CurrentCignaPolicy N/A

Oncology (Oral - HER2 Inhibitor) - Hernexeos Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for oral HER2 inhibitor Hernexeos (zongertinib) for treatment of unresectable or metastatic NSCLC with ERBB2 activating mutations for affected Cigna health benefit plans.

Policy Summary

PayerCigna

PolicyOncology (Oral - HER2 Inhibitor) - Hernexeos Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCoverage and criteria revisions (material)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with supporting documentation; approvals provided for up to 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Overview updated with new guideline information.

Deleted 'nonsquamous' in reference to disease type for NSCLC.

Removed requirement that mutation be detected by an approved test and removed requirement for prior systemic therapy.

1FDA-approved indication (NSCLC)

1 yearInitial approval duration

2026-02Hernexeos PI date

NCCN v3.2026Guideline referenced

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Coverage / Medical Necessity Criteria

Initial Therapy — FDA-Approved Indication

Covered when ALL of the following are met

FDA-Approved Indication for NSCLC: A) Patient is >= 18 years of age; AND B) Patient has unresectable or metastatic disease; AND C) Patient has human epidermal growth factor receptor 2 (HER2) [ERBB2] activating mutation.

Approve for 1 year when all conditions met

Hernexeos (zongertinib) is not medically necessary for any use other than the FDA‑approved indication. This determination will be revisited and the criteria updated as new published data become available.

Any use other than the specified FDA‑approved indication for HER2 (ERBB2) activating mutation‑positive unresectable or metastatic non‑small cell lung cancer is considered not medically necessary under this policy.

Regimen	Indication / NCCN listing	Coverage status
Hernexeos (zongertinib) oral tablets	ERBB2 (HER2) mutation–positive non–small cell lung cancer (NSCLC); listed by NCCN v3.2026 as a 'Preferred' subsequent therapy option (category 2A)	Covered with criteria

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior Authorization Recommended. Providers should obtain prior authorization for Hernexeos (zongertinib) through the plan's prescription benefit process. All approvals are provided for the duration noted in the policy (e.g., approvals for FDA‑approved indications are issued for 1 year).

Approval duration: 1 year for FDA‑approved NSCLC indication when criteria met

Documentation Required

Documentation and Benefit‑Plan Conformity

Coverage decisions must conform to the member's applicable benefit plan document. Providers must submit supporting medical records and documentation demonstrating that the requested service meets the policy criteria (age, disease stage, and HER2 activating mutation for the NSCLC indication). Requests and claims submitted without the required documentation or not consistent with the member's benefit plan may be denied.

Providers must follow the terms of the applicable benefit plan document (e.g., Evidence of Coverage, SPD).
Submit clinical documentation showing patient age (≥18), unresectable or metastatic disease, and HER2 (ERBB2) activating mutation.

Genomic / Biomarker Requirements

ERBB2 (HER2) activating mutation — biomarker requirement

Biomarker required for coveragePresence of a human epidermal growth factor receptor 2 (HER2) [ERBB2] activating mutation is required for approval.

Disease contextUnresectable or metastatic non-small cell lung cancer (NSCLC).

Age requirementPatient is ≥ 18 years of age.

Approval duration when criteria metApprove for 1 year when all coverage criteria are satisfied.

HER2 [ERBB2] activating mutation — definition

DefinitionHER2 [ERBB2] activating mutation refers to activating mutations in the ERBB2 (human epidermal growth factor receptor 2) tyrosine kinase domain.

Line of Therapy / Use Context

second-line

Subsequent therapy context: NCCN lists Hernexeos as a 'Preferred' subsequent therapy option (category 2A) for ERBB2 mutation-positive disease; Hernexeos use in first-line was not addressed by NCCN v3.2026.

Background

Hernexeos (zongertinib) is an oral kinase inhibitor indicated for adults with unresectable or metastatic non‑small cell lung cancer harboring ERBB2 (HER2) activating mutations. Approval was granted under accelerated approval based on objective response rate and duration of response; continued approval may depend on confirmatory trials.

Policy Revision History

2026-03-04revisionLatest

Policy updated (Selected Revision 2) as recorded in history; specific administrative revision recorded on 2026-03-04.

2025-09-10revision

Removed requirement that the ERBB2 (HER2) mutation be detected by an approved test and removed requirement for prior systemic therapy.

2025-08-21revision

Overview updated to reference NCCN NSCLC Guidelines version 3.2026 (12/24/2025).

Policy Summary

PayerCigna

PolicyOncology (Oral - HER2 Inhibitor) - Hernexeos Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCoverage and criteria revisions (material)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with supporting documentation; approvals provided for up to 1 year when criteria are met.

SourceLink

On This Page

Denial Risk

Coding‑Related Denial Risk

Claims billed with diagnosis or procedure codes that do not correspond to covered indications per this policy will be denied as not covered. Use the most appropriate and current codes as of the date of submission; billing for conditions or diagnoses not covered by this policy (or the member's benefit plan) risks denial.

Claims without covered diagnosis/procedure codes will be denied.
Ensure coding reflects HER2 (ERBB2) mutation‑positive unresectable or metastatic NSCLC when applicable.

Step Therapy

Step Therapy Context

Step‑therapy / Subsequent therapy context: NCCN lists Hernexeos among preferred subsequent HER2‑directed therapy options (category 2A) along with Hyrnuo (sevabertinib) and Enhertu (fam‑trastuzumab deruxtecan); Kadcyla is listed as an other recommended option. No payer‑specific step therapy sequencing is specified in this policy — coverage depends on meeting the policy criteria and the member's benefit plan.

NCCN preferred subsequent therapy options: Hernexeos, Hyrnuo, Enhertu (category 2A).
Kadcyla is an 'Other Recommended' subsequent therapy option.
No Cigna step‑therapy requirement is specified in this policy; follow benefit plan and prior authorization requirements.

Detection context in original approvalIndication described tumors with ERBB2 tyrosine kinase domain activating mutations as detected by an FDA-approved test (per original prescribing overview).

Regulatory noteApproval granted under accelerated approval based on objective response rate and duration of response; continued approval may depend on confirmatory trials.

2025-08-13new_policy_review

New policy created and initial review date recorded (New Policy, Review Date = 08/13/2025).

2025-09-10material_change

Deleted 'nonsquamous' in reference to disease type for NSCLC (material change).