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Cerdelga — Blue Cross Blue Shield of Alabama

Gaucher disease type 1 (GD1)

Initial criteria

  • ONE of the following:
  • - The requested agent is eligible for continuation of therapy AND ONE of the following:
  • • The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
  • • The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed
  • OR
  • ALL of the following:
  • - The patient has a diagnosis of Gaucher disease type 1 (GD1)
  • - ONE of the following:
  • • The patient has baseline glucocerebrosidase enzyme activity ≤ 15% of mean normal in fibroblasts, leukocytes, or other nucleated cells OR
  • • Genetic analysis confirmed two pathogenic alleles in the GBA gene
  • - If the patient has an FDA labeled indication, then ONE of the following:
  • • The patient’s age is within FDA labeling for the requested indication OR
  • • There is support for using the requested agent for the patient’s age for the requested indication
  • - The patient does NOT have any neuronopathic symptoms indicative of Gaucher disease type 2 or type 3
  • - The patient has at least ONE of the following at baseline:
  • • Anemia (Hb below lab’s lower limit of normal for age and gender) OR
  • • Thrombocytopenia (platelet count <100,000/μL on ≥2 measurements) OR
  • • Hepatomegaly OR
  • • Splenomegaly OR
  • • Growth failure OR
  • • Evidence of bone disease with other causes ruled out
  • - The patient is a CYP2D6 EM, IM, or PM, confirmed by FDA-cleared test
  • - The prescriber is a specialist (e.g., endocrinologist, geneticist) or has consulted with one
  • - The patient will NOT be using the requested agent in combination with another substrate reduction therapy agent (e.g., Opfolda, miglustat, Zavesca)
  • - The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • - The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • - The patient has had clinical benefit with the requested agent
  • - The prescriber is a specialist (e.g., endocrinologist, geneticist) or has consulted with one
  • - The patient will NOT be using the requested agent in combination with another substrate reduction therapy agent (e.g., Opfolda, miglustat, Zavesca)
  • - The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months