Prior Auth Protocol

FDA Approved Indications:

Myozyme is indicated for use in patients with Pompe disease (Acid alpha-glucosidase (GAA) deficiency). Myozyme has been shown to improve ventilator-free survival in patients with infantile-onset Pompe disease as compared to an untreated historical control, whereas the use of Myozyme^R in patients with other forms of Pompe disease has not been adequately studied to ensure safety and efficacy.
Lumizyme is a hydrolytic lysosomal glycogen-specifc enzyme indicated for patients with Pompe disease (GAA deficiency)

Health Net Approved Indications and Usage Guidelines:

Myozyme:Diagnosis of Infantile-onset Pompe disease (Acid alpha-glucosidase (GAA) deficiency)
Lumizyme: Diagnosis of Pompe disease (GAA deficiency)

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:

Boxed warning (Myozyme and Lumizyme): Life-threatening anaphylactic reactions, severe allergic reactions and immune mediated reactions have been observed in some patients during Myozyme and Lumizyme infusions.
Boxed warning (Myozyme and Lumizyme): Patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to infusion reactions, and require additional monitoring.

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
Myozyme(alglucosidase alfa)	20 mg/kg IV via infusion pump administered every 2 weeks	6 months or to member's renewal period, whichever is sooner.
Lumizyme (alglucosidase alfa)	20 mg/kg IV via infusion pump administered every 2 weeks	6 months or to member's renewal period, whichever is sooner.

Product Availability:

Single use vial: 50 mg lyophilized powder (cake) for injection that requires reconstitution prior to infusion.

References:

Myozyme [Prescribing Information]. Cambridge, MA: Genzyme Corporation; May 2014.
Lumizyme [Prescribing Information]. Cambridge, MA: Genzyme Corporation; August 2014.
Micromedex Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Reuters Healthcare. Updated periodically. Available at http://www.micromedexsolutions.com. Accessed June 22, 2015.
Clinical Pharmacology Web site. Available at http://www.clinicalpharmacology-ip.com. Accessed June 22, 2015.
Alglucosidase alfa. American Hospital Formulary Service Drug Information. Available at http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 22, 2015.