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 the following criteria:
-
For the treatment of chronic gout in adult individuals refractory to conventional therapy meeting the following criteria:
-
Failure to normalize serum uric acid to less than 6 mg/dL after three (3) months of maximum medically appropriate dose of:
-
Xanthine oxidase inhibitors (e.g., allopurinol, febuxostat);
or
-
Combination of a xanthine oxidase inhibitor and a uricosuric agent (e.g., probenecid);
or
-
Contraindication to xanthine oxidase inhibitors;
and
-
Adult individuals must have a documented diagnosis of symptomatic gout as defined by ONE or more of the following criteria:
-
Greater than or equal to three (3) gout flares in the previous 18 months;
or
-
Greater than or equal to one (1) 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 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).
The use of pegloticase (Krystexxa) 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
