ModifiedmhnPolicy CP.PHAR.408

Niraparib (Zejula) coverage

Defines medical necessity and prior authorization criteria for niraparib (Zejula) for ovarian and selected off-label cancers for members covered by the payer lines of business. Applies to providers requesting coverage for Zejula under Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyNiraparib (Zejula) coverage

Policy CodePolicy CP.PHAR.408

Change TypeMaterial revisions and restrictions

Effective DateJun 1, 2017

Next Review Date

Key ActionSubmit prior authorization with documentation of indication, BRCA/HRD results when required, baseline weight and platelet count, and requested dose within the 300 mg/day, 1 tablet/day limit.

SourceLink

POLICY UPDATE CHANGES

Manufacturer voluntarily withdrew the FDA-approved indication for Zejula in advanced HRD ovarian cancer after ≥ 3 prior chemotherapy regimens effective September 14, 2022.

Withdrew the FDA-approved indication for Zejula in advanced HRD-positive ovarian cancer after ≥3 prior chemotherapies effective September 14, 2022.

Restricted maintenance treatment in the second-or-later line platinum sensitive setting to germline BRCA-mutated patients in the U.S.

Updated dosing guidance including weight- and platelet-based starting doses (200 mg or 300 mg PO QD) and maximum dose.

Added prescriber attestation requirements for select non-germline BRCA uses and continued-therapy documentation requirements.

Revised quantity limit to 300 mg per day and limited dispensing to 1 tablet per day; removed obsolete capsule formulation.

300 mg/dayMaximum standard daily dose limit

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Coverage and Medical Necessity Criteria

inv-01: Initial Therapy - Ovarian Cancer

Covered when ALL of the following are met:

Ovarian Cancer Initial: 1. Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. For brand Zejula requests, member must use generic niraparib if available unless contraindicated or clinically significant adverse effects are experienced; 5. Member meets one of the following (a or b): (a) Member is in complete response or partial response, and one of the following: (i) Stage II-IV disease and completed first-line platinum-based chemotherapy, OR (ii) HRD-positive disease or recurrent germline BRCA-mutated disease with documentation of deleterious or suspected deleterious BRCA mutation and/or genomic instability on a CLIA-approved diagnostic test and completed platinum-based chemotherapy; (b) Member has platinum-sensitive persistent or recurrent disease and Zejula is prescribed in combination with bevacizumab and either serially rising CA-125 after prior chemotherapy or radiographic/clinical relapse ≥ 6 months after prior chemotherapy; 6. Zejula is prescribed as a single agent or in combination with bevacizumab; 7. Member has not previously received a PARP inhibitor; 8. Request does not exceed health-plan approved quantity limit; 9. Dose does not exceed 300 mg per day and 1 tablet per day, or the dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN

inv-02: Initial Therapy - Prostate Cancer (off-label)

Covered when ALL of the following are met:

Prostate Cancer Initial: 1. Diagnosis of metastatic castration-resistant prostate cancer (CRPC); 2. Prescribed by or in consultation with an oncologist or urologist; 3. Age ≥ 18 years; 4. Documentation of deleterious or suspected deleterious germline or somatic BRCA1/2 mutation; 5. For brand Zejula requests, member must use generic niraparib if available unless contraindicated or clinically significant adverse effects are experienced; 6. Prescribed in combination with abiraterone and steroids (prednisone or methylprednisolone); 7. Prescribed concurrently with systemic androgen deprivation therapy (ADT) or member has had bilateral orchiectomy; 8. Member has not previously received a PARP inhibitor; 9. Request does not exceed health-plan approved quantity limit; 10. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN

inv-03: Initial Therapy - Uterine Neoplasms (off-label)

Covered when ALL of the following are met:

Uterine Sarcoma Initial: 1. Diagnosis of uterine sarcoma; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. For brand Zejula requests, member must use generic niraparib if available unless contraindicated or clinically significant adverse effects are experienced; 5. Documented mutation in the BRCA2 gene; 6. Prescribed as a single-agent subsequent therapy; 7. Member has not previously received a PARP inhibitor; 8. Request does not exceed health-plan approved quantity limit; 9. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN

inv-04: Continuation Therapy

Continuation covered when ALL of the following are met:

