Pegloticase (KrystexxaaTM) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients' refractory to conventional therapy. Pegloticase achieves its therapeutic effect by catalyzing the oxidation of uric acid to allantoin, a purine metabolite readily excreted in the urine, thereby lowering serum uric acid.
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.
Pegloticase (Krystexxaa) may be considered medically necessary who meet BOTH of the following criteria:
- For the treatment of chronic gout in adult patients refractory to conventional therapy. Refractory will be defined as:
- Failure to normalize serum uric acid to less than 6 mg/dL after three months of maximum medically appropriate dose of xanthine oxidase inhibitors (e.g., allopurinol, febuxostat); or
- Contraindication to xanthine oxidase inhibitors; and
- Adult patients must have a documented diagnosis of symptomatic gout. Pegloticase is not recommended for the treatment of asymptomatic hyperuricemia. Symptomatic is defined as one of the following:
- Greater than or equal to three gout flares in the previous 18 months; or
- Greater than or equal to one gout tophus; or
- Gouty arthritis.
Pegloticase should be administered in a healthcare setting by a healthcare provider prepared to manage anaphylaxis. Patients should receive pre-infusion medications (e.g. antihistamines, corticosteroids), to minimize infusion reactions. Glucose-6-phosphate dehydrogenase (G6PD) Deficiency:Before starting Pegloticase, patients at higher risk for G6PD deficiency (e.g. those of African and Mediterranean ancestry should be screened due to risk of hemolysis and methemoglobinemia). G6PD deficiency is contraindication for pegloticase.
The use of pegloticase for any other indication is considered experimental/investigational, and therefore, not covered because the safety and/or effectiveness of this use cannot be established by review of the available published peer-reviewed literature.