Coverage is subject to the specific terms of the member’s benefit plan.
The use of laronidase (Aldurazyme) 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 must be, or in consult with, a geneticist, pediatric metabolic specialist, hematologist, or specialist in mucopolysaccharidoses (MPS); and
- The individual must have a diagnosis of mucopolysaccharidosis type I (Hurler syndrome, Hurler-Scheie syndrome, Scheie syndrome with moderate to severe symptoms) with the following (as evidenced with submitted documentation):
- Genetic testing confirming biallelic pathogenic mutations in the IDUA gene; and
- Deficiency in activity of the lysosomal enzyme α-L-iduronidase (IDUA) in fibroblast or leukocyte; and
- The provider must submit documentation of the individual’s current motor function, as evidenced by scores from the following assessments:
- 6-minute walk test (6MWT); and
- Forced Vital Capacity (FVC) via Pulmonary Function Test.
Initial Authorization: 6 months
Continuation of therapy with laronidase (Aldurazyme) may be considered medically necessary when ALL of the following are 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 the following scores and symptoms:
- Forced Vital Capacity (FVC) via Pulmonary Function Test; and
- 6-minute walk test (6MWT).
Continuation Authorization: 12 months
The use of laronidase (Aldurazyme) is considered experimental/investigational and therefore are non-covered for all other indications. Scientific evidence does not support the use of laronidase (Aldurazyme) for any other indication.