CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug Policy: Zejula (niraparib) — Coverage Criteria

Defines coverage, inclusion and exclusion criteria, and utilization management for Zejula (niraparib) for oncology indications (ovarian and select prostate cancer use) for members whose medication requests are processed by the payer's UM vendor.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZejula (niraparib) — Coverage Criteria (Drug Policy)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 25, 2024

Next Review DateOct 9, 2024

Key ActionSubmit prior authorization to Utilization Management with documentation supporting FDA labeling or guideline/compendium evidence and BRCA1/2 test results when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

300 mgsingle dose maximum

90 tabsmonthly limit

stage II-IVnewly diagnosed ovarian

BRCA1/2mutation requirement

mCRPC BRCA+prostate combo

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Coverage Criteria

Ovarian cancer — newly diagnosed maintenance

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

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 single‑agent maintenance

For members who are BRCA1/2 mutation positive as confirmed by an FDA‑approved test (per clause a).

Ovarian cancer — recurrent maintenance

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

Recurrent platinum‑sensitive maintenance: Member has recurrent platinum‑sensitive ovarian cancer AND Zejula (niraparib) is being used as single‑agent maintenance after completion of platinum‑based chemotherapy

Member is BRCA1/2 mutation positive as confirmed by an FDA‑approved test (per clause b).

Prostate cancer — combination therapy

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

mCRPC with BRCA mutation: Fixed‑dose niraparib in combination with abiraterone acetate and prednisone is prescribed for an adult member with deleterious or suspected deleterious BRCA‑mutated metastatic castration‑resistant prostate cancer (mCRPC)

Per policy indication for combination use.

Exclusions applicable to Zejula (niraparib) requests are explicit. Coverage is not permitted when the member experienced disease progression while receiving niraparib or while receiving another PARP inhibitor (for example, olaparib or rucaparib).

The policy limits maintenance therapy exposure: use of Zejula must not exceed more than one line of maintenance therapy for recurrent ovarian cancer. Requests lacking documentation of a deleterious BRCA1/2 mutation when required are excluded.

Dose and quantity limits are enforced: dosing that exceeds a single tablet maximum of 300 mg or treatment that exceeds the maximum of 90 (100 mg) tablets per month will be excluded. Investigational or off‑label uses without sufficient evidence (not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature) are also excluded.

The policy specifies that Zejula (niraparib) monotherapy is not supported for persistent disease or recurrence in members who have been treated with two or more lines of chemotherapy. This position reflects the FDA withdrawal and evidence (including guideline updates) that PARP inhibitor monotherapy in that setting has not demonstrated an overall survival benefit.

As a result, requests for niraparib as monotherapy after multiple prior lines of chemotherapy should be denied or considered not medically necessary unless clear, compelling evidence meeting the policy's standards (e.g., CMS‑recognized compendia or acceptable peer‑reviewed literature) is provided to justify the use.

Coding & Dosing Limits

Maximum single tablet dose

Maximum single tablet dose300 mg

Source sectionIII. EXCLUSION CRITERIA — Dosing exceeds single dose limit of Zejula (niraparib) 300 mg.

RelevanceRequests exceeding this single-tablet dose should be denied per exclusion criteria.

Maximum tablets per month

Maximum tablets per month (100 mg equivalents)90 (100 mg) tablets/month

Source sectionIII. EXCLUSION CRITERIA — Treatment exceeds the maximum limit of 90 (100 mg) tablets/month.

Application

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Zejula (niraparib) and all requests are processed by Utilization Management (Evolent). Submit prior authorization requests with complete clinical documentation to allow timely review. Prior authorization must be obtained before initiation of therapy.

All requests must be submitted to Evolent/UM for prior authorization
Authorization required prior to dispensing or administration
Include supportive documentation (see Documentation callout)

Step Therapy

Line-of-Therapy Restriction

Use of Zejula (niraparib) for maintenance therapy in recurrent ovarian cancer is limited to no more than one line of maintenance therapy. Requests for additional lines will be denied.

Limited to ≤ 1 line of maintenance therapy for recurrent ovarian cancer
Requests beyond this line-of-therapy limit will be referred to UM and are subject to denial

Definitions

Maintenance therapy definition

DefinitionMaintenance therapy: single-agent use of niraparib following completion of platinum-based chemotherapy to maintain disease control.

Context in policyUsed for newly diagnosed stage II-IV ovarian carcinoma after surgery and first-line platinum-based chemotherapy when given as single-agent maintenance.

DocumentationBRCA1/2 mutation positive confirmation required where specified (FDA-approved test).

Platinum-sensitive definition

DefinitionPlatinum-sensitive: disease recurrence after response to prior platinum-based chemotherapy where retreatment with platinum is appropriate prior to maintenance.

Policy applicationApplies to recurrent platinum-sensitive ovarian cancer eligible for single-agent niraparib maintenance after completion of platinum-based chemotherapy.

Initial Therapy Criteria

Initial therapy

Initial coverage criteria by indication:

Ovarian initial: Use as single‑agent maintenance after first‑line platinum‑based chemotherapy for newly diagnosed stage II–IV ovarian carcinoma; BRCA testing required where specified

FDA‑approved labeling and guideline‑supported uses only.

Prostate initial: Use in combination with abiraterone acetate plus prednisone for deleterious or suspected deleterious BRCA‑mutated mCRPC

Per policy statement.

Continuation (Renewal) Criteria

Continuation therapy exemption

Continuation (renewal) requests may be exempt from new‑authorization restrictions when ALL conditions are met:

Continuation exemption: Requested medication was used within the last year AND the member has not experienced disease progression and/or intolerance to the requested medication AND no additional medication(s) are being added to the continuation request

Continuation requests for a not‑approvable medication shall be exempt if these conditions are satisfied.

Step Therapy

Restriction	Policy detail
Line-of-therapy limit	Use of Zejula (niraparib) is limited to no more than one line of maintenance therapy for recurrent ovarian cancer.
Coverage label	Requests exceeding one line of maintenance therapy for recurrent ovarian cancer are excluded per policy.

Quantity Limits

Zejula (niraparib) quantity limit

Zejula (niraparib) monthly quantity limit90 tablets per month (100 mg tablet equivalents)

Policy locationIII. EXCLUSION CRITERIA — Treatment exceeds the maximum limit of 90 (100 mg) tablets/month; Quantity limits module lists 90 per month.

EnforcementRequests exceeding 90 tablets/month should be adjusted or denied in accordance with exclusion criteria.

Background

Niraparib is a PARP inhibitor included in this policy primarily for use as single‑agent maintenance therapy in ovarian cancer and, when used in combination with abiraterone acetate plus prednisone, for select BRCA‑mutated metastatic castration‑resistant prostate cancer. For ovarian cancer the policy permits single‑agent maintenance use in newly diagnosed stage II–IV disease after surgery and completion of first‑line platinum‑based chemotherapy, and for recurrent platinum‑sensitive disease following platinum‑based chemotherapy when the member is confirmed BRCA1/2 mutation positive by an FDA‑approved test.