Subject: Zejula SGM 1687-A P2024a

Drug

ZEJULA  (niraparib)

Policy:

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.

FDA-approved Indications¹

• 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.
• 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.

Compendial uses²

• Ovarian, fallopian tube, or primary peritoneal cancer – maintenance therapy for stage II-IV disease with germline or somatic BRCA mutation
• Uterine Leiomyosarcoma (uLMS)
• Prostate cancer

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

Documentation of laboratory report confirming BRCA mutation status, where applicable.

Coverage Criteria

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer^1,2

Authorization of 12 months may be granted for maintenance treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer when the member is in a complete or partial response to platinum-based chemotherapy and any of the following criteria are met:

• Member has advanced (stage II-IV) disease and requested medication will be used as a single agent or in combination with bevacizumab.
• Member has recurrent disease with a deleterious or suspected deleterious germline BRCA mutation and requested medication will be used as a single agent.

Uterine Leiomyosarcoma²

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.

Prostate Cancer²

Authorization of 12 months may be granted for treatment of metastatic castration-resistant prostate cancer when all of the following criteria are met:

• The disease has BRCA1 or BRCA2 mutation
• The member has had a bilateral orchiectomy or will be using the requested medication in combination with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix).
• The requested medication will be used in combination with abiraterone and concurrent steroids (prednisone or methylprednisolone).

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section 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:

1. Zejula [package insert]. Durham, NC: GlaxoSmithKline; May 2024.
2. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed December 17, 2024.

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.

June 02, 2025