Subject: Naglazyme 2056-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
Naglazyme is indicated for patients with mucopolysaccharidosis
VI (MPS VI, Maroteaux-Lamy syndrome). Naglazyme has been
shown to improve walking and stair-climbing capacity.
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: N-acetylgalactosamine 4-sulfatase
(arylsulfatase B) 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 VI (MPS VI)
Authorization of 12 months may be granted for treatment of
MPS VI when the diagnosis of MPS VI was confirmed by enzyme
assay demonstrating a deficiency of N-acetylgalactosamine 4-
sulfatase (arylsulfatase B) 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 VI (MPS VI, Maroteaux-Lamy syndrome)
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:
- Naglazyme [package insert]. Novato, CA: BioMarin Pharmaceutical Inc.; December 2019.
- Akyol, M.U., Alden, T.D., Amartino, H. et al. Recommendations for the management of MPS VI: systematic evidence- and consensus-based guidance. Orphanet J Rare Dis 14, 118 (2019).
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
