Prior Authorization and Coding Requirements

Prior authorization required for denosumab products. Requests must include the correct, product-specific HCPCS/administration codes and meet the policy's indication‑specific medical necessity criteria, dosing, and maximum quantity limits. For oncology uses, include the pertinent cancer ICD‑10 diagnosis code on the claim when applicable.

• Prior authorization must be obtained before administration for all restricted denosumab products listed in policy.
• Include product‑specific HCPCS codes (see dosing/coding table) on prior authorization and claim submissions.
• For oncology indications, submit the cancer ICD‑10 diagnosis code in addition to denosumab administration codes.

Biosimilar Step Therapy Requirement

Step therapy applies to non‑preferred denosumab products. When a non‑preferred denosumab is requested, the prescriber must document trial and inadequate response to the designated preferred denosumab biosimilars (examples provided in the policy).

• Non‑preferred denosumab requests require documented trials of the specified preferred biosimilars and evidence of inadequate response or intolerance.
• Examples of required prior trials: Jubbonti (denosumab‑bbdz) AND Stoboclo (denosumab‑bmwo) for certain Prolia non‑preferred agents; Osenvelt AND Wyost for certain Xgeva non‑preferred agents (see policy criteria).

Documentation Required for Non‑Preferred Product Approval

When approval for a non‑preferred denosumab product is requested due to intolerance, contraindication, or a serious adverse event to preferred biosimilars, medical record documentation is required. For serious adverse events, the prescriber must submit supporting documentation including the completed FDA MedWatch Adverse Event Reporting Form.

• Document prior trials and the nature of inadequate response or intolerance in the medical record.
• For documented serious adverse events related to preferred biosimilars, include medical records describing the event, interventions, and the submitted FDA MedWatch form.
• If claiming intolerance or contraindication, include clinical rationale why the preferred biosimilars are not appropriate and why the requested agent is expected to be tolerated.

Denial Risk and Billing/Coding Rules

Failure to document required step therapy trials, or submission using deleted/terminated HCPCS miscellaneous codes after their termination dates, may result in claim non‑adjudication or denial. Requests not meeting the medical necessity criteria (including age, diagnosis, prior therapy, or contraindication documentation) may be denied.

• Do not use terminated HCPCS miscellaneous codes (C9399, J3490, J3590, J9999) after their termination date (9/30/2025) — update to the current Q‑codes (e.g., Q5157, Q5158, Q5159, Q5136 as applicable) effective 10/01/2025.
• Provide complete medical record evidence of prior therapy trials and failures; absence of this documentation may lead to denial.
• Requests missing required age, diagnosis, or contraindication documentation are at high risk for denial.