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 criteria as outlined in prescribing information (PI) including recommendations for diagnosis and age; and
- The prescriber must be, or in consult with, a geneticist, metabolic specialist, or specialist in mucopolysaccharidoses (MPS); and
- The individual must have a diagnosis of mucopolysaccharidosis type IVA (Morquio A syndrome) with the following (as evidenced with submitted documentation):
- Genetic testing confirming biallelic pathogenic mutations in the GALNS gene; and
- Deficiency in activity of the n N-acetylgalactosamine 6-sulfatase (GALNS) enzyme; 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
- 6-minute walk test (6MWT); or
- 3-minute stair claim test (3-MSCT).
Initial Authorization: 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
- 6-minute walk test (6MWT); or
- 3-minute stair claim test (3-MSCT); or
- Reduced Urine Keratan Sulfate (KS) levels.
Continuation Authorization: 12 months
Elosulfase alfa (Vimizim) for any other indications not listed above is considered experimental/investigational and therefore, non-covered. Scientific evidence of safety and efficacy has not been proven for any other indications.
Procedure Codes
