Subject: Specialty Quantity Limit Xtandi 1879-H P2025

Drug

XTANDI  (enzalutamide)

Policy:

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.

Covered Quantities

Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.

Medication	Standard Limit	Exception Limit
Xtandi (enzalutamide) 40 mg capsules	120 per 30 days	180 per 30 days
Xtandi (enzalutamide) 40 mg tablets	120 per 30 days	180 per 30 days
Xtandi (enzalutamide) 80 mg tablets	60 per 30 days	90 per 30 days

FDA-Recommended dosing

160 mg once daily.

240 mg once daily if co-administered with a strong CYP3A4 inducer.

80 mg once daily if co-administered with a strong CYP2C8 inhibitor.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Xtandi [package insert]. Northbrook, IL: Astellas Pharma US, Inc.; March 2025.

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.

October 12, 2025