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.
Elosulfase alfa (Vimizim) may be considered medically necessary for patients five (5) years of age or older with a documented diagnosis of mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome) defined as meeting BOTH of the following criteria:
- Documented clinical signs and symptoms of the disease (e.g., kyphoscoliosis, corneal opacity, genu valgum, pectus carinatum, gait disturbance, growth deficiency); and
- Documented reduced fibroblast or leukocyte GALNS enzyme activity or molecular genetic testing confirming diagnosis of MPS IVA.
Reauthorization Criteria
Continuation therapy with elosulfase alfa (Vimizim) may be considered medically necessary when BOTH of the following criteria are met:
- Individual established on therapy; and
- Provider attestation that individual has demonstrated a disease stability or beneficial response to therapy from baseline.
Elosulfase alfa (Vimizim) for any other indications not listed above is considered experimental/investigational and therefore, non-covered. Scientific evidence of safety and efficacy has not been proven for any other indications.
Procedure Codes
