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mhn denosumab coverage & prior auth updates | OpenPayer

ModifiedmhnPolicy CP.PHAR.58

Denosumab and Biosimilars

Coverage and medical necessity criteria for denosumab (Prolia, Xgeva) and specified biosimilars across indications including osteoporosis, cancer-related bone disease, giant cell tumor of bone, and hypercalcemia of malignancy for members of the payer's lines of business.

Policy Summary

Payermhn

PolicyDenosumab and Biosimilars

Policy CodePolicy CP.PHAR.58

Change TypeMaterial updates (biosimilars, HCPCS, safety warnings, step therapy)

Effective DateMar 1, 2011

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation (office notes, labs, BMD T-score) showing the member meets indication-specific criteria.

SourceLink

POLICY UPDATE CHANGES

Added boxed warnings for severe hypocalcemia in patients with advanced kidney disease and added requirement that members with prostate or breast cancer do not have bone metastasis for fracture-prevention indications.

Multiple new biosimilars (Jubbonti, Wyost, denosumab-dssb, Osenvelt, Ospomyv, Stoboclo, Xbryk, denosumab-bnht, Bomyntra, Conexxence, Bildyos, Bilprevda, Bosaya, Aukelso, Enoby, Xtrenbo) were added to the policy criteria and product lists.

Added HCPCS codes Q5136, Q5157, Q5158, Q5159 and updated coding implications.

For oncology indications (multiple myeloma, solid tumor bone metastasis, systemic mastocytosis, giant cell tumor of bone, hypercalcemia of malignancy) redirection/step therapy to Osenvelt and Wyost was added for requests for other products.

Added Appendix F clarifying interpretation of bone mineral density (BMD) T-scores and osteoporosis definitions.

60 mgProlia dosing

120 mg

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Coverage Criteria and Indications

Initial Therapy - Osteoporosis

Covered when ALL of the following are met:

ALL of the following

Request is for Prolia, Bildyos, Bosaya, Conexxence, Enoby, Jubbonti, Ospomyv, Stoboclo, denosumab-bnht, or denosumab-dssb.
Diagnosis of postmenopausal osteoporosis (PMO), glucocorticoid‑induced osteoporosis (GIO), or male osteoporosis.
AND one of the following:
- Member is at very high risk for fracture as evidenced by one of: recent osteoporotic fracture within the past 12 months; BMD T‑score at hip or spine ≤ -3.0; OR BMD T‑score at hip or spine ≤ -2.5 AND major osteoporotic fracture (hip, spine, forearm, wrist, humerus).
- Member has completed a 3‑year trial of bisphosphonate therapy at up to maximally indicated doses (see Appendix B; generic alendronate preferred) unless one of the following applies: all bisphosphonates are contraindicated; clinically significant adverse effects to both IV and PO formulations; loss of BMD while on bisphosphonate therapy; lack of BMD increase after ≥ 12 months of bisphosphonate therapy; or osteoporotic/fragility fracture while receiving bisphosphonate therapy.
Age ≥ 18 years or documentation of closed epiphyses on x‑ray.
Prolia, Bildyos, Bosaya, Conexxence, Enoby, Jubbonti, Ospomyv, Stoboclo, denosumab-bnht, or denosumab-dssb are not prescribed concurrently with Xgeva, Aukelso, Bilprevda, Bomyntra, Osenvelt, Wyost, Xbryk, or Xtrenbo.
Dose does not exceed 60 mg every 6 months.

Initial Therapy - Prostate/Breast Cancer — Fracture Prevention

Covered when ALL of the following are met:

ALL of the following

Request is for Prolia, Bildyos, Bosaya, Conexxence, Enoby, Jubbonti, Ospomyv, Stoboclo, denosumab-bnht, or denosumab-dssb.
Diagnosis
- Prostate cancer, and member is receiving androgen deprivation therapy (ADT) (e.g., leuprolide, bicalutamide, nilutamide).
- Breast cancer, and member is receiving adjuvant endocrine therapy (e.g., tamoxifen or aromatase inhibitors such as anastrozole, exemestane, letrozole).
Member does not have bone metastasis.

