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.
Agalsidase beta (Fabrazyme) may be considered medically necessary for the treatment of Fabry disease when ALL of the following criteria are met:
- Individuals eight (8) years of age or older with a confirmed diagnosis of Fabry disease made by ONE of the following methods:
- For male individuals: clinical documentation of complete deficiency or negligible (less than 5%) of mean normal alpha-galactosidase A (Gal A) enzyme activity in leukocytes, dried blood spots, or serum (plasma) analysis; or
- For female individuals: documented galactosidase alpha gene; (GLA) mutation by gene sequencing; and
- ONE or more of the following symptoms or physical findings attributable to Fabry disease:
- Angiokeratomas; (clusters of small, dark red spots on the skin); or
- Acroparesthesias; (episodes of pain, particularly in the hands and feet); or
- Corneal verticillata (whorls); or
- Corneal opacity; or
- Personal or family history of exercise, heat, or cold intolerance; or
- Decreased sweating (anhidrosis or hypohidrosis); or
- Personal or family history of renal failure; or.
- Anhydrosis or hypohidrosis (impaired sweating); or
- Hearing manifestations (tinnitus); and
- The medication is prescribed by or in consultation with a physician who specializes in the treatment of inherited metabolic disorders.
Agalsidase beta (Fabrazyme) for any other indication is considered experimental/investigational, and therefore, non-covered. Scientific evidence does not support the use of Agalsidase beta (Fabrazyme) for other indications.