CurrentCentenePolicy CPPHAR406

Lorlatinib (Lorbrena) coverage policy

Defines medical necessity criteria, approval durations, and continuation requirements for lorlatinib (Lorbrena) for FDA-approved ALK-positive metastatic NSCLC and NCCN-recommended off-label indications across Centene lines of business (Commercial, HIM, Medicaid). Includes dosing limits, generic substitution preference, and contraindication to strong CYP3A inducers.

Policy Summary

PayerCentene

PolicyLorlatinib (Lorbrena) coverage policy

Policy CodePolicy CPPHAR406

Change TypeAnnual reviews with material revisions

Effective DateMar 1, 2019

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

2Q 2025 annual review removed Zykadia from list of ROS1-positive NSCLC failure agents and added pediatric diffuse high-grade glioma to NCCN-supported off-label indications.

2Q 2024 annual review added Augtyro as a failure option for ROS1-positive disease and added anaplastic cell lymphoma indication per NCCN; condensed uterine sarcoma/IMT-specific criteria.

2Q 2023 annual review added off-label NCCN-supported indications of diffuse B-cell lymphoma, Erdheim-Chester disease, IMT, and uterine sarcoma.

2Q 2022 annual review added criterion for use as single-agent therapy for NSCLC and corrected maximum dose to 100 mg (1 tablet per day); commercial approval duration clarified.

2Q 2021 annual review updated FDA-approved indication for NSCLC to allow first-line use per NCCN and removed requirement for prior therapies; added generic redirection language.

1FDA-approved indication covered

6NCCN off-label indications listed

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Coverage Summary

Coverage stance: covered_with_criteria. Scope: defines medical necessity criteria, approval durations, and continuation requirements for lorlatinib (Lorbrena) for the FDA-approved indication of ALK-positive metastatic non-small cell lung cancer (NSCLC) and for select NCCN-recommended off-label indications. Policy requires documentation supporting criteria and includes dosing limits and a generic-first preference. The policy explicitly contraindicates concomitant use with strong CYP3A inducers.

Policy applicability and dates: policy Reference Number CPPHAR406 effective 2019-03-01, last reviewed 2025-05-25; annual reviews (noted in the revision history) reflect updates to NCCN-supported off-label uses and prior-therapy requirements, which frame current policy applicability.

Maximum dose100 mg per day; 1 tablet per day

Minimum treatment duration prior to renewal>= 30 days

Initial Therapy Criteria

Additional NCCN-Recommended Off-Label Uses (Initial Approval)

Continuation Therapy Criteria

Other Diagnoses / Exclusions

Applicable Codes

Product availability / dosing strengthsmixed

Tablets: 25 mg, 100 mg

Available tablet strengths

Provider Actions

Prior Authorization

Documentation for approval

Provider must submit documentation (office chart notes, laboratory results, or other clinical information) supporting that the member meets all approval criteria for lorlatinib.

Prior Authorization

Prior authorization may be required for prior therapies

When documenting prior therapy failure for ROS1-positive disease, prior authorization may be required for Augtyro (repotrectinib), Rozlytrek (entrectinib), and Xalkori (crizotinib).

Documentation Required

Evidence for off-label dosing/indications

If the requested dose or off-label use is outside the FDA-approved regimen, the prescriber must submit supporting evidence such as practice guidelines or peer‑reviewed literature to justify the dose or indication.

Clinical Evidence & Guidelines

Primary reference: Lorbrena Prescribing Information, Pfizer, August 2024.

Guideline support: National Comprehensive Cancer Network (NCCN) Non-Small Cell Lung Cancer Version 3.2025.

Note: This policy includes NCCN-supported off-label indications (see policy section for listed NCCN-recommended uses).

Background

Background: Lorlatinib (Lorbrena) is a kinase inhibitor indicated for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. The policy also includes select NCCN-recommended off-label uses (for example: anaplastic cell lymphoma, diffuse large B-cell lymphoma, inflammatory myofibroblastic tumor, Erdheim-Chester disease, uterine IMT, and pediatric diffuse high-grade glioma) when all off-label criteria are met.

Contraindications and dosing: the policy lists concomitant use with strong CYP3A inducers as a contraindication. The approved dosing for ALK-positive NSCLC is 100 mg per day; product is available in 25 mg and 100 mg tablets.

Policy identifiers and dates: Reference Number CPPHAR406; Effective Date 2019-03-01; Last Review Date 2025-05-25.

ALKanaplastic lymphoma kinase

IMTinflammatory myofibroblastic tumor

NCCNNational Comprehensive Cancer Network

Revision History

05.21policy_revision

2Q 2021 annual review updated FDA-approved indication for NSCLC to allow first-line use per NCCN and removed requirement for prior therapies; added generic redirection language.

05.22policy_revision

2Q 2022 annual review added criterion for use as single-agent therapy for NSCLC and corrected maximum dose to 100 mg (1 tablet per day); commercial approval duration clarified.

05.23policy_revision