CurrentUnitedHealthcarePolicy 2025 P 1459-2

Lazcluze® (lazertinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Prior authorization/notification criteria for coverage of Lazcluze (lazertinib) for UnitedHealthcare Commercial Plans, including initial authorization, reauthorization, pediatric automatic approval under 19, NCCN recognition note, and administrative rules; effective date 2025-12-01 per header.

Policy Summary

PayerUnitedHealthcare

PolicyLazcluze® (lazertinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 1459-2

Change TypeAnnual review (no changes)

Effective DateDec 1, 2025

Next Review Date2026-10

Key ActionMembers aged 19 and older must meet the specified clinical criteria (NSCLC diagnosis, disease status, EGFR mutation, and use in combination with Rybrevant) for authorization; authorization is issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

10/2025 annual review without changes to coverage criteria; references updated.

12 moAuthorization duration

2Required EGFR mutations

1Required concomitant agent (Rybrevant)

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Prior authorization/notification criteria for Lazcluze (lazertinib) for UnitedHealthcare Commercial Plans. Indication: Lazcluze in combination with Rybrevant is for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletion or EGFR exon 21 L858R mutations. Effective date: 2025-12-01. Applicability: Members <19 years of age receive automatic approval (prescription will automatically process without coverage review) with authorization issued for 12 months; members ≥19 must meet specified clinical criteria (NSCLC diagnosis, disease status, EGFR mutation, and use in combination with Rybrevant) for authorization.

Initial Therapy Criteria

Initial Authorization

Lazcluze will be approved based on all of the following criteria:

ALL of the following

Diagnosis of non-small cell lung cancer (NSCLC)
Disease status
- Recurrent
- Advanced
- Metastatic
ANY of the following
- Epidermal growth factor receptor (EGFR) exon 19 deletion
- EGFR exon 21 L858R mutation
Used in combination with Rybrevant (amivantamab-vmjw)

Prior Authorization

Prior authorization required for patients >=19

Members aged 19 and older must meet the specified clinical criteria (NSCLC diagnosis, disease status, EGFR mutation, and use in combination with Rybrevant) for authorization; authorization is issued for 12 months.

Applies to members >=19
Authorization duration: 12 months
Requires combination with Rybrevant

Note

Rybrevant (amivantamab-vmjw)

Rybrevant: amivantamab-vmjw (combination agent required with Lazcluze per criteria).

Continuation / Reauthorization Criteria

Reauthorization

Lazcluze will be approved based on the following criterion:

ALL of the following

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

Denial Risk

Reauthorization denial if progression

Reauthorization requires that the patient does not show evidence of progressive disease while on Lazcluze therapy; claims may be denied if progression is documented.

Pediatric Automatic Processing

Patients less than 19 years of age

Lazcluze will be approved based on the following criterion:

ALL of the following

Patient is less than 19 years of age

Prior Authorization

Automatic processing for patients under 19

Prescriptions for members under 19 will automatically process without coverage review and authorization will be issued for 12 months.

Automatic approval for <19
Authorization duration: 12 months

NCCN Recognition

NCCN recommended regimens

ALL of the following

The drug is recognized by the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Lazcluze (lazertinib) is a kinase inhibitor indicated in combination with Rybrevant (amivantamab-vmjw) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. The NCCN also recommends continuation of Lazcluze plus Rybrevant following progression in certain scenarios (asymptomatic disease, symptomatic brain lesions, or symptomatic systemic limited progression).

Provider Actions & Documentation Requirements

Documentation Required

Mutation and combination therapy documentation

Document EGFR mutation status (exon 19 deletion or exon 21 L858R) and document that Lazcluze will be used in combination with Rybrevant to support authorization.

Document mutation type
Document planned combination with Rybrevant

Billing Rule

Supply limits and automated approvals may apply

Supply limits may be in place and UnitedHealthcare may approve initial and reauthorization based solely on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic.

Claims may be auto-approved using ICD-10
Supply limits may apply

Clinical Evidence & References

Evidence and references: P&T Approval dates: 10/2024 and 10/2025. Package insert: Lazcluze [package insert], Janssen Biotech, Inc., August 2025. NCCN Compendium access: Accessed September 9, 2025.

Background & Definitions

Drug class and clinical notes: Lazcluze is a kinase inhibitor used in combination with Rybrevant for first-line treatment of adults with EGFR exon 19 deletion or exon 21 L858R mutated locally advanced or metastatic NSCLC. Per NCCN guidance, the combination may be continued after progression in defined scenarios such as asymptomatic disease, symptomatic brain lesions, or symptomatic limited systemic progression.

Definitions:

Rybrevant: amivantamab-vmjw (combination agent required with Lazcluze per criteria).

Revision History

10/2024P&T Approval

P&T approval of the Lazcluze prior authorization/notification program (new program).

10/2025P&T ApprovalLatest

Annual review completed without changes to coverage criteria; references updated.

2025-12-01Effective Date

Policy effective date.

August 2025Reference Update

Updated package insert reference: Lazcluze [package insert], Janssen Biotech, Inc., August 2025.

September 9, 2025Reference Update

NCCN Drugs and Biologics Compendium accessed (reference updated).

Policy Summary

PayerUnitedHealthcare

PolicyLazcluze® (lazertinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 1459-2

Change TypeAnnual review (no changes)

Effective DateDec 1, 2025

Next Review Date2026-10

SourceLink

On This Page

OpenPayer

Lazcluze® (lazertinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Pediatric Automatic Processing

NCCN Recognition

Provider Actions & Documentation Requirements

Applicable Codes

Clinical Evidence & References

Background & Definitions

Revision History