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Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Specialty Quantity Limit Erleada 2503-H P2022a

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 or one 240 mg
  tablet) once daily

 

 

  Dose reduction due to adverse events: If patient
  experiences greater than or equal to grade 3
  adverse reaction, hold dosing until symptoms
  improve, then resume at the same dose or a
  reduced dose (180 mg or 120 mg)

 

  Erleada
  (apalutamide)
  240 mg tablet

  30 tablets
  per 30 days

 


Place of Service:

Outpatient

The above policy is based on the following references:

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

April 02, 2023
Aetna
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