Initial Therapy - Multiple Myeloma or Solid Tumor

Covered when ALL of the following are met:

ALL of the following

Request is for Xgeva, Aukelso, Bilprevda, Bomyntra, Osenvelt, Wyost, Xbryk, Xtrenbo, or denosumab-bnht.
Diagnosis
- Multiple myeloma, and member is receiving or initiating therapy (e.g., chemotherapy, transplant) for symptomatic disease.
- Bone metastasis secondary to solid tumor (e.g., breast, kidney, lung, prostate, thyroid).
Prescribed by or in consultation with an oncologist.

Initial Therapy - Giant Cell Tumor

Covered when ALL of the following are met:

ALL of the following

Request is for Xgeva, Aukelso, Bilprevda, Bomyntra, Osenvelt, Wyost, Xbryk, Xtrenbo, or denosumab-bnht.
Disease characterization
- Metastatic or unresectable giant cell tumor of bone.
- Localized giant cell tumor of bone when denosumab product is prescribed as a single agent or in combination with radiation therapy.
Prescribed by or in consultation with an oncologist.
Age ≥ 18 years or documentation of closed epiphyses on x‑ray.

Initial Therapy - Hypercalcemia of Malignancy

Covered when ALL of the following are met:

ALL of the following

Request is for Xgeva, Aukelso, Bilprevda, Bomyntra, Osenvelt, Wyost, Xbryk, Xtrenbo, or denosumab-bnht.
Diagnosis of hypercalcemia of malignancy.
Prescribed by or in consultation with an oncologist.
Age ≥ 18 years or documentation of closed epiphyses on x‑ray.
Albumin‑corrected calcium > 12.5 mg/dL despite IV bisphosphonate therapy in the last 30 days.

Initial Therapy - Systemic Mastocytosis (off-label)

Covered when ALL of the following are met:

ALL of the following

Request is for Xgeva, Aukelso, Bilprevda, Bomyntra, Osenvelt, Wyost, Xbryk, Xtrenbo, or denosumab-bnht.
Diagnosis of systemic mastocytosis.
Member has osteopenia or osteoporosis with bone pain.
Prescribed by or in consultation with an oncologist.
Age ≥ 18 years or documentation of closed epiphyses on x‑ray.
Prior therapy or exception

Continued Therapy

Covered when ALL of the following are met:

ALL of the following

Member meets one of the following: currently receiving medication via Centene benefit or previously met initial approval criteria; currently receiving medication and enrolled in a state/product with continuity of care regulations; OR documentation supports member is currently receiving the medication for a covered cancer‑related indication and has received it for at least 30 days.
Member is responding positively to therapy.
If request is for a product other than Osenvelt and Wyost for multiple myeloma, bone metastasis secondary to solid tumor, giant cell tumor of bone, hypercalcemia of malignancy, or systemic mastocytosis, member must use Osenvelt and Wyost unless clinically significant adverse effects are experienced, both are contraindicated, or request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings.
If request is for a dose increase, new dose does not exceed: Prolia/Bildyos/Bosaya/Conexxence/Enoby/Jubbonti/Ospomyv/Stoboclo/denosumab‑bnht/denosumab‑dssb: 60 mg every 6 months; Xgeva/Aukelso/Bilprevda/Bomyntra/Osenvelt/Wyost/Xbryk/Xtrenbo/denosumab‑bnht: 120 mg every 4 weeks or is supported by practice guidelines or peer‑reviewed literature for off‑label use (prescriber must submit supporting evidence).

Other diagnoses/indications

If not specifically listed above, follow one of the options below:

ANY of the following

If the drug has undergone a recent label change within the last 6 months that is not yet reflected in this policy, refer to the appropriate formulary/no coverage or non‑formulary policy for the relevant line of business (see policy references).
If the requested use (diagnosis, age, dosing) is NOT specifically listed under Diagnoses/Indications for which coverage is NOT authorized and the label change criterion does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Initial Therapy — Indication-Specific Criteria

Initial Therapy — Initial therapy criteria differ by indication and product group (osteoporosis vs oncology formulations).

Indication-specific dosing summarized

Osteoporosis (PMO/GIO/male): Denosumab (Prolia and listed biosimilars) dosed 60 mg subcutaneously once every 6 months for treatment of postmenopausal osteoporosis, glucocorticoid-induced osteoporosis, and male osteoporosis.60 mg q6 months

Appendix F defines BMD T-score diagnostic thresholds.

