CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lorbrena (lorlatinib) coverage for ALK-positive NSCLC, ROS1, and IMT

Defines prior authorization criteria, covered indications (FDA-approved and compendial uses), reauthorization rules, required documentation, and treatment durations for lorlatinib (Lorbrena) for members of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLorbrena (lorlatinib) coverage for ALK-positive NSCLC, ROS1, and IMT

Policy CodePolicy N/A

Change Typeclarified

Effective Date

Next Review Date

Key ActionSubmit chart documentation indicating ALK mutation status or ROS1 rearrangement status to initiate prior authorization review.

POLICY UPDATE CHANGES

Defines FDA-approved and compendial covered indications and specifies documentation and authorization durations.

4Covered Indications (FDA/compenial listed)

12Authorization duration (months)

Coverage Summary & Indications

Coverage stance: covered_with_criteria. Lorbrena (lorlatinib) is covered when all applicable authorization criteria are met for the FDA-approved indication of ALK-positive metastatic NSCLC and for specified compendial uses. Compendial covered uses include single-agent treatment of ALK rearrangement-positive recurrent, advanced, or metastatic NSCLC; single-agent treatment of ROS1 rearrangement-positive recurrent, advanced, or metastatic NSCLC following disease progression on crizotinib, entrectinib, or ceritinib; and treatment of ALK-positive inflammatory myofibroblastic tumor (IMT). Authorization for these indications may be granted in 12-month increments. All other indications not listed are considered experimental/investigational and not medically necessary.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required with documentation of mutation status

Submit chart documentation indicating ALK mutation status or ROS1 rearrangement status to initiate prior authorization review. Include copies of test reports or pathology results showing the ALK or ROS1 result.

Prior Authorization

Prior therapy requirement for ROS1 NSCLC

For ROS1-rearranged NSCLC, provide documentation that the disease has progressed on one of the listed prior therapies. Include clinical notes or imaging/pathology reports showing progression on ceritinib, crizotinib, or entrectinib.

Documentation Required

Reauthorization documentation

For reauthorization requests, document that the member has no evidence of unacceptable toxicity while on the current regimen for NSCLC. For IMT reauthorization, document absence of unacceptable toxicity and absence of disease progression while on the current regimen. Provide clinical progress notes, toxicity assessments, and imaging or other objective disease assessments as applicable.

Clinical Evidence & References

Evidence: Package insert - Lorbrena [package insert], Pfizer; March 2021; Compendium - NCCN Drugs & Biologics Compendium, May 2022. Background: Lorbrena (lorlatinib) is an ALK and ROS1 tyrosine kinase inhibitor (TKI) with FDA approval for ALK-positive metastatic NSCLC and compendial support for ROS1-rearranged NSCLC after progression on specified agents and for ALK-positive IMT.

Revision History

clarificationLatest

Policy clarifies covered indications including FDA-approved ALK-positive metastatic NSCLC and compendial uses (ALK-positive tumors, ROS1-rearranged NSCLC after progression on crizotinib/entrectinib/ceritinib, and ALK-positive IMT), specifies required documentation (chart documentation of ALK mutation or ROS1 rearrangement status), and defines authorization durations and reauthorization rules (typically 12 months for initial authorization and reauthorization with documentation of no unacceptable toxicity or no disease progression as applicable).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLorbrena (lorlatinib) coverage for ALK-positive NSCLC, ROS1, and IMT

Policy CodePolicy N/A

Change Typeclarified

Effective Date

Next Review Date

Key ActionSubmit chart documentation indicating ALK mutation status or ROS1 rearrangement status to initiate prior authorization review.

On This Page

OpenPayer

Lorbrena (lorlatinib) coverage for ALK-positive NSCLC, ROS1, and IMT

Coverage Summary & Indications

Initial Therapy — ROS1-specific Requirements

Continuation / Reauthorization Criteria

Exclusions / Not Medically Necessary

Provider Actions & Authorization Requirements

Applicable Codes and Reference IDs

Clinical Evidence & References

Definitions

Revision History