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.
Laronidase (Aldurazyme) may be considered medically necessary for individuals with the following:
- Diagnosis of ANY of the following forms of mucopolysaccharidosis type I confirmed by genetic testing or abnormal enzymology on cultured fibroblasts:
- Hurler; or
- Hurler-Scheie; or
- Scheie form with moderate to severe symptoms; and
- Baseline predicted forced vital capacity (FVC); or
- Baseline distance walked in six (6) minutes.
Reauthorization of laronidase (Aldurazyme) may be considered medically necessary when the following criteria are met:
- Individual diagnosed with MPS I (Hurler, Hurler-Scheie or Scheie form as listed above); and
- Documentation of stability or improvement from baseline in FVC or distance walked in six (6) minutes.
The use of laronidase (Aldurazyme) is considered experimental/investigational and therefore are non-covered for all other indications. Scientific evidence does not support the use of laronidase (Aldurazyme) for any other indication.