CurrentCentenePolicy CP PHAR.695

Lazertinib (Lazcluze) Coverage

Defines Centene medical necessity and authorization criteria for lazertinib (Lazcluze) when used in combination with amivantamab for adults with advanced or metastatic EGFR‑mutated non‑small cell lung cancer, and continuation/other-use guidance for affected lines of business.

Policy Summary

PayerCentene

PolicyLazertinib (Lazcluze) Coverage

Policy CodePolicy CP PHAR.695

Change TypeRoutine review — no material changes

Effective DateDec 1, 2024

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating diagnosis, EGFR mutation status, prescriber specialty, age, dosing, and response for continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

240 mg/dayMax daily dose

6 monthsInitial approval

12 monthsContinuation approval

>= 18Minimum age

With amivantamabCombination required

Coverage Criteria

Policy Summary

PayerCentene

PolicyLazertinib (Lazcluze) Coverage

Policy CodePolicy CP PHAR.695

Change TypeRoutine review — no material changes

Effective DateDec 1, 2024

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating diagnosis, EGFR mutation status, prescriber specialty, age, dosing, and response for continuation requests.

SourceLink

On This Page

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inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial Approval

Diagnosis of recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC).
Mutation: Disease is positive for EGFR exon 19 deletion(s) or exon 21 L858R substitution mutation(s) as detected by an FDA-approved test.
Prescriber: Prescribed by or in consultation with an oncologist.
Age: Patient is age >= 18 years.
Use Context: Lazcluze (lazertinib) is prescribed in combination with amivantamab (Rybrevant) either: (a) as first-line treatment OR (b) as continuation of the combination following disease progression for asymptomatic disease, symptomatic brain lesions, or symptomatic systemic limited progression.
Product Use: Member must use lazertinib (Lazcluze) if available unless contraindicated or clinically significant adverse effects are experienced.
Dose: Requested dose must not exceed 240 mg per day (not more than 2 tablets/day) OR the dose must be supported by practice guidelines or peer-reviewed literature for the relevant off‑label use with supporting evidence from the prescriber.240 mg/day
Prescribed regimen must be FDA‑approved or recommended by NCCN.

Provider Documentation: Provider must submit documentation (e.g., office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

inv-02: Continuation Therapy — Covered for continuation when ALL of the following are met

Covered for continuation when ALL of the following are met:

Continued Therapy

Current Use: Member is currently receiving Lazcluze via the Centene benefit, or documentation supports that the member has received Lazcluze for a covered indication for at least 30 days.
Diagnosis: Non‑Small Cell Lung Cancer (NSCLC) for which therapy was initiated.
Response: Member is responding positively to therapy.
Product Use: For continuation, member must use lazertinib (Lazcluze) if available unless contraindicated or clinically significant adverse effects are experienced.

Requests to use lazertinib (Lazcluze) for indications that are not FDA‑approved and that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53) or other evidence of coverage.

Use of lazertinib for diagnoses or indications that are not FDA‑approved and that lack adequate supporting off‑label evidence per the referenced off‑label use policies is not authorized.

Initial Therapy

inv-13: Initial Therapy — initial authorization requirements (duplicate/alternate grouping for clarity)

Initial authorization requirements

Initial Therapy

Diagnosis of recurrent, advanced, or metastatic NSCLC.
Mutation: Documented EGFR exon 19 deletion or exon 21 L858R substitution mutation as detected by an FDA‑approved test.
Prescriber: Prescribed by or in consultation with an oncologist.
Age: Patient is age >= 18 years.
Use Context: Lazcluze must be prescribed in combination with amivantamab (Rybrevant) either as first‑line therapy or as continuation of the combination per the policy-defined scenarios.
Product Use: Member must use Lazcluze (lazertinib) if available unless contraindicated or clinically significant adverse effects occur.
Dose requested must not exceed 240 mg per day (2 tablets/day) OR must be supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use with submitted evidence.240 mg/day
Prescribed regimen must be FDA‑approved or recommended by NCCN.

Required Documentation: Provider must submit documentation (e.g., office chart notes, lab results, or other clinical information) supporting that the member has met all initial authorization criteria.

Continuation Criteria

inv-14: Continuation Therapy — criteria for continued coverage

Criteria for continued coverage

Continued Therapy

Current Use: Member is currently receiving Lazcluze via Centene benefit, or documentation supports at least 30 days of therapy.
Diagnosis: Non‑Small Cell Lung Cancer (NSCLC) for which therapy was initiated.
Response: Member is responding positively to therapy.
Dose Change: If the request is for a dose increase, the new dose must not exceed 240 mg per day (2 tablets/day) OR be supported by practice guidelines or peer‑reviewed literature with supporting evidence from the prescriber.240 mg/day
Prescribed regimen must be FDA‑approved or recommended by NCCN.

Provider Documentation: Provider must submit documentation (e.g., office chart notes, lab results, or other clinical information) supporting that the member meets criteria for continued coverage.

Provider Actions / Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lazcluze. Provider must obtain prior authorization and submit documentation that the criteria for initial or continued therapy are met.

Applies to initial and continuation requests
Approval durations: Initial — 6 months; Continued — 12 months

Billing Rule

Product Availability and Dosing Requirements

If Lazcluze is available for the member, the member must use lazertinib (Lazcluze) unless it is contraindicated or the member experiences clinically significant adverse effects. Dosing limits: do not exceed 240 mg per day (equivalent to 2 tablets per day). Dose increases must be supported by practice guidelines or peer-reviewed literature for off‑label uses with supporting evidence from the prescriber.

Maximum dose: 240 mg/day (2 tablets/day)
If prescribing for an off‑label indication, prescriber must submit supporting evidence if dose exceeds standard limits

Documentation Required

Required Documentation

Provider must submit supporting clinical documentation (e.g., office chart notes, lab results, imaging, and other relevant clinical information) with the prior authorization request to demonstrate that the member meets all approval criteria for initial or continued therapy.

Include documentation of diagnosis, mutation status (EGFR exon 19 deletion or exon 21 L858R), treatment history, and response to therapy as applicable
For off‑label requests, include practice guideline or peer‑reviewed literature supporting the regimen

Denial Risk

Non‑FDA Indications / Off‑Label Requests

Requests for indications not addressed in this policy (non‑FDA approved/ off‑label) will be denied unless sufficient documentation of efficacy and safety is provided in accordance with applicable off‑label use policies (CP CPA.09, HIM.PA.154, CP PMN.53) or other evidence of coverage documents.

Prescribed regimen should be FDA‑approved or recommended by NCCN when possible
For continuation requests, member must have been on therapy at least 30 days and be responding to therapy

OpenPayer

Lazertinib (Lazcluze) Coverage

Coverage Criteria

Initial Therapy

Continuation Criteria

Provider Actions / Requirements

Coding and Dosing

Step Therapy Requirements

Quantity Limits

Background

Definitions