Subject: Specialty Quantity Limit Zejula 1688-H P2022c

Drug

ZEJULA  (niraparib)

Policy:

      I.  PROGRAM DESCRIPTION

          The standard limit is designed to allow a quantity sufficient for
          the most common uses of the medication. The recommended
          dosing parameters for all FDA-approved indications fall within
          the standard limits. Coverage of an additional quantity may be
          reviewed on a case-by-case basis upon request.

 
   II.  COVERED QUANTITIES

Medication	Standard Limit	FDA-recommended dosing
Zejula (niraparib)  100 mg capsules	90 per 30 days	First-line maintenance treatment of advanced   ovarian cancer:   •  200 mg once daily for patients weighing less       than 77 kg (170 lbs) OR with a platelet count       less than 150,000/µL   •  300 mg once daily for patients weighing 77 kg       or greater AND with a platelet count greater       than or equal to 150,000/µL   For maintenance treatment of recurrent germline   BRCA-mutated ovarian cancer: 300 mg once   daily   Dose reduction may be required for adverse   reactions or moderate hepatic impairment.
Zejula (niraparib)  100 mg tablets	30 per 30 days
Zejula (niraparib)  200 mg tablets	30 per 30 days
Zejula (niraparib)  300 mg tablets	30 per 30 days

           

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Zejula capsules [package insert]. Durham, NC: GlaxoSmithKline; April 2023.
2. Zejula tablets [package insert]. Durham, NC: GlaxoSmithKline; April 2023.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 18, 2023