Subject: Xalkori 1666-A SGM P2021
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 Indications
1. Non-Small Cell Lung Cancer (NSCLC)
Xalkori is indicated for the treatment of patients with metastatic non-small cell lung
cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-
positive as detected by an FDA-approved test.
2. Anaplastic Large Cell Lymphoma (ALCL)
Xalkori is indicated for the treatment of pediatric patients 1 year of age and older and
young adults with relapsed or refractory, systemic anaplastic large cell lymphoma
(ALCL) that is ALK-positive.
B. Compendial Uses
1. NSCLC, recurrent, advanced or metastatic ALK rearrangement-positive or ROS1
rearrangement-positive tumors
2. NSCLC with high-level MET amplification or MET exon 14 skipping mutation
3. Inflammatory myofibroblastic tumor (IMT) with ALK translocation
4. Anaplastic large cell lymphoma, relapsed or refractory ALK-positive
5. Histiocytic Neoplasms:
a. Erdheim-Chester Disease (ECD)
b. Langerhans Cell Histiocytosis (LCH)
c. Rosai-Dorfman Disease
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: ALK mutation or translocation status, ROS-1 mutation status, MET exon 14 skipping
mutation status, or high-level MET amplification status (where applicable).
III. CRITERIA FOR INITIAL APPROVAL
A. Non-Small Cell Lung Cancer (NSCLC)
Authorization of 12 months may be granted for treatment of NSCLC when the member
meets any of the following criteria:
1. Member has recurrent, advanced or metastatic ALK-positive NSCLC and will be used
as a single agent.
2. Member has recurrent, advanced or metastatic ROS1-positive NSCLC and will be used
as a single agent.
3. Member has NSCLC with high-level MET amplification or MET exon 14 skipping
mutation.
B. Inflammatory Myofibroblastic Tumor (IMT)
Authorization of 12 months may be granted for treatment of ALK-positive IMT as a single
agent.
C. Anaplastic Large Cell Lymphoma (ALCL)
Authorization of 12 months may be granted for treatment of relapsed or refractory ALK-
positive ALCL as a single agent.
D. Histiocytic Neoplasms
Authorization of 12 months may be granted for the treatment of any of the following
histiocytic neoplasm subtypes as a single agent in members with an ALK gene fusion:
1. Symptomatic or relapsed/refractory Erdheim-Chester Disease (ECD)
2. Symptomatic or relapsed/refractory Rosai-Dorfman Disease
3. Langerhans Cell Histiocytosis (LCH)
IV. CONTINUATION OF THERAPY
A. ALK-positive Non-Small Cell Lung Cancer (NSCLC)
Authorization of 12 months may be granted for continued treatment of ALK-positive non-
small cell lung cancer (NSCLC) in members requesting reauthorization when there is no
evidence of unacceptable toxicity while on the current regimen.
B. All Other Indications
Authorization of 12 months may be granted for continued treatment 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:
V. REFERENCES
- Xalkori [package insert]. New York, NY: Pfizer Inc.; January 2021.
- The NCCN Drugs & Biologics Compendium 2020 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed March 10, 2021.
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.
August 30, 2021
