Prior authorization required and contingent on meeting clinical criteria

Prior authorization is required for all denosumab agents; approval is contingent on meeting the product-specific clinical criteria for osteoporosis (Prolia-type) or metabolic bone disease (Xgeva-type) and adherence to the quantity limits (60 mg every 6 months for Prolia-type; 120 mg per 28 days for Xgeva-type).

• Initial and continuation requests are reviewed under the clinical criteria sections for Prolia- or Xgeva-type agents.
• Quantity limits must match the product type (Prolia-type 60 mg/6 months; Xgeva-type 120 mg/28 days).

Prior authorization must include product-specific HCPCS/J/Q code

Submit the specific denosumab product name with the matching HCPCS/J/Q code when requesting prior authorization; formulary/preferred status by benefit line and date of service affects approval requirements.

• Examples of product-level codes include J0897, C9399, and Q-series codes (see coding tables).
• Formulary lists (Commercial and Medicare) and document history show product-specific coding and effective dates that determine PA processing.

Step therapy: use preferred denosumab agent or document intolerance

Plan-level step therapy may require use of a preferred denosumab agent; requests for non-preferred agents require documentation of a trial and an allergy or severe intolerance to an inactive ingredient in the preferred agent.

• Preferred agent lists are maintained by the plan; providers should reference the plan's preferred-agent list when initiating PA.
• Non-preferred requests based on convenience (device, concentration, regimen) are not sufficient for approval.

Updated step therapy requirements for biosimilars

Step therapy tables and sequences have been added/updated to align biosimilar use with standard biosimilar step therapy criteria; follow the updated step therapy sequence when requesting non-preferred biosimilars.

• Document history notes addition of step therapy tables and alignment with biosimilar step therapy (8/15/2025 and subsequent updates).
• Providers must follow the updated step therapy sequences in the policy when requesting non-preferred biosimilars.

Required clinical documentation: DXA, fractures, risk factors, prior therapy

Include clinical documentation that supports the diagnosis and indication: DXA BMD T-score results or history of fragility fracture, relevant risk factors, prior osteoporosis therapy trials, intolerance or contraindications, and repeat BMD when applicable.

• Osteoporosis defined as BMD T-score ≤ -2.5 in spine, femoral neck, total hip or distal 1/3 radius.
• For continuation after ≥24 months, provide repeat BMD showing stable or increased BMD and evidence of clinical response (no new fractures).

Product-level coding must be documented (product name + HCPCS/J/Q code)

Document the exact denosumab product and bill using the corresponding HCPCS/J/Q code listed in the policy (examples include J0897 for Prolia; Q5157–Q5162 and C9399/J3590 where specified for biosimilars).

• Coding tables list product-to-code mappings and note when C9399 or J3590 may be used with a specified product.
• Recent document history shows additions/removals and effective dates for Q-codes—use current policy coding assignments for PA and claims.

Denial triggers: combination use or unmet clinical criteria

Requests will be denied when a denosumab product is used in combination with another denosumab agent or when the submitted clinical information does not meet the policy criteria for the specified indication.

• Policy explicitly lists 'In combination with another denosumab agent' as a non-approved use for both Prolia- and Xgeva-type sections.
• Requests lacking the required clinical criteria for the chosen product/indication are not eligible for approval.

Coding-based denial risk: use current HCPCS/Q-code assignments and effective dates

Claims and authorizations may be denied or impacted if providers submit doses under HCPCS NOC codes that were removed or use product codes inconsistent with the policy's current coding updates and effective dates; ensure coding reflects the latest document history.

• Document history shows removals from C9399/J3590 effective 3/31/26 and additions of Q5161/Q5162 effective 4/1/26—use the codes effective for the date of service.
• Multiple prior coding updates and separations of Prolia vs Xgeva biosimilar coding are documented; billing must follow the policy's current assignments.