CurrentCignaPolicy N/A

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

Prior authorization policy for Lazcluze (lazertinib tablets) for prescription benefit coverage under Cigna plans, specifying clinical criteria for FDA-approved indication and non-covered uses, approval duration, references, and revision history.

Policy Summary

PayerCigna

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

Policy CodePolicy N/A

Change TypeAnnual Revision (criteria removed) + administrative title change

Effective Date

Next Review Date

Key ActionPrior Authorization is required; approve for 1 year when criteria are met and document EGFR exon 19 deletion or exon 21 L858R substitution mutation and that Lazcluze will be used in combination with Rybrevant.

SourceLink

POLICY UPDATE CHANGES

Annual Revision deleted criterion requiring the medication will be used as first-line treatment for NSCLC.

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

Annual Revision recorded on 08/20/2025 (review date).

New Policy initially created with review date 08/26/2024.

1Covered Indications (FDA-approved)

1 yearApproval Duration

1Required companion drug (Rybrevant)

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Coverage Summary

Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) is covered with criteria for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who have EGFR exon 19 deletions or EGFR exon 21 L858R substitutions; approvals are provided for 1 year when the criteria are met.

Coverage Stancecovered_with_criteria

Approval Duration1 year

Required Companion DrugRybrevant (amivantamab-vmjw) - combination required

Age Threshold≥ 18 years

FDA-Approved Indication — Initial Therapy Criteria

FDA-Approved Indication - Non-Small Cell Lung Cancer (NSCLC)

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

ALL of the following

A: Patient is ≥ 18 years of age>= 18 years
age threshold
B: Patient has locally advanced or metastatic disease
C: Patient has epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an approved test
mutation must be detected by an FDA-approved test
D: Medication is used in combination with Rybrevant (amivantamab-vmjw intravenous infusion)

Continuation Therapy

Approvals are provided for 1 year when criteria are met.

Unproven / Not Medically Necessary Uses

Conditions Not Covered

Not medically necessary for ANY other use(s):

ANY of the following

Any use of Lazcluze (lazertinib tablets) not meeting the FDA-approved indication criteria listed above

Applicable Codes

Drug (NDC)NDCCovered

No codes listed

Provider Actions & Billing Notes

Prior Authorization

Prior authorization required

Prior Authorization is recommended/required for prescription benefit coverage of Lazcluze; approvals are provided for 1 year when criteria are met.

Documentation Required

Mutation test documentation

Provider must document EGFR exon 19 deletion or exon 21 L858R substitution mutation detected by an approved test.

See definitions: "EGFR exon 19 deletions / exon 21 L858R substitution mutations"

Clinical Evidence & References

Lazcluze tablets prescribing information, Janssen; August 2024

NCCN NSCLC Clinical Practice Guidelines v8.2025 (August 15, 2025)

Background

The FDA indication is for Lazcluze in combination with Rybrevant for first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitutions in adults, as detected by an approved test.

The NCCN NSCLC Clinical Practice Guidelines (v8.2025, August 15, 2025) list Lazcluze + Rybrevant as an 'Other Recommended' regimen for first-line treatment of EGFR exon 19 deletion or exon 21 L858R mutation-positive NSCLC, with osimertinib (Tagrisso) noted as the preferred first-line agent.

Definitions

Policy Thresholds / Key Limits

Age>= 18 years

IndicationLocally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitutions (detected by an approved test) - must be used in combination with Rybrevant

Coverage DurationApprove for 1 year

Other numeric limits

Revision History

08/26/2024creation

New Policy initially created with review date 08/26/2024.

04/21/2025administrative_update

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

(Annual Revision)material_change

Annual Revision deleted criterion requiring the medication will be used as first-line treatment for NSCLC; policy now requires combination with Rybrevant for the FDA-approved indication.