Initial therapy — Initial therapy criteria by indication (multiple chunks).

Initial therapy — Initial therapy criteria by indication (selected dosing summarized):

Oncology indications: Denosumab (Xgeva and listed oncology biosimilars) dosed 120 mg subcutaneously once every 4 weeks for multiple myeloma and solid tumor bone metastasis; for giant cell tumor of bone and hypercalcemia of malignancy regimens include additional 120 mg doses on Days 8 and 15 of the first month when indicated by product labeling.

Continuation Therapy and Renewal Rules

Continuation Therapy

Continued therapy — Covered when ALL of the following are met:

Continued therapy general: 1) Member meets one: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; or (c) documentation that member is currently receiving denosumab or listed biosimilars for a covered cancer-related indication and has received it for ≥ 30 days; 2) Member is responding positively to therapy; 3) For specified oncology conditions, redirection to Osenvelt and Wyost applies for requests for other products unless adverse effects/contraindications or state regulation prohibits; 4) If dose increase is requested, new dose must not exceed Prolia-group 60 mg q6 months or Xgeva-group 120 mg q4 weeks unless supported by guidelines/literature with prescriber evidence.

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to member's renewal date.

Continuation rules

Continuation rules — specific continued therapy requirements:

Continued therapy nodes: See criteria: documentation of prior approval or current receipt, positive clinical response, adherence to step therapy preferences for specified oncology conditions (use of Osenvelt and Wyost unless clinically inappropriate or state exception), and dose limits for any requested increases (60 mg q6 months for Prolia-group; 120 mg q4 weeks for Xgeva-group unless supported by evidence).

Step Therapy and Biosimilar Preference

Prior Authorization

Provider Actions — Overview

Prior authorization is required for initial and continued denosumab and biosimilar requests. Medical necessity determinations are used to make coverage decisions. Coverage is conditional on benefit documents and applicable state regulations (see Appendix E for states that prohibit step therapy/redirection in advanced/metastatic cancer and applicable state addenda for continuity of care).

Prior authorization required for initial and continued therapy requests.
Coverage decisions based on medical necessity and benefit document limits.
State-specific exceptions apply (see Appendix E); Illinois HIM bypass per IL HB 5395 applies to certain requests.

Step Therapy

Step therapy and biosimilar preference

For oncology indications (multiple myeloma, bone metastasis from solid tumor, giant cell tumor of bone, hypercalcemia of malignancy, systemic mastocytosis) and their continuation therapy, step therapy and biosimilar redirection rules apply: - Requests must be for an included denosumab product listed in Section I (e.g., Xgeva, Aukelso, Bilprevda, Bomyntra, Osenvelt, Wyost, Xbryk, Xtrenbo, denosumab-bnht, denosumab-dssb, etc.). - If the request is for a product other than Osenvelt or Wyost, the member must use Osenvelt and Wyost first unless both are contraindicated or clinically significant adverse effects occur, or the request is for treatment associated with cancer in a state with regulations against step therapy/redirection (see Appendix E). - Illinois HIM: step therapy/redirection bypass applies per IL HB 5395 for HIM requests effective 1/1/2026, unless the biosimilar is FDA-designated interchangeable per the Purple Book. - Redirection to preferred biosimilars Osenvelt and Wyost was added for both initial and continuation therapy for the oncology indications listed above.

Coding and Dosing Key Facts

Covered HCPCS/Codes referencedHCPCS

J0897

Injection, denosumab, 1 mg.

Biosimilar HCPCS codesHCPCS

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.

inv-20: Age or skeletal maturity — Age ≥ 18 years or documentation of closed epiphyses on x-ray.

RequirementAge ≥ 18 years or documentation of closed epiphyses on x-ray

ContextApplies to initial therapy and most indication-specific criteria (osteoporosis, oncology, giant cell tumor, hypercalcemia of malignancy)

DocumentationProvider must submit x-ray documentation of closed epiphyses when member is under 18 or maturity unclear

inv-21: Albumin-corrected calcium for hypercalcemia — > 12.5 mg/dL despite IV bisphosphonate therapy in the last 30 days.

ThresholdAlbumin-corrected calcium > 12.5 mg/dL despite IV bisphosphonate therapy in the last 30 days

Indication

Dose Limits and Product Groups

inv-55: Denosumab products — Dose limits specified per indication.

