ModifiedAmbetter NevadaPolicy CP.PHAR.713

Zenocutuzumab-zbco (Bizengri) Coverage Criteria

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Prior authorization and medical-necessity coverage for Bizengri in adults with NRG1 gene fusion-positive advanced, unresectable, or metastatic non-small cell lung cancer or pancreatic adenocarcinoma across commercial, health insurance marketplace, and Medicaid lines of business.

Policy Summary

PayerAmbetter Nevada

PolicyZenocutuzumab-zbco (Bizengri) Coverage Criteria

Policy CodePolicy CP.PHAR.713

Change TypeModified

Effective DateMar 1, 2025

Last ReviewFeb 1, 2026

Next Review DateN/A

Key ActionSubmit chart notes, laboratory results, and other clinical information showing that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

HCPCS code J9382 for zenocutuzumab-zbco injection was added, and codes J3590 and C9399 were removed.

The initial approval duration for Health Insurance Marketplace and Medicaid members was extended from 6 months to 12 months.

Minimum left ventricular ejection fraction requirements were added in accordance with product labeling.

The policy references were reviewed and updated during the 1Q 2026 annual review.

2FDA-approved disease indications

750 mg q2wStandard dose

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ModifiedAmbetter NevadaPolicy CP.PHAR.713

Zenocutuzumab-zbco (Bizengri) Coverage Criteria

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Policy Summary

PayerAmbetter Nevada

PolicyZenocutuzumab-zbco (Bizengri) Coverage Criteria

Policy CodePolicy CP.PHAR.713

Change TypeModified

Effective DateMar 1, 2025

Last ReviewFeb 1, 2026

Next Review DateN/A

Key ActionSubmit chart notes, laboratory results, and other clinical information showing that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

HCPCS code J9382 for zenocutuzumab-zbco injection was added, and codes J3590 and C9399 were removed.

The initial approval duration for Health Insurance Marketplace and Medicaid members was extended from 6 months to 12 months.

Minimum left ventricular ejection fraction requirements were added in accordance with product labeling.

The policy references were reviewed and updated during the 1Q 2026 annual review.

2FDA-approved disease indications

750 mg q2wStandard dose

≥1Prior systemic therapies

J9382Current HCPCS code

12 mo HIM/MedicaidApproval duration

Coverage Criteria

Initial Therapy — Non-Small Cell Lung Cancer

Coverage is available when ALL of the following criteria are met:

ALL of the following

Diagnosis of advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC).
Prescribed by or in consultation with an oncologist.
Member is age ≥ 18 years.
Disease is positive for an NRG1 gene fusion.
Failure of at least one prior systemic therapy (see Appendix B for examples).
Left ventricular ejection fraction (LVEF) is ≥ 50%.≥ 50% LVEF
ONE of the following dosing and regimen requirements
- Dose does not exceed 750 mg every 2 weeks.≤ 750 mg every 2 weeks
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use; the prescriber must submit supporting evidence.
Prescribed regimen is FDA-approved or recommended by NCCN.

Initial Therapy — Pancreatic Adenocarcinoma

Coverage is available when ALL of the following criteria are met:

ALL of the following

Diagnosis of advanced, unresectable, or metastatic pancreatic adenocarcinoma.
Prescribed by or in consultation with an oncologist.
Member is age ≥ 18 years.
Disease is positive for an NRG1 gene fusion.
Failure of at least one prior systemic therapy (see Appendix B for examples).
Left ventricular ejection fraction (LVEF) is ≥ 50%.

Continuation Therapy — All Indications in Section I

Continued therapy is covered when ALL of the following criteria are met:

ALL of the following

Member is currently receiving the medication through a Centene benefit, or documentation supports that the member is currently receiving Bizengri for a covered indication and has received this medication for at least 30 days.At least 30 days of therapy
Member is responding positively to therapy.
If the request is for a dose increase, ONE of the following must apply
- New dose does not exceed 750 mg every 2 weeks.≤ 750 mg every 2 weeks

Other Diagnoses and Indications

For other diagnoses or indications, coverage is handled when ONE of the following criteria applies:

ONE of the following

Criterion 1 — Recent label change
- The drug has recently, within the last 6 months, undergone a label change (for example, a newly approved indication, age expansion, or new dosing regimen) that is not yet reflected in this policy.
- Refer to the applicable policy based on formulary or PDL status
  - For drugs on the formulary (commercial or health insurance marketplace) or PDL (Medicaid), refer to the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, or CP.PMN.255 for Medicaid.
  - For drugs not on the formulary (commercial or health insurance marketplace) or PDL (Medicaid), refer to the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, or CP.PMN.16 for Medicaid.

Non-FDA-approved indications that are not addressed in this policy are not authorized for coverage unless there is sufficient documentation of efficacy and safety under the applicable off-label use policy—CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, or CP.PMN.53 for Medicaid—or unless otherwise supported by applicable evidence of coverage documents.

