Subject: Specialty Quantity Limit Ruconest 3056-H P2023

Drug

RUCONEST  (C1 esterase inhibitor [recombinant])

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
Ruconest 2100   unit single-dose   vial for   reconstitution	60 vials per 90 days	For patients weighing less than 84 kg: infuse 50   units per kg   For patients weighing 84 kg or more: infuse   4200 units (2 vials)   If the attack symptoms persist, an additional   (second) dose can be administered at the   recommended dose level. Do not exceed 4200   units per dose. No more than two doses should   be administered within a 24-hour period.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Ruconest [package insert]. Warren, NJ: Pharming Healthcare, Inc.; April 2020.

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.

October 22, 2023