Pharmacy Prior Authorization Criteria

Zejula (niraparib)

For diagnosis of First-Line Maintenance Treatment of Advanced Ovarian Cancer
Indicated for the 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.
For diagnosis of Maintenance Treatment of Recurrent Germline BRCA-mutated Ovarian Cancer
Indicated for the 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.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

2024-05-01, 2023-07-28, 2023-07-03, 2023-06-05, 2023-03-02, 2022-10-04, 2021-05-04, 2020-07-01, 2020-04-14, 2020-01-15

Zejula Prescribing Information. GlaxoSmithKline, LLC. Research Triangle Park, NC. April 2023.
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer v.1.2022. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Accessed April 21, 2022.

2024-05-01: 2024 Annual Review - updated references
2023-07-28: Update guideline
2023-07-03: Removed specialist requirement
2023-06-05: 2023 Annual Review - Program update to remove clinical criteria such as disease severity, mutation status, and used for maintenance treatment criterion.
2023-03-02: Updated indication for ovarian cancer
2022-10-04: Update to remove FDA withdrawn indication
2021-05-04: 2021 Annual Review, no changes to criteria.
2020-07-01: Guideline updated for new indication
2020-04-14: 2020 Annual Review, no changes to criteria
2020-01-15: Guideline updated for new indication