ModifiedUnitedHealthcarePolicy IEXD0082.08

Krystexxa (Pegloticase) for chronic gout — Medical Benefit Drug Policy (Individual Exchange)

Defines medical necessity criteria, coding, and authorization guidance for Krystexxa (pegloticase) for treatment of chronic gout for UnitedHealthcare Individual Exchange plans (excludes MA, NV, NY). Affects prescribers and prior authorization reviewers.

Policy Summary

PayerUnitedHealthcare

PolicyKrystexxa (Pegloticase) — Medical Benefit Drug Policy (Individual Exchange)

Policy CodePolicy IEXD0082.08

Change TypeOperational nomenclature and background updates (non-material)

Effective Date11/01/2025

Next Review DateN/A

Key ActionSubmit prior authorization with baseline serum uric acid > 6 mg/dL, documentation of prior trials/failure or contraindication to allopurinol and febuxostat, and prescriber specialty (rheumatologist or nephrologist).

SourceLink

POLICY UPDATE CHANGES

Replaced branded drug references 'Zyloprim (allopurinol)' and 'Uloric (febuxostat)' with generic names 'allopurinol' and 'febuxostat' in the Coverage Rationale.

Updated Background and References sections to reflect the most current information.

12 monthsmax initial auth

12 monthsmax reauth

J2507HCPCS

>6 mg/dLSUA requirement

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Pegloticase (Krystexxa)

Initial therapy — Krystexxa

Krystexxa is medically necessary for chronic gout when ALL of the following are met:

Initial therapy criteria: Diagnosis of symptomatic gout defined by one of the following: history of ≥2 gout flares in the previous 12 months OR at least 1 gouty tophus OR chronic gouty arthropathy; AND history of contraindication, intolerance, or treatment failure (failure to normalize serum uric acid to < 6 mg/dL) after ≥3 months of therapy at maximally medically appropriate dose with BOTH allopurinol AND febuxostat; AND submission of baseline serum uric acid level > 6 mg/dL; AND prescriber attests that serum uric acid levels will be monitored prior to each infusion and that treatment will be considered for discontinuation if preinfusion levels increase above 6 mg/dL; AND prescribed by a rheumatologist or nephrologist; AND Krystexxa is initiated and titrated according to US FDA–labeled dosing; AND initial authorization will be for no more than 12 months.

Continuation therapy — Reauthorization

Reauthorization when ALL of the following are met:

Continuation criteria: Patient has previously received Krystexxa; AND patient has experienced a positive clinical response to Krystexxa (for example, serum uric acid < 6 mg/dL, reduction in tophi, or other clinical improvement); AND patient has not had two consecutive serum uric acid measurements > 6 mg/dL after initiating treatment with Krystexxa; AND prescribed by a rheumatologist or nephrologist; AND Krystexxa is continued per US FDA–labeled dosing; AND reauthorization will be for no more than 12 months.

Not medically necessary — Pegloticase

Unproven / not medically necessary: Krystexxa (pegloticase) is unproven and not medically necessary for the treatment of asymptomatic hyperuricemia.

Medical Necessity Criteria for Pegloticase

Covered when ALL of the following are met

Patient criteria: Patient is an adult with chronic gout refractory to conventional therapy (failed to normalize serum uric acid and signs/symptoms inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose, or these drugs are contraindicated).

Supported by FDA indication and policy background.

Prior therapy and step requirements: Documented history of contraindication, intolerance, or treatment failure after ≥3 months at maximally medically appropriate dose with BOTH allopurinol and febuxostat, or intolerance/contraindication to xanthine oxidase inhibitors; prior use and optimization of other first-line urate-lowering therapies expected per guideline recommendations.

Per policy step therapy expectations and FDA definition of refractory gout.

Severe disease features (at least one): Frequent gout flares (≥2 flares/year) OR nonresolving subcutaneous tophi OR crystal-proven severe debilitating chronic tophaceous gout with poor quality of life.

Derived from ACR and EULAR recommendations.

Treatment of asymptomatic hyperuricemia is listed as an exclusion in this policy. The policy specifies that Krystexxa (pegloticase) is intended for adults with chronic gout refractory to conventional therapy and not for patients who have elevated serum uric acid alone without clinical manifestations of gout.

The U.S. Food and Drug Administration states that Krystexxa is not recommended for the treatment of asymptomatic hyperuricemia. This policy aligns with that limitation of use and explicitly notes that pegloticase should not be used for asymptomatic hyperuricemia.

Use of pegloticase for asymptomatic hyperuricemia is considered unproven and not medically necessary under this policy. The coverage criteria require clinical manifestations of gout and prior therapy failure or intolerance before pegloticase is considered.

