Subject: Lumizyme 2055-A SGM P2024

Drug

LUMIZYME  (alglucosidase alfa)

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
          Lumizyme is indicated for patients with Pompe disease (acid alpha-glucosidase [GAA]
          deficiency).

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


    II.  DOCUMENTATION

          Submission of the following information is necessary to initiate the prior authorization review:
          A.  Initial requests: acid alpha-glucosidase enzyme assay or genetic testing results supporting
               diagnosis.
          B.  Continuation requests: chart notes documenting a positive response to therapy.


   III.  CRITERIA FOR INITIAL APPROVAL

          Pompe disease
          Authorization of 12 months may be granted for treatment of Pompe disease when the
          diagnosis of Pompe disease was confirmed by enzyme assay demonstrating a deficiency of
          acid alpha-glucosidase enzyme activity or by genetic testing.


   IV.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for continued treatment in members requesting
          reauthorization for an indication listed in Section III who are responding to therapy (e.g.,
          improvement, stabilization, or slowing of disease progression for

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Lumizyme [package insert]. Cambridge, MA: Genzyme Corporation; March 2023.

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.

August 18, 2024