Zenocutuzumab-zbco (Bizengri) — CPB 1076 | AETNA Coverage Update

TL;DR: Aetna modified CPB 1076 for zenocutuzumab-zbco (Bizengri), effective December 20, 2025. Billing teams that handle oncology claims need to act now — this policy controls coverage for J9382 and infusion codes 96413 and 96415 across two specific cancer indications.

This policy update to CPB 1076 formalizes coverage criteria for zenocutuzumab-zbco (Bizengri), a targeted therapy for NRG1 fusion-positive cancers. Aetna covers Bizengri for two indications only: advanced unresectable or metastatic non-small cell lung cancer (NSCLC) and advanced unresectable or metastatic pancreatic adenocarcinoma. Both require documented NRG1 gene fusion-positive status and prior systemic therapy failure. Every other use is experimental — no exceptions.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna
Policy	Zenocutuzumab-zbco (Bizengri) — CPB 1076
Policy Code	CPB 1076
Change Type	Modified
Effective Date	December 20, 2025
Impact Level	High
Specialties Affected	Medical Oncology, Hematology-Oncology
Key Action	Submit precertification before billing J9382 — call (866) 752-7021 or fax (888) 267-3277

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Aetna Zenocutuzumab-zbco Coverage Criteria and Medical Necessity Requirements 2025

The Aetna zenocutuzumab-zbco coverage policy is narrow by design. Bizengri gets covered under exactly two diagnoses, and both carry the same two-part medical necessity test. Miss either requirement and the claim will deny.

For NSCLC (ICD-10 C34.x range):

#	Covered Indication Copy
1	The member has advanced unresectable or metastatic disease
2	The member has experienced disease progression on or after prior systemic therapy
3	The member has confirmed NRG1 (neuregulin 1) gene fusion-positive disease

For Pancreatic Adenocarcinoma (ICD-10 C25.x range):

#	Covered Indication Copy
1	The member has advanced unresectable or metastatic disease
2	The member has experienced disease progression on or after prior systemic therapy
3	The member has confirmed NRG1 gene fusion-positive disease

The structure is identical across both indications. That's actually useful — your team only needs to check two boxes for either diagnosis. But both boxes must be checked. Aetna doesn't cover Bizengri as a first-line treatment. Prior systemic therapy failure is a hard requirement, not a soft preference.

The real issue here is the NRG1 gene fusion test. Aetna does not list a specific CPT code for NRG1 gene fusion testing in CPB 1076. The policy table labels this explicitly: "Neuregulin 1 (NRG1) gene testing – No specific code." Your team needs documentation of a positive NRG1 fusion result in the medical record, but don't expect a clean code-to-code linkage in the prior authorization workflow. Talk to your compliance officer about how your institution documents and submits molecular testing results when no dedicated CPT code exists in the policy.

Prior Authorization Is Mandatory

Aetna requires precertification for zenocutuzumab-zbco (Bizengri) on all participating provider and member accounts in applicable plan designs. No exceptions are listed in the policy.

To get prior authorization, call (866) 752-7021 or fax (888) 267-3277. For a Statement of Medical Necessity form, go to Aetna's Specialty Pharmacy Precertification page. Submit precertification before the first infusion — a missed prior auth is one of the fastest paths to a claim denial on a high-cost oncology drug.

Bizengri is not cheap. J9382 bills at 1 mg increments — and this is an IV-administered biologic. Reimbursement exposure on a single missed precertification is significant. Build the auth check into your scheduling workflow before the infusion date is set.

Continuation of Therapy (Reauthorization)

Aetna continues coverage for members already on Bizengri under reauthorization, provided there is no evidence of unacceptable toxicity or disease progression on the current regimen. This is standard language, but it matters operationally. Your team needs to pull clinical documentation from the treating oncologist at each reauthorization cycle confirming the patient is still responding and tolerating the drug. Don't submit a reauth with just the original approval criteria — show current status.

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Aetna Zenocutuzumab-zbco Exclusions and Non-Covered Indications

Aetna's position here is direct: all indications not explicitly listed in CPB 1076 are considered experimental, investigational, or unproven.

That means any use of Bizengri outside of NRG1 fusion-positive advanced NSCLC or NRG1 fusion-positive advanced pancreatic adenocarcinoma will not be covered under this policy. This includes:

This is a tight policy. The FDA approved Bizengri specifically for NRG1 fusion-positive cancers, so Aetna's coverage criteria track the label closely. Don't expect success appealing off-label use — Aetna's "experimental/investigational" designation on all other indications signals they're not moving without new clinical evidence.

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Coverage Indications at a Glance

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Aetna Zenocutuzumab-zbco Billing Guidelines and Action Items 2025

The effective date is December 20, 2025. If your oncology billing team is already seeing Bizengri claims, these steps apply now.

Copy Action Items

If your payer mix includes Medicare patients, note that CPB 1076 applies only to commercial plans. Medicare criteria follow separate Part B guidelines — don't use this policy's criteria for Medicare claims.

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CPT, HCPCS, and ICD-10 Codes for Zenocutuzumab-zbco (Bizengri) Under CPB 1076

Covered HCPCS Code (When Selection Criteria Are Met)

Code	Type	Description Copy
J9382	HCPCS	Injection, zenocutuzumab-zbco, 1 mg

Chemotherapy Administration CPT Codes

Code	Type	Description Copy
96413	CPT	Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug
96415	CPT	Chemotherapy administration, IV infusion technique; each additional hour (list in addition to code for primary procedure)

Note on NRG1 Gene Fusion Testing: Aetna's policy explicitly states there is no specific CPT code assigned for NRG1 gene testing within CPB 1076. You still need documented NRG1 gene fusion-positive results — Aetna just hasn't assigned a dedicated code to it in this policy. Document the testing in the medical record and confirm with your compliance officer how your institution handles billing for molecular testing in this context.

Key ICD-10-CM Diagnosis Codes

The descriptions below reflect the CPB 1076 policy source data. Sub-code descriptions are from the ICD-10-CM code set and are provided for reference only — CPB 1076 lists all C25.x and C34.x codes under the descriptions "Malignant neoplasm of pancreas" and "Malignant neoplasm of bronchus and lung," respectively.

Pancreatic Adenocarcinoma (C25.x)

Non-Small Cell Lung Cancer / Bronchus and Lung (C34.x)

The policy covers an extensive range of C34.x codes — refer to the full CPB 1076 code list for the complete set. Don't default to C34.9 (unspecified) if the record documents a specific lobe and laterality.

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