CurrentAvMedPolicy Pub. 100-2

Denosumab Biosimilars for Osteoporosis — Prior Authorization and Step-Edit Criteria

Defines prior authorization, step-edit, quantity limits, and clinical criteria for denosumab biosimilars and originator (Prolia) when used for osteoporosis in AvMed members; applies to providers submitting PA requests.

Policy Summary

PayerAvMed

PolicyDenosumab Biosimilars for Osteoporosis — Prior Authorization and Step-Edit Criteria

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionProvide required documentation and, for non-preferred products, document trials showing inadequate response or intolerance to both preferred biosimilars Jubbonti and Stoboclo.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

60 mgdose

6 mofrequency

12 moinit auth

12 moreauth

2biosimilar trials

Coverage criteria for denosumab products

Initial and continuation coverage criteria

Covered when ALL of the following are met

Diagnosis of osteoporosis

Applicable to initial and continuation requests

Dose and administration: Dose 60 mg subcutaneously administered by a healthcare professional once every 6 months60 mg every 6 months

Quantity limit: 60 billable units every 6 months

Documentation: Supporting documentation including labs, diagnostics, and chart notes must be provided for each checked clinical criterion

Requests may be denied if documentation not provided

Policy Summary

PayerAvMed

PolicyDenosumab Biosimilars for Osteoporosis — Prior Authorization and Step-Edit Criteria

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionProvide required documentation and, for non-preferred products, document trials showing inadequate response or intolerance to both preferred biosimilars Jubbonti and Stoboclo.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Step-edit criteria for non-preferred denosumab products

Step therapy for non-preferred products: If requesting a non-preferred product, member must have documented trial with inadequate response or intolerance to both preferred biosimilars Jubbonti (denosumab-bbdz) AND Stoboclo (denosumab-bmwo)trial of both preferred products

Required for approval of non-preferred denosumab products

Use of samples to initiate therapy does not meet the step-edit or prior authorization requirements. Sample doses are not acceptable documentation of a trial for step therapy purposes and will not satisfy the requirement to demonstrate a documented trial with inadequate response or intolerance to preferred biosimilar products.

Coding and quantity limits

Preferred HCPCSHCPCSCovered

Q5136	Jubbonti (denosumab-bbdz)
Q5157	Stoboclo (denosumab-bmwo)

Preferred HCPCSHCPCS

No codes listed

Non-Preferred HCPCS/J-codesHCPCSNot Covered

Q5162	Bildyos (denosumab-nxxp)
C9399	Enoby (denosumab-qbde) - billed as C9399/J3590
J3590	Enoby (denosumab-qbde) - alternate billing
Q5161	Bosaya (denosumab-kyqq)
Q5159	Ospomyv (denosumab-dssb)
Q5158	Conexxence (denosumab-bnht)
J0897	Prolia (denosumab)

Quantity limit (billable units)

Limit60 billable units every 6 months

IndicationOsteoporosis, fracture risk reduction

Administration60 mg subcutaneously administered by a healthcare professional once every 6 months

Dosage formSingle-use prefilled syringe and single-use vial (1 mL of 60 mg/mL)

denosumab products for osteoporosis

Quantity limit (units)60

Per6 months

Applies toDenosumab products for osteoporosis (fracture risk reduction)

Administration settingMust be administered by a healthcare professional (office or specialty pharmacy)

What providers must do

Prior Authorization

Prior Authorization Required

Prior authorization is required for listed non-preferred denosumab products. Requests for these products must include complete and legible information; incomplete or illegible requests may be delayed or denied.

Fax completed form to 1-877-535-1391
Prescriber signature required (preprinted stamps not valid); prescriber must clearly print name
Include phone and fax numbers; incorrect contact info can delay process

Note

Preferred Products — No Prior Authorization

Preferred biosimilar denosumab products do not require prior authorization.

Step Therapy

Step Therapy Requirement for Non-Preferred Products

If requesting a non-preferred denosumab product, the member must have a documented trial with inadequate response or intolerance to both preferred biosimilar denosumab products.

Step therapy applies to initial and reauthorization requests for non-preferred products
Use of samples to initiate therapy does not meet step edit/preauthorization criteria
Previous therapies will be verified through pharmacy paid claims or submitted chart notes

Documentation Required

Required Documentation / Triggers for Delay or Denial

Authorization may be delayed or denied if the request is incomplete, incorrect, or illegible, or if required supporting documentation (labs, diagnostics, chart notes) is not provided. Ensure all required drug and patient information is included to avoid denial.

Required: prescriber signature and printed name (no preprinted stamps)
Required: drug form/strength, dosing schedule, length of therapy, diagnosis, ICD code (if applicable), weight and date weight obtained
Supporting documentation: lab results, diagnostics, and chart notes for all checked clinical criteria
For continuation requests, all applicable documentation must be provided or request may be denied

Background and clinical context

Denosumab products (including biosimilars and originator Prolia) are indicated for the treatment of osteoporosis to reduce fracture risk and are administered as a 60 mg subcutaneous injection once every 6 months. For osteoporosis, the policy specifies a quantity limit of 60 billable units every 6 months and requires that the injection be administered by a healthcare professional. Supporting documentation (labs, diagnostics, chart notes) must be provided for each clinical criterion checked on the request form; requests may be delayed or denied if documentation is incomplete.

Dosing and definitions

Osteoporosis dosing

Dose60 mg subcutaneously

FrequencyOnce every 6 months

Who administersHealthcare professional

Available formsSingle-use prefilled syringe; single-use vial (1 mL of 60 mg/mL)

Initial authorization requirements

Initial authorization

Initial duration: Initial authorization: 12 months12 months

All criteria must be met for approval

Reauthorization requirements

Reauthorization

Reauthorization requirements

Reauthorization duration: Reauthorization granted for 12 months when criteria are met12 months

Applicable to all continuation of therapy requests

Step therapy rules

Step	Requirement	Coverage status
1	Documented trial with inadequate response or intolerability to BOTH preferred biosimilars: Jubbonti (denosumab-bbdz) AND Stoboclo (denosumab-bmwo)	Must meet step therapy requirement prior to approval of non-preferred denosumab products

Administration and dispensing site

Note

Administration setting — office or specialty pharmacy

Denosumab for osteoporosis must be administered by a healthcare professional; medication may be provided through the physician's office or a specialty pharmacy.

Administration setting: physician's office OR specialty pharmacy
Dose: 60 mg subcutaneously once every 6 months (administered by a healthcare professional)

Biosimilar product notes

Billing Rule

Jubbonti (Q5136) — preferred, no PA required

Jubbonti (Q5136) is listed as preferred and does not require prior authorization.

Code: Q5136 — Jubbonti (denosumab-bbdz)

Billing Rule

Stoboclo (Q5157) — preferred, no PA required

Stoboclo (Q5157) is listed as preferred and does not require prior authorization.

Code: Q5157 — Stoboclo (denosumab-bmwo)