CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1509

Lazcluze (lazertinib)

Defines accepted indications, inclusion and exclusion criteria, coding, and utilization management authority for lazertinib (Lazcluze) including FDA-approved and off-label uses supported by recognized compendia or peer-reviewed literature. Applies to medication requests processed by Evolent/Neighborhood Health Plan of Rhode Island for applicable lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLazcluze (lazertinib)

Policy CodePolicy UM ONC_1509

Change TypeRevised

Effective DateDec 27, 2024

Next Review Date

Key ActionAll medication requests for lazertinib must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

POLICY UPDATE CHANGES

Policy reviewed and approved December 12, 2024 with effective date December 27, 2024.

1Primary disease area referenced (NSCLC)

1Single dose maximum specified

2HCPCS/J-code entries

Coverage Summary

Policy stance: mixed coverage for Lazcluze (lazertinib) — the policy recognizes FDA-labeled indications and allows evidence-supported off-label uses when supported by accepted sources. Evolent is responsible for processing all medication requests for lazertinib and may deem medications not authorized by Evolent as not approvable and not reimbursable. Requests for use must be supported by FDA product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

Initial Therapy Criteria

Non-Small Cell Lung Cancer (policy note)

Policy position regarding first-line use in NSCLC with common sensitizing EGFR mutations:

Non-Small Cell Lung Cancer (policy note): Lazcluze (lazertinib) in combination with Rybrevant (amivantamab-vmjw) is NOT supported by Evolent Policy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations due to lack of Level 1 evidence showing superior outcomes compared to Evolent recommended alternatives

This is a policy note about first-line use; combination with amivantamab for common EGFR mutations is not supported as first-line therapy.

Continuation Therapy Criteria

Continuation requests exemption

Continuation requests for a not-approvable medication shall be exempt from this Evolent policy provided:

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorizationno lapse > 30 days within prior year
Continuation authorization lapse tolerance
Additional medication(s) are not being added to the continuation request

Unproven Uses and Exclusions

ANY of the following

Disease progression while taking Lazcluze (lazertinib).
Use of Lazcluze (lazertinib) without concurrent administration with Rybrevant (amivantamab-vmjw) when the combination is required by the indication or policy.
Dosing that exceeds the single dose limit of 240 mg.
Sufficient evidence not met if any of the following apply
- The clinical characteristics of the patient and the cancer are not adequately represented in the published evidence.
- The administered chemotherapy/biologic therapy/immune therapy/targeted therapy/other oncologic therapy regimen is not adequately represented in the published evidence.
- The reported study outcomes do not represent clinically meaningful outcomes experienced by patients (for example, do not meet commonly accepted thresholds such as ASCO recommendations: e.g., Hazard Ratio < 0.80 and survival benefit for OS or PFS of at least 3 months).
- The experimental design is not appropriate to address the investigative question given the drugs and conditions under investigation (notwithstanding situations where randomization or blinding may be infeasible).
- Evidence is limited to non-randomized clinical trials without a significant number of subjects (insufficient supportive evidence).
- Evidence consists primarily of case reports, which are uncontrolled and anecdotal and do not provide adequate supportive clinical evidence for determining accepted uses of drugs.
- Evidence is limited to abstracts (including meeting abstracts) without the full peer-reviewed article, which lack sufficient supporting clinical evidence.

Denial Risk

Denial Risk — Provider Action

Claims may be denied if any of the following apply: the member experienced disease progression on Lazcluze (lazertinib); Lazcluze is used without required concurrent Rybrevant (amivantamab-vmjw); the prescribed single dose exceeds 240 mg; or the requested off-label indication lacks sufficient supporting evidence as defined by CMS-recognized compendia or acceptable peer-reviewed literature.

Disallowed scenarios: disease progression on lazertinib; use without required concurrent amivantamab; dosing > 240 mg single dose; off-label/investigational use without sufficient evidence.

Provider Actions / Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: All medication requests for lazertinib must be processed by Evolent. Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

C9399
J8999

Documentation Required

Support for use

Support for use: Use of lazertinib must be supported by FDA-approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Denial Risk

Denial risk — disallowed scenarios

Claims may be denied for the following disallowed scenarios: disease progression while taking lazertinib; use without required concurrent administration of amivantamab (when indicated by the policy); dosing that exceeds the single dose maximum of 240 mg; or off-label use that does not meet the policy’s defined standards for sufficient evidence.

Background

Background: This policy establishes accepted uses of lazertinib including FDA-approved indications and off-label indications that are supported by recognized evidence sources. Evolent processes all medication requests and requires support from the FDA label, CMS-recognized compendia, NCCN/ASCO clinical guidelines, or peer-reviewed literature that meets the CMS Medicare Benefit Policy Manual Chapter 15 requirements. The policy also specifies continuation-exemption conditions, a position on first-line combination use with amivantamab in EGFR-mutant NSCLC, exclusion criteria (including disease progression, use without required concurrent amivantamab, and a single dose limit of <= 240 mg), and coding entries for C9399 and J8999.

Revision History

2024-10-09committee_review

Committee review by Evolent Specialty Services Clinical Guideline Review Committee.

2024-12-12committee_review

Committee review by Evolent Specialty Services Clinical Guideline Review Committee.

2024-12-12approvalLatest

Policy reviewed and approved by Evolent Specialty Services Clinical Guideline Review Committee; approval date December 12, 2024.

2024-12-27effective_date

Policy effective date December 27, 2024.