CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lorbrena (lorlatinib) coverage and utilization guideline

Defines accepted indications, usage constraints, coding, and authorization expectations for lorlatinib (Lorbrena) for payers and network providers processing medication requests.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLorbrena (lorlatinib) coverage and utilization guideline

Policy CodePolicy N/A

Change TypeClarification and template conversion

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization using billing code J8999 for all lorlatinib requests processed by Evolent.

SourceLink

POLICY UPDATE CHANGES

Updated 'continuation request' verbiage.

Converted to new Evolent guideline template and replaced prior UM ONC_1347 Lorbrena (lorlatinib).

1FDA-approved indication

J8999Billing code

100 mgSingle dose max

120/30Monthly tablet limits

Commercial, Exchange, MedicaidLines of business

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Coverage Criteria for Lorbrena (lorlatinib)

Initial or subsequent therapy for ALK-positive NSCLC

Covered when ALL of the following are met

ALK-positive NSCLC indication: Member has recurrent or metastatic ALK-positive non-small cell lung cancer

lorlatinib may be used as initial or subsequent monotherapy

Continuation therapy exemption

Continuation authorization criteria (exemption from standard non-approvable rules)

Continuation request conditions: Member has not experienced disease progression on lorlatinib AND the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization AND additional medication(s) are not being added to the continuation request

Continuation requests for otherwise not-approvable medications are exempt when these conditions are met

Coverage will be denied when any of the following exclusion criteria apply: disease progression while receiving Lorbrena (lorlatinib); concurrent use with other chemotherapy; dosing that exceeds the single-dose limit of 100 mg; or treatment that exceeds the maximum monthly tablet limits of 120 (25 mg) or 30 (100 mg) tablets/month. Requests that meet these conditions should be declined per policy.

Lorlatinib (Lorbrena) use for off-label or investigational indications is not approvable when the requested indication lacks sufficient supporting evidence or is not generally accepted by the medical community. The policy requires support from CMS-recognized compendia or acceptable peer‑reviewed literature; evidence deficiencies include inadequate representation of the patient or disease in published studies, regimens not represented in the evidence, outcomes that are not clinically meaningful (for example, hazard ratio ≥ 0.80 or survival benefits below recommended thresholds), inappropriate experimental design for the question, reliance solely on case reports or abstracts, or otherwise insufficient study quality or relevance.

Regimen	Indication	Dosing constraints
Lorlatinib (Lorbrena) monotherapy per prescribing information	Recurrent or metastatic ALK‑positive non‑small cell lung cancer (initial or subsequent therapy)	Single‑dose limit: 100 mg; Maximum monthly tablet limits: 120 tablets if 25 mg strength or 30 tablets if 100 mg strength

Billing and Coding

Covered HCPCS codes (drug administered)HCPCSCovered

J8999

lorlatinib

inv-06: Maximum single dose — 100 mg

Maximum single dose100 mg

Source guidanceDosing exceeds single dose limit of Lorbrena (lorlatinib) 100 mg (exclusion criteria)

ImplicationRequests for doses >100 mg will be excluded/denied

inv-07: Maximum monthly tablet limit — 120 (25 mg) or 30 (100 mg) tablets/month

Monthly tablet limit (25 mg)Up to 120 tablets per month

Monthly tablet limit (100 mg)Up to 30 tablets per month

Exclusion note

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required for lorlatinib. Use billing code J8999 for authorization and claims processing.

Prior authorization required
Billing / HCPCS code: J8999

Step Therapy

Line of Therapy Guidance

Lorlatinib may be used as monotherapy in members with recurrent or metastatic ALK-positive non-small cell lung cancer (NSCLC) as initial or subsequent therapy; there is no explicit step-therapy sequencing requirement stated in the source.

No required prior ALK inhibitor sequence mandated by this policy — may be initial or subsequent monotherapy

Line of Therapy Guidance

first-line | second-line

Allowed lines: Lorlatinib may be used as initial (first-line) or subsequent therapy for recurrent or metastatic ALK-positive NSCLC

Biomarker and Diagnostic Requirements

inv-15: ALK rearrangement — biomarker requirement for therapy

BiomarkerALK rearrangement

RequirementPresence of ALK gene rearrangement is required for coverage of ALK-directed therapy (lorlatinib)

Indication contextApplies to members with recurrent or metastatic ALK-positive NSCLC

Definitions

inv-13: ALK-positive NSCLC — definition and eligibility for ALK-targeted therapy

DefinitionALK-positive NSCLC: non-small cell lung cancer characterized by anaplastic lymphoma kinase (ALK) gene rearrangements

Eligibility for ALK-targeted therapyMembers with recurrent or metastatic ALK-positive NSCLC may receive lorlatinib monotherapy as initial or subsequent therapy

Exclusion conditionsDisease progression on lorlatinib or concurrent use with other chemotherapy excludes coverage

Background

Lorlatinib (Lorbrena) is an oral anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor indicated for members with recurrent or metastatic ALK-positive non–small cell lung cancer (NSCLC). This guideline defines the conditions for coverage of lorlatinib as monotherapy for recurrent or metastatic ALK-positive NSCLC, permits use as initial or subsequent therapy, and specifies documentation, dosing limits, and exclusion criteria to support prior authorization and utilization decisions.

Revision History

March 2025operational_template_conversionLatest

Converted to new Evolent guideline template and replaced prior UM ONC_1347 Lorbrena (lorlatinib).

March 2024text_revision

Updated NCH verbiage to Evolent and clarified 'continuation request' wording.