Prior authorization required — document indication, prior therapies, and evidence

Prior authorization is required for Abraxane/paclitaxel, protein-bound; the request must document the indication, prior therapies, and supporting evidence (e.g., practice guidelines or peer‑reviewed literature) when requesting dosing outside listed limits or for off‑label regimens.

• Prescriber must show indication and prior therapies.
• If dose exceeds listed maximums, prescriber must submit supporting evidence from guidelines or peer‑reviewed literature.

Submit PA with supporting diagnosis and clinical documentation

Providers must submit prior authorization requests with a supporting diagnosis and clinical documentation demonstrating that the member meets the coverage criteria (including oncologist involvement and age requirements).

• Include clinical justification per payer procedure.
• Attach documentation showing applicable covered indication.

Prior authorization applies to Abraxane (use J9264; removed codes noted)

Prior authorization requirements apply to covered uses of Abraxane/paclitaxel, protein‑bound (HCPCS J9264); the policy notes prior references to removed HCPCS codes (e.g., J9259) but PA applies to currently covered codes and NCCN‑recommended off‑label uses.

• Use HCPCS J9264 when submitting claims/PA requests.
• Do not use removed codes such as J9259/J9258 (these were removed per policy).

Agent preference — must use paclitaxel first unless contraindicated

Step/agent preference: members must use paclitaxel (conventional) first if available unless contraindicated or clinically significant adverse effects occur; for Abraxane requests, member must use paclitaxel protein‑bound particles if available unless contraindicated.

• Therapeutic alternatives (e.g., paclitaxel/Taxol) are listed in Appendix B and may require PA.
• Provider must document contraindication or intolerance to alternatives when applicable.

Step therapy / state‑mandated bypass — IL HIM (IL HB 5395)

A step therapy bypass for Illinois Health Insurance Marketplace (HIM) members was added per IL HB 5395; for Illinois HIM requests, the step therapy requirement to use paclitaxel first does not apply as of 1/1/2026.

• Operational implications apply to IL HIM line of business.
• Other lines of business remain subject to step therapy requirements unless otherwise specified.

Illinois HIM step therapy bypass in effect (IL HB 5395)

Step therapy bypass added specifically for the Illinois Health Insurance Marketplace (per IL HB 5395) — providers submitting IL HIM requests should not be required to show prior use of paclitaxel as a step prior to Abraxane.

• Ensure PA submissions for IL HIM reflect the statutory bypass effective per policy notes.

Supportive documentation required — chart notes and labs

Providers must submit supportive clinical documentation (office chart notes, laboratory results, or other clinical information) demonstrating that the member meets all approval criteria.

• Include objective evidence of diagnosis, treatment history, and response to prior therapies.
• Attach lab results when relevant (e.g., neutrophil counts).

Billing documentation — include J9264 and supporting ICD‑10 code

When submitting claims, include HCPCS code J9264 (Injection, paclitaxel protein‑bound particles, 1 mg) and an ICD‑10‑CM diagnosis code from the policy's supported list to support coverage.

• Use J9264 for paclitaxel, protein‑bound billing; reference ICD‑10 codes from the policy's list.
• Do not bill using removed HCPCS codes noted in the policy.

Document medical necessity per plan coverage and this policy

Providers must follow plan coverage documents and submit documentation supporting medical necessity consistent with this clinical policy and applicable benefit contract terms.

• Coverage decisions are subject to evidence of coverage and contract terms.
• Submit all documentation required by the Health Plan to justify medical necessity.

Off‑label uses not addressed may be denied without sufficient documentation

Requests for non–FDA‑approved (off‑label) indications that are not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per the referenced off‑label use policies.

• Refer to CP.CPA.09, HIM.PA.154, or CP.PMN.53 for off‑label documentation requirements.
• Prescriber must submit supporting evidence from guidelines or peer‑reviewed literature for off‑label uses.

Unsupported diagnosis on claim may trigger denial — include a supporting ICD‑10

Claims billed without an ICD‑10 diagnosis code that supports the policy's coverage criteria may be denied; ensure the submitted diagnosis matches one of the ICD‑10‑CM codes listed in the policy.

• Confirm the ICD‑10 code on the claim is in the policy's 'ICD‑10‑CM Diagnosis Codes that Support Coverage Criteria' list.
• Attach clinical documentation linking the diagnosis to the requested service.

Coding‑based denial risk — removed HCPCS codes may be denied

Claims using removed HCPCS codes (for example, J9259 and J9258) may be denied; the policy documents removal of these codes and identifies J9264 as the covered procedure code.

• Do not submit claims using J9259 or J9258; use J9264 with appropriate diagnosis code.
• Verify coding guidance prior to submission as policy was updated to remove obsolete HCPCS entries.

Infusion center — single‑use vial reconstitution; administer in infusion setting

Administer paclitaxel protein‑bound as an injectable suspension supplied in single‑use vials for reconstitution; provide administration in an appropriate infusion setting per standard oncology practice.

• Product availability: lyophilized powder, 100 mg per single‑use vial for reconstitution; administer in an infusion center or appropriate oncology infusion setting.