Continued Therapy: 1. Member is currently receiving Zejula via the Centene benefit, or documentation shows member has received Zejula for at least 30 days; 2. For advanced HRD ovarian cancer after >3 lines of chemotherapy, provider attestation acknowledging withdrawal of that FDA indication due to potential OS detriment; 3. For non-germline BRCA mutated platinum-sensitive recurrent ovarian cancer in the second or later line maintenance setting, provider attestation acknowledging possible OS detriment with Zejula use; 4. Member is responding positively to therapy; 5. For brand Zejula requests, member must use generic niraparib if available unless contraindicated or clinically significant adverse effects are experienced; 6. Request does not exceed health-plan approved quantity limit; 7. If request is for a dose increase, new dose does not exceed 300 mg per day and 1 tablet per day, or is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN

inv-05: Second-or-later line platinum-sensitive maintenance (germline BRCA only)

Maintenance therapy in recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (second or later line platinum-sensitive): covered only when ALL of the following are met:

gBRCA-restriction: Patient has a documented germline BRCA mutation confirmed by a CLIA-approved diagnostic test (e.g., BRACAnalysis CDx).

Policy restricts second-or-later line platinum-sensitive maintenance to germline BRCA-mutated patients per manufacturer/FDA request (U.S.).

response-to-platinum: Patient is in complete response or partial response to platinum-based chemotherapy given in the second or later line setting or has platinum-sensitive persistent or recurrent disease per NCCN.

Requirement clarified in 1Q2026 review to include CR/PR or platinum-sensitive persistent/recurrent disease.

dose-and-quantity: Requested dose does not exceed plan quantity limits (maximum 300 mg/day; 1 tablet/day) and is supported by baseline weight and platelet data.300 mg/day; 1 tablet/day

inv-06: Advanced HRD-positive disease after ≥3 prior chemotherapies

Advanced HRD-positive ovarian, fallopian tube, or primary peritoneal cancer after ≥3 prior chemotherapy regimens:

withdrawn-indication: Manufacturer voluntarily withdrew the FDA-approved indication for this setting; physicians should not initiate new treatment in this indication.

Withdrawal effective Sept 14, 2022; QUADRA study provided single-arm data without comparative OS information.

inv-07: Dose determination

Dosing rules for covered uses:

starting-dose-low: If patient weight <77 kg OR platelet count <150,000/mcL, start niraparib 200 mg PO QD.<77 kg OR platelets <150,000/mcL

Document baseline weight and platelet count.

starting-dose-standard: If patient weight ≥77 kg AND platelet count ≥150,000/mcL, start niraparib 300 mg PO QD. Germline BRCA-mutated disease default start dose is 300 mg PO QD; maximum dose 300 mg/day.≥77 kg AND platelets ≥150,000/mcL

Maximum dose listed as 300 mg/day; tablets available in 100 mg, 200 mg, 300 mg strengths.

Requests for use of niraparib (Zejula) for non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the payer's off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other applicable evidence‑of‑coverage documents.

The manufacturer voluntarily withdrew the FDA‑approved indication for niraparib in adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have received ≥3 prior chemotherapy regimens and whose tumors are HRD‑positive. This withdrawal became effective on September 14, 2022, and clinicians should not initiate niraparib for this withdrawn indication.

Maintenance niraparib for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer given as second‑or‑later line platinum‑sensitive maintenance is restricted in the U.S. to patients with a documented germline BRCA mutation. This restriction was implemented at the manufacturer's request following the final overall survival (OS) analysis from the NOVA trial, which showed an OS benefit in the germline BRCA cohort but a potential OS detriment in non‑germline BRCA cohorts; clinicians should consider this restriction when evaluating requests for maintenance niraparib in this setting.

Initial Therapy Rules and Dosing

inv-27: Initial therapy rules

Initial therapy approvals are indication-specific and require meeting all listed criteria.

Initial therapy: See per-indication initial approval criteria: diagnosis, specialist involvement, age ≥ 18, BRCA/HRD testing when required, completion of relevant platinum-based chemotherapy where specified, combination requirements, prior PARP inhibitor exclusion, quantity and dose limits (max 300 mg/day; 1 tablet/day).

