Elelyso® (taliglucerase alfa)

Covered for FDA‑approved Type 1 Gaucher disease and compendial off‑label Type 3 use (only for impaired growth, hematologic or visceral — NOT neurologic — manifestations) in patients ≥4 years; patients <4 or Type 3 neurologic indications are excluded. Requires confirmed diagnosis by deficient β‑glucocerebrosidase activity or biallelic GBA pathogenic variants, prescription by or consultation with a geneticist/endocrinologist/metabolic/lysosomal disorder specialist, adherence to dosing limits (Type 1: 60 U/kg IV q2w; Type 3: ≤120 U/kg IV q2w), documentation of indication and specialist involvement, and authorization is limited to 1 year.

"Type 1 Gaucher disease: Elelyso is indicated for the treatment of individuals with Type 1 Gaucher disease."

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