Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Galsulfase (Naglazyme) may be considered medically necessary for the treatment of mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). when the following criteria are met:
- Absence or deficiency of fibroblast or leukocyte enzyme activity of N-acetylgalactosamine 4-sufatase (arylsulfatase); or
- Molecular genetic confirmation of mutations is the ASB gene; and
- Presence of clinical signs and symptoms of the disease (e.g., kyphoscolosis, genu valgum, pectus carinatum, gait disturbance, growth deficiency).
Reauthorization Criteria
- Continuation therapy with galsulfase (Naglazyme) may be considered medically necessary for individuals diagnosed with MPS VI when BOTH of the following criteria are met:
- Individual is established on therapy with galsulfase (Naglazyme); and
- Provider attestation that individual has demonstrated a disease stability or beneficial response to therapy from baseline.
The use of galsulfase (Naglazyme) for any other indication, is considered experimental/investigational and therefore, non-covered, due to lack of supporting published peer reviewed literature.
Procedure Code
