Subject: Specialty Quantity Limit Haegarda 2993-H P2023

Drug

HAEGARDA  (C1 Esterase Inhibitor Subcutaneous [Human])

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
Haegarda 2000 IU   single-dose vial for   reconstitution	20 vials per 30 days	60 IU per kg body weight   subcutaneously  twice weekly   (every 3 or 4 days)
Haegarda 3000 IU   single-dose vial for   reconstitution

Place of Service:

Outpatient

The above policy is based on the following references:

1. Haegarda [package insert]. Kankakee, IL: CSL Behring LLC; January 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.

October 22, 2023