Subject: Lorbrena 2787-A SGM P2022
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indication
Lorbrena is indicated for the treatment of adult patients with metastatic non-small cell lung cancer
(NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
B. Compendial Uses
1. Single-agent therapy for recurrent, advanced or metastatic NSCLC in patients with:
a. ALK rearrangement-positive tumors
b. ROS1 rearrangement-positive tumors, following disease progression on crizotinib, entrectinib or ceritinib
2. Inflammatory myofibroblastic tumor (IMT) with ALK translocation
3. Erdheim-Chester disease with ALK fusion
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: Chart documentation indicating ALK mutation status or ROS1 rearrangement status (where applicable).
III. CRITERIA FOR INITIAL APPROVAL
A. Non-Small Cell Lung Cancer (NSCLC)
1. Authorization of 12 months may be granted for treatment of ALK rearrangement-positive advanced or metastatic NSCLC (including brain
metastases from NSCLC) as a single-agent.
2. Authorization of 12 months may be granted for treatment of advanced or metastatic NSCLC as a single-agent therapy when all of the
following criteria are met:
a. The disease is ROS1 rearrangement-positive
b. The disease has progressed on any of the following: ceritinib, crizotinib, or entrectinib.
B. Inflammatory Myofibroblastic Tumor (IMT)
Authorization of 12 months may be granted for treatment of ALK-positive IMT as a single agent.
C. Erdheim-Chester Disease
Authorization of 12 months may be granted for treatment of ALK-positive Erdheim-Chester disease as a single agent.
IV. CONTINUATION OF THERAPY
A. Non-Small Cell Lung Cancer (NSCLC)
Authorization of 12 months may be granted for continued treatment of non-small cell lung cancer (NSCLC) in members requesting
reauthorization when there is no evidence of unacceptable toxicity while on the current regimen.
B. Inflammatory Myofibroblastic Tumor (IMT) and Erdheim-Chester Disease
Authorization of 12 months may be granted for continued treatment of inflammatory myofibroblastic tumor or Erdheim-Chester disease
in members requesting reauthorization when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Lorbrena [package insert]. New York, NY: Pfizer, Inc.; March 2021.
- The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed July 14, 2022.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
January 28, 2023
