ModifiedUnitedHealthcarePolicy 2025 P 1216-10

Zejula (niraparib) prior authorization policy

UnitedHealthcare prior authorization/notification policy specifying coverage criteria, initial authorization and reauthorization rules, and special population rules for niraparib (Zejula) for ovarian, fallopian tube, primary peritoneal cancers, recurrent platinum-sensitive disease (with bevacizumab), BRCA-mutated mCRPC (with abiraterone/Yonsa), and BRCA2-altered uterine leiomyosarcoma; includes age <19 automatic approval and NCCN recognition clause.

Policy Summary

PayerUnitedHealthcare

PolicyZejula (niraparib) prior authorization policy

Policy CodePolicy 2025 P 1216-10

Change TypeRevised (FDA label and NCCN updates)

Effective DateNov 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Zejula except prescriptions for members under 19 years automatically process without coverage review; authorizations issued for 12 months when criteria met.

SourceLink

POLICY UPDATE CHANGES

Effective 11/01/2025 policy updated to reflect FDA label revisions and NCCN guideline updates for ovarian and prostate cancer; criteria for prostate cancer and ovarian cancer updated.

Added automatic processing for prescriptions for members under 19 years of age.

5Covered Indications (major)

12 monthsAuthorization duration

8/2025Most recent P&T approval

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Coverage Summary

This policy covers niraparib (Zejula) as maintenance therapy for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancers in patients who meet HRD or gBRCAmut criteria as specified; maintenance for recurrent epithelial ovarian/fallopian tube/primary peritoneal cancer with deleterious germline BRCA mutation; recurrent platinum‑sensitive disease when used in combination with bevacizumab; BRCA‑mutated metastatic castration‑resistant prostate cancer (mCRPC) when used in combination with abiraterone or Yonsa; and BRCA2‑altered uterine leiomyosarcoma (uLMS) as second‑line or subsequent therapy for advanced, recurrent/metastatic, or inoperable disease. The policy includes an NCCN recognition clause for covered indications.

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Policy highlights

Authorization duration12 months

Covered Indications (major)5

Most recent P&T approvalP&T 8/2025

Policy effective date11/01/2025

Prior authorization rulePrescriptions for members under 19 automatically process; other uses require prior authorization

Initial Authorization — Ovarian / Fallopian Tube / Primary Peritoneal Cancer

Initial Authorization - Ovarian / Fallopian tube / Primary peritoneal cancer

Zejula will be approved based on all of the following criteria:

ALL of the following

Diagnosis of one of the following: epithelial ovarian cancer; fallopian tube cancer; primary peritoneal cancer
Disease is stage II-IV
One of the following
- Option A - First-line maintenance with HRD
  - Maintenance therapy for those who are in complete or partial response after first-line platinum-based chemotherapy

Reauthorization — Ovarian / Fallopian Tube / Primary Peritoneal Cancer

Reauthorization - Ovarian / Fallopian tube / Primary peritoneal cancer

Zejula will be approved based on the following criterion:

ALL of the following

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

Initial Authorization — Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Initial Authorization - Castration-resistant distant metastatic (M1) prostate cancer

Zejula will be approved based on all of the following criteria:

ALL of the following

Diagnosis of castration-resistant distant metastatic (M1) prostate cancer
Patient is positive for pathogenic BRCA1 or BRCA2 mutation
Patient has not had treatment since disease progression to metastatic castration-resistant prostate cancer (mCRPC)
One of the following prior therapy statuses
- Patient has not received prior docetaxel and prior novel hormone therapy

Reauthorization — mCRPC

Reauthorization - mCRPC

Zejula will be approved based on the following criterion:

ALL of the following

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

Initial Authorization — Uterine Leiomyosarcoma (uLMS)

Initial Authorization - Uterine leiomyosarcoma (uLMS)

Zejula will be approved based on all of the following criteria:

ALL of the following

Diagnosis of BRCA-2 altered uterine leiomyosarcoma (LMS)
Disease is advanced, recurrent/metastatic, or inoperable
Used as second-line or subsequent therapy

Reauthorization — Uterine Sarcoma

Reauthorization - Uterine Sarcoma

Zejula will be approved based on the following criterion:

ALL of the following

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

NCCN Recognition

NCCN Recommended Regimens

Authorization based on NCCN recognition:

ALL of the following

The drug has been recognized for treatment of the cancer indication by The NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Applicable Codes

Relevant diagnosis concepts (listed in policy text)ICD-10

No codes listed

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Zejula (niraparib) except prescriptions for members under 19 years will automatically process without a coverage review. When clinical criteria are met, authorizations are issued for 12 months.

