CurrentUnitedHealthcarePolicy CS2026D0082L

Krystexxa (Pegloticase)

This UnitedHealthcare Medical Benefit Drug Policy defines medical necessity criteria, applicable codes, prescriber requirements, monitoring, and authorization limits for Krystexxa (pegloticase) for treatment of chronic gout in adults refractory to conventional therapy. It excludes certain states where state-specific guidance applies.

Policy Summary

PayerUnitedHealthcare

PolicyKrystexxa (Pegloticase)

Policy CodePolicy CS2026D0082L

Change TypeTemplate Update; removed Louisiana-specific language

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit laboratory values demonstrating baseline serum uric acid > 6 mg/dL and document prior therapy/failure and monitoring for authorization and reauthorization.

POLICY UPDATE CHANGES

Template Update and removed content/language pertaining to the state of Louisiana.

1Drug HCPCS listed

200+ICD-10 diagnosis codes listed

12 monthsMax authorization period (initial/reauthor)

Coverage Summary

Pegloticase (Krystexxa) is a PEGylated uricase indicated for the treatment of chronic gout in adults refractory to conventional therapy. The policy stance is covered with criteria: use is medically necessary only when specified clinical and documentation criteria are met (see criteria for initial and continuation therapy), with initial and reauthorization limits of no more than 12 months. The policy applies broadly but explicitly excludes certain states where state-specific guidance applies (e.g., Arizona, Florida, Indiana, Kansas, North Carolina, Ohio, Pennsylvania, Washington) as noted in the scope.

Continuation Therapy (Medically Necessary)

Covered when ALL of the following are met:

ALL of the following

Prior Krystexxa treatment: Patient has previously received treatment with Krystexxa
Positive clinical response: Patient has experienced a positive clinical response to Krystexxa (e.g., serum uric acid levels < 6 mg/dL, tophus reduction, etc.)Uric acid treatment target: < 6 mg/dL
Examples non-exhaustive
Continuation failure criterion: Patient has not had two consecutive uric acid levels above 6 mg/dL after initiating treatment with KrystexxaTwo consecutive uric acid levels > 6 mg/dL
If criterion met, discontinuation/review indicated
Prescriber specialty
- Rheumatologist
- Nephrologist
Dosing: Krystexxa is initiated and titrated according to FDA labeled dosing for chronic gout
Reauthorization limit: Reauthorization will be for no more than 12 months12 months

Applicable Codes

Drug HCPCSHCPCS

J2507

Injection, pegloticase, 1mg

Applicable Diagnosis Codes (Chronic gout and variants)ICD-10

M1A.00X0	Idiopathic chronic gout, unspecified site, without tophus (tophi)
M1A.00X1	Idiopathic chronic gout, unspecified site, with tophus (tophi)
M1A.0110	Idiopathic chronic gout, right shoulder, without tophus (tophi)
M1A.0111	Idiopathic chronic gout, right shoulder, with tophus (tophi)
M1A.0120	Idiopathic chronic gout, left shoulder, without tophus (tophi)
M1A.0121	Idiopathic chronic gout, left shoulder, with tophus (tophi)
M1A.0190	Idiopathic chronic gout, unspecified shoulder, without tophus (tophi)
M1A.0191	Idiopathic chronic gout, unspecified shoulder, with tophus (tophi)
M1A.0210	Idiopathic chronic gout, right elbow, without tophus (tophi)
M1A.0211	Idiopathic chronic gout, right elbow, with tophus (tophi)

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Authorization, Documentation, and Monitoring

Prior Authorization

Authorization required for initial and continuation therapy

Initial authorization limited to no more than 12 months; reauthorization limited to no more than 12 months and requires documentation of prior treatment, baseline labs, positive clinical response, and uric acid monitoring.

J2507
Initial and reauthorization limits: no more than 12 months

Documentation Required

Required laboratory documentation

Submit laboratory values demonstrating baseline serum uric acid > 6 mg/dL and ongoing pre-infusion serum uric acid values prior to each infusion.

> 6 mg/dL
Monitor serum uric acid prior to each infusion

Documentation Required

Prior therapy documentation

Document history of contraindication, intolerance, or treatment failure after 3 months at the maximally medically appropriate dose with both allopurinol and febuxostat, including failure to normalize uric acid to < 6 mg/dL.

Prior XOI therapy duration: 3 months at maximally medically appropriate dose
Failure to normalize serum uric acid to < 6 mg/dL

Documentation Required

Prescriber specialty requirement

Krystexxa must be prescribed by a rheumatologist or nephrologist.

Documentation Required

Monitoring requirement

Prescriber must attest that serum uric acid levels will be monitored prior to each infusion and that treatment will be discontinued if preinfusion levels increase above 6 mg/dL.

Discontinue if preinfusion uric acid > 6 mg/dL
Monitor prior to each infusion

Denial Risk

Not covered for asymptomatic hyperuricemia

Claims for Krystexxa for asymptomatic hyperuricemia are considered unproven and not medically necessary and may be denied.

Clinical Evidence & Indication

Evidence includes the FDA indication line: Treatment of chronic gout in adults refractory to conventional therapy. Key trials supporting efficacy are the phase 3 randomized controlled trials reported by Sundy et al. (JAMA 2011) and the tophus reduction analyses by Baraf et al. (Arthritis Res Ther 2013); these phase 3 RCTs demonstrated clinical efficacy including serum uric acid lowering and reduction in tophus burden.

Background

Pegloticase is a uricase enzyme that is PEGylated and works by catalyzing the oxidation of uric acid to allantoin, a more water-soluble metabolite that is readily eliminated, thereby lowering serum uric acid. It is indicated for adult patients with chronic gout refractory to conventional therapy. "Gout refractory to conventional therapy" is defined as patients who have failed to normalize serum uric acid and whose signs/symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

Policy Summary

PayerUnitedHealthcare

PolicyKrystexxa (Pegloticase)

Policy CodePolicy CS2026D0082L

Change TypeTemplate Update; removed Louisiana-specific language

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit laboratory values demonstrating baseline serum uric acid > 6 mg/dL and document prior therapy/failure and monitoring for authorization and reauthorization.

On This Page

OpenPayer

Krystexxa (Pegloticase)

Coverage Summary

Applicable Codes

Authorization, Documentation, and Monitoring

Key Clinical Thresholds

Clinical Evidence & Indication

Background

Revision History