Subject: Lumizyme 2055-A SGM P2023

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 (e.g., improvement stabilization, or
               slowing of disease progression for motor function, walking
               capacity, cardiorespiratory function, decrease in left
               ventricular mass index [LVMI], delay in death).


  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 motor function, walking capacity,
          cardiorespiratory function, decrease in left ventricular mass
          index (LVMI),delay in death).

Place of Service:

Outpatient

The above policy is based on the following references:

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

August 18, 2023