Kanuma® (sebelipase alfa)

Kanuma (sebelipase alfa) is covered only for the FDA‑approved treatment of lysosomal acid lipase (LAL) deficiency and is not authorized for non‑LAL indications. Approval (12 months) requires diagnostic confirmation by deficient LAL enzyme activity or molecular genetic testing showing biallelic pathogenic/likely pathogenic variants, prescribing by or consultation with a geneticist/endocrinologist/metabolic disorder or lysosomal storage disorder specialist, adherence to specified age‑based dosing and stepwise escalation (infants: 1→3→5 mg/kg weekly; pediatric/adult: 1→3 mg/kg every other week) and documentation of rapid infant disease or clinical justification for any dose increase.

"Kanuma (sebelipase alfa) is indicated for the treatment of individuals with lysosomal acid lipase (LAL) deficiency."

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