Bosaya); Denosumab-bnht (Conexxence); Denosumab-qbde (Enoby); Denosumab-bbdz (Jubbonti); Denosumab-dssb (Ospomyv); Denosumab-desu (Osvyrti); Denosumab-bmwo (Stoboclo)

Medication quantity limits / dosingmixed

Dose/regimen

Subcutaneous 60 mg every 6 months for listed products and indications

Denosumab products and dosingmixed

Prolia / Ospomyv / Stoboclo (denosumab and biosimilars)

Denosumab products, 60 mg subcutaneous every 6 months for osteoporosis and related indications; product names listed in policy (Prolia; Ospomyv; Stoboclo and biosimilars enumerated)

T-score threshold — osteoporosis and osteopenia

Osteoporosis (T-score)Pre-treatment T-score ≤ -2.5 defines osteoporosis for coverage

Osteopenia definitionPre-treatment T-score between -1 and -2.5

Osteopenia coverage requirementOsteopenia requires a high pre-treatment FRAX probability in addition to T-score for coverage

Glucocorticoid exposure threshold

Glucocorticoid exposure thresholdEquivalent prednisone dose ≥ 2.5 mg/day for ≥ 3 months is a criterion for glucocorticoid‑induced osteoporosis coverage

Associated requirement

Prior authorization, documentation, and required actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Documentation must include the requested indication, route and dosing (denosumab 60 mg subcutaneous every 6 months), and clinical evidence supporting medical necessity (e.g., T-score, FRAX probability, history of fragility fracture, or documentation of high fracture risk). For continuation requests, include previous authorization or evidence of clinical benefit and absence of clinically significant adverse events.

Required dosing: 60 mg SC every 6 months.
Include indication-specific evidence: T-score, FRAX score/probability, history of fragility fractures, documentation of high fracture risk (age, frailty, glucocorticoid use, very low T-scores ≤ -3, fall risk).
For cancer-related indications, include documentation of ongoing ADT (prostate cancer) or aromatase inhibitor therapy (breast cancer).
For glucocorticoid-induced osteoporosis, document current or planned glucocorticoid use and dose/duration.
Continuation: documentation of prior authorization or ≥24 months of therapy OR evidence of clinical benefit/stability and no significant adverse events.

Clinical background

Denosumab is indicated to treat osteoporosis in postmenopausal women and in men at high risk for fracture, for glucocorticoid‑induced osteoporosis in patients expected to remain on glucocorticoids, and to increase bone mass in men receiving androgen deprivation therapy (ADT) and in postmenopausal women receiving aromatase inhibitors. Compendial uses also include preventing treatment‑related bone loss in prostate cancer and inhibiting progression of bone erosion in rheumatoid arthritis.

Key definitions and thresholds

High risk for fracture — FDA definition

FDA definition of high riskHistory of an osteoporotic fracture or multiple risk factors for fracture (FDA‑defined)

Glucocorticoid‑induced contextFor glucocorticoid‑induced osteoporosis, high risk includes history of fracture, multiple risk factors, or failure/intolerance to other therapy

Compendial uses notedPolicy also recognizes compendial uses (e.g., ADT‑related bone loss) where high fracture risk considerations apply

Osteopenia

Osteopenia rangePre‑treatment T‑score between -1 and -2.5 defines osteopenia

Coverage conditionOsteopenia may qualify for coverage only when accompanied by a high pre‑treatment FRAX probability as specified in policy

Policy revision history

2026-07-31policy effectiveLatest

Policy approved and effective (Do Not Implement until) 07/31/2026 for denosumab products, listing indications, dosing (60 mg SC every 6 months), and authorization criteria.

2025-10-01reference update

Package insert and reference updates recorded (e.g., Jubbonti package insert cited October 2024 and multiple 2025 package inserts referenced in the policy bibliography).

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyDenosumab products (Prolia and listed biosimilars) for osteoporosis and cancer-related bone loss — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 31, 2026

Last ReviewJul 31, 2026

Next Review DateJul 31, 2026

Key ActionSubmit prior authorization with documentation of indication, dosing (60 mg SC every 6 months), and fracture risk (FRAX) or supporting compendia for off-label uses per Tennessee mandate.

SourceLink

On This Page

Member must also have inadequate response or intolerance to prior bisphosphonate therapy (when specified)

Part of combined criteriaGlucocorticoid exposure is one element of the BOTH‑criteria set for glucocorticoid‑induced osteoporosis coverage

High FRAX threshold

High FRAX — major osteoporotic fracture10‑year major osteoporotic fracture probability ≥ 20% meets the high FRAX threshold for coverage

High FRAX — hip fracture10‑year hip fracture probability ≥ 3% meets the high FRAX threshold for coverage

FRAX useFRAX score referenced in policy Appendix to determine high fracture risk when required (see policy)

Denial Risk

Experimental / Investigational Exclusions

All uses of the medication that are not FDA-approved indications or listed compendial uses are considered experimental/investigational and are not medically necessary, except where applicable state mandate requires coverage for off-label uses recognized by statutory compendia or peer-reviewed literature.

Compendial/recognized uses (see policy) may be considered; all other indications are excluded.
Tennessee mandate (TCA §56-7-2352) may require coverage for certain off-label uses if supported by recognized compendia or peer-reviewed literature.

Step Therapy

Refer to Clinical Guidelines for Therapy Sequencing

Refer to current clinical practice guidelines and authoritative compendia for appropriate therapy sequencing and step therapy expectations when assessing prior authorization requests.

Guidelines referenced include NCCN Drugs & Biologics Compendium, Endocrine Society, AACE/ACE, and other cited literature.
Policy requires failure or intolerance to other osteoporosis therapies for certain indications (e.g., prior oral or injectable bisphosphonates, teriparatide, abaloparatide) per guideline-concordant sequencing.

Use in criteria setsOsteopenia + high FRAX appears in postmenopausal and male osteoporosis and glucocorticoid‑induced osteoporosis criteria

High FRAX probability

High FRAX thresholds10‑year major osteoporotic fracture probability ≥ 20% OR 10‑year hip fracture probability ≥ 3%

FRAX referenceFRAX tool is cited (https://fraxplus.org) for calculation of fracture probabilities

ApplicationHigh FRAX is used to determine eligibility when osteopenia (T‑score -1 to -2.5) is present

Glucocorticoid FRAX correction

Glucocorticoid FRAX correctionIf glucocorticoid dose > 7.5 mg prednisone equivalent/day, multiply FRAX major osteoporotic fracture risk by 1.15 and hip fracture risk by 1.2

Threshold for correctionCorrection applies when prednisone‑equivalent dose exceeds 7.5 mg/day

PurposeUse the corrected FRAX score when assessing fracture risk for members on higher‑dose glucocorticoids