ModifiedPremera BluecrossPolicy 5.01.658

Denosumab products

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This policy defines medical necessity, coverage criteria, coding, documentation, and benefit application for denosumab products for Premera Bluecross members.

Policy Summary

PayerPremera Bluecross

PolicyDenosumab products

Policy CodePolicy 5.01.658

Change TypeRevised preferred designationsdosing limit added

Effective DateAug 7, 2026

Last ReviewJul 1, 2026

Next Review DateAug 7, 2026

Key ActionPrior authorization is required with documentation of prior bisphosphonate trials or documented intolerance before coverage; enforce dose limits (60 mg every 6 months for select osteoporosis products; 120 mg every 4 weeks for oncology SRE prevention).

SourceLink

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ModifiedPremera BluecrossPolicy 5.01.658

Denosumab products

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This policy defines medical necessity, coverage criteria, coding, documentation, and benefit application for denosumab products for Premera Bluecross members.

Policy Summary

PayerPremera Bluecross

PolicyDenosumab products

Policy CodePolicy 5.01.658

Change TypeRevised preferred designationsdosing limit added

Effective DateAug 7, 2026

Last ReviewJul 1, 2026

Next Review DateAug 7, 2026

SourceLink

POLICY UPDATE CHANGES

Changed preferred and non-preferred designations for multiple denosumab products and updated criteria to require inadequate response or intolerance to specified preferred products before non-preferred products are approved.

Updated criteria to limit the dose for prevention of skeletal-related events in multiple myeloma and bone metastases to 120 mg every 4 weeks for several denosumab products.

Specified which denosumab products are managed through the medical benefit versus pharmacy benefit.

60 mg/6modose limit for osteoporosis

120 mg/4wkoncology SRE dose limit

multipleproduct tiers

2benefit pathways

Coverage Criteria and Medical Necessity

Coverage criteria overview

Covered when ALL of the following indication- and product-specific criteria are met:

ALL of the following

Applicable products: Bildyos (denosumab-nxxp) SC; Enoby (denosumab-qbde) SC.
One of
- Osteoporosis: individual has tried and had an inadequate response or intolerance to 2 generic bisphosphonates (either 2 oral agents or 1 oral agent and 1 IV agent), unless bisphosphonates are contraindicated.
- To increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.
- To increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Dose threshold: 60 mg every 6 months.

ALL of the following

Applicable products: Ospomyv (denosumab-dssb) SC; Osvyrti (denosumab-desu); Prolia (denosumab) SC; Stoboclo (denosumab-bmwo) SC.
Prerequisite therapy: individual has tried and had an inadequate response or intolerance to Bildyos (denosumab-nxxp) AND Enoby (denosumab-qbde).
Dose threshold: 60 mg every 6 months.

ALL of the following

Applicable products: Bilprevda (denosumab-nxxp) and Xtrenbo (denosumab-qbde).
Indication for SRE prevention
- Used for prevention of skeletal-related events in individuals with multiple myeloma.
- Used for prevention of skeletal-related events in individuals with bone metastases from solid tumors; for breast cancer the individual has expected survival >= 3 months.
For hypercalcemia of malignancy or giant cell tumor of bone: document inadequate response or intolerance to IV 4 mg zoledronic acid where required.

ALL of the following

Applicable products: Aukelso (denosumab-kyqq), Bomyntra (denosumab-bnht), Jubereq (denosumab-desu), Osenvelt (denosumab-bmwo), Oziltus (denosumab-mobz), Wyost (denosumab-bbdz), Xbryk (denosumab-dssb), Xgeva (denosumab).
Prerequisite therapy: individual has tried and had an inadequate response or intolerance to Bilprevda (denosumab-nxxp) AND Xtrenbo (denosumab-qbde).
For castration recurrent prostate cancer: document inadequate response or intolerance to IV 4 mg zoledronic acid where required.
Dose threshold for SRE prevention and oncology indications: 120 mg every 4 weeks.

ALL of the following

Any denosumab product or indication not described above is considered investigational and not covered.

