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.
Agalsidase beta (Fabrazyme) may be considered medically necessary when the following criteria are met:
- Individuals two (2) years of age or older with a confirmed diagnosis of Fabry disease made by ONE of the following methods:
- For male individuals: documentation of complete deficiency or less than 1% of mean normal alpha-galactosidase A (α-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
- At least one of the following signs and symptoms:
- 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
- Hearing manifestations (tinnitus); and
- The medication is prescribed by or in consultation with a physician who specializes in the treatment of inherited metabolic disorders; and
- Individual will not concomitantly be treated with migalastat.
Reauthorization Criteria
Reauthorization of agalsidase beta (Fabrazyme) may be considered medically necessary when the following criteria are met:
- The individual has previously been approved for agalsidase beta (Fabrazyme) through Blue Cross Blue Shield of North Dakota's precertification process; and
- Provider attestation that individual has demonstrated disease stability or beneficial response to therapy; and
- Individual will not concomitantly be treated with migalastat.
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.
Procedure Codes
