Criteria
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 (Krystexxa) may be considered medically necessary for individuals who meet BOTH of the following criteria:
- For the treatment of chronic gout in adult individuals refractory to conventional therapy. Refractory will be defined as:
- Failure to normalize serum uric acid to less than 6 (six) mg/dL after 3 (three) months of maximum medically appropriate dose of xanthine oxidase inhibitors (e.g., allopurinol, febuxostat); or
- Contraindication to xanthine oxidase inhibitors; and
- Adult individuals 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.
Reauthorization Criteria
Reauthorization of pegloticase (Krystexxa) may be considered medically necessary when the following criteria are met:
- Individual meets all initial authorization criteria; and
- Individual has demonstrated a positive clinical response from baseline as demonstrated by two (2) consecutive documented uric acid levels less than 6 (six) mg/mL.
Pegloticase should be administered in a healthcare setting by a healthcare provider prepared to manage anaphylaxis. Individuals should receive pre-infusion medications (e.g., antihistamines, corticosteroids), to minimize infusion reactions.
Glucose-6-phosphate dehydrogenase (G6PD) Deficiency
Before starting pegloticase (Krystexxa), individuals 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 (Krystexxa).
Pegloticase (Krystexxa) not meeting the criteria listed in this policy 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.
Procedure Codes
