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Cerdelga — Blue Cross Blue Shield of Illinois

Gaucher disease type 1 (GD1)

Initial criteria

  • ONE of the following: (A) The requested agent is eligible for continuation of therapy AND prescriber states the patient has been treated with the requested agent (not on samples) within the past 90 days AND is at risk if therapy is 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 glucocerebrosidase (GBA) gene
  • If the patient has an FDA labeled indication, ONE of the following: (A) Patient’s age is within FDA labeling for indication OR (B) There is support for using the requested agent for the patient’s age for the requested indication
  • Patient does NOT have any neuronopathic symptoms indicative of Gaucher disease type 2 or type 3 (e.g., bulbar signs, pyramidal signs, oculomotor apraxia, tonic-clonic seizures, myoclonic epilepsy, dementia, ataxia)
  • Patient has at least ONE of the following clinical features at baseline: (A) Anemia (Hb below lab lower limit of normal) OR (B) Thrombocytopenia (platelet count < 100,000/microliter on ≥2 measurements) OR (C) Hepatomegaly OR (D) Splenomegaly OR (E) Growth failure OR (F) Bone disease with other causes ruled out
  • Patient is a CYP2D6 extensive, intermediate, or poor metabolizer as detected by FDA-cleared CYP2D6 genotype test
  • Prescriber is a specialist in the area of diagnosis (e.g., endocrinologist, geneticist) or has consulted with such a specialist
  • Patient will NOT be using the requested agent in combination with another substrate reduction therapy agent (e.g., Opfolda, miglustat, Zavesca)
  • Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

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

Approval duration

12 months