CurrentColorado Rocky Mountain Health PlansPolicy CS2026D0082M

Krystexxa (Pegloticase)

Defines medical benefit drug coverage criteria, applicable coding, prescribing provider requirements, and authorization durations for Krystexxa (pegloticase) for treatment of chronic gout refractory to conventional therapy. Excludes asymptomatic hyperuricemia and lists state-specific applicability exceptions.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyKrystexxa (Pegloticase)

Policy CodePolicy CS2026D0082M

Change TypeApplication revised

Effective DateJune 1, 2026

Next Review Date

Key ActionSubmit documentation of symptomatic gout criteria, baseline serum uric acid > 6 mg/dL, and evidence of intolerance/contraindication or treatment failure of both allopurinol and febuxostat after 3 months at maximally appropriate dose; prescriber must attest to pre-infusion uric acid monitoring and consider discontinuation if preinfusion > 6 mg/dL.

POLICY UPDATE CHANGES

Application: Removed language indicating this Medical Benefit Drug Policy does not apply to the state of Indiana.

1Drug covered with criteria

12 monthsMax authorization duration

>6 mg/dLBaseline SUA threshold

2Minimum flares in 12 months

Coverage Summary

Defines medical benefit drug coverage criteria, applicable coding, prescribing provider requirements, and authorization durations for Krystexxa (pegloticase) for treatment of chronic gout refractory to conventional therapy; excludes asymptomatic hyperuricemia and lists state-specific applicability exceptions. Drug is covered with criteria. Effective: 2026-06-01; Last review: 2026-06-01; Policy number: CS2026D0082M.

Key thresholds and authorization parameters

Baseline serum uric acid> 6 mg/dL

Max authorization duration12 months

Minimum flares in 12 monthsAt least 2 flares

Treatment failure definitionFailure to normalize uric acid to < 6 mg/dL after 3 months at the maximally medically appropriate dose

Discontinuation trigger (pre-infusion)Consider discontinuation if preinfusion serum uric acid increases above 6 mg/dL

Initial Therapy / Medical Necessity

Initial Therapy / Medically Necessary

Covered when ALL of the following are met:

ALL of the following

ONE of
- History of at least 2 gout flares in the previous 12 monthsAt least 2 flares in previous 12 months
- At least 1 gouty tophus
- Chronic gouty arthropathy
ALL of the following
- Allopurinol
- Febuxostat
Submission of laboratory values demonstrating baseline serum uric acid level > 6 mg/dLBaseline serum uric acid > 6 mg/dL
Prescriber attests that serum uric acid levels will be monitored prior to each infusion and that discontinuation of treatment will be considered if preinfusion levels increase above 6 mg/dLConsider discontinuation if preinfusion SUA > 6 mg/dL
ANY of the following
- Rheumatologist
- Nephrologist
Krystexxa is initiated and titrated according to FDA labeled dosing for chronic gout
Initial authorization will be for no more than 12 monthsAuthorization duration: 12 months

Continuation of Therapy / Reauthorization

Reauthorization is covered when ALL of the following are met:

ALL of the following

Patient has previously received treatment with Krystexxa
Patient has experienced a positive clinical response to Krystexxa (e.g., serum uric acid levels < 6 mg/dL, tophus reduction, etc.)SUA < 6 mg/dL or tophus reduction as examples of response
Patient has not had two consecutive uric acid levels above 6 mg/dL after initiating treatment with KrystexxaNot two consecutive SUA > 6 mg/dL
ANY of the following
- Rheumatologist
- Nephrologist
Krystexxa is initiated and titrated according to FDA labeled dosing for chronic gout
Reauthorization will be for no more than 12 monthsAuthorization duration: 12 months

Not Medically Necessary / Unproven

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Denial Risk

Not covered indication

Treatment of asymptomatic hyperuricemia is considered unproven and not medically necessary and may be denied.

Asymptomatic hyperuricemia may be denied.

Applicable Codes

Drug HCPCSHCPCSCovered

J2507

Injection, pegloticase, 1 mg

Applicable Diagnosis Codes (Chronic Gout and Subtypes)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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Provider Actions / Authorization Requirements

Prior Authorization

Initial prior authorization requirements

Submit documentation of symptomatic gout criteria, baseline serum uric acid > 6 mg/dL, and evidence of intolerance/contraindication or treatment failure of both allopurinol and febuxostat after 3 months at the maximally medically appropriate dose. Prescriber must attest that serum uric acid levels will be monitored prior to each infusion and that discontinuation of treatment will be considered if preinfusion serum uric acid increases above 6 mg/dL.

J2507

Documentation Required

Prescriber specialty requirement

Krystexxa must be prescribed by a rheumatologist or nephrologist for both initial and continuation authorizations.

Billing Rule

Authorization duration

Initial and reauthorization approvals are limited to no more than 12 months per authorization period.

Clinical Evidence

FDA indication (informational): Treatment of chronic gout in adults refractory to conventional therapy.

Key RCTs: Phase 3 randomized controlled trials demonstrating efficacy in refractory chronic gout (Sundy et al. JAMA 2011). Evidence is provided for informational purposes.

Background

Pegloticase is a PEGylated uricase (uric acid–specific enzyme) that lowers serum uric acid by catalyzing the oxidation of uric acid to allantoin; it is indicated for the treatment of chronic gout in adults refractory to conventional therapy.

Definitions

Gout refractory to conventional therapyPatients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

Revision History

2026-06-01material_changeLatest

Archived previous policy version CS2026D0082L

2026-06-01revised_textLatest