Subject: Specialty Quantity Limit Empaveli 4741-H P2022

Drug

EMPAVELI  (pegcetacoplan)

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	FDA-recommended               dosing
Empaveli     1080mg/20mL     single-dose vial	10 single-dose vials      per 30 days	1,080 mg by subcutaneous      infusion twice weekly via a      commercially available      infusion pump with a      reservoir of at least 20 mL.        For lactate dehydrogenase      (LDH) levels greater than      2× the upper limit of normal      (ULN), adjust the dosing      regimen to 1,080 mg every     three days.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Empaveli [package insert]. Waltham, MA: Apellis Pharmaceuticals, Inc.; May 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