CurrentEmblemHealthPolicy UM ONC_1519

Bizengri (zenocutuzumab-zbco) — Coverage Criteria

Defines coverage and utilization management requirements for Bizengri (zenocutuzumab-zbco) for oncology indications (NRG1 fusion-positive tumors) for members under the payer's managed lines of business.

Policy Summary

PayerEmblemHealth

PolicyBizengri (zenocutuzumab-zbco) — Coverage Criteria

Policy CodePolicy UM ONC_1519

Change TypeNo material change

Effective DateJan 31, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of NRG1 gene fusion and evidence of disease progression on or after prior systemic therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Adultscovered population

NRG1+target biomarker

≤750 mgper-dose max

J9999billing code

Coverage Criteria for Bizengri (zenocutuzumab-zbco)

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Initial coverage criteria for Bizengri: 1) Member is an adult with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma harboring an NRG1 gene fusion; 2) Member has disease progression on or after prior systemic therapy; 3) Use is supported by FDA labeling, a CMS-recognized compendium, NCCN/ASCO guideline, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards; 4) No contraindications such as left ventricular ejection fraction < 50%; 5) Planned dosing does not exceed the single-dose limit of 750 mg.

Derived from Purpose, sections B and C, and Exclusion Criteria.

Continuation Therapy

Covered when ALL of the following are met:

Continuation criteria: 1) Member has not experienced disease progression while receiving Bizengri; 2) Prior authorization was active within the last year without a lapse greater than 30 days; 3) No additional medications are being added to the continuation request; 4) No new exclusion conditions have developed (e.g., LVEF < 50% or dosing that would exceed single-dose limit).

From Purpose continuation exemption and Exclusion Criteria.

Coverage for Bizengri (zenocutuzumab-zbco) excludes use in members who do not have an NRG1 gene fusion, as presence of this genomic alteration is a required criterion for authorization. Coverage is also excluded for members with disease progression while taking Bizengri, for concurrent use with other anticancer therapies, and for members with a left ventricular ejection fraction < 50%. Additionally, dosing that exceeds a single dose limit of 750 mg is not covered. These exclusions reflect conditions that render treatment noncompliant with the policy’s clinical criteria and safety thresholds.

Use of Bizengri for investigational or off‑label indications that lack sufficient supporting evidence is considered not medically necessary. The policy defines insufficient evidence as situations where the patient or tumor characteristics are not adequately represented in the published evidence, the treatment regimen is not represented, study outcomes are not clinically meaningful, study design is inappropriate to the question, or the available evidence is limited to uncontrolled case reports or meeting abstracts without full peer‑reviewed publication. Coverage will not be provided when the indication is not generally accepted by the medical community or is unsupported by CMS‑recognized compendia or acceptable peer‑reviewed literature.

Initial Therapy Authorization Criteria

Initial therapy

Initial authorization is approved when ALL of the following structured conditions are met:

Diagnosis and biomarker: Member is an adult with advanced, unresectable, or metastatic NSCLC OR pancreatic adenocarcinoma AND tumor harbors an NRG1 gene fusion.

Supported by sections B and C.

Prior therapy and disease status: Member has documented disease progression on or after prior systemic therapy appropriate for the indication.

Supported by sections B and C and Purpose.

Supporting evidence: Treatment is consistent with FDA-approved labeling OR is supported by a CMS-recognized compendium, NCCN/ASCO guideline, or acceptable peer-reviewed literature meeting CMS standards.

From Purpose.

Concomitant therapy and contraindications: No concurrent anticancer therapies are being used with Bizengri AND member does not have contraindications such as left ventricular ejection fraction < 50%.

Derived from Exclusion Criteria.

Dosing limits: Requested dosing does not exceed the single-dose maximum of 750 mg.≤ 750 mg

From Exclusion Criteria and quantity limits.

Continuation Therapy Authorization Criteria

Continuation therapy

Continuation authorization is approved when ALL of the following structured conditions are met:

Clinical status: Member has not experienced disease progression while on Bizengri.

From Purpose and Exclusion Criteria (disease progression while taking Bizengri is exclusion).

Authorization history: Member had an active authorization for Bizengri within the last year with no lapse greater than 30 days.

From Purpose continuation exemption.

