CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zejula (niraparib) drug coverage

Defines clinical and utilization management criteria for coverage of Zejula (niraparib) for oncology indications (ovarian and prostate cancer) for members whose medication requests are processed by the payer's UM organization.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZejula (niraparib) drug coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateOct 25, 2024

Next Review DateOct 9, 2024

Key ActionMedication requests for Zejula require prior authorization from the UM department; continuation requests may be exempt if prior use within the last year with no progression or intolerance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

300 mgsingle dose maximum

90 tabletsmonthly treatment limit

Stage II-IVnewly diagnosed ovarian stage

BRCA1/2 requiredBRCA requirement

Coverage Criteria for Zejula (niraparib)

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Ovarian cancer — newly diagnosed maintenance

Covered when ALL of the following are met for ovarian cancer maintenance use:

Newly diagnosed maintenance: Member has newly diagnosed stage II-IV ovarian carcinoma AND has undergone surgery (with or without optimal debulking) AND has completed first-line platinum-based chemotherapy AND Zejula (niraparib) is being used as a single-agent maintenance

BRCA1/2 mutation positive required for the maintenance therapy statement in clause a per document

Ovarian cancer — recurrent platinum-sensitive maintenance

Covered when ALL of the following are met for recurrent platinum-sensitive ovarian cancer maintenance:

Recurrent platinum-sensitive maintenance: Member has recurrent platinum-sensitive ovarian cancer AND Zejula (niraparib) is being used as a single-agent maintenance after completion of platinum-based chemotherapy AND member is BRCA1/2 mutation positive as confirmed by an FDA-approved test

per clause b

Prostate cancer — mCRPC (BRCA-mutated)

Covered when ALL of the following are met for prostate cancer:

Prostate cancer combination regimen: Fixed-dose combination of niraparib and abiraterone acetate with prednisone is prescribed for adult members with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC)

per clause C.1

Investigational or off‑label uses that lack sufficient evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature are excluded. The policy specifies criteria for sufficiency of evidence, including representativeness of the patient population and regimen in published studies, appropriateness of study design, and exclusion of uncontrolled case reports or abstracts without full peer‑reviewed publication.

Monotherapy use of Zejula is not supported for persistent disease or recurrence in members (with or without deleterious germline BRCA1/2 mutation) who have been treated with two or more lines of chemotherapy. This position is based on FDA withdrawal and guideline updates indicating lack of overall survival benefit for PARP inhibitor monotherapy in this setting.

Dose and Quantity Limits

Single dose limit — 300 mg

Single dose limit300 mg per single dose

Source statementDosing exceeds single dose limit of Zejula (niraparib) 300 mg.

Related enforcementRequests exceeding this single dose may be denied per exclusion criteria.

Monthly tablet limit — 90 (100 mg) tablets/month

Monthly tablet limit90 tablets per month (100 mg tablets)

Source statementTreatment exceeds the maximum limit of 90 (100 mg) tablets/month.

Related enforcementRequests for quantities above this monthly limit may be denied per exclusion criteria.

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization and continuation exemption

Medication requests for Zejula (niraparib) are processed by the UM (Evolent) department and require prior authorization. Continuation (renewal) requests are exempt from this policy when the medication was used within the last year, there is no documented disease progression or intolerance, and no additional medications are being added to the request.

Evolent processes all medication requests
Continuation exemption requires: used within last year; no disease progression/intolerance; no additional meds added

Step Therapy

Line-of-therapy restriction

Zejula (niraparib) is limited to use in no more than one line of maintenance therapy for recurrent ovarian cancer. Requests for use beyond one line of maintenance therapy will be excluded.

Not to exceed more than 1 line of maintenance therapy for recurrent ovarian cancer

Documentation Required

Supporting evidence and BRCA test

Support for Zejula use must include documentation from one of the following sources: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS standards. When BRCA status is required for the indication, documentation of BRCA1 or BRCA2 mutation detection by an FDA-approved test must be provided.

Acceptable evidence: FDA labeling; CMS-approved compendia; NCCN/ASCO guidelines; acceptable peer-reviewed literature meeting CMS standards
When required, provide BRCA1 or BRCA2 mutation confirmation by an FDA-approved test

Denial Risk

Progression on PARP inhibitor

Use of Zejula (niraparib) is excluded in members who experienced disease progression while receiving Zejula or another PARP inhibitor (e.g., olaparib, rucaparib). Such history should be documented and may trigger denial.

Disease progression while on a PARP inhibitor (including Zejula, olaparib, rucaparib) is an exclusion

Billing Rule

Dose or quantity limits exceeded

Requests that exceed dosing or quantity limits may be denied. Exclusion criteria include a single dose above 300 mg or total treatment exceeding 90 tablets (100 mg strength) per month.

Single dose limit: 300 mg
Maximum: 90 (100 mg) tablets per month

Background on Niraparib (Zejula)

Niraparib (Zejula) is a PARP inhibitor indicated as maintenance monotherapy in certain ovarian cancer settings and, in combination with abiraterone acetate plus prednisone, for adult patients with deleterious or suspected deleterious BRCA‑mutated metastatic castration‑resistant prostate cancer (mCRPC). The policy references FDA labeling and major oncology guidelines and requires supporting evidence consistent with CMS‑recognized compendia or peer‑reviewed literature.

Definitions

maintenance therapy — Definition

DefinitionMaintenance therapy: use of Zejula (niraparib) as single-agent therapy after completion of platinum-based chemotherapy to maintain disease control.

Example — newly diagnosedUsed as single-agent maintenance after first‑line platinum-based chemotherapy for newly diagnosed stage II-IV ovarian carcinoma following surgery.

Example — recurrentUsed as single-agent maintenance after completion of platinum-based chemotherapy for recurrent platinum-sensitive ovarian cancer (BRCA1/2 mutation positive).

mCRPC (BRCA-mutated) — Definition

TermmCRPC (BRCA-mutated)

DefinitionMetastatic castration-resistant prostate cancer with deleterious or suspected deleterious BRCA mutation.

Approved regimenFixed-dose combination of niraparib and abiraterone acetate with prednisone for adult members with this diagnosis.

Continuation Therapy Criteria

Continuation therapy exemption

Continuation requests exempt from this policy when all criteria met:

Continuation exemption: Requested medication was used within the last year AND member has not experienced disease progression and/or intolerance to the requested medication AND additional medication(s) are not being added to the continuation request

per Section II.A

Restriction	Details
Line-of-therapy limit	Not to exceed more than 1 line of maintenance therapy for recurrent ovarian cancer.
Related exclusion entries	Listed in exclusions: Use of Zejula (niraparib) not to exceed more than 1 line of maintenance therapy for recurrent ovarian cancer.