agalsidase beta (Fabrazyme ®)

Office Administration

Indication(s) for Prior Authorization

Fabry disease

Patients must meet all the following criteria for the indication above:

Male with Fabry Disease

Diagnosed and followed by a geneticist or nephrologist
Either of the following

Low or undetectable levels of Alpha-Gal A (<1.5 nmol/hr/ml in plasma or <4 nmol/hrmg in leukocytes OR
DNA test showing a mutation

Female with Fabry Disease

Diagnosed and followed by a geneticist or nephrologist
DNA test showing mutation,

AND

Has clinical symptoms of the disease (renal dysfunction, cardiomyopathy, neuropathy, proteinuria, acroparesthesias, etc.)

The following indications do not meet the criteria for use established by the Western Health Advantage Pharmacy and Therapeutics Committee

Disease states not listed above

Dosing

Up to 1mg/kg infusion every 2 weeks


Western Health Advantage Pharmacy and Therapeutics Committee

Approved: December 2014                                    Reviewed: