Criteria
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 FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
- Pegloticase (Krystexxa) must be prescribed by, or in consult with, a rheumatologist; and
- The individual must have failed a three (3)-month trial of two of the following, as evidenced by paid claims or pharmacy print outs:
- allopurinol; or
- febuxostat; or
- allopurinol or febuxostat in combination with probenecid; and
- The failure of previous trials must be documented by both of the following:
- Serum uric acid level greater than or equal to 6 mg/dL within the past month; and
- One of the following;
- At least three (3) gout flares in the previous 18 months that were inadequately controlled; or
- One (1) gout tophus or gouty arthritis.
Initial Authorization: Six (6) months
Reauthorization Criteria
Continuation of therapy with pegloticase (Krystexxa) may be considered medically necessary when the following is met:
- The individual is not experiencing infusion reactions; and
- The individual must have experienced and maintained clinical benefit since starting treatment with pegloticase (Krystexxa), 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 less than 6mg/dl within the past month; and
- Decrease in gout flares or nonrevolving tophaceous deposits.
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
