CurrentBlue Cross Blue Shield - IowaPolicy 05.05.64

Lazcluze (lazertinib) — coverage criteria for EGFR-mutant NSCLC

Defines coverage, prior authorization, dosing limits, and documentation requirements for Lazcluze (lazertinib) for treatment of EGFR exon 19 deletion or exon 21 L858R substitution mutation positive non-small cell lung cancer; applies to members whose benefits include the therapy.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyLazcluze (lazertinib) — coverage criteria for EGFR-mutant NSCLC

Policy CodePolicy 05.05.64

Change TypeRoutine review — no material changes

Effective DateMar 11, 2026

Next Review Date

Key ActionObtain and submit test results showing EGFR exon 19 deletion or exon 21 L858R substitution to initiate prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

240 mg dailyFDA dosing

60 / 30d80 mg limit

30 / 30d240 mg limit

EGFR exon19/21required mutation

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Coverage Criteria for Lazcluze (lazertinib)

Initial and Continued Therapy

Covered when ALL of the following are met

Eligibility for coverage: 1) Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) (including recurrent, advanced, or metastatic disease per compendial use) AND 2) Tumor positive for EGFR exon 19 deletion OR exon 21 L858R substitution as shown by an FDA-approved test or submitted test results AND 3) Lazcluze (lazertinib) will be used in combination with amivantamab (or amivantamab and hyaluronidase per combination option).

Authorization may be granted for 12 months for initial treatment; reauthorization may be granted for 12 months if no unacceptable toxicity.

Lazcluze (lazertinib) is not medically necessary for members who do not meet the coverage criteria set forth in this policy.

Use of Lazcluze when the member does not meet the policy criteria (for example, absence of the required EGFR exon 19 deletion or exon 21 L858R substitution tumor mutation or other stated approval requirements) is considered not medically necessary and will not be authorized.

Initial Therapy

Initial approval criteria

Initial Approval: 1) Member has locally advanced or metastatic NSCLC (or recurrent/advanced/metastatic per compendia) AND 2) Documented EGFR exon 19 deletion OR exon 21 L858R substitution mutation (submit test results) AND 3) Therapy to be given in combination with amivantamab (or amivantamab and hyaluronidase).

Authorization may be granted for up to 12 months.

Continuation / Reauthorization Criteria

Continuation Therapy

Reauthorization conditions

Reauthorization: Authorization of 12 months may be granted for continued treatment when there is no evidence of unacceptable toxicity while on the current regimen.

Applies to members previously approved for an indication listed in the Initial Approval criteria.

Procedures, Codes, and Quantity Limits

Procedures and billing codesmixed

No codes listed

Quantity limits per product

Lazcluze (lazertinib) 80 mg tabletStandard limit: 60 tablets per 30 days

Lazcluze (lazertinib) 240 mg tabletStandard limit: 30 tablets per 30 days

FDA recommended dosing (context)240 mg orally once daily (available as 80 mg and 240 mg tablets); dose reductions to 160 mg or 80 mg once daily permitted for adverse reactions

Product Quantity Limits

Lazcluze (lazertinib) 80 mg tablet — standard limit

ProductLazcluze (lazertinib) 80 mg tablet

Standard limit60 tablets per 30 days

Related dosing noteFDA recommended dosing for therapy is 240 mg once daily (administered using available tablet strengths)

Lazcluze (lazertinib) 240 mg tablet — standard limit

ProductLazcluze (lazertinib) 240 mg tablet

Standard limit30 tablets per 30 days

Dose adjustment info

Prior Authorization, Documentation, and Denial Conditions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lazcluze (lazertinib) for treatment of recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC). Submit supporting documentation as described below at time of prior authorization request. Authorizations, when approved, may be granted for up to 12 months and reauthorization may be approved for continued treatment when there is no evidence of unacceptable toxicity while on the current regimen.

Authorization period: up to 12 months
Reauthorization: may be granted for 12 months if member is tolerating therapy

Documentation Required

Required Mutation Test Documentation

Ensure all required mutation test documentation is submitted with the request. Specifically, provide test results demonstrating the presence of an EGFR exon 19 deletion or EGFR exon 21 L858R substitution mutation.

Required: EGFR exon 19 deletion OR exon 21 L858R substitution mutation test results

Definitions

EGFR exon 19 deletion or exon 21 L858R substitution — required activating mutations

DefinitionEGFR exon 19 deletion: an activating deletion in exon 19 of the epidermal growth factor receptor (EGFR) gene associated with sensitivity to EGFR-targeted therapy

DefinitionEGFR exon 21 L858R substitution: the L858R point mutation in exon 21 of the EGFR gene (substitution at codon 858) that confers sensitivity to EGFR-targeted therapy

Clinical contextThese specific activating EGFR mutations define patients eligible for Lazcluze in combination with amivantamab per FDA indication; compendial use includes recurrent, advanced, or metastatic disease with these mutations

Background

Lazcluze (lazertinib) is indicated for use in patients with EGFR mutation–positive non–small cell lung cancer. Coverage under this policy is limited to members who meet the specified criteria, including documented presence of an EGFR exon 19 deletion or exon 21 L858R substitution mutation and use in the approved combination regimens; members who do not meet these requirements are not eligible for coverage.

Site of Care Considerations

Billing Rule

Approvals may be subject to dosing limits; no site restriction

Approvals for Lazcluze may be subject to dosing limits in accordance with FDA labeling, compendia, and guidelines; the policy does not state an explicit site‑of‑care restriction for infusion center use.

Dosing limits may be applied consistent with FDA‑approved labeling and accepted compendia/guidelines
No explicit restriction against infusion center site of care is specified in the policy