eliglustat — Blue Cross Blue Shield of Montana

Gaucher disease type 1 (GD1)

Initial criteria

ONE of the following: A. The requested agent is eligible for continuation of therapy AND prescriber states patient has been treated with requested agent (not sample) within past 90 days and is at risk if therapy changed OR B. ALL of the following:
• Diagnosis of Gaucher disease type 1 (GD1)
• ONE of the following: A. baseline glucocerebrosidase enzyme activity ≤ 15% of mean normal in fibroblasts, leukocytes, or other nucleated cells OR B. genetic analysis confirmed two pathogenic alleles in the GBA gene
• If FDA labeled indication: ONE of the following: A. patient’s age within FDA labeling OR B. support exists for using agent for patient’s age
• Patient does NOT have any neuronopathic symptoms indicative of Gaucher disease type 2 or type 3 (e.g., bulbar, pyramidal, oculomotor, seizure, dementia, ataxia)
• Patient has at least ONE of: anemia (Hb below lower limit of normal), thrombocytopenia (<100,000/microliter on 2 measurements), hepatomegaly, splenomegaly, growth failure, or bone disease with other causes ruled out
• Patient is a CYP2D6 extensive, intermediate, or poor metabolizer detected by FDA-cleared test
• Prescriber is a specialist (e.g., endocrinologist, geneticist) or has consulted with one
• Patient will NOT use requested agent with another substrate reduction therapy agent (e.g., Opfolda, miglustat, Zavesca)
• Patient does NOT have any FDA labeled contraindications

• Patient previously approved through plan’s prior authorization
• Patient has had clinical benefit with requested agent
• Prescriber is specialist (e.g., endocrinologist, geneticist) or has consulted with one
• Patient will NOT use in combination with another substrate reduction therapy agent (e.g., Opfolda, miglustat, Zavesca)
• Patient does NOT have any FDA labeled contraindications

12 months