Alglucerase (Ceredase) (J0205), imiglucerase (Cerezyme) (J1786) and velaglucerase alfa (VPRIV) (J3385) are indicated for use as a long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of Type I Gaucher disease.

Alglucerase, imiglucerase and velaglucerase alfa are indicated for treatment when one or more of the following conditions exists in patients with confirmed Type I Gaucher disease:

• Anemia with hemoglobin of:
  11.5 g/dL or less for females;
  12.5 g/dL or less for males;
• Thrombocytopenia with platelet count less than or equal to 120,000/mm³;
• Bone disease (e.g., osteonecrosis, osteopenia, secondary pathologic fractures);
• Clinically significant hepatomegaly or splenomegaly;
• Symptomatic disease, including abdominal or bone pain, fatigue, exertional limitation, weakness, or cachexia.

The use of alglucerase, imiglucerase, and velaglucerase alfa for any other indication, including but not limited to the following, is considered experimental/investigational and, therefore, not covered.

• Type II Gaucher disease
• Type III Gaucher disease

A participating, preferred, or network provider can bill the member for the non-covered service.

NOTE:

Coverage is determined according to individual or group customer benefits. These drugs are not reimbursable under the prescription drug benefit.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient's condition.

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Zimran A, Altarescu G, Phillips M, et al. Phase I/II and extension study of velaglucerase alfa (Gene-ActivatedTM human glucocerebrosidase) replacement therapy in adults with type 1 Gaucher disease: 48-month experience. Blood. 2010;115(23):4651-4656.

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