eliglustat — Blue Cross Blue Shield of Texas
Gaucher disease type 1 (GD1)
Initial criteria
- ONE of the following: A. continuation of therapy if patient treated within past 90 days and at risk if changed OR B. ALL of the following:
- Diagnosis of Gaucher disease type 1 (GD1)
- Baseline glucocerebrosidase enzyme activity ≤ 15% of mean normal OR genetic analysis confirms two pathogenic GBA alleles
- Patient age within FDA labeling or supported for use at that age
- No neuronopathic symptoms indicative of Gaucher disease type 2 or type 3 (e.g., bulbar signs, pyramidal signs, oculomotor apraxia, seizures, dementia, ataxia)
- At least one of: anemia, thrombocytopenia, hepatomegaly, splenomegaly, growth failure, or bone disease
- Patient is CYP2D6 EM, IM, or PM by FDA-cleared test
- Prescriber is a specialist (e.g., endocrinologist, geneticist) or has consulted a specialist
- Patient will not use in combination with another substrate reduction therapy (e.g., Opfolda, miglustat, Zavesca)
- No FDA labeled contraindications
Reauthorization criteria
- Patient previously approved through plan's Prior Authorization process
- Clinical benefit with requested agent
- Prescriber is a specialist (e.g., endocrinologist, geneticist) or has consulted a specialist
- Patient will not use in combination with another substrate reduction therapy agent (e.g., Opfolda, miglustat, Zavesca)
- Patient has no FDA labeled contraindications
Approval duration
12 months