Initial Evaluation

Cerezyme, Elelyso, Vpriv will be approved when ALL of the following are met:

    1. The patient has a diagnosis of Gaucher disease type 1 (GD1) confirmed by ONE of the following:

A. A baseline glucocerebrosidase enzyme activity of less than or equal to 15% of mean normal in peripheral blood leukocytes, fibroblasts, or other nucleated cells

 OR

B. Confirmation of genetic mutation of GBA gene with two disease-causing alleles

AND

    2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist, hematologist, specialist in metabolic diseases) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis

AND

    3. The prescriber has drawn baseline measurements of hemoglobin, platelet count, liver volume, and spleen volume

AND

    4. Prior to any treatment for the intended diagnosis, the patient has had at least ONE of the following clinical presentations:

A. Anemia [defined as mean hemoglobin (Hb) level below the testing laboratory’s lower limit of the normal range based on age and gender]

OR

B. Thrombocytopenia (defined as a platelet count of less than 100,000 per microliter)

OR

C. Hepatomegaly

OR

D. Splenomegaly

OR

E. Growth failure (i.e., growth velocity below the standard mean for age)

OR

F. Evidence of bone disease with other causes ruled out

Length of Approval: 12 months

Renewal Evaluation

Cerezyme, Elelyso, Vpriv will be approved when ALL of the following are met:

    1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria

AND

    2. The patient has a diagnosis of Gaucher disease type 1 (GD1)

AND

    3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist, hematologist, specialist in metabolic diseases) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis

AND

    4. The patient has had improvement and/or stabilization from baseline in at least ONE of the following:

        A. Hemoglobin (Hb) level

OR

        B. Platelet count

OR

        C. Liver volume

OR

        D. Spleen volume

OR

        E. Growth velocity

OR

        F. Bone pain or disease

Length of Approval: 12 months