Regimen changes: No additional medications are being added to the continuation request (i.e., the regimen remains unchanged).

From Purpose continuation exemption.

New exclusions: No new exclusion criteria have developed since the prior authorization (for example LVEF remains ≥ 50% and planned dosing remains ≤ 750 mg).

From Exclusion Criteria and quantity limits.

Coding and Quantity Limits

Covered HCPCS CodeHCPCSCovered

J9999

zenocutuzumab-zbco

inv-06: Single dose limit — per-dose maximum

Per-dose maximumSingle dose limit ≤ 750 mg

ScopeApplies to zenocutuzumab-zbco (Bizengri) dosing per administration

EnforcementRequests exceeding 750 mg per single dose are grounds for denial (see exclusion criteria)

inv-16: zenocutuzumab-zbco — single dose ≤ 750 mg (quantity limits)

Drug and codezenocutuzumab-zbco (Bizengri) — HCPCS J9999

Quantity limit (per dose)Single dose ≤ 750 mg

Policy actionDosing requests >750 mg per single administration may be denied under exclusion criteria

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Bizengri (zenocutuzumab-zbco). Requests must document presence of an NRG1 (neuregulin 1) gene fusion and clinical evidence of disease progression on or after prior systemic therapy for the corresponding malignancy. Continuation requests may be exempt from prior authorization review if ALL of the following are met: the member has not experienced disease progression on Bizengri; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request.

Prior authorization required for initial and most continuation requests
Continuation exemption allowed when no progression, use within past year without >30-day lapse, and no added medications

Documentation Required

Required Documentation

Documentation supporting the medical necessity of Bizengri must reference one or more of the following: FDA-approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN) guidelines, American Society of Clinical Oncology (ASCO) guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards. Clinical justification should include pathology/genomic testing confirming an NRG1 gene fusion, prior systemic therapies received, dates and evidence of disease progression, and relevant supporting literature or guideline citations (e.g., Bizengri prescribing information, NCCN, ASCO, or accepted compendia).

Provide documentation of NRG1 gene fusion (test type and result)
List prior systemic therapies and dates
Provide imaging/pathology or clinical notes demonstrating disease progression
Cite FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer-reviewed literature

Denial Risk

Triggers for Denial

Requests will be denied when any of the following apply: absence of an identified NRG1 gene fusion in the tumor; documented disease progression while taking Bizengri; concurrent use of Bizengri with other anticancer therapies; left ventricular ejection fraction (LVEF) < 50%; dosing requests that exceed the single-dose limit of 750 mg; or requests for investigational/off-label uses lacking sufficient evidence or not supported by CMS-recognized compendia or acceptable peer-reviewed literature.

Denial if no documented NRG1 fusion
Denial for progression on Bizengri
Denial for concurrent anticancer therapies
Denial if LVEF < 50%
Denial if single dose > 750 mg
Denial for investigational/off-label uses without sufficient supporting evidence

Step	Requirement
1	Prior systemic therapy must have been tried and member must have documented disease progression on or after prior systemic therapy.

Definitions

inv-12: NRG1 gene fusion — required genomic alteration for coverage; members without are excluded

Required genomic alterationPresence of an NRG1 gene fusion in tumor tissue is required for coverage

Population excluded without alterationMembers without an NRG1 gene fusion are excluded from coverage

Supporting documentationMedical records must document NRG1 gene fusion status to support prior authorization

Site of Care

Note

Site-of-care not specified — follow FDA label and plan rules

The policy does not specify a required site of care for administration; providers should follow the FDA prescribing information and any plan-specific site-of-care rules when determining infusion center use.

Refer to the Bizengri FDA label for administration instructions.
Follow plan-specific site-of-care policies for infusion centers.

Background

Bizengri (zenocutuzumab-zbco) is a targeted monoclonal antibody therapy indicated for adult patients with advanced, unresectable, or metastatic cancers that harbor NRG1 gene fusions, including certain non‑small cell lung cancers and pancreatic adenocarcinomas, when disease has progressed on prior systemic therapy. Authorization and continued coverage require documentation consistent with FDA labeling and recognized compendia or peer‑reviewed literature, and consideration of safety parameters such as left ventricular ejection fraction and dosing limits.