Automatic processing for members <19 years — no coverage review required.
Authorization duration — 12 months when criteria met.

Documentation Required

Clinical documentation required

Clinical documentation must support the requested use. Required information includes the diagnosis and disease stage where applicable (e.g., stage II–IV for epithelial ovarian, fallopian tube, or primary peritoneal cancers), evidence of BRCA mutation status or HRD status as required by the indication, prior therapy history for mCRPC, and documentation of combination therapy use when applicable (for example bevacizumab with recurrent platinum-sensitive ovarian disease or abiraterone/Yonsa with mCRPC).

Clinical Evidence & References

Supporting references for the policy include the product labeling and professional compendium: Zejula [package insert], GlaxoSmithKline; June 2025, and the NCCN Drugs and Biologics Compendium (accessed July 21, 2025).

Background

Niraparib (Zejula) is described as a PARP inhibitor indicated for maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first‑line platinum chemotherapy when disease is HRD‑positive (deleterious or suspected BRCA mutation and/or genomic instability), and for maintenance of recurrent disease with deleterious or suspected germline BRCA mutation. The NCCN also recommends Zejula for use in recurrent platinum‑sensitive ovarian/fallopian tube/primary peritoneal cancer in combination with bevacizumab, for BRCA2‑altered uterine leiomyosarcoma as second‑line or subsequent therapy, and for castration‑resistant distant metastatic (M1) prostate cancer. The policy reflects updates from FDA label revisions and NCCN guideline changes.

HRD (Homologous recombination deficient)Defined by a deleterious or suspected deleterious BRCA mutation and/or genomic instability

gBRCAmut (germline BRCA mutation)Deleterious or suspected deleterious germline BRCA mutation

Revision History

2025-11-01material_changeLatest

Effective 11/01/2025 policy updated to reflect FDA label revisions and NCCN guideline updates for ovarian and prostate cancer; criteria for prostate cancer and ovarian cancer updated (material change).

12/2024revision

12/2024: Annual review updated criteria for ovarian cancer per NCCN guidelines, consolidated maintenance and treatment sections, added new criteria for prostate cancer, and updated uterine sarcoma section per NCCN (material change noted in change history).

8/2025

Policy Summary

PayerUnitedHealthcare

PolicyZejula (niraparib) prior authorization policy

Policy CodePolicy 2025 P 1216-10

Change TypeRevised (FDA label and NCCN updates)

Effective DateNov 1, 2025

Next Review Date

SourceLink

On This Page

Disease is homologous recombination deficient (HRD) defined by a deleterious or suspected deleterious BRCA mutation and/or genomic instability

Option B - Recurrent disease with gBRCAmut

Maintenance therapy for those who are in complete or partial response to platinum-based chemotherapy for recurrent disease
Disease with a deleterious or suspected deleterious germline BRCA mutation

Option C - Recurrent platinum-sensitive with bevacizumab

Recurrent therapy for platinum-sensitive disease
Used in combination with bevacizumab

Patient had progression on prior docetaxel therapy and has not received prior novel hormone therapy

Patient had progression on prior novel hormone therapy and has not received prior docetaxel therapy

Must be used in combination with one of

Abiraterone
Yonsa (fine-particle abiraterone)

Diagnosis and disease stage (ovarian-related cancers: stage II–IV).

BRCA mutation status or HRD status as required by indication.

Prior therapy history for mCRPC (permitted prior therapy scenarios documented).

Evidence of combination therapy use where applicable (e.g., bevacizumab, abiraterone/Yonsa).

Billing Rule

Automated approval allowance

UnitedHealthcare may approve initial requests and reauthorizations based solely on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic via program automation. Supply limits may be applied. Note that prescriptions for members under 19 years automatically process without coverage review and authorizations are issued for 12 months when criteria are met.

Automated approval possible using prior claims, medication history, diagnosis codes, and claim logic.
Supply limits may be in place.
Members <19 years — automatic processing (no coverage review); authorization duration 12 months when criteria met.

8/2025: Annual review updated background due to FDA label revision and updated criteria for ovarian and prostate cancer per NCCN guidelines and FDA label (reflected in change history).

2025-11-01authorization_clarificationLatest

Authorization rule clarified: prescriptions for members under 19 years automatically process without coverage review and authorizations for patients under 19 are issued for 12 months (automatic processing and 12-month duration).

ongoingadministrativeLatest

Automated approval processes permitted: UnitedHealthcare may approve initial and reauthorization based on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; supply limits may apply.