CurrentBlue Cross Blue Shield - IowaPolicy 05.05.64

Lazcluze (lazertinib) — Coverage Criteria for EGFR-mutant NSCLC

This policy governs prior authorization, coverage criteria, quantity limits, and continuation rules for Lazcluze (lazertinib) for treatment of EGFR exon 19 deletion or exon 21 L858R mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) when used in combination with amivantamab. It applies to members covered under the payer's benefit plans where the benefit exists.

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 DateNov 30, 2024

Next Review DateAug 1, 2025

Key ActionSubmit prior authorization with confirmatory EGFR mutation test results to request a 12-month authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moinitial authorization duration

12 mocontinuation duration

240 mg/daymax dosing

6080 mg tablet limit

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Coverage Criteria for Lazcluze (lazertinib)

inv-01: Initial Therapy

Authorization of 12 months may be granted for first-line treatment when ALL of the following are met:

Initial approval criteria: 1) Diagnosis of recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 19 deletion or exon 21 L858R substitution mutation as detected by an FDA‑approved test; 2) Use of Lazcluze (lazertinib) in combination with amivantamab (Rybrevant) for first‑line treatment; 3) Submission of confirmatory EGFR mutation test results with the prior authorization request; 4) Therapy is for an indication consistent with the FDA‑approved or compendial uses described in this policy.

12‑month initial authorization per policy

inv-02: Continuation Therapy

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

Continuation criteria: 1) Member is currently receiving Lazcluze for an indication previously authorized under this policy (an indication listed in the Criteria for Initial Approval); 2) There is no evidence of unacceptable toxicity while on the current regimen; 3) Continued use remains consistent with the originally authorized combination with amivantamab and clinical benefit is maintained or expected.

Reauthorization limited to 12 months per policy

This policy applies only when the prescribed therapy is a covered benefit under the member's contract and all approval criteria are met. Coverage is limited to the indications described in this document; members with contract exclusions are not eligible for coverage under this medical policy. Providers should confirm that the member's benefit plan includes coverage for Lazcluze (lazertinib) before submitting a prior authorization request.

Use of Lazcluze (lazertinib) is considered not medically necessary for members who do not meet the specific approval criteria outlined in this policy.

Initial Therapy

inv-11: Initial Therapy

Authorization of 12 months may be granted for first-line treatment when ALL of the following are met:

Initial authorization: 1) Diagnosis of locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutation; 2) Treatment is first‑line and in combination with amivantamab (Rybrevant); 3) Prior authorization submission includes EGFR mutation test results confirming the relevant mutation; 4) Prescribed use aligns with FDA‑approved indication or accepted compendial use.

Initial authorization duration: 12 months

Continuation / Reauthorization Criteria

inv-12: Continuation

Reauthorization may be granted for continued treatment when ALL of the following are met:

Reauthorization: 1) Member has a prior authorization for Lazcluze for an indicated diagnosis under this policy; 2) No evidence of unacceptable toxicity while on the current regimen; 3) Continued therapy is for the same authorized indication and combination (with amivantamab) and clinical response or tolerance supports ongoing treatment.

Reauthorization duration: 12 months

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lazcluze (lazertinib). Authorization of up to 12 months may be granted for first-line treatment of recurrent, advanced, or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 L858R substitution mutations when used in combination with amivantamab (Rybrevant).

12-month authorization may be granted for first-line treatment

Note

Provider Action

Provider should follow payer prior authorization workflows and submit all requested clinical information to avoid delays. Check member eligibility and benefits before initiating therapy.

Documentation Required

Required Documentation

Definitions

EGFR exon 19 deletion or exon 21 L858R mutation-positive NSCLC — definition

Target populationAdults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations as detected by an FDA-approved test; compendial use includes recurrent, advanced, or metastatic disease in combination with amivantamab.

Required diagnostic evidenceConfirmatory EGFR mutation test results (demonstrating exon 19 deletion or exon 21 L858R) must be submitted with the prior authorization request.

Therapeutic contextUse is indicated when Lazcluze (lazertinib) is given in combination with amivantamab (Rybrevant) for first-line treatment; compendial use supports combination therapy in recurrent/advanced/metastatic settings.

Disease stageLocally advanced or metastatic NSCLC; compendial applications include recurrent, advanced, or metastatic disease.

Quantity Limits

Lazcluze (lazertinib) 80 mg tablet — quantity limit

Product and strengthLazcluze (lazertinib) 80 mg tablet

Standard quantity limit60 tablets per 30 days

Related dosing noteFDA-recommended dosing guidance notes dose reductions to 160 mg then 80 mg once daily if adverse reactions occur.

Lazcluze (lazertinib) 240 mg tablet — quantity limit

Product and strengthLazcluze (lazertinib) 240 mg tablet

Standard quantity limit30 tablets per 30 days

Related dosing note

Background

Lazcluze (lazertinib) is an EGFR tyrosine kinase inhibitor indicated in combination with amivantamab for first-line treatment of adults with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations. The therapy is also supported for compendial use in recurrent, advanced, or metastatic disease when used in combination with amivantamab; prior authorization and required documentation (including confirmatory EGFR mutation test results) are necessary for coverage determination.