CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lorbrena 2787 A Sgm P2022

Defines prior authorization criteria, documentation, and authorization durations for Lorbrena (lorlatinib) for FDA-approved ALK-positive metastatic NSCLC and specified compendial uses (ROS1-positive NSCLC after progression on listed TKIs, ALK-positive IMT, ALK-positive Erdheim-Chester disease).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLorbrena 2787 A Sgm P2022

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.

SourceLink

POLICY UPDATE CHANGES

Document identifies FDA-approved and specific compendial uses for Lorbrena and specifies required documentation and 12-month authorization periods.

1FDA-approved indications listed

3Compendial uses specified

12Typical authorization duration (months)

Coverage Summary

Status: CURRENT. Lorbrena (lorlatinib) is covered with criteria when approval criteria are met and the member has no exclusions. Coverage includes the FDA-approved indication for treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK-positive as detected by an FDA-approved test, and the specified compendial uses: single-agent therapy for recurrent/advanced/metastatic NSCLC with ALK rearrangement-positive tumors; single-agent therapy for recurrent/advanced/metastatic NSCLC with ROS1 rearrangement-positive tumors after disease progression on crizotinib, entrectinib, or ceritinib; treatment of inflammatory myofibroblastic tumor (IMT) with ALK translocation; and treatment of Erdheim-Chester disease with ALK fusion.

Indications Considered Covered & Authorization Criteria

Indications Considered Covered (Overview)

Covered indications include the FDA-approved ALK-positive metastatic NSCLC indication and compendial uses listed below. Authorization durations and specific requirements for each indication are provided in the authorization criteria groups.

Indications considered covered:

- FDA-approved: metastatic NSCLC that is ALK-positive as detected by an FDA-approved test.

- Compendial uses: ROS1-positive NSCLC after progression on crizotinib, entrectinib, or ceritinib; ALK-positive inflammatory myofibroblastic tumor (IMT); ALK-positive Erdheim‑Chester disease.

Authorization Criteria — Non-Small Cell Lung Cancer (NSCLC)

Authorization criteria and conditions for coverage for non‑small cell lung cancer (NSCLC).

FDA-approved ALK-positive metastatic NSCLC
- Member has a diagnosis of metastatic non-small cell lung cancer (NSCLC).
- Tumor is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
- Lorbrena will be used as a single-agent therapy.
- Authorization duration: 12 months.
ROS1-rearrangement positive NSCLC
- Member has a diagnosis of advanced or metastatic NSCLC that is ROS1 rearrangement-positive.
- Disease has progressed on at least one of: crizotinib, entrectinib, or ceritinib.
- Lorbrena will be used as a single-agent therapy.
- Authorization duration: 12 months.

Authorization Criteria — Inflammatory Myofibroblastic Tumor (IMT)

Authorization criteria for inflammatory myofibroblastic tumor (IMT).

Member has a diagnosis of inflammatory myofibroblastic tumor (IMT).
Tumor is ALK-positive (ALK translocation or fusion).
Lorbrena will be used as a single-agent therapy.
Authorization duration: 12 months.

Authorization Criteria — Erdheim-Chester Disease

Authorization criteria for Erdheim‑Chester disease.

Member has a diagnosis of Erdheim‑Chester disease.
Disease harbors an ALK fusion or ALK-positive alteration.
Lorbrena will be used as a single-agent therapy.
Authorization duration: 12 months.

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required with documentation of ALK or ROS1 status

Submit chart documentation indicating ALK mutation status or ROS1 rearrangement status to initiate prior authorization review. Prior authorization is required before coverage is approved.

Documentation Required

Documentation for progression on prior ROS1 TKIs

For ROS1-rearrangement-positive NSCLC, provide documentation that disease progressed on ceritinib, crizotinib, or entrectinib to support the compendial use.

Prior Authorization

Authorization duration

Authorizations are generally granted for 12 months for initial requests and for reauthorization when the approval criteria are met.

Denial Risk

Coverage denial for unlisted indications

Requests for Lorbrena for indications other than the FDA-approved or specified compendial uses will be considered experimental/investigational and not medically necessary, and may be denied.

Reauthorization / Continued Therapy Criteria

Reauthorization / Continued Therapy — NSCLC

ALL of the following

Member requesting reauthorization for continued treatment of NSCLC.
There is no evidence of unacceptable toxicity while on the current regimen.
Authorization of 12 months may be granted for continued treatment.

Reauthorization / Continued Therapy — IMT and Erdheim-Chester Disease

ALL of the following

Member requesting reauthorization for continued treatment of IMT or Erdheim-Chester disease.
There is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Authorization of 12 months may be granted for continued treatment.

Background

Background: Lorbrena (lorlatinib) is a targeted therapy indicated by the FDA for treatment of adult patients with metastatic NSCLC whose tumors are ALK-positive. The policy also lists compendial uses for ROS1-positive NSCLC after progression on the specified TKIs (crizotinib, entrectinib, ceritinib), and for ALK-positive inflammatory myofibroblastic tumor (IMT) and ALK-positive Erdheim-Chester disease. Coverage requires submission of chart documentation showing ALK mutation status or ROS1 rearrangement status to initiate prior authorization review.