CurrentColorado Rocky Mountain Health PlansPolicy Program Number 2025 P 1493-1

Hernexeos (zongertinib) prior authorization and coverage criteria

Prior authorization/notification program defining coverage criteria for Hernexeos (zongertinib) for treatment of adult patients with unresectable or metastatic non-squamous NSCLC harboring ERBB2 (HER2) tyrosine kinase domain activating mutations; includes special handling for patients under 19 years of age and reauthorization rules.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyHernexeos (zongertinib) prior authorization and coverage criteria

Policy CodePolicy Program Number 2025 P 1493-1

Change TypeNew program / criteria publication

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit prior authorization for adult members and document ERBB2 (HER2) tyrosine kinase domain activating mutation by an FDA‑approved test and prior systemic therapy to demonstrate eligibility; provide documentation of non-progression for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12Authorization duration (initial and reauthorization)

age <19Prescriptions for members <19 years process without coverage review

FDA-testHER2 mutation detection requirement

Prior therapyRequired before initiation in adults

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Authorization Criteria for Hernexeos (zongertinib)

Patients less than 19 years of age

Prescriptions for members under 19 process without a coverage review and will be approved when the following is met:

ALL of the following

Patient is less than 19 years of age

Initial Authorization (Adults)

Hernexeos will be approved when ALL of the following are met:

ALL of the following

Diagnosis of non-small cell lung cancer (NSCLC)
Disease status (one required)
- Recurrent
- Advanced
- Metastatic
- Unresectable
Presence of ERBB2 (HER2) tyrosine kinase domain activating mutation
Mutation should be detected by an FDA-approved test
Patient has received prior systemic therapy

Reauthorization

Reauthorization will be approved when the following is met:

ALL of the following

Patient does not show evidence of disease progression while on Hernexeos

NCCN Recognition

Additional pathway for approval based on guideline recognition:

ALL of the following

Drug is recognized for the cancer indication in the NCCN Drugs & Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Requirements and Documentation

Prior Authorization

Prior authorization required for adults

Prior authorization/notification is required for Hernexeos in adult members; coverage will only be approved when the clinical criteria are met, including a diagnosis of non-small cell lung cancer (NSCLC), the disease status (recurrent, advanced, metastatic, or unresectable), presence of an ERBB2 (HER2) tyrosine kinase domain activating mutation detected by an FDA‑approved test, and documentation that the patient has received prior systemic therapy.

Documentation Required

Documentation of HER2 mutation required

Provider must document the presence of an ERBB2 (HER2) tyrosine kinase domain activating mutation detected by an FDA‑approved test as a condition of coverage.

Prior Authorization

Reauthorization documentation

Referenced Codes

Clinical Background

Hernexeos (zongertinib) is a kinase inhibitor indicated for adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors harbor HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA‑approved test. Coverage under this program applies to adults who have received prior systemic therapy for their NSCLC; the presence of the specified ERBB2 activating mutation is required for authorization.

Defined Terms

Definitions

ERBB2 (HER2) tyrosine kinase domain activating mutationAn activating mutation in the ERBB2 (HER2) tyrosine kinase domain detected by an FDA‑approved test; required for coverage.

Prior systemic therapyAny prior line(s) of systemic anticancer therapy appropriate for NSCLC as documented in the patient's medical record.

Operational Notes & Scope

Authorizations are generally issued for 12 months for both initial approvals and reauthorizations. UnitedHealthcare may use automated approval and reauthorization processes and may approve requests based on prior claims/medication history, diagnosis codes, and/or claim logic without additional clinical review. Supply limits may apply. This policy is identified as Program Number 2025 P 1493-1 and is effective 1/1/2026; state mandates, federal requirements, and the member’s specific benefit plan may affect coverage and override parts of these criteria where applicable.

For members under age 19, prescriptions will automatically process without a coverage review and, when approved under that pathway, will be authorized for 12 months.

Key Statistics and Process Notes

Authorization duration (initial and reauthorization)12 months

Prescriptions for members <19 years process without coverage reviewage <19 auto-approve

HER2 mutation detection requirementFDA-approved test required

Required before initiation in adults