Subject: Zykadia 1668-A SGM P2023
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. Inflammatory myofibroblastic tumor (IMT) with ALK
translocation
3. Brain metastases from ALK rearrangement-positive
NSCLC
4. 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. 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)
C. 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 2023 National Comprehensive Cancer Network, I https://www.nccn.org. Accessed March 1, 2023.
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, 2023
