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eliglustatBlue 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