Coverage is subject to the specific terms of the member’s benefit plan.
The use of sebelipase alfa (Kanuma) may be considered medically necessary when ALL of the following criteria are met:
- The individual must meet criteria as outlined in prescribing information (PI) including recommendations for diagnosis and age; and
- The prescriber is a, or in consult with, a specialist in the treatment of lysosomal acid lipase (LAL) such as a lipidologist, endocrinologist, cardiologist, or hepatologist; and
- Documentation must be attached to confirm one of the following:
- Genetic testing confirming 2 mutations in the LIPA gene; or
- Deficiency of the LAL in peripheral blood leukocytes, fibroblasts, or dried blood spots.
Initial Authorization: 6 months
Continuation of therapy with sebelipase alfa (Kanuma) may be considered medically necessary when the following is met:
- The individual must have experienced and maintained clinical benefit since starting treatment with the requested medication, as evidenced by medical documentation (e.g. chart notes) attached to the request (subject to clinical review) including improvement in weight for age Z-scores for individuals with growth failure, improved LDL, HDL, AST, ALT and/or triglycerides.
Continuation Authorization: 12 months
Sebelipase alfa (Kanuma) for any other indication is considered experimental/investigational and therefore, not covered. Scientific evidence does not support its use for any other indications.