Coding and Clinical Parameters

HCPCS CodesHCPCS

J9382

Injection, zenocutuzumab-zbco, 1 mg

Removed CodesHCPCS

J3590	Removed code; description not provided in document
C9399	Removed code; description not provided in document

Left ventricular ejection fraction

Required thresholdLVEF ≥ 50%

Applies toInitial therapy for NSCLC and pancreatic adenocarcinoma

Clinical measureLeft ventricular ejection fraction

Bizengri dose

Maximum dose750 mg

Dosing intervalEvery 2 weeks

Administration750 mg IV every 2 weeks for NSCLC and pancreatic adenocarcinoma

Provider Authorization and Documentation

Prior Authorization

Initial Bizengri Authorization

Prior authorization is required for initial Bizengri therapy. The request must document a qualifying advanced, unresectable, or metastatic disease indication—NSCLC or pancreatic adenocarcinoma—and satisfy all applicable clinical criteria.

Prescribed by or in consultation with an oncologist.
Member is age ≥ 18 years and the disease is positive for an NRG1 gene fusion.
Initial approval duration: Medicaid/HIM—12 months; Commercial—6 months or the member’s renewal date, whichever is longer.

Prior Authorization

Continuation Authorization

For continuation authorization, document that the member remains on Bizengri through the Centene benefit or has received Bizengri for at least 30 days for a covered indication, and that the member is responding positively to therapy.

For a dose increase, the new dose must not exceed 750 mg every 2 weeks, or the prescriber must submit practice guidelines or peer-reviewed literature supporting the relevant off-label regimen.

Policy Background

Zenocutuzumab-zbco (Bizengri) is a bispecific antibody directed against HER2 and HER3. This policy addresses adults with NRG1 gene fusion-positive, advanced, unresectable, or metastatic non-small cell lung cancer or pancreatic adenocarcinoma after progression on or after prior systemic therapy.

Definitions

Zenocutuzumab-zbco (Bizengri)

MedicationZenocutuzumab-zbco (Bizengri)

Drug classBispecific antibody

TargetsHuman epidermal growth factor receptor 2 (HER2) and HER3

NRG1

AbbreviationNRG1

Full termNeuregulin 1

Policy relevanceCovered disease must be positive for an NRG1 gene fusion

Initial Therapy Criteria

NSCLC Initial Therapy

Initial approval for NSCLC requires ALL of the following:

NSCLC initial therapy

Qualifying diagnosis: Advanced, unresectable, or metastatic non-small cell lung cancer
Specialist prescriber: Prescribed by or in consultation with an oncologist
Age: Adult age at least 18 years≥ 18 years
Biomarker:

Continuation Criteria

Continuation Therapy

Continuation therapy for all covered indications requires ALL of the following:

Continuation criteria

Current treatment status
- Centene benefit: Currently receiving medication via the Centene benefit
- Established therapy: Documentation supports that the member is currently receiving Bizengri for a covered indication and has received it for at least 30 days≥ 30 days
Treatment response: Member is responding positively to therapy

Step Therapy Requirement

Step	Requirement
1	Before initial Bizengri therapy, the member must have failed at least one prior systemic therapy.

Quantity Limits

Zenocutuzumab-zbco (Bizengri)

DrugZenocutuzumab-zbco (Bizengri)

Quantity limit750 mg

Limit frequencyEvery 2 weeks

Policy Summary

PayerAmbetter Nevada

PolicyZenocutuzumab-zbco (Bizengri) Coverage Criteria

Policy CodePolicy CP.PHAR.713

Change TypeModified

Effective DateMar 1, 2025

Last ReviewFeb 1, 2026

Next Review DateN/A

Key ActionSubmit chart notes, laboratory results, and other clinical information showing that the member meets all approval criteria.

SourceLink

On This Page

ONE of the following dosing and regimen requirements

Dose does not exceed 750 mg every 2 weeks.≤ 750 mg every 2 weeks
Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use; the prescriber must submit supporting evidence.

Prescribed regimen is FDA-approved or recommended by NCCN.

New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use; the prescriber must submit supporting evidence.

Prescribed regimen is FDA-approved or recommended by NCCN.

The dose-increase alternatives apply when the request is for a dose increase.

Criterion 2 — Other requested use

The requested use, such as the diagnosis, age, or dosing regimen, is NOT specifically listed under Section III, Diagnoses/Indications for which coverage is NOT authorized.
Criterion 1 above does not apply.
Refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, or CP.PMN.53 for Medicaid.

Continuation therapy duration

Minimum current-therapy durationAt least 30 days

Applies toContinuation therapy for all covered indications

Additional requirementThe member must be responding positively to therapy

The prescribed regimen must be FDA-approved or recommended by NCCN.

Step Therapy

Prior Systemic Therapy Required

At least one prior systemic therapy must have failed before initial Bizengri approval. The prior treatment history and failure must be documented for the applicable indication.

NSCLC examples include platinum chemotherapy such as carboplatin or cisplatin; anti-PD-1/PD-L1 therapy such as pembrolizumab, cemiplimab, nivolumab, durvalumab, or atezolizumab; bevacizumab; gemcitabine; and taxane chemotherapy such as paclitaxel or docetaxel.
Pancreatic adenocarcinoma examples include FOLFIRINOX, NALIRIFOX, gemcitabine-based therapy, capecitabine-based therapy, and taxane-based chemotherapy such as albumin-bound paclitaxel.

