Subject: Elaprase 2052-A SGM P2022
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)
Authorization of 12 months may be granted for treatment of
MPS II 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
mucopolysaccharidosis II (MPS II) 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:
- Elaprase [package insert]. Lexington, MA: Shire Human Genetic Therapies, Inc.; November 2018.
- 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 26, 2022
