Subject: Zejula 1687-A SGM P2022
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 recurrent
epithelial ovarian, fallopian tube, or primary peritoneal
cancer who are in a complete or partial response to
platinum-based chemotherapy.
3. Treatment of adult patients with advanced ovarian,
fallopian tube, or primary peritoneal cancer who have
been treated with three or more prior chemotherapy
regimens and whose cancer is associated with
homologous recombination deficiency (HRD) positive
status defined by either:
a. a deleterious or suspected deleterious BRCA
mutation, or
b. genomic instability and who have progressed more
than six months after response to the last platinum-
based chemotherapy.
Select patients for therapy based on an FDA-approved
companion diagnostic for Zejula.
B. Compendial uses
1. Ovarian, fallopian tube, or primary peritoneal cancer -
single agent for maintenance treatment
2. Epithelial ovarian, fallopian tube, or primary peritoneal
cancer - in combination with bevacizumab for platinum-
sensitive persistent or recurrent disease
3. 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:
A. Documentation of laboratory report confirming BRCA
mutation status, where applicable.
B. Documentation of laboratory report confirming
homologous recombination deficiency status, where
applicable.
III. CRITERIA FOR INITIAL APPROVAL
A. Epithelial Ovarian, Fallopian Tube, or Primary
Peritoneal Cancer
1. Authorization of 12 months may be granted for
maintenance treatment of recurrent or advanced (stage
II-IV) epithelial ovarian, fallopian tube, or primary
peritoneal cancer as a single agent when the member is
in a complete or partial response to chemotherapy.
2. Authorization of 12 months may be granted for the
treatment of persistent, recurrent, or advanced ovarian,
fallopian tube, or primary peritoneal cancer as a single
agent when all of the following criteria are met:
a. Member has been treated with three or more prior
chemotherapy regimens
b. Member’s cancer is associated with homologous
recombination deficiency (HRD) positive status
defined by one of the following:
i. Member has a deleterious or suspected
deleterious BRCA mutation
ii. Member has genomic instability and has
progressed more than six months after response
to the last platinum-based chemotherapy
3. Authorization of 12 months may be granted for the
treatment of persistent or recurrent ovarian, fallopian
tube, or primary peritoneal cancer, in combination with
bevacizumab for platinum-sensitive disease.
B. Uterine Leiomyosarcoma
Authorization of 12 months may be granted for treatment
of BRCA altered uterine leiomyosarcoma (uLMS) as second-
line therapy when used as a single agent.
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]. Research Triangle Park, NC: GlaxoSmithKline; May 2021.
- The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed January 5, 2022.
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.
July 26, 2022
