CurrentNeighborhood Health Plan of Rhode IslandPolicy 1687-A

Niraparib (Zejula) — Coverage Criteria for Oncology Indications

This policy governs prior authorization and coverage criteria for niraparib (Zejula) for oncology indications (ovarian, fallopian tube, primary peritoneal cancer, uterine leiomyosarcoma, and prostate cancer) for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNiraparib (Zejula) — Coverage Criteria for Oncology Indications

Policy CodePolicy 1687-A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; submit BRCA mutation laboratory report when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

BRCA1/2biomarker

FDA + compendiacoverage basis

BRCA reportrequired doc

Coverage Criteria for Niraparib (Zejula)

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Epithelial ovarian/fallopian tube/primary peritoneal maintenance: Member is an adult with advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy; requested medication will be used as a single agent or in combination with bevacizumab.

Covers FDA first-line maintenance indication and stage II-IV disease per compendia.

Epithelial Ovarian/Fallopian Tube/Primary Peritoneal Cancer — Recurrent gBRCAmut maintenance

Covered when ALL of the following are met for recurrent disease with gBRCA mutation:

Recurrent gBRCAmut ovarian/fallopian tube/primary peritoneal: Member has recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer with deleterious or suspected deleterious germline BRCA mutation and is in complete or partial response to platinum-based chemotherapy; requested medication will be used as a single agent.

Matches FDA-approved maintenance for recurrent gBRCAmut disease.

Uterine Leiomyosarcoma — BRCA2-altered subsequent therapy

Covered when ALL of the following are met for uterine leiomyosarcoma:

uLMS BRCA2-altered treatment: Member has BRCA2-altered uterine leiomyosarcoma (uLMS) that is advanced, recurrent, metastatic, or inoperable and the requested medication will be used as a single agent for subsequent treatment.

Authorization of 12 months may be granted.

Prostate Cancer — mCRPC with BRCA1/2

Covered when ALL of the following are met for metastatic castration-resistant prostate cancer (mCRPC):

mCRPC with BRCA1/2: Disease has BRCA1 or BRCA2 mutation; member has had bilateral orchiectomy or will use the requested medication with an LHRH agonist/antagonist; and the requested medication will be used in combination with abiraterone and concurrent steroids (prednisone or methylprednisolone).

Authorization of 12 months may be granted.

Continuation Therapy

Continuation of therapy covered when ALL of the following are met:

Continuation Therapy: Member requests reauthorization for an indication listed in the coverage criteria and there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Authorization of 12 months may be granted for continued treatment.

Regimen	Indication	Coverage status
Niraparib as a single agent
Niraparib in combination with bevacizumab
Use for maintenance treatment in advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer when member is in complete or partial response to platinum-based chemotherapy

Regimen	Required conditions	Coverage status
Niraparib combined with abiraterone and concurrent steroids (prednisone or methylprednisolone)
Member has BRCA1 or BRCA2 mutation; member has had bilateral orchiectomy or will use an LHRH agonist/antagonist (e.g., goserelin, leuprolide, degarelix, relugolix)
Indication: metastatic castration-resistant prostate cancer (mCRPC)

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization may be granted for up to 12 months for indications meeting the coverage criteria (see coverage criteria section).

Authorization duration: up to 12 months

Documentation Required

Required Documentation

Submit documentation to support the request. Include a laboratory report confirming BRCA mutation status when applicable to the indication being requested.

Denial Risk

Experimental/Investigational Exclusions

The following uses are covered per compendia: maintenance therapy for ovarian, fallopian tube, or primary peritoneal cancer (stage II–IV) with germline or somatic BRCA mutation; BRCA2‑altered uterine leiomyosarcoma (uLMS); and metastatic castration‑resistant prostate cancer with BRCA1/2 mutation when criteria are met. All other indications are considered experimental/investigational and are not medically necessary; requests for these indications are subject to denial.

Note

Provider Action — Source Reference

Retain source reference for any additional provider-action content not captured here.

Key Definitions

inv-13: Maintenance treatment — definition/key value

DefinitionMaintenance treatment — therapy given for patients in complete or partial response to platinum-based chemotherapy to prevent recurrence.

Applicable indication (FDA)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.

Regimen contextMay be used as a single agent or in combination with bevacizumab for first-line maintenance in advanced (stage II-IV) disease.

Recurrent disease noteMaintenance for recurrent disease with deleterious or suspected deleterious germline BRCA mutation when in complete or partial response to platinum-based chemotherapy.

inv-14: BRCA-altered — definition/key value

DefinitionBRCA-altered — presence of deleterious or suspected deleterious germline or somatic BRCA1/2 mutation as specified per indication.

Indications requiring BRCA alterationRecurrent epithelial ovarian/fallopian tube/primary peritoneal cancer (germline BRCA mutation) and select compendial uses (e.g., uterine leiomyosarcoma BRCA2-altered, prostate cancer with BRCA1/2).

Documentation requiredSubmit laboratory report confirming BRCA mutation status where applicable for prior authorization.

Compendial referenceCompendial uses include ovarian primary maintenance for stage II-IV disease with germline or somatic BRCA mutation and uLMS; prostate cancer listed as compendial.

Line of Therapy Details

first-line — top-level node for first-line criteria

First-line maintenance: Patient is in complete or partial response to first-line platinum-based chemotherapy for advanced disease (stage II-IV)

FDA first-line maintenance indication

second-line — top-level node for second-line criteria

Recurrent maintenance: Patient with recurrent disease and deleterious or suspected deleterious germline BRCA mutation in complete or partial response to platinum-based chemotherapy

FDA recurrent maintenance for gBRCAmut

Biomarker Requirements (BRCA)

inv-17: BRCA1/BRCA2 — deleterious or suspected deleterious germline or somatic mutation as specified per indication

Required mutation typeDeleterious or suspected deleterious germline or somatic mutation in BRCA1 or BRCA2 as specified for each indication.

When requiredBRCA1/2 mutation is required for: recurrent gBRCAmut ovarian/fallopian tube/primary peritoneal maintenance (germline) and for mCRPC coverage; BRCA2-altered is required for uLMS subsequent therapy.

DocumentationLaboratory report confirming BRCA mutation status must be submitted when applicable for prior authorization.

Source of specificationMutation requirement and whether germline or somatic is specified per individual indication in the FDA indications and compendial guidance.

Covered Regimens and Combinations

Regimen	Indication / notes	Coverage status
Niraparib as single agent
Maintenance therapy for epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to platinum-based chemotherapy; may be used in combination with bevacizumab for first-line maintenance in advanced (stage II-IV) disease.
Authorization of up to 12 months may be granted when criteria are met.

Regimen	Indication / required conditions	Coverage status
Niraparib in combination with abiraterone and concurrent steroids (prednisone or methylprednisolone)
Indication: metastatic castration-resistant prostate cancer (mCRPC) with documented BRCA1 or BRCA2 mutation; member has had bilateral orchiectomy or will use niraparib with an LHRH agonist/antagonist.
Authorization of up to 12 months may be granted when criteria are met.

Background

Niraparib (Zejula) is a PARP inhibitor included in compendial guidance for maintenance therapy in ovarian, fallopian tube, and primary peritoneal cancers and for select other tumor types. The compendial listing specifically includes maintenance therapy for stage II–IV ovarian, fallopian tube, or primary peritoneal cancer with germline or somatic BRCA mutation, uterine leiomyosarcoma (uLMS), and prostate cancer. Per this policy, uses not reflected in FDA approvals or these compendial entries are considered experimental/investigational and are not eligible for coverage.