Subject: Specialty Quantity Limit Ultomiris 5644-H P2023

Drug

ULTOMIRIS  (ravulizumab-cwvz)

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
Ultomiris (ravulizumab-   cwvz) 245 mg/3.5 mL (70   mg/mL) single-dose   prefilled cartridge for use   only with the supplied   single-use on-body injector	8 single-dose prefilled   cartridges per 28 days	•   The recommended subcutaneous Ultomiris        maintenance dose is 490 mg once weekly in        adult patients greater than or equal to 40 kg        body weight with paroxysmal nocturnal        hemoglobinuria (PNH) or atypical hemolytic        uremic syndrome (aHUS).

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Ultomiris [package insert]. Boston, MA: Alexion Pharmaceuticals, Inc.; July 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 31, 2023