WHA

Zejula (niraparib)

Indications for Prior Authorization

Zejula (niraparib)
  • For diagnosis of First-Line Maintenance Treatment of HRD-Positive 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 and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.

  • 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.

Criteria

Zejula

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of one of the following:
    • Epithelial ovarian cancer
    • Fallopian tube cancer
    • Primary peritoneal cancer
Zejula

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient does not show evidence of progressive disease while on therapy

  • Guideline ID
    GL-346196

  • Formulary
    Premium

  • Effective date
    Oct 1, 2025

  • P&T approval date
    Jun 28, 2017

P & T Revisions

1970-01-01, 2025-05-02, 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

  1. Zejula Prescribing Information. GlaxoSmithKline, LLC. Research Triangle Park, NC. June 2025.
  2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer v.3.2025. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Accessed July 21, 2025.
  • 2025-05-02: 2025 Annual Review - no criteria changes
  • 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