Krystexxa (pegloticase) for refractory chronic gout
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Medical necessity criteria, prior authorization guidance, and coverage stance for Krystexxa (pegloticase) in adults with refractory chronic gout for Bluecross Idaho members.
Updated policy statements with initial and continuing approval durations.
Adopted Blue Cross of Idaho policy as revised, effective 04/01/2026.
Coverage Criteria for Krystexxa (pegloticase)
Initial Therapy
Covered when ALL of the following are met:
Initial approval duration 24 weeks
Continuation Therapy
Covered when ALL of the following are met:
Continuation approval duration 1 year
Not Medically Necessary
Not covered in listed conditions
Krystexxa (pegloticase) should not be used in individuals with a known G6PD deficiency because of risk and because such use is explicitly listed as not medically necessary. Additionally, the policy states that concomitant administration of Krystexxa with oral urate‑lowering therapy (for example, allopurinol, febuxostat, probenecid) is considered not medically necessary and therefore is not covered.
The policy identifies the following situations as not medically necessary for Krystexxa (pegloticase): asymptomatic hyperuricemia defined as uric acid >6.8 mg/dL without prior gout flares or subcutaneous tophi; known G6PD deficiency; and use in combination with oral urate‑lowering therapy (including but not limited to allopurinol, febuxostat, probenecid). Uses that do not meet the listed medical necessity criteria are also not covered.
Coding and Laboratory Thresholds
| J2507 | Injection, pegloticase, 1 mg |
Prior Authorization, Documentation, and Step Therapy
Prior authorization required (HCPCS J2507)
Prior authorization is required for Krystexxa (pegloticase) billed with HCPCS code J2507. Initial requests must meet the policy's medical necessity criteria, including age, refractory chronic gout diagnosis, baseline serum uric acid > 8 mg/dL, and required prior medication trials.
- Use HCPCS code J2507 (Injection, pegloticase, 1 mg) when submitting prior authorization requests.
Required step therapy trials (allopurinol, febuxostat, combination)
Before Krystexxa is authorized, document that the member failed, was intolerant of, or has contraindications to appropriately dosed allopurinol and febuxostat and to combination therapy with a xanthine oxidase inhibitor plus probenecid; each therapy must have been tried at appropriate dosing for at least 3 months without achieving serum uric acid <6 mg/dL.
- Allopurinol: appropriately dosed ≥3 months (often >300 mg/day up to 800 mg/day) with UA not <6 mg/dL.
- Febuxostat: appropriately dosed ≥3 months with dose titration up to 80 mg/day and UA not <6 mg/dL.
- Combination of a xanthine oxidase inhibitor (allopurinol or febuxostat) plus probenecid: appropriately dosed ≥3 months with UA not <6 mg/dL.
Required clinical documentation
Include objective clinical documentation with the prior authorization: patient age (>18), diagnosis of refractory chronic gout, frequency of gout flares in the past 18 months, presence of tophi, evidence of chronic gouty arthropathy, baseline serum uric acid, and documentation of prior therapy trials and outcomes.
- Age > 18 years and diagnosis of refractory chronic gout (≥3 flares in past 18 months, presence of tophi, chronic gouty arthropathy).
- Baseline serum uric acid > 8 mg/dL prior to initiation.
- Records showing trials, intolerances, contraindications, or failures of allopurinol, febuxostat, and combination therapy.
- For continuation: two most recent serum uric acid levels < 6 mg/dL and evidence of clinical improvement (eg, reduced flares or tophus resolution).
Denial risks: not medically necessary conditions
Requests may be denied if the individual has conditions or uses that the policy lists as not medically necessary, including asymptomatic hyperuricemia, known G6PD deficiency, or concomitant use with oral urate-lowering therapy.
- Asymptomatic hyperuricemia: uric acid > 6.8 mg/dL without prior gout flares or subcutaneous tophi.
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Concomitant use of Krystexxa with oral urate-lowering therapies (eg, allopurinol, febuxostat, probenecid).
- Any request that does not meet the listed medical necessity criteria.
Background
Pegloticase (Krystexxa) is an intravenous uricolytic agent indicated for adults with refractory chronic gout. The policy clarifies circumstances under which Krystexxa is not medically necessary, including patients with asymptomatic hyperuricemia (uric acid >6.8 mg/dL without flares or tophi), individuals with known G6PD deficiency, and when used concomitantly with oral urate‑lowering therapies such as allopurinol, febuxostat, or probenecid. Providers should use these exclusions when assessing appropriateness of therapy and prior authorization requests.
Definitions
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