generic miglustat — Medical Mutual

Initial criteria

• Member must be age ≥ 18 years; AND
• Cerdelga, Yargesa, generic miglustat, or Zavesca is prescribed by or in consultation with a geneticist, an endocrinologist, a metabolic disorder sub-specialist, or a physician who specializes in the treatment of Gaucher Disease; AND
• Diagnosis of Type I Gaucher Disease established by at least one of the following: white blood cell or skin fibroblast glucocerebrosidase activity < 30% of normal OR mutation of two glucocerebrosidase genome alleles; AND
• At least one of the following is met: hemoglobin > 1.0 g/dL below lower limit of normal for age and sex (< 11.5 g/dL for females, < 12.5 g/dL for males) OR platelet count < 120,000/mm3 OR clinically significant hepatomegaly (liver > 1.25 times normal size by MRI or CT) OR clinically significant splenomegaly (spleen > 5 times normal size by MRI or CT) OR skeletal involvement (e.g. Erlenmeyer flask deformity, osteopenia, pathological fracture, radiological evidence of joint deterioration, avascular necrosis); AND
• If request is for Cerdelga, member has had an FDA-cleared test showing the member’s CYP2D6 metabolizer status [documentation required]; AND
• If request is for Brand Zavesca or Cerdelga, one of the following is met: member has tried and failed generic miglustat OR prescribing physician attests that the request for brand is due to a difference in formulation or inactive ingredients that has or would result in a significant allergy or serious adverse reaction

Reauthorization criteria

• Patient has been started on Cerdelga, generic miglustat, or Zavesca; AND
• Approve if the drug continues to provide clinical benefit (e.g. improvement in symptoms, platelet count, or decrease in liver or spleen size) AND the requested medication continues to be prescribed by or in consultation with a geneticist, endocrinologist, metabolic disorder sub-specialist, or physician specializing in Gaucher Disease

Approval duration

1 year initial, 1 year reauth