CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

niraparib (Zejula) — coverage criteria for ovarian, fallopian tube, primary peritoneal cancers and uterine leiomyosarcoma

Defines medical necessity and prior authorization requirements for niraparib (Zejula) as maintenance or subsequent therapy for specified ovarian, fallopian tube, primary peritoneal cancers and uterine leiomyosarcoma for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policyniraparib (Zejula) coverage for ovarian and related cancers

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation (including BRCA laboratory report when applicable); prior authorization of up to 12 months may be granted when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

BRCA requiredBRCA requirement

FDA & compendiaCoverage basis

Coverage Criteria for niraparib (Zejula)

inv-01: FDA-Approved Indications

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

FDA-approved maintenance (advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer): Member is an adult with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy.

Authorization of 12 months may be granted.

FDA-approved maintenance (germline BRCA-mutated recurrent disease): Member has recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer with deleterious or suspected deleterious germline BRCA mutation in complete or partial response to platinum-based chemotherapy.

Documentation of BRCA mutation required where applicable; authorization of 12 months may be granted.

inv-02: Compendial Indications

Compendial uses accepted when ALL of the following are met:

Compendial: maintenance for stage II-IV disease with BRCA mutation: Ovarian, fallopian tube, or primary peritoneal cancer: maintenance therapy for stage II-IV disease with germline or somatic BRCA mutation.

Authorization of 12 months may be granted.

Compendial: uterine leiomyosarcoma (uLMS): BRCA2-altered uterine leiomyosarcoma: single-agent subsequent treatment for advanced, recurrent, metastatic, or inoperable disease.

Authorization of 12 months may be granted for subsequent treatment.

Covered Regimens and Usage

Regimen	Indication / Use	Reauthorization requirement	Coverage status
Niraparib (Zejula) — single agent	Continued treatment for an approved indication listed in the policy when the member is receiving niraparib as maintenance or subsequent single‑agent therapy	Authorization of up to 12 months may be granted for reauthorization when there is no evidence of unacceptable toxicity or disease progression on the current regimen	Covered with criteria

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Authorization of up to 12 months may be granted when approval criteria are met and there is no unacceptable toxicity or disease progression on the current regimen.

Authorization of 12 months for maintenance treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer when member is in complete or partial response to platinum-based chemotherapy and criteria met.
Authorization of 12 months for subsequent treatment of BRCA2-altered uterine leiomyosarcoma for advanced, recurrent, metastatic, or inoperable disease.
Reauthorization: evidence of no unacceptable toxicity or disease progression required.

Prior Authorization

Reauthorization Requirement

Reauthorization requires documentation demonstrating no unacceptable toxicity and no evidence of disease progression while on the current regimen.

Reauthorization requests should include clinical progress notes and toxicity assessments.
Reauthorization may be granted for up to 12 months when criteria are met.

Documentation Required

BRCA Mutation Documentation

Submit laboratory report confirming BRCA mutation status when applicable as part of prior authorization documentation.

BRCA mutation documentation required for indications listing germline or somatic BRCA mutation (e.g., ovarian, fallopian tube, primary peritoneal cancer maintenance).
Include the laboratory report showing deleterious or suspected deleterious BRCA mutation when claimed.
Failure to provide BRCA documentation may result in denial or delay of prior authorization.

Denial Risk

Non-covered Indications

Indications not listed in the covered or compendial uses are considered experimental/investigational and are not medically necessary.

Covered/compendial uses: 1) Maintenance therapy for stage II-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer with germline or somatic BRCA mutation; 2) Uterine leiomyosarcoma (uLMS).
All other uses (including uses outside FDA-approved or compendial listings) will be denied as experimental/investigational.
Provide supporting clinical rationale and references if requesting coverage for an unlisted use; absence of such support will result in denial.

Key Definitions

Maintenance treatment — definition and scope

DefinitionMaintenance treatment: therapy given to patients in complete or partial response to platinum-based chemotherapy to delay progression.

IntentGiven to patients in complete or partial response to platinum-based chemotherapy to maintain disease control and delay progression.

Applicable settingAdult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy.

Duration noteAuthorization of up to 12 months may be granted when criteria are met and there is no unacceptable toxicity or disease progression.

Also applicableMaintenance after response to platinum-based chemotherapy for deleterious or suspected deleterious germline BRCA-mutated recurrent disease.

Line of Therapy Criteria

inv-12: first-line

First-line maintenance: Patients in complete or partial response to first-line platinum-based chemotherapy may receive niraparib as maintenance therapy for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Authorization up to 12 months.

inv-13: second-line

Second-line (recurrent) maintenance: Patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer and deleterious or suspected deleterious germline BRCA mutation may receive niraparib maintenance after response to platinum-based chemotherapy.

Documentation of BRCA mutation required where applicable; authorization up to 12 months.

inv-14: salvage

Salvage/subsequent therapy for uLMS: BRCA2-altered uterine leiomyosarcoma may receive niraparib as single-agent subsequent treatment for advanced, recurrent, metastatic, or inoperable disease.

Authorization of 12 months may be granted for subsequent treatment.

Biomarker and Genetic Testing Requirements

BRCA (germline or somatic) — biomarker requirements

Markers acceptedBRCA — germline (deleterious or suspected deleterious) or somatic BRCA mutation accepted depending on indication.

When requiredDocumentation of germline BRCA mutation is required for recurrent gBRCAmut indications; laboratory report confirming BRCA mutation status must be submitted when applicable.

Compendial requirementMaintenance therapy for stage II-IV ovarian, fallopian tube, or primary peritoneal cancer requires germline or somatic BRCA mutation per compendial use.

uLMS noteBRCA2-altered uterine leiomyosarcoma (uLMS) is a compendial indication for subsequent single-agent treatment when BRCA2 alteration is present.

Evidence submissionSubmit laboratory report confirming BRCA mutation status as part of prior authorization documentation when applicable.