Subject: Xalkori 1666-A SGM P2024
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 adult 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.
3. Inflammatory myofibroblastic tumor (IMT)
Xalkori is indicated for the treatment of adult and pediatric patients 1 year of age and
older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT)
that is ALK-positive.
Limitations of Use: The safety and efficacy of Xalkori have not been established in older
adults with relapsed or refractory, systemic ALK-positive ALCL.
B. Compendial Uses
1. Cutaneous Melanoma
2. NSCLC, recurrent, advanced or metastatic ALK rearrangement-positive or ROS1
rearrangement-positive tumors
3. NSCLC, recurrent, advanced or metastatic MET exon 14 skipping positive tumors
4. NSCLC with high-level MET amplification
5. Inflammatory myofibroblastic tumor (IMT) with ALK translocation
6. Anaplastic large cell lymphoma, relapsed or refractory ALK-positive
7. 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-rearrangement positive NSCLC and
will be used as a single agent.
2. Member has recurrent, advanced or metastatic ROS1-rearrangement positive NSCLC
and will be used as a single agent.
3. Member has recurrent, advanced, or metastatic MET exon 14 skipping mutation-positive
NSCLC and will be used as a single agent.
4. Member has NSCLC with high-level MET amplification.
B. Inflammatory Myofibroblastic Tumor (IMT)
Authorization of 12 months may be granted for treatment of ALK-translocation positive IMT
as a single agent when either of the following criteria are met:
1. The member has uterine sarcoma and the disease is advanced, recurrent, metastatic, or
inoperable
2. The member has a soft tissue sarcoma (not including uterine sarcoma)
C. Anaplastic Large Cell Lymphoma (ALCL)
Authorization of 12 months may be granted for initial palliative therapy or for treatment of
relapsed or refractory ALK-positive ALCL as a single agent.
D. Histiocytic Neoplasms
Authorization of 12 months may be granted for 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)
E. Cutaneous Melanoma
Authorization of 12 months may be granted for subsequent treatment of unresectable or
metastatic cutaneous melanoma when all of the following criteria are met:
1. The disease is ROS1 gene fusion-positive
2. The member had disease progression, had an intolerance or has a projected risk of
progression with BRAF-targeted therapy (e.g., dabrafenib, encorafenib)
3. The requested medication will be used as a single agent
IV. CONTINUATION OF THERAPY
A. ALK-rearrangement positive Non-Small Cell Lung Cancer (NSCLC) and ROS1-
rearrangement positive Non-Small Cell Lung Cancer (NSCLC)
Authorization of 12 months may be granted for continued treatment of ALK-rearrangement
positive non-small cell lung cancer (NSCLC) and ROS1-rearrangement 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:
- Xalkori [package insert]. New York, NY: Pfizer Inc.; September 2023.
- The NCCN Drugs & Biologics Compendium ® © 2024 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed March 4, 2024.
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 18, 2024
