CurrentCignaPolicy N/A

Oncology (Oral - Epidermal Growth Factor Receptor Inhibitor) - Lazcluze Prior Authorization Policy

Defines Cigna's prior authorization and medical necessity criteria for coverage of Lazcluze (lazertinib tablets) in combination with Rybrevant for adults with EGFR exon 19 deletion or exon 21 L858R mutated locally advanced or metastatic non‑small cell lung cancer.

Policy Summary

PayerCigna

PolicyOncology (Oral - Epidermal Growth Factor Receptor Inhibitor) - Lazcluze Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevised — removed first‑line requirementpolicy renamed

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation confirming age ≥18, locally advanced or metastatic NSCLC, an FDA‑approved test showing EGFR exon 19 deletion or exon 21 L858R, and that Lazcluze will be used in combination with Rybrevant.

SourceLink

POLICY UPDATE CHANGES

Deleted criterion requiring the medication will be used as first-line treatment.

Policy name changed to 'Oncology (Oral - Epidermal Growth Factor Receptor Inhibitor) - Lazcluze PA Policy'.

EGFR 19 del / 21 L858Rrequired actionable mutations

1 yearstandard approval duration

Combination with Rybrevantregimen requirement

Not medically necessary

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Coverage Criteria

Initial therapy (FDA‑approved indication) — Covered when ALL of the following are met

Covered when ALL of the following are met:

FDA‑approved indication criteria: A) Patient is >= 18 years of age; AND B) Patient has locally advanced or metastatic non‑small cell lung cancer; AND C) Patient has EGFR exon 19 deletions or exon 21 L858R substitution mutations as detected by an approved test; AND D) Lazcluze (lazertinib) is used in combination with Rybrevant (amivantamab) intravenous infusion.

Approval duration: 1 year.

Lazcluze (lazertinib) is not medically necessary for any use outside the specific FDA‑approved indication described in this policy. The policy’s exclusions will be updated if new published data expand or change approved uses.

Any use of Lazcluze other than in combination with Rybrevant (amivantamab) for EGFR exon 19 deletion or exon 21 L858R mutated locally advanced or metastatic non‑small cell lung cancer is considered not medically necessary and may be denied.

Regimen	Indication	Coverage status
Lazcluze (lazertinib) in combination with Rybrevant (amivantamab)	First‑line treatment of locally advanced or metastatic non‑small cell lung cancer with EGFR exon 19 deletion or exon 21 L858R substitution mutation (as detected by an approved/FDA‑approved test)	Covered when criteria met; prior authorization required (approve for 1 year)

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for prescription benefit coverage. Approvals are provided for the duration noted in the policy (e.g., 1 year for the FDA‑approved indication below).

Prior authorization required for Lazcluze (lazertinib)
Approvals provided for specified duration (see FDA‑Approved Indication: 1 year)

Step Therapy

Guideline Context (may affect step therapy decisions)

NCCN guidance may affect prescribing and step‑therapy decisions. The NCCN NSCLC (v8.2025) lists the Lazcluze + Rybrevant combination as an 'Other Recommended' regimen (category 1) for first‑line treatment of EGFR exon 19 deletion or exon 21 L858R mutation‑positive NSCLC. Osimertinib (Tagrisso) is the preferred first‑line agent in this setting. Lazcluze + Rybrevant is also recommended for continuation of therapy after progression in selected circumstances and for brain metastases.

NCCN v8.2025: Lazcluze + Rybrevant = 'Other Recommended' (category 1) for first‑line EGFR exon 19 or exon 21 L858R NSCLC

Biomarker Requirements

EGFR exon 19 deletion or exon 21 L858R substitution mutation — detected by an approved test

Required biomarkerEGFR exon 19 deletion or EGFR exon 21 L858R substitution mutation

Detection methodAs detected by an approved test (FDA‑approved test referenced in policy)

Clinical contextRequired for adults with locally advanced or metastatic non‑small cell lung cancer (NSCLC)

Policy linkageListed in FDA‑Approved Indication and coverage criteria — presence of these mutations is required for approval

Line of Therapy

first-line

Context for line‑of‑therapy placement:

line of therapy context: NCCN lists Lazcluze + Rybrevant as an 'Other Recommended' first‑line regimen; osimertinib (Tagrisso) is the preferred first‑line treatment. The policy previously included then deleted a requirement that Lazcluze be used as first‑line therapy.

Authorization criteria do not explicitly constrain treatment to first‑line in the current policy; approvals are for the FDA‑approved indication in combination with Rybrevant.

Definitions & Required Findings

Actionable EGFR mutations required for coverage — EGFR exon 19 deletion or exon 21 L858R substitution mutation

Actionable mutations required for coverageEGFR exon 19 deletion or exon 21 L858R substitution mutation

Approved indication linkMutation requirement is part of the FDA‑approved indication for Lazcluze in combination with Rybrevant

PopulationAdults with locally advanced or metastatic NSCLC

Testing requirementMutation must be detected by an approved/FDA‑approved test as specified in the policy

Background

Lazcluze (lazertinib) given in combination with Rybrevant (amivantamab) is the FDA‑indicated regimen for adults with locally advanced or metastatic non‑small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R substitutions. Prior authorization is required for prescription benefit coverage and approvals are provided for 1 year when the coverage criteria are met. NCCN lists the combination as an “Other Recommended” first‑line regimen while osimertinib (Tagrisso) is the preferred first‑line option; this guideline context may affect utilization review and step‑therapy decisions.