CurrentNeighborhood Health Plan of Rhode IslandPolicy 2787-A

Lorbrena (lorlatinib) coverage policy

Defines prior authorization coverage criteria, documentation requirements, covered indications (FDA and compendial), duration of authorization, and reauthorization criteria for lorlatinib (Lorbrena) across referenced product lines.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLorbrena (lorlatinib) coverage policy

Policy CodePolicy 2787-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit chart documentation indicating ALK mutation status or ROS1 rearrangement status to initiate prior authorization review; authorization may be granted for up to 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes noted.

8Covered Indications Listed (FDA or Compendial)

12Authorization Duration (months)

Coverage Summary & Covered Indications

Lorbrena (lorlatinib) is an ALK tyrosine kinase inhibitor with FDA approval for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK-positive as detected by an FDA‑approved test. The policy also includes additional compendial uses recognized by the NCCN Drugs & Biologics Compendium. Prior authorization is required and providers must submit documentation (see documentation requirements) to initiate review.

Initial Therapy Criteria & Authorization Duration

Prior Authorization

Prior authorization required with documentation

Submit chart documentation indicating ALK mutation status or ROS1 rearrangement status to initiate prior authorization review; authorization may be granted for up to 12 months when criteria are met.

Reauthorization / Continued Treatment Criteria

Denial Risk

Not medically necessary for non-listed indications

Claims for indications not listed in the FDA-approved or compendial uses are considered experimental/investigational and may be denied as not medically necessary.

Provider Actions & Documentation Requirements

Documentation Required for Prior Authorization

Required submission to initiate prior authorization review:

Documentation required: Chart documentation indicating ALK mutation status (where applicable) or ROS1 rearrangement status (where applicable).

Documentation Required

Molecular test documentation

Providers must supply results from an FDA-approved ALK test for ALK-positive indications or ROS1 rearrangement test results where applicable to support the prior authorization request.

Submit chart documentation indicating ALK mutation status or ROS1 rearrangement status to initiate prior authorization review. Authorization decisions will be made based on the listed coverage and authorization criteria.

Not Covered / Experimental

Standard exclusion statement:

Not covered / experimental: All other indications not listed in the FDA-approved or compendial uses are considered experimental/investigational and not medically necessary.

Background

Lorbrena (lorlatinib) is an ALK tyrosine kinase inhibitor (ALK TKI) approved by the FDA for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA‑approved test. The coverage policy also incorporates compendial uses listed in the NCCN Drugs & Biologics Compendium, including multiple tumor types with ALK or ROS1 alterations.

Prior authorization is required to initiate treatment and must be accompanied by chart documentation indicating ALK mutation status or ROS1 rearrangement status (where applicable). Authorization decisions and durations follow the specified criteria in the policy.