Sebelipase Alfa Injections (Kanuma®)

Covered: Sebelipase alfa (Kanuma) is covered only for the FDA‑approved indication of lysosomal acid lipase (LAL) deficiency (not covered for non‑FDA indications). Key requirements: approval for 12 months requires documented confirmation by deficient LAL enzyme activity (leukocytes, fibroblasts, or liver) or molecular LAL gene mutation, prescription or consultation with a geneticist, endocrinologist, metabolic disorder subspecialist, or lysosomal storage disorder specialist, and is limited to IV dosing up to 3 mg/kg no more than once weekly.

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

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