Criteria
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 FDA-approved label for use (e.g., use outside of studied population will be considered investigational);
and
-
Laronidase (Aldurazyme) must be prescribed by, or in consult with, an expert in lysosomal storage diseases;
and
-
Documentation of the individual's diagnosis must be submitted, as evidenced by the following:
-
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
-
Documentation of the individual's current motor function must be submitted, as evidenced by scores from the following assessments:
-
Six (6)-minute walk test (6MWT);
and
- Forced Vital Capacity (FVC) via Pulmonary Function Test.
Initial Authorization: Six (6) months
Reauthorization Criteria
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
- Six (6)-minute walk test (6MWT).
The use of laronidase (Aldurazyme) 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
