CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zejula (niraparib)

Defines clinical indications, inclusion and exclusion criteria, and utilization management requirements for coverage of Zejula (niraparib) including FDA-approved and certain off-label uses (per CMS-recognized compendia, NCCN, ASCO, or peer-reviewed literature). Applies to medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZejula (niraparib)

Policy CodePolicy N/A

Change TypeRevised

Effective DateOct 25, 2024

Next Review Date

Key ActionAll medication requests for Zejula must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

POLICY UPDATE CHANGES

Approval date October 9, 2024 and effective date October 25, 2024 recorded for Zejula (niraparib) policy.

2Primary covered malignancy categories (ovarian, prostate)

4Key exclusion rules listed

2Dose/quantity limits specified

Coverage Summary

This policy defines the accepted indications and utilization management requirements for Zejula (niraparib). It applies to FDA‑approved indications and certain off‑label uses when supported by CMS‑recognized compendia, NCCN, ASCO, or acceptable peer‑reviewed literature. Evolent is responsible for processing all medication requests for Neighborhood Health Plan of Rhode Island and handles utilization management decisions; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Initial Therapy Criteria (Indications)

Indications - Ovarian Cancer (Monotherapy)

Zejula (niraparib) may be used as monotherapy when ALL of the following are met:

Use cases

Newly diagnosed maintenance
- Member has newly diagnosed stage II-IV ovarian carcinoma
- Member has undergone surgery (with or without optimal debulking) and has completed first-line platinum-based chemotherapy
- Zejula is being used as a single-agent maintenance therapy
- Member is BRCA1 or BRCA2 mutation positive as confirmed by an FDA-approved test
Recurrent platinum-sensitive maintenance
- Member has recurrent platinum-sensitive ovarian cancer
- Zejula is being used as a single agent for maintenance therapy after completion of platinum-based chemotherapy
- Member is BRCA1 or BRCA2 mutation positive as confirmed by an FDA-approved test

Notes

NOTE: Zejula monotherapy 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
Policy position is informed by FDA withdrawal and ASCO guideline updates showing lack of overall survival benefit in certain relapsed settings

Exclusion Criteria and Investigational Use

Clinically meaningful outcomes (ASCO): Hazard ratio < 0.80 and recommended survival benefit for overall survival (OS) and progression‑free survival (PFS) should be at least 3 months. This ASCO guidance is used to inform exclusion rules where insufficient evidence is defined in part by lack of clinically meaningful outcomes.

Provider Actions & Billing Rules

Prior Authorization

Medication requests processed by Evolent

All medication requests for Zejula (niraparib) must be processed by Evolent. Requests for medications not authorized by Evolent may be considered not approvable and therefore not reimbursable.

Documentation Required

BRCA mutation documentation required

For covered ovarian indications, documentation confirming a BRCA1 or BRCA2 mutation detected by an FDA‑approved test is required.

Mutation must be confirmed by an FDA‑approved test

Denial Risk

Exclusion for prior PARP progression

Requests may be denied if the member experienced disease progression while receiving olaparib (Lynparza) or rucaparib (Rubraca).

Billing Rule

Dose and quantity limits enforced

Claims may be denied if dosing exceeds the policy limits: single dose greater than 300 mg or monthly quantity exceeding 90 tablets (100 mg strength referenced).

Single dose limit: ≤ 300 mg
Monthly tablet limit: ≤ 90 tablets (100 mg strength referenced)

Clinical Evidence & References

Referenced evidence and sources: GSK Dear Health Care Provider letters (niraparib) 2022; ASCO rapid update on PARP inhibitor use in ovarian cancer; PRIMA/ENGOT‑OV26/GOG‑3012 trial; ENGOT‑OV16/INOVA trial; MAGNITUDE trial (Niraparib and Abiraterone); Zejula (niraparib) Prescribing Information (2024); AKEEGA Prescribing Information; Clinical Pharmacology Elsevier Gold Standard (2024); NCCN Cancer Guidelines and Drugs and Biologics Compendium (2024); and Medicare Benefit Policy Manual Chapter 15.

Policy Statistics (quick view)

Primary covered categories2 (ovarian, prostate)

Key exclusion rules listed4 (e.g., progression on olaparib/rucaparib; excess maintenance lines; missing BRCA documentation; investigational/off-label without sufficient evidence)

Dose/quantity limits specified2 (single dose ≤300 mg; monthly ≤90 tablets of 100 mg)

Background

Background and intent: the policy establishes which indications for Zejula (niraparib) are accepted for coverage, including FDA‑approved uses and off‑label uses when supported by CMS‑recognized compendia, NCCN, ASCO, or acceptable peer‑reviewed literature. Evolent is responsible for processing all medication requests and making utilization management determinations; medications not authorized by Evolent may be considered not approvable and not reimbursable.

Revision History

2024-10-09committee_approvalLatest

Committee review and approval recorded through multiple committee review dates, with final approval date October 9, 2024.

2024-10-25effective_date

Policy effective date recorded as October 25, 2024.

2022-03-09 to 2023-10-11committee_review_history

Multiple prior committee review dates documented (03/09/22, 05/11/22, 09/14/22, 10/12/22, 11/09/22, 01/11/23, 03/08/23, 05/10/23, 09/13/23, 10/11/23) indicating ongoing review history prior to the October 9, 2024 approval.

ongoingpolicy_scope

Evolent is designated as responsible for processing medication requests and utilization management decisions for Zejula (niraparib); policy defines accepted indications and requirements for supporting evidence.