Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of elosulfase alfa (Vimizim) 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
-
Documentation of the member's diagnosis must be submitted, as evidenced by the following:
-
Genetic testing confirming biallelic pathogenic mutations in the GALNS gene;
and
-
Deficiency in activity of the N-acetylgalactosamine 6-sulfatase (GALNS) enzyme;
and
-
Elosulfase alfa (Vimizim) must be prescribed by, or in consult with, a geneticist, metabolic specialist, or specialist in mucopolysaccharidoses (MPS);
and
-
The individual is experiencing musculoskeletal signs and symptoms of MSP-IVA such as knee deformity, kyphosis, hip dysplasia, arthralgia, etc.;
and
-
Documentation of one of the following must be submitted:
-
Forced Vital Capacity (FVC) via Pulmonary Function Test;
or
-
Six (6)-minute walk test (6MWT);
or
- Three (3)-minute stair claim test (3-MSCT).
Initial Authorization: Six (6) months
Reauthorization Criteria
Continuation of therapy with elosulfase alfa (Vimizim) 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) by one of the following scores:
-
Forced Vital Capacity (FVC) via Pulmonary Function Test;
or
-
Six (6)-minute walk test (6MWT);
or
-
Three (3)-minute stair claim test (3-MSCT);
or
- Reduced Urine Keratan Sulfate (KS) levels.
The use of elosulfase alfa (Vimizim) 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
