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.
Idursulfase (Elaprase) may be considered medically necessary for use in individuals with Hunter syndrome (Mucopolysaccharidosis II, MPS II) when the following criteria are met.
- Individual is five (5) years of age or greater; and
- Individual has demonstrated a deficiency of IDS enzyme activity in white blood cells (WBC), fibroblasts or plasma; or
- Individual has hemizygous mutation in IDS gene; and
- Prescribed by or in consultation with a clinical geneticist, rheumatologist or hematologist.
Reauthorization Criteria
Continuation therapy with idursulfase (Elaprase) may be considered medically necessary when ANY of the following are met:
- Individual meets or previously met the above criteria; and
- Has decreased urinary glycosaminoglycans (uGAGS); or
- Has a positive clinical response indicated by an improvement of the previously reported laboratory values and symptoms.
The use of idursulfase (Elaprase) for any indication other than Hunter syndrome is considered experimental/investigational, and therefore, not covered. The safety and efficacy for any other indication has not been established.
