Subject: Adagen 2118-A SGM P2022

Drug

ADAGEN injection  (pegademase bovine injection)

Policy:

       I.  INDICATIONS

            The indications below including FDA-approved
            indications and compendial uses are considered a
            covered benefit provided that all the approval criteria
            are met and the member has no exclusions to the
            prescribed therapy.

            FDA-Approved Indication
            Adagen is indicated for enzyme replacement therapy
            for adenosine deaminase (ADA) deficiency in patients
            with severe combined immunodeficiency disease
            (SCID) who are not suitable candidates for—or who
            have failed—bone marrow transplantation. Adagen is
            recommended for use in infants from birth or in
            children of any age at the time of diagnosis.

            All other indications are considered
            experimental/investigational and are not medically
            necessary.

 
      II.  DOCUMENTATION

            Submission of the following information is necessary
            to initiate the prior authorization review: enzyme
            assay or genetic testing results supporting diagnosis
            of ADA deficiency.

 
    III.  CRITERIA FOR INITIAL APPROVAL

            Authorization of 12 months may be granted for
            treatment of severe combined immunodeficiency
            disease (SCID) associated with adenosine deaminase
            (ADA) deficiency when the condition has failed to
            respond to a bone marrow transplant (BMT) or the
            member is not currently a suitable candidate for BMT.

 

     IV.  CONTINUATION OF THERAPY

            Authorization of 12 months may be granted for
            continued treatment in members requesting
            reauthorization for SCID associated with ADA
            deficiency who are experiencing benefit from therapy
            as evidenced by disease stability or disease
            improvement.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Adagen [package insert]. Gaithersburg, MD: Leadiant Biosciences, Inc.; November 2017.

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.

June 26, 2022