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.
Imiglucerase (Cerezyme®), taliglucerase alfa (Elelyso®), and velaglucerase alfa (VPRIV®) are indicated for use as a long-term enzyme replacement therapy for pediatric and adult individuals with a confirmed diagnosis of Type I Gaucher disease.
Imiglucerase (Cerezyme), velaglucerase alfa (VPRIV) and taliglucerase alfa (Elelyso), are indicated for treatment when ONE or more of the following conditions exists in individuals with confirmed Type I Gaucher disease:
- Anemia with hemoglobin of:
- Less than or equal to 11.5 g/dL for females; or
- Less than or equal to 12.5 g/dL for males; or
- Less than or equal to 1.0 g/dL or more below the lower limit of normal for age and sex; or
- Thrombocytopenia with platelet count less than or equal to 120,000/mm³; or
- Bone disease (e.g., osteonecrosis, osteopenia, secondary pathologic fractures); or
- Clinically significant hepatomegaly (liver size 1.25 or more times normal) or splenomegaly (spleen size five (5) or more times normal); or
- Symptomatic disease, including abdominal or bone pain, fatigue, exertional limitation, weakness, or cachexia.
The use of imiglucerase (Cerezyme), velaglucerase alfa (VPRIV) and taliglucerase alfa (Elelyso), for any other indication, including but not limited to the following, is considered experimental/investigational and, therefore, not covered. Scientific evidence of safety and efficacy has not been proven.
- Type II Gaucher disease
- Type III Gaucher disease