Subject: Specialty Quantity Limit abiraterone-Zytiga 1878-H P2022

Drug

ZYTIGA  (abiraterone)

abiraterone

Policy:

I.   PROGRAM DESCRIPTION

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. If the member’s plan allows a quantity limit exception review for the requested medication, coverage of an additional quantity may be provided up to the exception limit with prior authorization.

II.  COVERED QUANTITIES** 

Medication	Standard Limit	Exception Limit*	FDA-Recommended dosing
Zytiga (abiraterone) 250 mg tablets	120 per 30 days	240 per 30 days	· 1000 mg (two 500 mg tablets or four 250 mg tablets)      once daily     · 1000 mg twice daily if co-administered with a strong      CYP3A4 inducer
Zytiga (abiraterone) 500 mg tablets	60 per 30 days	120 per 30 days

*   Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.
** The limits may apply to the generic equivalent medication.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Zytiga [package insert]. Horsham, PA: Janssen Biotech, Inc.; August 2021.
2. Abiraterone [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; November 2021.

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.

December 29, 2022