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eliglustat — Blue Cross Blue Shield of Kansas

Gaucher disease type 1 (GD1)

Initial criteria

  • 1. ONE of the following:
  • A. The requested agent is eligible for continuation of therapy AND ONE of the following: patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR prescriber states 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
  • B. ALL of the following:
  • 1. Diagnosis of Gaucher disease type 1 (GD1) AND
  • 2. 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 AND
  • 3. If the patient has an FDA labeled indication, ONE of the following: (A) Patient’s age is within FDA labeling for the requested indication OR (B) There is support for using the requested agent for the patient’s age for the requested indication AND
  • 4. The patient does NOT have any neuronopathic symptoms indicative of Gaucher disease type 2 or type 3 [e.g., bulbar signs (stridor, strabismus, swallowing difficulty), pyramidal signs (opisthotonos, head retroflexion, spasticity, trismus), oculomotor apraxia, tonic-clonic seizures, myoclonic epilepsy, dementia, ataxia] AND
  • 5. The patient has at least ONE of the following clinical presentations at baseline: (A) Anemia (mean hemoglobin below lab’s normal range) OR (B) Thrombocytopenia (platelet count <100,000/microliter on at least 2 measurements) OR (C) Hepatomegaly OR (D) Splenomegaly OR (E) Growth failure (growth velocity below standard mean for age) OR (F) Evidence of bone disease with other causes ruled out AND
  • 6. The patient is a CYP2D6 extensive metabolizer (EM), intermediate metabolizer (IM), or poor metabolizer (PM), as detected by an FDA-cleared test for CYP2D6 genotype AND
  • 2. Prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist), or has consulted with such a specialist AND
  • 3. The patient will NOT be using the requested agent in combination with another substrate reduction therapy agent (e.g., Opfolda, miglustat, Zavesca) for the requested indication AND
  • 4. The patient does NOT have any FDA labeled contraindications to the requested agent.

Reauthorization criteria

  • 1. Patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
  • 2. Patient has had clinical benefit with the requested agent AND
  • 3. Prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist), or has consulted with such a specialist AND
  • 4. Patient will NOT be using the requested agent in combination with another substrate reduction therapy agent (e.g., Opfolda, miglustat, Zavesca) for the requested indication.

Approval duration

12 months