GeneralDose limits are specified per indication (Prolia-type for osteoporosis; Xgeva-type for oncology) and must be adhered to for approvals

DocumentationPrescriber must submit supporting evidence when dosing exceeds FDA maximum or for off-label uses

Prior authorizationPrior authorization is required for denosumab and listed biosimilars per clinical policy

inv-56: Xgeva-group products — Oncology dosing limit 120 mg.

Maximum dose (oncology)120 mg per dose (120 mg every 4 weeks)

IndicationsMultiple myeloma, bone metastases from solid tumors, giant cell tumor of bone, hypercalcemia of malignancy (oncology formulations)

Provider Actions, Documentation, and Denial Triggers

Prior Authorization

Prior authorization is required

Prior authorization is required for denosumab products; prior authorization may also be required for referenced bisphosphonates used in step‑therapy pathways.

Policy notes that prior authorization may be required for bisphosphonates referenced in step therapy (chunk 8).
Provider must submit documentation to support that member meets all approval criteria as part of the prior authorization process (chunk 4).

Prior Authorization

Prior authorization for denosumab and biosimilars

Prior authorization is required for denosumab and listed biosimilars; specific approval criteria differ by indication (for example, hypercalcemia of malignancy and systemic mastocytosis have indication‑specific requirements).

Hypercalcemia of malignancy criteria and prior authorization note are included in the hypercalcemia section (chunk 18).
Continuation and indication‑specific prior authorization rules are described in the continued therapy and coverage sections (chunk 25).

Biosimilar Products and Preference Rules

Billing Rule

Preferred oncology biosimilars: Osenvelt and Wyost first

For many oncology indications, members must use the preferred denosumab biosimilars Osenvelt and Wyost prior to other oncology biosimilars unless both are contraindicated or clinically significant adverse effects occur.

This biosimilar preference applies to multiple myeloma, giant cell tumor of bone, hypercalcemia of malignancy, systemic mastocytosis, and solid tumor bone metastasis (chunks 13, 51).

Billing Rule

Preferred products: use Osenvelt and Wyost before alternatives

When a request is for a denosumab product other than the preferred products, the member must use Osenvelt and Wyost first unless both are contraindicated, clinically significant adverse effects occur, or state regulations prohibit redirection.

Applies across oncology and certain fracture‑prevention pathways; Appendix E lists states where redirection/step therapy may be prohibited in metastatic cancer settings (chunks 18, 13, 35).

Administration Setting and Product Formats

Note

Definitions and Clinical Thresholds

inv-42: High risk of fracture — definition includes history of osteoporotic fracture, multiple risk factors, or failure/intolerance to other therapy.

DefinitionHigh risk of fracture: history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy

ApplicationUsed to determine eligibility for osteoporosis treatment indications (PMO, GIO, male osteoporosis)

ExamplesIncludes recent osteoporotic fracture, low BMD T-scores, or failure/intolerance to bisphosphonate therapy

inv-43: BMD T-score — The T-score is the SD of individual's BMD from the mean for young normal women; threshold and interpretation referenced (Appendix F).

UseT-score is used to diagnose postmenopausal osteoporosis per WHO and AACE/ACE guidance (see Appendix F)

Interpretation

Background and Clinical Context

Denosumab and the listed biosimilars are RANKL inhibitors indicated to reduce fracture risk and increase bone mass in osteoporosis settings (Prolia‑type, typically dosed 60 mg subcutaneously every 6 months) and to prevent or treat bone complications in oncology settings (Xgeva‑type, typically dosed 120 mg subcutaneously every 4 weeks, with additional Day 8 and 15 doses in the first month for certain oncology regimens).

Policy Revision History and Material Changes

2025-04-14biosimilar_addition

RT4: added biosimilars denosumab-bnht (Bomyntra/Conexxence) to the policy criteria.

2025-03-06biosimilar_addition

RT4: added biosimilars denosumab-dssb (Ospomyv/Xbryk), Osenvelt, Ospomyv, Stoboclo, and Xbryk to the policy criteria.

2024-10-22safety_update

1Q 2025 annual review: updated Prolia and Jubbonti prescribing information to add boxed warnings for severe hypocalcemia in patients with advanced kidney disease and added requirement that members with prostate or breast cancer do not have bone metastasis for fracture-prevention indications.