CurrentUnitedHealthcarePolicy 2025 P 1486-1

Zegfrovy (sunvozertinib) prior authorization criteria

Prior authorization and coverage criteria for Zegfrovy (sunvozertinib) for treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations; includes special handling for patients under 19 years of age and references to state/federal mandates and NCCN compendium recognition.

Policy Summary

PayerUnitedHealthcare

PolicyZegfrovy (sunvozertinib) prior authorization criteria

Policy CodePolicy 2025 P 1486-1

Change TypeNo material changes

Effective DateJan 17, 2026

Next Review Date

Key ActionObtain prior authorization for adults with documentation of NSCLC and an EGFR exon 20 insertion detected by an FDA‑approved test; authorizations are issued for 12 months and patients under 19 process automatically without coverage review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12Authorization period for initial and reauthorization

>=1Required prior therapy for adults

<19Automatic processing without coverage review

NCCN 1/2A/2BRecognized by NCCN Drugs & Biologics Compendium

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Pediatric patients (under 19 years)

Zegfrovy will be approved for patients under 19 if the following is met:

ALL of the following

Patient is less than 19 years of age

Initial authorization for adults

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

ALL of the following

Diagnosis of non-small cell lung cancer (NSCLC)
Disease is positive for an EGFR exon 20 insertion mutation
Mutation must be detected by an FDA‑approved test as stated in background
Disease status (one of)
- Recurrent
- Advanced
- Metastatic
Patient has received at least one prior systemic therapy (e.g., immune checkpoint inhibitor, platinum-based chemotherapy)
Required prior systemic therapies: at least 1

Reauthorization / Continuation

Zegfrovy will be approved for reauthorization when the following is met:

ALL of the following

Patient does not show evidence of progressive disease while on Zegfrovy therapy

NCCN recognition

Supportive criterion:

ALL of the following

Zegfrovy is recognized for the indicated cancer by the NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus 1, 2A, or 2B

Prior Authorization, Documentation, and Operational Notes

Prior Authorization

Prior authorization required for adults

Prior authorization is required for coverage of Zegfrovy in adults; approval is contingent on meeting the specified diagnostic and prior therapy criteria and authorization will be issued for 12 months.

Prior Authorization

Automatic processing for patients under 19

Prescriptions for members under 19 years of age will automatically process without a coverage review; authorization will be issued for 12 months.

Documentation Required

Diagnostic test documentation

Documentation must support a diagnosis of non‑small cell lung cancer (NSCLC) and evidence that an EGFR exon 20 insertion mutation was detected by an FDA‑approved test (per the product background).

Denial Risk

Reauthorization contingent on disease control

Reauthorization may be denied if there is evidence of progressive disease while the patient is on Zegfrovy therapy.

Note

Automated approvals

UnitedHealthcare may approve initial requests and reauthorizations based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; use of automated approval and re‑approval processes varies by program.

Clinical and Regulatory Context

Zegfrovy (sunvozertinib) is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum‑based chemotherapy. Approval requires that the mutation be detected by an FDA‑approved test. The agent is recognized in the NCCN Drugs and Biologics Compendium for this indication with a Category of Evidence and Consensus of 1, 2A, or 2B.

Policy Dates

Policy Number: 2025 P 1486-1. Effective Date: 2026-01-17. Last Review Date: 2025-09-01.

Scope: Prior authorization and coverage criteria for Zegfrovy (sunvozertinib) for the treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. The policy includes special handling for patients under 19 years of age (automatic processing without coverage review) and references applicable state/federal mandates and recognition in the NCCN Compendium.

Policy Summary

PayerUnitedHealthcare

PolicyZegfrovy (sunvozertinib) prior authorization criteria

Policy CodePolicy 2025 P 1486-1

Change TypeNo material changes

Effective DateJan 17, 2026

Next Review Date

SourceLink

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OpenPayer

Zegfrovy (sunvozertinib) prior authorization criteria

Medical Necessity Criteria for Zegfrovy (sunvozertinib)

Relevant Codes

Prior Authorization, Documentation, and Operational Notes

Clinical and Regulatory Context

Defined Terms

Quick Metrics

Policy Dates