Subject: Zykadia 1668-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 Indication
Zykadia 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. NSCLC, recurrent, advanced or metastatic ALK rearrangement-positive or ROS1
rearrangement-positive tumors
2. Anaplastic large cell lymphoma (ALCL), ALK-positive
3. Inflammatory myofibroblastic tumor (IMT) with ALK translocation
i. Uterine sarcoma
ii. Soft tissue sarcoma
4. Brain metastases from ALK rearrangement-positive NSCLC
5. Erdheim-Chester Disease (ECD) 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:
ALK mutation or translocation status or ROS-1 mutation 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 as a single agent when
the member meets either of the following criteria:
1. Member has recurrent, advanced, or metastatic ALK-positive NSCLC (including brain
metastases from NSCLC).
2. Member has recurrent, advanced, or metastatic ROS1-positive NSCLC.
B. Anaplastic Large Cell Lymphoma (ALCL)
Authorization of 12 months may be granted for initial palliative therapy or treatment of
relapsed/refractory ALK-positive ALCL as a single agent.
C. Inflammatory Myofibroblastic Tumor (IMT)
Authorization of 12 months may be granted for treatment of ALK-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)
D. Erdheim-Chester Disease (ECD)
Authorization of 12 months may be granted for treatment of symptomatic or
relapsed/refractory 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. All Other Indications
Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for all other indications listed in Section III 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:
- Zykadia [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; October 2021.
- The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, I https://www.nccn.org. Accessed March 14, 2024.
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Non-Small Cell Lung Cancer. Version 3.2024. Accessed March 14, 2024. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf
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
