Sebelipase Alfa Injections (Kanuma®)

Sebelipase alfa (Kanuma) is covered only for the FDA‑approved treatment of lysosomal acid lipase (LAL) deficiency and is not covered for other indications. Coverage requires documented deficient LAL enzyme activity (leukocytes, fibroblasts, or liver) or an LAL gene mutation, prescription or consultation with a geneticist, endocrinologist, metabolic disorder subspecialist, or lysosomal storage disorder specialist, approval limited to 12 months, and dosing limited to ≤3 mg/kg IV no more than once weekly with supporting lab/genetic and clinical documentation.

"Treatment of individuals with lysosomal acid lipase (LAL) deficiency (FDA-approved indication)."

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