Subject: Elaprase 2052-A SGM P2024

Drug

ELAPRASE  (idursulfase)

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
          Elaprase is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
          Elaprase has been shown to improve walking capacity in patients 5 years and older. In patients
          16 months to 5 years of age, no data are available to demonstrate improvement in disease-
          related symptoms or long term clinical outcome; however, treatment with Elaprase has reduced
          spleen volume similarly to that of adults and children 5 years of age and older. The safety and
          efficacy of Elaprase have not been established in pediatric patients less than 16 months of
          age.

          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: iduronate-2-sulfatase enzyme assay or genetic testing results supporting
               diagnosis.
          B.  Continuation requests: chart notes documenting a clinically positive response to therapy,
               which shall include improvement, stabilization, or slowing of disease progression.


   III.  CRITERIA FOR INITIAL APPROVAL

          Mucopolysaccharidosis II (MPS II, Hunter syndrome)
          Authorization of 12 months may be granted for treatment of MPS II (Hunter syndrome) when
          the diagnosis of MPS II was confirmed by enzyme assay demonstrating a deficiency of
          iduronate-2-sulfatase 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 have a clinically positive response to
          therapy, which shall include improvement, stabilization, or slowing of disease progression.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Elaprase [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; September 2021.
2. Muenzer J, Beck M, Eng CM, et al. Multidisciplinary management of Hunter syndrome. Pediatrics. 2009;124(6):e1228-e1239.

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 16, 2024