The American College of Rheumatology (ACR) 2020 guidelines strongly recommend against the choice of pegloticase as first-line therapy. ACR also advises that pegloticase is not appropriate for patients who have infrequent flares (<2 per year) and no tophi; consideration of pegloticase is reserved for patients with frequent flares or nonresolving tophi after failure of other urate-lowering therapies.

Coding — HCPCS and ICD-10

Applicable HCPCS CodesHCPCSCovered

J2507

Injection, Pegloticase, 1mg

Applicable ICD-10 Diagnosis Codes (partial list shown)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)

1–10 of 14

1/2

Applicable ICD-10 CodesICD-10

M1A.3720	Chronic gout due to renal impairment, left ankle and foot, without tophus (tophi)
M1A.3721	Chronic gout due to renal impairment, left ankle and foot, with tophus (tophi)
M1A.3790	Chronic gout due to renal impairment, unspecified ankle and foot, without tophus (tophi)
M1A.3791	Chronic gout due to renal impairment, unspecified ankle and foot, with tophus (tophi)
M1A.38X0	Chronic gout due to renal impairment, vertebrae, without tophus (tophi)
M1A.38X1	Chronic gout due to renal impairment, vertebrae, with tophus (tophi)
M1A.39X0	Chronic gout due to renal impairment, multiple sites, without tophus (tophi)
M1A.40X0	Other secondary chronic gout, unspecified site, without tophus (tophi)
M1A.40X1	Other secondary chronic gout, unspecified site, with tophus (tophi)
M1A.4111	Other secondary chronic gout (description as listed in policy)

1–10 of 52

1/6

Baseline serum uric acid

Baseline serum uric acid requirement> 6 mg/dL (submission of laboratory values demonstrating baseline serum uric acid > 6 mg/dL is required)

Monitoring expectationPrescriber must attest serum uric acid levels will be monitored prior to each infusion

Discontinuation threshold noteConsider discontinuation if preinfusion serum uric acid increases above 6 mg/dL

Serum uric acid (SUA) target

SUA target guidanceGuideline-recommended uricemia targets should be used to guide therapy (aim for SUA < target per treating guidelines)

EULAR high SUA threshold

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Krystexxa (pegloticase). Initial authorization may be granted for up to 12 months when all initial-therapy criteria are met. Reauthorization may be granted for up to 12 months when continuation criteria are met. Coverage decisions must follow the member-specific benefit plan document; the plan governs in the event of a conflict.

Initial and reauthorization up to 12 months when criteria met
Prescriber types: Rheumatologist or Nephrologist
Krystexxa must be initiated and titrated per FDA labeled dosing

Step Therapy

Step Therapy: Trial of Other ULTs Expected

Before approval, documentation must show the patient has chronic gout refractory to conventional therapy and has had appropriate prior trials of urate-lowering therapies (ULTs). A trial and optimization of first-line ULTs is expected, including failure, contraindication, or intolerance after an appropriate trial at maximally medically appropriate doses.

Background and Clinical Context

Krystexxa (pegloticase) is a PEGylated recombinant uricase indicated for adults with chronic gout refractory to conventional therapy. The policy scope covers symptomatic gout (for example, recurrent flares, tophi, or chronic gouty arthropathy) in patients who have failed to normalize serum uric acid despite optimized therapy with xanthine oxidase inhibitors or who have contraindications to those agents. Prior authorization is required and initial approvals are limited to a maximum of 12 months; continuation requires documented clinical benefit and monitoring. The policy excludes treatment of asymptomatic hyperuricemia and follows FDA limitations of use and guideline-based step-therapy expectations.

Definitions Used in This Policy

Symptomatic gout

Definition (recurrent flares)History of at least 2 gout flares in the previous 12 months

Definition (tophus)At least 1 gouty tophus

Definition (chronic arthropathy)Chronic gouty arthropathy

Gout refractory to conventional therapy

Failure to normalize SUAPatient has failed to normalize serum uric acid despite xanthine oxidase inhibitors at maximum medically appropriate dose

Inadequate control of signs/symptomsSigns and symptoms (e.g., flares, tophi, arthropathy) remain inadequately controlled despite conventional therapy

Policy Revision History and Changes

2025-11-01policy_effective_dateLatest

Policy effective date updated to 11/01/2025 and administrative background/instructions refreshed.

nomenclature_update

Operational update replacing branded drug references (e.g., 'Zyloprim' and 'Uloric') with generic names 'allopurinol' and 'febuxostat' in the Coverage Rationale.