Subject: Specialty Quantity Limit Erleada 2503-H P2022

Drug

ERLEADA  (apalutamide)

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
Erleada (apalutamide) 60 mg tablet	120 tablets per 30 days	240 mg (four 60 mg tablets) once daily  Dose reduction due to adverse events: If patient experiences greater than or equal to grade 3 toxicity, hold dosing until symptoms improve, then resume at the same dose or a reduced dose (180 mg or 120 mg)

 

Place of Service:

Outpatient

The above policy is based on the following references:

1.   Erleada [package Erleada [package insert]. Horsham, PA: Janssen Products, LP; April 2022.insert]. Horsham, PA: Janssen Products, LP; April 2022.

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