Criteria
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
®
), velaglucerase alfa (VPRIV
®
) and taliglucerase alfa (Elelyso
®
), may be considered medically necessary for individuals with the following:
Initial Authorization Criteria
-
A diagnosis of Gaucher disease Type I or Type III as confirmed by
EITHER
of the following:
-
Deficiency in glucocerebrosidase in peripheral blood leukocytes or other nucleated cells (e.g., glucocerebrosidase activity of 0-15% of mean normal);
or
-
Confirmation of biallelic pathogenic variants in the GBA gene;
and
-
Clinical manifestations of non-neuropathic Gaucher disease from
ANYONE
of the following conditions:
-
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 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/mm
³
;
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.
Reauthorization Criteria
Continuation of therapy with imiglucerase (Cerezyme), velaglucerase alfa (VPRIV), or taliglucerase alfa (Elelyso) may be considered medically necessary when the following criteria are met:
-
The individual has one of the above diagnoses;
and
-
The prescriber has provided documentation that the individual has demonstrated a disease stability or beneficial response to therapy from baseline as shown by
ANY
of the following:
-
Reduction in liver volume;
or
-
Reduction in spleen volume;
or
-
Increase in hemoglobin levels;
or
- Increase in platelet counts.
The use of imiglucerase (Cerezyme), velaglucerase alfa (VPRIV) and taliglucerase alfa (Elelyso), for any other indication is considered experimental/investigational and, therefore, not covered. Scientific evidence of safety and efficacy has not been proven.
Procedure Codes
