Subject: Zejula 1687-A SGM P2022b
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. Maintenance treatment of adult patients with advanced
epithelial ovarian, fallopian tube, or primary peritoneal
cancer who are in a complete or partial response to first-
line platinum-based chemotherapy.
2. Maintenance treatment of adult patients with deleterious
or suspected deleterious germline BRCA-mutated
(gBRCAmut) recurrent epithelial ovarian, fallopian tube,
or primary peritoneal cancer who are in a complete or
partial response to platinum-based chemotherapy.
B. Compendial uses
1. Ovarian, fallopian tube, or primary peritoneal cancer –
maintenance therapy for stage II-IV disease with
germline or somatic BRCA mutation
2. Uterine Leiomyosarcoma (uLMS)
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:
Documentation of laboratory report confirming BRCA mutation
status, where applicable.
III. CRITERIA FOR INITIAL APPROVAL
A. Epithelial Ovarian, Fallopian Tube, or Primary
Peritoneal Cancer
Authorization of 12 months may be granted for maintenance
treatment of epithelial ovarian, fallopian tube, or primary
peritoneal cancer as a single agent when the member is in a
complete or partial response to platinum-based
chemotherapy and any of the following criteria are met:
1. Member has advanced (stage II-IV) disease
2. Member has recurrent disease with a deleterious or
suspected deleterious germline BRCA mutation
B. Uterine Leiomyosarcoma
Authorization of 12 months may be granted for subsequent
treatment of BRCA2-altered uterine leiomyosarcoma (uLMS)
when used as a single agent for advanced, recurrent,
metastatic, or inoperable disease.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication 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:
- Zejula [package insert]. Durham, NC: GlaxoSmithKline; December 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed January 3, 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.
March 28, 2023
