CurrentUnitedHealthcarePolicy 2026 P 1510-1

Hyrnuo (sevabertinib) prior authorization

Prior authorization and notification requirements for Hyrnuo (sevabertinib) for treatment of adult patients with locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations; includes initial and reauthorization criteria and pediatric automatic processing under 19. Affects UnitedHealthcare members covered under applicable benefit plans.

Policy Summary

PayerUnitedHealthcare

PolicyHyrnuo (sevabertinib) prior authorization

Policy CodePolicy 2026 P 1510-1

Change TypeNo material changes

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization demonstrating diagnosis of advanced/metastatic/recurrent/unresectable non-small cell lung cancer with ERBB2 (HER2) TKD activating mutation and prior systemic therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

adult NSCLCindication

prior systemic therapyinitial prerequisite

age <19 auto-approvepediatric processing

Coverage Criteria for Hyrnuo (sevabertinib)

Policy Summary

PayerUnitedHealthcare

PolicyHyrnuo (sevabertinib) prior authorization

Policy CodePolicy 2026 P 1510-1

Change TypeNo material changes

Effective DateMay 1, 2026

Next Review DateN/A

SourceLink

On This Page

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inv-01: Initial Authorization

Covered when ALL of the following are met

Initial Authorization criteria

Disease status: Advanced OR Metastatic OR Recurrent OR Unresectable

inv-02: Reauthorization

Covered when ALL of the following are met

Reauthorization criteria: Patient does not show evidence of disease progression while on Hyrnuo

Authorization will be issued for 12 months

inv-03: Patients less than 19 years of age

Automatic approval for patients under 19

Patients <19: Patient is less than 19 years of age

Authorization will be issued for 12 months; prescriptions for members under 19 process without coverage review

Coverage decisions for Hyrnuo (sevabertinib) are subject to member-specific benefit plan terms and applicable state mandates. Some states require coverage for off‑label uses or mandate the use of specific compendia; when such state mandates apply, they supersede the language in this benefit document and the notification/authorization criteria.

Providers should also be aware that other utilization management programs or plan‑level exclusions may affect coverage for a given member. For members under 19 years of age, prescriptions for Hyrnuo will automatically process without a coverage review, per the plan rules.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for members except for those under 19 years of age, who are processed without coverage review.

Applies to Hyrnuo (sevabertinib)
Authorization issued for 12 months for initial and reauthorization approvals

Step Therapy

Step Therapy Requirement

Prior exposure to systemic therapy is required before initial approval for Hyrnuo.

Requirement: documentation of prior systemic therapy (agent name(s) and dates)
No specific agents or sequence mandated — any prior systemic therapy for NSCLC suffices

Documentation Required

Required Documentation

Provide documentation to support diagnosis, disease stage, and molecular testing showing an ERBB2 (HER2) tyrosine kinase domain (TKD) activating mutation.

Clinical documentation confirming diagnosis of non-small cell lung cancer (NSCLC)
Staging or clinical notes confirming advanced, metastatic, recurrent, or unresectable disease
Pathology/genomic report demonstrating ERBB2 (HER2) TKD activating mutation — include test name and result; if applicable, indicate FDA-approved test used
Documentation of prior systemic therapy — agent names, dates, and response or reason for discontinuation

Denial Risk

Denial Triggers and Risk

Requests that do not meet the initial authorization criteria or lack required documentation will be denied.

Denial triggers include: absence of documented ERBB2 (HER2) TKD activating mutation, no evidence of prior systemic therapy, diagnosis not NSCLC, or disease not advanced/metastatic/recurrent/unresectable
Incomplete medical records, missing pathology/genomic reports, or lack of test name/result may lead to denial
Reauthorization may be denied if there is evidence of disease progression while on Hyrnuo

Step	Requirement
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Key Definitions

ERBB2 (HER2) TKD activating mutation — definition / detection by FDA-approved test

DefinitionHER2 (ERBB2) tyrosine kinase domain (TKD) activating mutation

Detection methodAs detected by an FDA-approved test

Indication contextRequired biomarker for Hyrnuo (sevabertinib) use in adult patients with locally advanced or metastatic non-squamous NSCLC

Regulatory noteIndication approved under accelerated approval based on ORR and DOR; continued approval may depend on confirmatory trial results

Prior therapy requirementPatients must have received a prior systemic therapy

Background

Hyrnuo (sevabertinib) is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non‑squamous non‑small cell lung cancer that harbors HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations as detected by an FDA‑approved test. The approval is based on objective response rate and duration of response under an accelerated approval pathway; continued approval may depend on verification of clinical benefit in confirmatory trials.

OpenPayer

Hyrnuo (sevabertinib) prior authorization

Coverage Criteria for Hyrnuo (sevabertinib)

Initial Therapy

Reauthorization / Continuation Therapy

Provider Actions and Requirements

Step Therapy Requirements

Key Definitions

Background