Documentation Required

Clinical Documentation Required

Submit documentation supporting that the member has met all approval criteria. Clinical records should be sufficiently detailed to establish diagnosis, treatment history, and the requested regimen.

Office chart notes, laboratory results, and other supporting clinical information must be submitted with the authorization request.

Documentation Required

Required Clinical Evidence

Required clinical evidence includes documentation of the qualifying diagnosis and disease status, member age, NRG1 fusion status, prior systemic therapy failure, cardiac function, and the prescribed Bizengri dose.

Advanced, unresectable, or metastatic NSCLC or pancreatic adenocarcinoma.
Age ≥ 18 years and a positive NRG1 gene fusion result.
At least one failed prior systemic therapy, with the regimen and outcome identified.
LVEF ≥ 50%, supported by appropriate clinical or diagnostic records.
Requested dose and schedule, including confirmation that the regimen is FDA-approved or recommended by NCCN when applicable.

Documentation Required

Off-Label Regimen Support

If the requested dose or regimen is off-label, the prescriber must support it with practice guidelines or peer-reviewed literature addressing the relevant use.

For initial therapy, the dose must not exceed 750 mg every 2 weeks unless supporting evidence is submitted.
For continuation dose increases, the new dose must not exceed 750 mg every 2 weeks unless supporting evidence is submitted.

Denial Risk

Initial Criteria Not Met

An initial request may be denied when the member does not have a qualifying covered disease, the request does not meet treatment requirements, or required clinical criteria are not documented.

Disease is not advanced, unresectable, or metastatic NSCLC or pancreatic adenocarcinoma.
Bizengri is not prescribed by or in consultation with an oncologist, the member is under age 18, or the disease is not NRG1-fusion positive.
No failure of at least one prior systemic therapy is documented.
LVEF is below 50%, or the requested dose or regimen exceeds 750 mg every 2 weeks without practice-guideline or peer-reviewed-literature support.

Denial Risk

Continuation Criteria Not Met

A continuation request may be denied when ongoing-therapy requirements are not satisfied or the requested dose increase lacks the required support.

The member is not currently receiving Bizengri through the Centene benefit and documentation does not establish at least 30 days of therapy for a covered indication.
The member is not responding positively to therapy.
For a dose increase, the new dose exceeds 750 mg every 2 weeks without supporting practice guidelines or peer-reviewed literature, or the regimen is not FDA-approved or recommended by NCCN.

Denial Risk

Unauthorized Indication

Coverage is not authorized for non-FDA-approved indications that are not addressed in this policy unless sufficient efficacy and safety documentation is provided under the applicable off-label use policy or evidence of coverage document.

Commercial: CP.CPA.09.
Health Insurance Marketplace: HIM.PA.154.
Medicaid: CP.PMN.53.

NSCLC

AbbreviationNSCLC

Full termNon-small cell lung cancer

Covered disease statusAdvanced, unresectable, or metastatic disease with an NRG1 gene fusion

LVEF

AbbreviationLVEF

Full termLeft ventricular ejection fraction

Initial-therapy thresholdAt least 50%

NCCN

AbbreviationNCCN

Full termNational Comprehensive Cancer Network

Regimen requirementThe prescribed regimen must be FDA-approved or recommended by NCCN

Disease is positive for an NRG1 gene fusion

NRG1 gene fusion positive

Prior therapy: Failure of at least one prior systemic therapy≥ 1 prior systemic therapy

See Appendix B for examples

Cardiac function: Left ventricular ejection fraction≥ 50%

Regimen requirement

Standard dose: Dose does not exceed 750 mg every 2 weeks≤ 750 mg every 2 weeks
Supported off-label dose: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use; prescriber must submit supporting evidence
Prescribed regimen must be FDA-approved or recommended by NCCN

Pancreatic Adenocarcinoma Initial Therapy

Initial approval for pancreatic adenocarcinoma requires ALL of the following:

Pancreatic adenocarcinoma initial therapy

Qualifying diagnosis: Advanced, unresectable, or metastatic pancreatic adenocarcinoma
Specialist prescriber: Prescribed by or in consultation with an oncologist
Age: Adult age at least 18 years≥ 18 years
Biomarker: Disease is positive for an NRG1 gene fusionNRG1 gene fusion positive
Prior therapy: Failure of at least one prior systemic therapy≥ 1 prior systemic therapy
See Appendix B for examples
Cardiac function: Left ventricular ejection fraction≥ 50%
Regimen requirement
- Standard dose: Dose does not exceed 750 mg every 2 weeks≤ 750 mg every 2 weeks
- Supported off-label dose: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use; prescriber must submit supporting evidence
  Prescribed regimen must be FDA-approved or recommended by NCCN

Dose increase, if applicable

Standard increased dose: New dose does not exceed 750 mg every 2 weeks≤ 750 mg every 2 weeks
Supported off-label increased dose: New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use; prescriber must submit supporting evidence
Prescribed regimen must be FDA-approved or recommended by NCCN