Prior authorization validity

Prior authorization is required. Initial prior authorization validity will be provided for 4 months (120 days) and may be renewed every 4 months (120 days).

HCPCS codes to use for prior authorization

Use the HCPCS codes listed in the policy when requesting authorization or submitting claims. Billing units are defined as 1 billable unit = 1 mcg. Relevant codes include J1442, Q5110, Q5101, J1447, Q5125, Q5148; use J3590 or C9399 for Filkri/hospital outpatient unclassified reporting as applicable.

• J1442, Q5110, Q5101, J1447, Q5125, Q5148
• J3590 — Unclassified biologics (Filkri only)
• C9399 — Unclassified drugs/biologicals (hospital outpatient, Filkri only)
• Billing unit: 1 billable unit = 1 mcg

NDC listing only — no PA specified in this section

These document excerpts present NDC numbers only and do not specify any prior authorization requirements in this section.

NDC entries without PA rules

The cited excerpts list product NDCs and presentations (strengths and container types) but do not state prior authorization requirements.

NDC listing — no PA specified

This portion of the policy provides NDC listings only and does not specify prior authorization requirements for the listed products.

NDC listing for billing/identification (no PA stated)

The policy supplies NDCs for covered short-acting G‑CSF products for billing/identification; prior authorization requirements (if any) are not specified in this portion.

NDC reference (no PA rules in this excerpt)

This excerpt provides NDC identifiers for products; no prior authorization rules are stated in this chunk.

NDC listings only — no PA specified

These chunks present NDC listings and do not state prior authorization requirements for the products shown.

NDC listings without explicit PA language

Only NDC listings and product identifiers appear in these excerpts; no prior authorization codes or explicit PA requirements are provided here.

Prior authorization may be required (NQTL considerations)

Utilization management prior authorization was considered due to the drug indication and cost; prior authorization may be applied per the NQTL checklist.

• NQTL factors considered include indication and cost and support consideration for PA (Appendix A).

Required trial of preferred agents (Nivestym and Zarxio)

Member must have a contraindication, intolerance, or documented failure to both Nivestym and Zarxio before another short-acting G‑CSF product will be considered.

• Document prior use and reason for discontinuation (contraindication, intolerance, or treatment failure) for Nivestym and Zarxio.

Required clinical documentation — prior use and reason

Document prior use of Nivestym and Zarxio and record the clinical reason (contraindication, intolerance, or failure) before other short‑acting G‑CSF agents will be considered.

• Indicate the specific covered indication and supporting clinical details (ANC values, risk factors, chemotherapy regimen risk level, prior responses).

Required documentation for billing — product, dose, units/NDC

Document the product name and dose (mcg) and align billing units with the HCPCS billing definition (1 billable unit = 1 mcg) or use the appropriate NDC on the claim.

• Record product name and mcg dose on documentation and claim.
• Match billed units to HCPCS (1 unit = 1 mcg) or include the correct NDC for pharmacy billing.

NDCs for Zarxio, Releuko, Neupogen, Nivestym (use for billing)

NDC listings for Zarxio, Releuko, Neupogen, and Nivestym are provided to support product identification and billing; refer to the listed NDCs when submitting claims or PA requests.

• Use the listed NDC(s) for the exact product strength and presentation on claims or prior authorization forms.

NDC presentation guidance for billing/identification

The document provides NDC numbers paired with product presentations (strength and single‑dose vial or prefilled syringe); reference these when identifying products for dispensing or claims.

• Refer to NDC plus presentation (e.g., 300 mcg vial, 480 mcg syringe) when documenting product dispensed.

NDC codes for pharmacy billing (identification only)

Use the listed NDC codes for pharmacy billing and product identification; this section does not change dosing rules but supports accurate claim submissions.

Use listed NDCs on claims and PA requests

When submitting claims or prior authorization requests for short‑acting G‑CSF products, include the listed NDC(s) to ensure accurate drug identification on the request or claim.

NDC identifiers for PA and claims

These sections list NDC identifiers for short‑acting G‑CSF products; use the provided NDCs to identify the drug on claims and prior authorization forms.

Supporting references to support documentation

References including package inserts and the NCCN Drugs & Biologics Compendium are provided and may be used to support clinical documentation submitted for prior authorization.

• Package inserts for Neupogen, Nivestym, Zarxio, Releuko, Granix, Nypozi are cited.
• NCCN Drugs & Biologics Compendium entries are listed as supporting references.

Submit covered diagnosis code from Appendix 1

Submit an appropriate covered ICD‑10 diagnosis code from Appendix 1 with the authorization or claim to support coverage (examples include D70.1 — agranulocytosis secondary to cancer chemotherapy; Z51.11 — encounter for antineoplastic chemotherapy).

• Include one of the covered ICD‑10 codes from Appendix 1 on the PA form or claim.

Denial risk: unacceptable toxicity on renewal

Renewal may be denied if the member exhibits unacceptable toxicity from the drug; examples include splenic rupture, ARDS, serious allergic reactions/anaphylaxis, sickle cell crisis, glomerulonephritis, leukocytosis, capillary leak syndrome, potential tumor growth stimulation, aortitis, alveolar hemorrhage/hemoptysis, thrombocytopenia, cutaneous vasculitis, or treatment‑related MDS/AML.

• If unacceptable toxicity is present, prior authorization renewal may be denied.

Coding/claim risk — use listed HCPCS or appropriate unclassified codes

Claims submitted without the listed HCPCS codes (or without using J3590/C9399 for Filkri in applicable outpatient settings) or without the appropriate NDCs may be denied or miscoded, placing claims at risk for denial or mispayment.

• Use the specific HCPCS codes listed in the policy when billing.
• For Filkri, use J3590 or hospital outpatient C9399 as indicated.

Prior authorization considered per NQTL checklist

Utilization management prior authorization was considered in design of this policy (see Appendix A); indication and drug cost were factors leading to consideration of PA.

• Appendix A (NQTL checklist) documents that indication and cost supported consideration for prior authorization.