Pegloticase

This policy covers pegloticase (Krystexxa) infusions to lower serum uric acid and treat chronic refractory or tophaceous gout in adults (≥18) with baseline SUA ≥6 mg/dL and symptomatic disease (recurrent flares, tophi, or gouty arthritis) when conventional urate‑lowering therapies have failed, are not tolerated, or are contraindicated. Coverage requires documented failure/intolerance/contraindication to xanthine oxidase inhibitors and uricosurics at maximally appropriate doses, recommends weekly methotrexate co‑therapy (or pegloticase monotherapy only if methotrexate is contraindicated), mandates discontinuation if SUA >6 mg/dL (especially with infusion reactions), and excludes asymptomatic hyperuricemia and indications not supported by accepted compendia or two peer‑reviewed studies.

"Coverage of any FDA‑approved drug when prescribed for a use recognized as safe and effective for a given indication in one or more standard medical reference compendia adopted by HHS, even if the F..."