Subject: Zydelig 1706-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 Indications
Relapsed chronic lymphocytic leukemia (CLL), in combination
with rituximab, in patients for whom rituximab alone would
be considered appropriate therapy due to other co-
morbidities
Limitations of use:
Zydelig is not indicated and is not recommended for first-line
treatment of any patient, including patients with chronic
lymphocytic leukemia (CLL), small lymphocytic lymphoma
(SLL), follicular lymphoma (FL), and other indolent non-
Hodgkin lymphomas.
Zydelig is not indicated and is not recommended in
combination with bendamustine and rituximab, or in
combination with rituximab for the treatment of patients with
FL, SLL, and other indolent non-Hodgkin lymphomas.
B. Compendial Uses
Relapsed or refractory CLL/SLL
All other indications are considered experimental/investigational
and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
Chronic lymphocytic leukemia (CLL)/small lymphocytic
lymphoma (SLL)
Authorization of 12 months may be granted for treatment of
relapsed or refractory CLL/SLL when either of the following
criteria are met:
1. The requested drug will be used as a single agent, or
2. The requested drug will be used in combination with
rituximab.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication listed in Section II 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:
- Zydelig [package insert]. Foster City, CA: Gilead Sciences, Inc.; February 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed June 2, 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.
December 09, 2023
