Criteria
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 FDA-approved label for use (e.g., use outside of studied population will be considered investigational);
and
-
Sebelipase alfa (Kanuma) must be prescribed by, or in consult with, a specialist in the treatment of lysosomal acid lipase (LAL) such as a lipidologist, endocrinologist, cardiologist, or hepatologist;
and
-
Documentation of the individual's diagnosis must be submitted, as evidenced by the following:
-
Genetic testing confirming two (2) mutations in the LIPA gene;
or
- Deficiency of the LAL in peripheral blood leukocytes, fibroblasts, or dried blood spots.
Initial Authorization: Six (6) months
Reauthorization Criteria
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.
Sebelipase alfa (Kanuma) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
