CurrentUnitedHealthcarePolicy 2025 P 1216-10

Zejula (niraparib) prior authorization

Prior authorization and coverage criteria for Zejula (niraparib) for oncology indications including ovarian, fallopian tube, primary peritoneal cancer, recurrent disease, castration-resistant metastatic prostate cancer, and BRCA2-altered uterine leiomyosarcoma; applies to UnitedHealthcare pharmacy benefit members (automatic processing for members <19).

Policy Summary

PayerUnitedHealthcare

PolicyZejula (niraparib) prior authorization

Policy CodePolicy 2025 P 1216-10

Change TypeRevised criteriaadded mCRPC indication

Effective Date11/1/2025

Next Review Date

Key ActionSubmit prior authorization documentation showing diagnosis, stage, mutation/HRD status, prior therapies, and concurrent medications; approvals issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Updated background due to FDA label revision and updated criteria for ovarian and prostate cancer per NCCN and FDA changes.

Added new criteria for prostate cancer per NCCN guidelines.

Updated criteria for ovarian cancer per NCCN guidelines and FDA label.

12 monthsauthorization duration issued for approved uses

Patients <19automatic processing without coverage review

Multipleindications covered

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Coverage Criteria for Zejula (niraparib)

Initial Authorization — Ovarian/fallopian tube/primary peritoneal

Covered when ALL of the following are met

Initial Authorization - Ovarian/fallopian/primary peritoneal: (1) Diagnosis of one of the following: epithelial ovarian cancer OR fallopian tube cancer OR primary peritoneal cancer; AND (2) Disease is stage II-IV; AND (3) One of the following suboptions: (a) Maintenance therapy for patients in complete or partial response after first-line platinum-based chemotherapy AND disease is homologous recombination deficient (HRD) defined by a deleterious or suspected deleterious BRCA mutation and/or genomic instability; OR (b) Maintenance therapy for patients in complete or partial response to platinum-based chemotherapy for recurrent disease AND disease has a deleterious or suspected deleterious germline BRCA mutation; OR (c) Recurrent therapy for platinum-sensitive disease AND used in combination with bevacizumab.

Authorization issued for 12 months

Reauthorization

Reauthorization criteria

Reauthorization - general: Patient does not show evidence of progressive disease while on Zejula therapy.

Authorization issued for 12 months

Initial Authorization — mCRPC (prostate cancer)

Covered when ALL of the following are met

Initial Authorization - mCRPC: (1) Diagnosis of castration-resistant distant metastatic (M1) prostate cancer; AND (2) Patient is positive for a pathogenic BRCA1 or BRCA2 mutation; AND (3) Patient has not had treatment since disease progression to mCRPC; AND (4) One of the following prior-therapy statuses: (a) patient has not received prior docetaxel and prior novel hormone therapy; OR (b) patient had progression on prior docetaxel therapy and has not received prior novel hormone therapy; OR (c) patient had progression on prior novel hormone therapy and has not received prior docetaxel therapy; AND (5) Used in combination with abiraterone OR Yonsa (fine-particle abiraterone).

Authorization issued for 12 months

Initial Authorization — Uterine sarcoma (BRCA2-altered uLMS)

Covered when ALL of the following are met

Initial Authorization - BRCA2-altered uLMS: (1) Diagnosis of BRCA-2 altered uterine leiomyosarcoma (LMS); AND (2) Disease is advanced, recurrent/metastatic, or inoperable; AND (3) Used as second-line or subsequent therapy.

Authorization issued for 12 months

NCCN Recommended Regimens

NCCN recognition: The drug has been recognized for treatment of the cancer indication by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B.

Used to support coverage decisions per policy

Some states have statutes that require coverage for certain off-label medication uses or require use of specific compendia to support coverage. Where applicable, these state-specific mandates or compendium requirements supersede the criteria in this policy. In addition, federal regulatory requirements and the terms of the member’s specific benefit plan may affect coverage determinations.

Initial therapy rules

Initial authorization criteria by indication

Initial - ovarian family indications: See Initial Authorization — Ovarian/fallopian tube/primary peritoneal: diagnosis, stage II-IV, and one of the specified maintenance or recurrent suboptions (HRD or gBRCA requirements or combination with bevacizumab).

