Prior Auth Protocol

FDA Approved Indications:

For use in patients with Fabry disease. Fabrazyme reduces globotriaosyleceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types.

Health Net Approved Indications and Usage Guidelines:

Diagonosis of Fabry disease

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

Fabry disease is a rare inherited X-linked lysosomal storage disorder leading to systemic diseases of the kidney, heart, and central nervous system.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Fabrazyme	1 mg/kg body weight by IV infusion every 2 weeks.	Medical: 6 months or renewal date, whichever is longer

Product Availability:

Vial: 5 mg or 35 mg

References:

1. Fabrazyme [Prescribing Information] Cambridge, MA: Genzyme Corporation; May 2010.

2. Eng CM, Guffon N, Wilcox WR, et al. Safety and efficacy of recombinant human alpha-galactosidase A replacement therapy in Fabrys disease. N Eng J Med. 2001;345:9:9-16.

3. Desnick RJ, Brady R, Barranger J, et al. Fabry disease, an under-recognized multisystemic disorder: Expert recommendations for diagnosis, management, and enzyme replacement therapy. Annals of Int Med. 2003;138:4:338-347.

4. Fabrazyme. In: DrugPoints^R system [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed May 27, 2015.

5. Fabrazyme. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed May 27, 2015.

6. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com/. Accessed May 27, 2015.