Prescribed regimen must be FDA-approved or recommended by NCCN

inv-28: Initial dosing

Initial dosing selection

initial-dose-criteria: Start niraparib at 200 mg PO QD for patients weighing <77 kg or with platelet count <150,000/mcL; start at 300 mg PO QD for patients weighing ≥77 kg and platelet count ≥150,000/mcL. For germline BRCA-mutated disease, the default start dose is 300 mg PO QD. Maximum dose 300 mg/day.see dosing thresholds

Criteria for Continued Therapy

inv-29: Continuation therapy rules

Continuation requires evidence of prior use and specific provider attestations for populations with known safety/efficacy concerns.

Continuation - general: 1. Member must be currently receiving Zejula via the Centene benefit or have documentation of at least 30 days of prior therapy; 2. Member is responding to therapy; 3. Provider attestations required for specific ovarian cancer populations (acknowledgement of withdrawn HRD >3 lines indication or possible OS detriment in non-germline BRCA 2nd+ line maintenance); 4. Request does not exceed health-plan approved quantity limit; 5. Dose increases must not exceed 300 mg/day and 1 tablet/day or be supported by practice guidelines/literature.

Prescribed regimen must be FDA-approved or recommended by NCCN

inv-30: Continued therapy considerations

Continued therapy for non-germline BRCA maintenance patients currently on niraparib:

physician-discussion: Physicians treating non-germline BRCA-mutated patients in the second-or-later line platinum-sensitive maintenance setting should discuss NOVA OS findings and potential OS risk with patients to support individualized benefit-risk decisions.

Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation that all initial approval criteria are met (diagnosis, oncologist involvement when applicable, prior therapies completed, dosing within limits, and other applicable clinical criteria).

Prior authorization required for all indications addressed by this policy
Requests must not exceed health-plan approved quantity limit (300 mg/day and 1 tablet/day)

Prior Authorization

Prior Authorization — Required Documentation and Dose Limits

Prior authorization must document the clinical indication for use and key supporting data. For indications where BRCA status is relevant, include mutation status per policy requirements. Baseline weight and platelet count must be provided to justify starting dose selection. The requested dose must not exceed the plan-approved limits unless peer-reviewed literature or guideline-supported rationale is supplied.

Document indication and disease status (e.g., complete or partial response, platinum-sensitive persistent or recurrent disease)

Dosing Thresholds and Key Clinical Values

Weight and platelet dosing thresholds

Weight <77 kg OR platelet <150,000/mcLStart niraparib 200 mg PO QD

Weight ≥77 kg AND platelet ≥150,000/mcLStart niraparib 300 mg PO QD

Germline BRCA-mutated disease dosingDefault start 300 mg PO QD

Formulary Quantity and Dispensing Constraints

niraparib (Zejula) — quantity limit notes

Plan quantity limit (policy note)Health-plan approved quantity limit applies (see prior authorization requirements)

FormulationTablets only — capsules obsolete per 1Q2026 update

Approval durationTypical approval duration: 12 months (Medicaid/HIM/Commercial per policy)

niraparib (Zejula) — 300 mg quantity limit

Maximum daily dose300 mg/day (policy revised quantity limit)

Dispensing limit1 tablet per day

Tablet strengths available

Therapeutic Alternatives and Step Requirements

Therapeutic alternatives	Notes
Platinum-based chemotherapy regimens (examples: paclitaxel/carboplatin; paclitaxel/cisplatin; docetaxel/carboplatin; carboplatin/liposomal doxorubicin; carboplatin/ifosfamide; cisplatin/ifosfamide; paclitaxel/ifosfamide; 5‑fluorouracil/leucovorin/oxaliplatin)	Listed as preferred therapeutic alternatives; may not be formulary agents and may require prior authorization per formulary rules.
Bevacizumab-containing platinum regimens (examples: paclitaxel/carboplatin/bevacizumab; docetaxel/carboplatin/bevacizumab; docetaxel/oxaliplatin/bevacizumab; 5‑fluorouracil/leucovorin/oxaliplatin + bevacizumab; capecitabine/oxaliplatin + bevacizumab)	Offered as combination alternatives; dosing regimens vary and may require prior authorization.

Policy note	Authorization implication
Insufficient data regarding consecutive PARP inhibitor use	Most pivotal trials excluded prior PARP inhibitor exposure; limited evidence may lead to denial or individualized review of requests for sequential PARP inhibitor therapy.
NCCN and randomized trial guidance	NCCN does not make explicit recommendations for consecutive PARP inhibitor use outside ovarian cancer where data are limited; authorization should consider prior PARP inhibitor use and current evidence.

Clinical Background

Niraparib is an oral PARP inhibitor primarily used as maintenance therapy in certain ovarian, fallopian tube, and primary peritoneal cancers. Policy updates reflect three key regulatory and safety actions: the manufacturer voluntarily withdrew the indication for use in advanced HRD‑positive disease after ≥3 prior chemotherapies (effective September 14, 2022), the manufacturer/FDA restricted second‑or‑later line platinum‑sensitive maintenance to the germline BRCA‑mutated population in the U.S., and off‑label uses not addressed in this policy require supporting documentation per the payer's off‑label use policies. Providers should confirm applicable indications, document BRCA/HRD testing when required, and follow the policy's authorization and documentation requirements before initiating or continuing therapy.

Key Definitions

Definition — Castrate-Resistant Prostate Cancer (CRPC)

DefinitionCRPC is prostate cancer that progresses clinically, radiographically, or biochemically despite castrate levels of serum testosterone (< 50 ng/dL)

Clinical progressionMay be indicated by radiographic progression, clinical signs, or rising PSA despite castrate testosterone

Management notePer NCCN, continue androgen deprivation therapy (ADT) when treating CRPC

Definitions — BRCA / HRD

BRCARefers to the breast cancer gene (BRCA1/BRCA2)

HRDHomologous recombination deficiency (HRD)

Site-of-Care Considerations

Note

No site‑of‑care restrictions specified

No site‑of‑care restrictions are specified in this portion of the document.

Policy Summary

Payermhn

PolicyNiraparib (Zejula) coverage

Policy CodePolicy CP.PHAR.408

Change TypeMaterial revisions and restrictions

Effective DateJun 1, 2017

Next Review Date

SourceLink

On This Page

Denial Risk

Non‑Covered Indications — Risk of Denial

Requests for uses that are not FDA-approved and are not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per the plan's off-label use policies. Off-label requests must include supporting peer-reviewed literature or compendium recommendations as specified.

Non-FDA approved indications not addressed in this policy require thorough supporting documentation per CP.CPA.09 (Commercial), HIM.PA.154 (HIM), or CP.PMN.53 (Medicaid) as applicable

Denial Risk

Denial Risk — Non‑Germline BRCA in 2nd+ Line Maintenance

Requests for maintenance niraparib (Zejula) in the second-or-later line platinum-sensitive setting for patients without a confirmed germline BRCA mutation may be denied due to the manufacturer/FDA restriction and observed overall survival data indicating potential harm in the non-germline BRCA population.

Maintenance use in second-or-later line platinum-sensitive setting is restricted to germline BRCA‑mutated patients only (see Appendix F)
Physician attestation and documented CLIA‑approved germline BRCA test result required for continuation in this setting; non-germline BRCA requests present denial risk

Documentation Required

Required Supporting Documentation

Provider must submit supporting documentation (office notes, laboratories, diagnostic test reports) demonstrating that the member meets all approval criteria. Lack of adequate documentation may result in denial or delay.

Include office chart notes outlining diagnosis, prior therapies (e.g., completion of platinum-based chemotherapy), and current disease status
Attach relevant lab results (baseline platelet count, other pertinent labs), imaging reports, and pathology or molecular diagnostic reports as applicable

Documentation Required

Prescriber Attestation and BRCA Test Documentation

When BRCA status is required by the criteria (for example, restricted second-or-later line maintenance), the prescriber must attest to the result and submit documentation of testing performed on a CLIA‑approved diagnostic (e.g., BRACAnalysis CDx) or other FDA‑approved companion diagnostic.

Prescriber attestation confirming germline BRCA mutation status is required for restricted indications (Appendix F)
Submit CLIA‑approved diagnostic test report (e.g., BRACAnalysis CDx) or FDA‑approved companion diagnostic documentation

Documentation Required

Baseline Weight and Platelet Documentation Required for Dosing

Baseline weight and platelet count must be documented to support the selected starting dose per dosing guidance. The two-tiered dosing approach depends on weight and platelet parameters.

For patients weighing < 77 kg OR with platelet count < 150,000/µL: starting dose = 200 mg PO QD
For patients weighing ≥ 77 kg AND platelet count ≥ 150,000/µL: starting dose = 300 mg PO QD
Germline BRCA‑mutated disease dosing: 300 mg PO QD (document weight/platelets as applicable)