Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of imiglucerase (Cerezyme®), velaglucerase alfa (VPRIV®) and taliglucerase alfa (Elelyso®) may be considered medically necessary when
ALL
of the following criteria are met:
-
The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational);
and
-
The requested medication must be prescribed by, or in consult with, a geneticist, an endocrinologist, or a physician who specializes in the treatment of lysosomal storage disorders;
and
-
The individual must have a diagnosis of Gaucher disease Type I or Type III with the one of the following (as evidenced with submitted documentation):
-
Deficiency in beta-glucocerebrosidase enzyme activity in peripheral leukocytes;
or
-
Genetic testing confirming biallelic pathogenic variants in the GBA1 gene;
and
-
The individual must be experiencing one or more of the following (as evidenced with submitted documentation):
- Anemia with hemoglobin less than or equal to the laboratory reported low for patient age and gender
- Thrombocytopenia with platelet count less than 100,000/mm³
- Bone disease (T-score below -1.0 [DXA], height SDS less than -2.25 with decreased growth velocity, bone crisis)
- Hepatomegaly (liver size 1.25 or more times normal)
-
Splenomegaly (spleen size five (5) or more times normal);
and
- For imiglucerase (Cerezyme) and velaglucerase alfa (VPRIV), information has been provided to explain why the preferred agent, taliglucerase alfa (Elelyso), cannot be used.
Initial Authorization: Six (6) months
Reauthorization Criteria
Continuation of therapy with imiglucerase (Cerezyme®), velaglucerase alfa (VPRIV®) and taliglucerase alfa (Elelyso®) may be considered medically necessary when
ALL
of the following are met:
-
Documentation has been submitted that member has experienced a disease stability or beneficial response to therapy from baseline as shown by one or more of the following:
- Reduction in liver volume to normal size or by 10%
- Reduction in spleen volume by 15%
- Increase in hemoglobin levels by 1mg/dl
- Increase in platelet levels by 15%
- Increased T-score [DXA] by 0.3, normalized growth velocity, or decrease in bone crisis.
The use of imiglucerase (Cerezyme), velaglucerase alfa (VPRIV) and taliglucerase alfa (Elelyso), for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Codes
