Subject: Specialty Quantity Limit Empaveli 4741-H P2025

Drug

Empaveli  (pegcetacoplan)

Policy:

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.

Covered Quantities

Medication	Standard Limit
Empaveli 1080mg/20mL single-dose vial	10 single-dose vials per 30 days

FDA-Recommended dosing

1,080 mg by subcutaneous infusion twice weekly via a commercially available infusion pump with a reservoir of at least 20 mL or with Empaveli Injector.

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.; June 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.

December 13, 2025