Coverage criteria and operational rules

Coverage and operational rules that affect product sequencing, benefit routing, and dosing limits:

ALL of the following

Preferred products: Bildyos (denosumab-nxxp), Enoby (denosumab-qbde), Bilprevda (denosumab-nxxp), and Xtrenbo (denosumab-qbde) as updated in the 2026 policy update.
Access to non-preferred product requires
- For non-preferred osteoporosis/bone-mass products: documented inadequate response or intolerance to Bildyos AND Enoby prior to approval of listed non-preferred products (per 2026 update).
- For non-preferred oncology products: documented inadequate response or intolerance to Bilprevda AND Xtrenbo prior to approval of listed non-preferred oncology products (per 2026 update).

ALL of the following

Coding, Billing, and Approval Lengths

HCPCS/Q-codes and J-codes for denosumab products and biosimilarsHCPCS | CPT | mixed

J0897	Injection, denosumab (Prolia/Xgeva) 1 mg
J3590	Unclassified biologics (use to report: Aukelso, Bildyos, Bilprevda, Boncresa, Bosaya, Enoby, Jubereq, Osvyrti, Oziltus, and Xtrenbo)
J9999	Not otherwise classified (use to report: Bilprevda)
Q5136	Injection, denosumab-bbdz (Jubbonti/Wyost), biosimilar, 1 mg
Q5157	Injection, denosumab-bmwo (Stoboclo/Osenvelt), biosimilar, 1 mg
Q5158	Injection, denosumab-bnht (Bomyntra/Conexxence), biosimilar, 1 mg
Q5159	Injection, denosumab-dssb (Ospomyv/Xbryk), biosimilar, 1 mg
Q5161	Injection, denosumab-kyqq (Aukelso/Bosaya), biosimilar, 1 mg
Q5162	Injection, denosumab-nxxp (Bildyos/Bilprevda), biosimilar, 1 mg
Q5165	Injection, denosumab-mobz (Oziltus), biosimilar, 1 mg

1–10 of 13

1/2

coding notesmixed

No specific HCPCS/NDC/CPT codes listed in this document section.

Length of approval (non-formulary vs others)

Standard approvals (many listed products)May be approved up to 2 years when condition is stabilized or improved and no serious/intolerable side effects are present.

Short-term approvals (specific products)Aukelso, Bilprevda, Bomyntra, Jubereq, Osenvelt, Oziltus, Wyost, Xbryk, Xgeva, and Xtrenbo may be approved up to 6 months.

Non‑formulary exception durationNon‑formulary exception reviews for listed products may be approved up to 12 months when documentation shows stability/improvement and tolerability.

Oncology SRE dosing threshold

Oncology SRE dosing thresholdDose limited to 120 mg every 4 weeks for prevention of skeletal‑related events in multiple myeloma and bone metastases from solid tumors.

Prior Authorization, Step Therapy, and Benefit Routing

Prior Authorization

Prior authorization with required bisphosphonate trials or documented contraindication

Prior authorization is required. Document that the member has tried and had an inadequate response or intolerance to the required bisphosphonate trials per drug-specific criteria (either two oral bisphosphonates or one oral plus one IV; if oral bisphosphonates are contraindicated, only IV zoledronic acid is required). Include documentation of contraindications to oral bisphosphonates when applicable (e.g., esophageal disorders). Dose limits apply per indication (60 mg every 6 months for select osteoporosis indications; 120 mg every 4 weeks for specified oncology indications).

For Bildyos and Enoby (first-line): trial and inadequate response or intolerance to 2 generic bisphosphonates (2 oral or 1 oral + 1 IV) unless bisphosphonates contraindicated.
If oral bisphosphonates are contraindicated, only IV zoledronic acid is required.
Record dose-limits: 60 mg every 6 months for certain osteoporosis indications; 120 mg every 4 weeks for oncology SRE prevention.

Step Therapy

Step therapy: required sequencing through preferred denosumab products

Definitions and Product Context

Denosumab products

Drug classDenosumab products are RANK ligand inhibitors.

Primary effectReduce bone resorption and increase bone mass.

