CurrentHealth NetPolicy CP PHAR.695

Clinical Policy: Lazertinib (Lazcluze)

Clinical policy describing medical necessity criteria, dosing, and approval durations for lazertinib (Lazcluze) in combination with amivantamab for first-line treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations; includes continuation criteria and references to off-label/non-formulary policies.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Lazertinib (Lazcluze)

Policy CodePolicy CP PHAR.695

Change TypePolicy creation / establishment

Effective DateDec 1, 2024

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria including mutation testing results.

SourceLink

POLICY UPDATE CHANGES

Policy created; Lazcluze clinical policy established 10.10.24 with P&T approval date 11.24.

1Covered Indication (FDA first-line EGFR-mutant NSCLC with amivantamab)

240 mg/dayRecommended Dose

6 moInitial Approval Duration

12 moContinued Approval Duration

Coverage Summary & Indications

Clinical policy describing medical necessity criteria, dosing, and approval durations for lazertinib (Lazcluze) in combination with amivantamab (Rybrevant) for first-line treatment of adults with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R substitutions.

Coverage stance: Covered with criteria. Effective date: 12.01.24. Last review/P&T approval date: 11.24.

Background: Lazertinib (Lazcluze) is indicated in combination with amivantamab for first-line treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitutions.

Approval Duration - Initial

Approval duration: 6 months.

Continued Therapy Criteria

Covered when ALL of the following are met:

ALL of the following

Member is currently receiving medication via Centene benefit, or documentation supports that member has received Lazcluze for a covered indication for at least 30 days.Minimum trial duration prior to continued therapy: >= 30 days
Diagnosis: Non-Small Cell Lung Cancer.
Member is responding positively to therapy.
For Lazcluze requests, member must use lazertinib, if available, unless contraindicated or clinically significant adverse effects are experienced.
If request is for a dose increase, new dose must meet one of the following:
- New dose does not exceed both (i) 240 mg per day and (ii) 2 tablets per day.Maximum daily dose: 240 mg/day; Tablets per day: <= 2
- New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
  Prescribed regimen must be FDA-approved or recommended by NCCN

Continued Therapy - Approval Duration

Approval duration: 12 months.

Diagnoses/Indications NOT Authorized

Non-FDA approved indications not addressed in this policy are not covered unless there is sufficient documentation of efficacy and safety per the referenced off-label use policies (CP.CPA.09 for commercial; HIM.PA.154 for health insurance marketplace; CP.PMN.53 for Medicaid) or evidence of coverage documents.

Prior Authorization, Documentation, and Prescribing Requirements

Prior Authorization

Prior authorization required

Requests require review against the policy criteria; approval durations are 6 months for initial and 12 months for continuation. Prescriber must supply supporting evidence for off-label dosing/regimens.

Approval durations: 6 months (initial), 12 months (continuation).
Prescriber must submit supporting evidence for off-label dosing/regimens.

Documentation Required

Submit supporting documentation

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria, including mutation testing results.

Billing Rule

Dose limits

Dose must not exceed 240 mg per day and must not exceed 2 tablets per day unless the new or requested dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence). Maximum dose stated as 240 mg/day.

Documentation Required

Specialty prescriber requirement

Medication must be prescribed by or in consultation with an oncologist.

Provider notes: Thresholds include a Maximum daily dose: 240 mg/day; Tablets per day: ≤ 2; and Minimum trial duration prior to continued therapy: ≥ 30 days.

Product Strengths and Related Policy References

Product availability / dosage strengthsNDC

80 mg	Oral tablet strength
240 mg	Oral tablet strength; recommended dose 240 mg PO QD in combination with amivantamab; maximum dose 240 mg/day

Related referenced policies (for off-label / formulary status)mixed

CP.CPA.09	Commercial off-label use policy
HIM.PA.154	Health insurance marketplace off-label policy
CP.PMN.53	Medicaid off-label policy
CP.CPA.190	Commercial no coverage criteria / non-formulary policy reference
HIM.PA.33	Health insurance marketplace no coverage criteria reference
CP.PMN.255	Medicaid no coverage criteria reference
HIM.PA.103	Health insurance marketplace non-formulary policy
CP.PMN.16	Medicaid non-formulary policy

Clinical Evidence & Background

Lazertinib (Lazcluze) is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

Policy aligns coverage to the FDA-approved indication and to NCCN/guideline-supported use for off-label dosing where applicable; dosing for NSCLC is 240 mg PO QD in combination with amivantamab and oral tablet strengths are available as 80 mg and 240 mg.

Key trial/publication: Cho BC et al., N Engl J Med. Amivantamab plus lazertinib in previously untreated EGFR‑mutated advanced NSCLC. Published online June 26, 2024.

Prescribing information: Lazcluze Prescribing Information, Janssen Biotech, Inc.; August 2024.

NCCN reference: NCCN Non‑Small Cell Lung Cancer Version 10.2024 and Drugs & Biologics Compendium.

EGFR: epidermal growth factor receptor.

NSCLC: non-small cell lung cancer.

Rybrevant: brand name for amivantamab.