Coverage is subject to the specific terms of the member’s benefit plan.
The use of pegloticase (Krystexxa) may be considered medically necessary when ALL of the following criteria are met:
- The individual must meet criteria as outlined in prescribing information (PI) including recommendations for diagnosis and age; and
- The prescriber is a, or in consult with, a rheumatologist; and
- The individual must have failed a 90-day trial of each of the following, as evidenced by paid claims or pharmacy print outs:
- allopurinol at 300mg/day (or maximally tolerated dose) in combination with probenecid; and
- febuxostat in combination with probenecid; and
- Failure of previous treatment must be documented by each of the following:
- Serum uric acid level ≥ 6 mg/dL within the past month; and
- Two or more gout flares per year or nonrevolving tophaceous deposits; and
- The individual must have one or more of the following symptoms (as evidenced by documentation):
- Greater than or equal to three gout flares in the previous 18 months
- Greater than or equal to one gout tophus
- Gouty arthritis.
Initial Authorization: 6 months
Continuation of therapy with pegloticase (Krystexxa) may be considered medically necessary when the following is met:
- The individual must have experienced and maintained clinical benefit since starting treatment with the requested medication, as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review) including both of the following:
- Serum uric acid levels <6mg/dl within the past month; and
- Decrease in gout flares or nonrevolving tophaceous deposits.
Continuation Authorization: 12 months
The use of pegloticase (Krystexxa) 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.