7. Does the adult patient have chronic gout refractory to conventional therapy proven by having ALL the following present in the documentation?
Baseline serum uric acid of at least 8mg/dl
Has symptomatic gout with at least 3 gout flares in the previous 18 months, at least 1 gout tophi (sodium urate monohydrate, or uric acid, builds up around your joints) or gouty arthritis
Patient is currently on NSAIDS or Colchicine or both within last 30 days OR Documented intolerance, FDA labeled contraindication or hypersensitivity to both
Insufficient response uric acid levels > 6mg/dl after at least 3 months of therapy with both allopurinol and febuxostat at maximum tolerated doses unless medically contraindicated. If the patient has well documented medical contraindications, monotherapy will be considered as sufficient.
Progress note or medical record should support conventional therapy proven by all listed based on medical standard of care.
8. Does the dosage and administration meet FDA approved guidelines of 8 mg intravenous (IV) infusion every 2 weeks?
