Subject: Specialty Quantity Limit Empaveli 4741-H P2023

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.; 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.

December 31, 2023