Authorization issued for 12 months

Initial - mCRPC: See Initial Authorization — mCRPC (prostate cancer): diagnosis of castration-resistant distant metastatic (M1) prostate cancer, pathogenic BRCA1/2 positivity, prior-therapy status as specified, and used in combination with abiraterone or Yonsa.

Authorization issued for 12 months

Initial - uLMS: See Initial Authorization — BRCA2-altered uLMS: BRCA-2 altered uterine LMS that is advanced/recurrent/metastatic or inoperable, used as second-line or subsequent therapy.

Authorization issued for 12 months

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Zejula (niraparib) for covered indications. Authorizations are issued for 12 months when criteria are met.

Applies to all covered indications listed in this policy.
Authorization duration: 12 months when approved.

Note

Program-level Automation & Limits

Use of automated approval and re-approval processes varies by program; supply limits may be in place. UnitedHealthcare may approve initial and reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic.

Automated validation may rely on prior claims or pharmacy history.
Supply limits may apply per program or therapeutic class.

Initial Therapy Criteria by Indication

Initial therapy rules

Initial authorization criteria by indication

Authorization issued for 12 months

Initial - uLMS: See Initial Authorization — BRCA2-altered uLMS: BRCA-2 altered uterine LMS that is advanced/recurrent/metastatic or inoperable, used as second-line or subsequent therapy.

Continuation / Reauthorization Criteria

Continuation/Reauthorization

Reauthorization/continuation criteria

Continuation therapy: Patient must not show evidence of progressive disease while on Zejula therapy for reauthorization to be approved.

Authorization issued for 12 months

Step Therapy and Automation

Step	Program note
1
Use of automated approval and re-approval processes varies by program; prior claims/medication history, diagnosis codes, and/or claim logic may be used to approve initial authorizations and reauthorizations. Supply limits may be in place.

Site-of-Care Guidance

Note

Supply limits / infusion center guidance

Supply limits may be in place for administration or dispensing; the policy does not specify site‑of‑care restrictions beyond noting potential supply limits.

Definitions and Key Terms

HRD-positive — Homologous recombination deficient disease definition

DefinitionHomologous recombination deficient (HRD) disease is defined by a deleterious or suspected deleterious BRCA mutation and/or genomic instability.

Clinical contextHRD-positive status is required for first‑line maintenance after platinum-based chemotherapy in advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (patients in complete or partial response).

Recurrent disease noteFor recurrent epithelial ovarian/fallopian tube/primary peritoneal cancer, maintenance after platinum response requires a deleterious or suspected deleterious germline BRCA mutation (gBRCAmut).

mCRPC — Castration-resistant distant metastatic (M1) prostate cancer definition

DefinitionCastration‑resistant distant metastatic (M1) prostate cancer (mCRPC).

Background

Niraparib (Zejula) is a PARP inhibitor used primarily as maintenance therapy for ovarian-family cancers and in select other tumor types. It is indicated for maintenance treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients responding to platinum-based chemotherapy with HRD-positive disease (including BRCA mutations) and for maintenance treatment of recurrent disease in patients with a deleterious germline BRCA mutation. The agent is also used in NCCN-recognized regimens such as combination with bevacizumab for platinum-sensitive recurrent ovarian cancer, for BRCA2-altered uterine leiomyosarcoma as a second-line or subsequent therapy, and for castration-resistant metastatic prostate cancer (mCRPC) in patients with pathogenic BRCA1/2 mutations when given in combination with abiraterone or fine-particle abiraterone (Yonsa).

Policy Revision History

2025-08annual review - material updateLatest

Annual review updated background due to FDA label revision and updated criteria for ovarian and prostate cancer per NCCN and FDA changes.

2024-12annual review - criteria revision

Annual review updated criteria for ovarian cancer per NCCN guidelines, consolidated maintenance and treatment sections, added new prostate cancer criteria per NCCN, and updated uterine sarcoma section.

2023-06annual review - background and guidelines updated