Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Vestronidase alfa-vjbk (Mepsevii) may be considered medically necessary in individuals age five (5) months and older that meets ALL of the following criteria:
- Diagnosis of MPS VII (Sly syndrome) as confirmed by either:
- Molecular genetic confirmation of pathogenic mutations in the GUSB gene; or
- Decreased level of beta-glucuronidase activity in cultured leukocytes or fibroblasts; and
- Clinical signs and symptoms of MPS VII (may include but are not limited to skeletal abnormalities shown on x-ray, short stature, macrocephaly, hepatosplenomegaly; and
- Increased level of urinary GAGs.
Continuation therapy with vestronidase alfa-vjbk (Mepsevii) may be considered medically necessary for individuals diagnosed with MPS VII when ALL of the following criteria are met:
- Individual is established on therapy with vestronidase alfa-vjbk (Mepsevii); and
- The prescriber has provided documentation that the individual has demonstrated a disease stability or beneficial response to therapy from baseline.
The use of vestronidase alfa-vjbk (Mepsevii) for any other indication is considered experimental/investigational and therefore, non-covered. There is a lack of clinical data to support its safety and efficacy in the treatment of other conditions.