Indications covered in policyTreatment of osteoporosis and prevention/treatment of skeletal‑related events in oncology settings.

Generic bisphosphonates (examples)

AlendronateExample generic bisphosphonate (oral).

IbandronateExample generic bisphosphonate (oral).

RisedronateExample generic bisphosphonate (oral).

Policy Summary

PayerPremera Bluecross

PolicyDenosumab products

Policy CodePolicy 5.01.658

Change TypeRevised preferred designationsdosing limit added

Effective DateAug 7, 2026

Last ReviewJul 1, 2026

Next Review DateAug 7, 2026

SourceLink

On This Page

Osteoporosis / fragility fracture dosing limit for indicated products: 60 mg every 6 months (applies to specified osteoporosis indications and products).

Oncology / prevention of skeletal-related events dosing limit: 120 mg every 4 weeks for listed oncology products (applies to prevention of SREs in multiple myeloma and bone metastases from solid tumors).

Policy notes: drug use must follow the product's FDA dosage and administration prescribing information in addition to the limits specified here.

ALL of the following

Some denosumab products are managed under the pharmacy benefit and others under the medical benefit; product-specific assignment is described in the policy benefit section.
Several products are administered subcutaneously every six months for osteoporosis indications (see product-specific dosing above).

ALL of the following

Age limits are determined according to FDA-approved indications where applicable.

ALL of the following

Prior authorization is required and must document prior trials, inadequate response, or intolerance to required preferred products or to IV zoledronic acid when specified by indication and product.

Coverage of non-preferred denosumab products requires documented inadequate response or intolerance to specified preferred products in the sequence defined by the policy (e.g., Bildyos and Enoby must be tried and failed before certain non-preferred osteoporosis products; Bilprevda and Xtrenbo must be tried and failed before a separate group of non-preferred oncology products).

Osteoporosis pathway: non-preferred products require prior inadequate response/intolerance to Bildyos (denosumab-nxxp) AND Enoby (denosumab-qbde).
Oncology/prevention of SREs pathway: many non-preferred products require prior inadequate response/intolerance to Bilprevda (denosumab-nxxp) AND Xtrenbo (denosumab-qbde).

Billing Rule

Benefit assignment and administration route for denosumab products

Follow the policy's benefit routing: some denosumab products are managed under the pharmacy benefit and others under the medical benefit; many products are administered subcutaneously every six months when used for osteoporosis indications.

Managed through pharmacy and medical benefit: Bildyos, Boncresa, Bosaya, Conexxence, Enoby, Jubbonti, Ospomyv, Osvyrti, Prolia, and Stoboclo.
Managed through the medical benefit: Aukelso, Bilprevda, Bomyntra, Jubereq, Osenvelt, Oziltus, Wyost, Xbryk, Xgeva, and Xtrenbo.
Administration note: specified products are administered subcutaneously every six months for applicable indications.

Billing Rule

Dose limit: 120 mg every 4 weeks for oncology SRE prevention

Enforce the oncology dosing limit for prevention of skeletal-related events: denosumab products used for multiple myeloma or bone metastases from solid tumors are limited to 120 mg every 4 weeks.

For prostate cancer with castration-recurrent disease, require documented inadequate response or intolerance to IV 4 mg zoledronic acid and apply the 120 mg every 4 weeks limit.
Dose limit applies to the listed products for prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors.

Zoledronic acidExample generic bisphosphonate (IV).

Consideration of Age

Age determination approachAge limits specified in this policy are determined according to FDA‑approved indications, where applicable.

ApplicabilityUse FDA labeling to define age eligibility for individual denosumab products.

Policy guidanceWhen FDA indication includes age limits, those limits apply for coverage determinations.

Product naming / context (Prolia vs Xgeva)

Prolia naming/indicationProlia (denosumab) refers to denosumab when used for osteoporosis indications.

Xgeva naming/indicationXgeva (denosumab) refers to denosumab when used for oncology indications such as prevention of skeletal‑related events.

Brand context in policyPolicy distinguishes product naming by indication to align coverage criteria and dosing limits (osteoporosis vs oncology).