Gaucher Enzyme Replacement Agents – Cerezyme, Elelyso, Vpriv Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

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:
   1. A baseline (prior to therapy for the requested indication) glucocerebrosidase enzyme activity of less than or equal to 15% of mean normal in peripheral blood leukocytes, fibroblasts, or other nucleated cells
      OR
   2. Confirmation of genetic mutation of glucocerebrosidase (GBA) gene with two disease-causing alleles
      AND
2. The prescriber has drawn baseline (prior to therapy for the requested indication) measurements of hemoglobin, platelet count, liver volume, and spleen volume
   AND
3. Prior to any treatment for the intended diagnosis, the patient has had at least ONE of the following clinical presentations:
   1. Anemia [defined as mean hemoglobin (Hb) level below the testing laboratory’s lower limit of the normal range based on age and gender]
      OR
   2. Thrombocytopenia (defined as a platelet count of less than 100,000 per microliter)
      OR
   3. Hepatomegaly
      OR
   4. Splenomegaly
      OR
   5. Growth failure (i.e., growth velocity below the standard mean for age)
      OR
   6. Evidence of bone disease with other causes ruled out
      AND
4. 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
5. The requested dose is within FDA labeled dosing for the requested indication

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 patient has had improvement and/or stabilization from baseline (prior to therapy for the requested indication) in at least ONE of the following:
   1. Hemoglobin (Hb) level
      OR
   2. Platelet count
      OR
   3. Liver volume
      OR
   4. Spleen volume
      OR
   5. Growth velocity
      OR
   6. Bone pain or disease
      AND
4. 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
5. The requested dose is within FDA labeled dosing for the requested indication

Length of Approval: 12 months