eliglustat — Blue Cross Blue Shield of Oklahoma

Gaucher disease type 1 (GD1)

Initial criteria

ONE of the following: (A) Eligible for continuation of therapy AND prescriber states patient has been treated with requested agent within past 90 days and at risk if therapy changed OR (B) ALL of the following:
Patient has a 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 GBA gene
If FDA labeled indication, ONE of the following: (A) Patient’s age is within FDA labeling OR (B) Support for use in patient's age for Requested indication
Patient does NOT have any neuronopathic symptoms indicative of Gaucher disease type 2 or 3
Patient has at least ONE of following at baseline: (A) Anemia (Hb below lab lower limit) OR (B) Thrombocytopenia (platelet < 100,000/μL 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 test
Prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist) or has consulted a specialist
Patient will NOT use 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

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

12 months