DraftUnitedHealthcarePolicy 2025D0082H

Krystexxa (Pegloticase) — Medical Benefit Drug Policy

Medical benefit drug policy describing clinical coverage criteria, coding references, and authorization requirements for Krystexxa (pegloticase) for UnitedHealthcare Commercial members.

Policy Summary

PayerUnitedHealthcare

PolicyKrystexxa (Pegloticase) — Medical Benefit Drug Policy

Policy CodePolicy 2025D0082H

Change TypeEditorial updatesreferences refreshed

Effective DateNov 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation of diagnosis, baseline serum uric acid > 6 mg/dL, and prior treatment failure or intolerance to allopurinol and febuxostat.

SourceLink

POLICY UPDATE CHANGES

Coverage Rationale replaced branded references 'Zyloprim (allopurinol)' and 'Uloric (febuxostat)' with generic names 'allopurinol' and 'febuxostat'.

Background and References sections updated to reflect most current information.

12 monthsmaximum initial authorization duration

J2507listed HCPCS injection code for pegloticase

>6 mg/dLbaseline serum uric acid requirement

>=2/yrone diagnostic criterion for symptomatic gout

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indication covered (adult)

0Medicare NCD/LCD for Krystexxa

Coverage Criteria for Krystexxa (pegloticase)

Initial Therapy

Covered when ALL of the following are met for initial therapy

Initial therapy criteria: Patient has symptomatic gout (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 uric acid to < 6 mg/dL after 3 months at maximally medically appropriate dose) with BOTH allopurinol AND febuxostat AND submission of laboratory values demonstrating 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 discontinuation will be considered 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 for chronic gout AND initial authorization will be for no more than 12 months.

Continuation Therapy

Covered when ALL of the following are met for continuation of therapy

Continuation therapy criteria: Patient has previously received treatment with Krystexxa AND patient has experienced a positive clinical response to Krystexxa (e.g., serum uric acid < 6 mg/dL, tophus reduction) AND patient has not had two consecutive uric acid levels > 6 mg/dL after initiating treatment with Krystexxa AND prescribed by a rheumatologist or nephrologist AND Krystexxa is initiated and titrated according to US FDA labeled dosing for chronic gout AND reauthorization will be for no more than 12 months.

Not Medically Necessary

Unproven indication: Krystexxa is unproven and not medically necessary for the treatment of asymptomatic hyperuricemia.

Initial therapy / Coverage criteria

Covered when ALL of the following are met:

Indication: Patient is an adult with chronic gout refractory to conventional therapy (per FDA: 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.

Failure of conventional therapy: Patient has failed to normalize serum uric acid and has signs/symptoms inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose, or these drugs are contraindicated.

Per FDA label and policy description.

Clinical course criteria: Patient has frequent gout flares (≥ 2 flares/year) OR non-resolving subcutaneous tophi after prior therapies failed; ACR 2020 recommends pegloticase for patients with frequent flares or non-resolving tophi and recommends against pegloticase for patients with infrequent flares (< 2/year) and no tophi.≥ 2 flares/year

Krystexxa (pegloticase) is explicitly not covered for the treatment of asymptomatic hyperuricemia. The policy states that Krystexxa is "unproven and not medically necessary" for this indication.

Per the FDA labeling cited in this policy, Krystexxa is not recommended for the treatment of asymptomatic hyperuricemia and its indicated use is limited to adults with chronic gout refractory to conventional therapy.

The policy reiterates that use of Krystexxa for asymptomatic hyperuricemia is not medically necessary and is listed among the exclusions to coverage.

The American College of Rheumatology (ACR) 2020 guidance strongly recommends against using pegloticase as first-line urate-lowering therapy. The ACR advises that switching to pegloticase is appropriate only after failure of xanthine oxidase inhibitors, uricosurics, and other interventions — and is recommended for patients with frequent flares (≥ 2 flares/year) or persistent tophi; conversely, pegloticase is strongly recommended against for patients with infrequent flares (< 2/year) and no tophi.

Coding and Diagnostic Codes

Applicable HCPCSHCPCS

J2507

Injection, Pegloticase, 1mg

Example ICD-10 diagnosis codes (many chronic gout codes listed)ICD-10

M1A.00X0	Idiopathic chronic gout, unspecified site, without tophus (tophi)
M1A.00X1	Idiopathic chronic gout, unspecified site, with tophus (tophi)

Applicable ICD-10-CM Diagnosis CodesICD-10

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.39X1	Chronic gout due to renal impairment, multiple sites, with 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.4110	Other secondary chronic gout, right shoulder, without tophus (tophi).
M1A.4111	Other secondary chronic gout, right shoulder, with tophus (tophi).
M1A.4120	Other secondary chronic gout, left shoulder, without tophus (tophi).

1–10 of 55

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inv-12: Baseline serum uric acid

Baseline serum uric acid threshold> 6 mg/dL

Documentation requiredSubmission of laboratory values demonstrating baseline serum uric acid level > 6 mg/dL

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

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Krystexxa (pegloticase). Providers must submit documentation of the diagnosis of chronic gout refractory to conventional therapy and evidence of prior treatment failure, intolerance, or contraindication to both allopurinol and febuxostat. Include baseline laboratory values (serum uric acid > 6 mg/dL) and a prescriber attestation that serum uric acid will be monitored prior to each infusion and that treatment will be discontinued if pre-infusion uric acid increases above 6 mg/dL. Initial authorizations are limited to no more than 12 months.

Affected drug: Krystexxa (pegloticase)
Required labs: baseline serum uric acid > 6 mg/dL; ongoing pre-infusion uric acid monitoring
Initial authorization: ≤ 12 months

Note

Prior Authorization and Benefit Verification

Verify member-specific benefits and prior authorization requirements before administration. For Medicare Advantage members, confirm Part B rules for drugs furnished 'incident to' a physician's service and refer to applicable Medicare Part B step therapy programs and local guidance when present. The member's benefit document and any federal/state mandates govern coverage.

Background

Krystexxa (pegloticase) is a PEGylated recombinant uricase — a uric acid–specific enzyme that catalyzes the oxidation of uric acid. It is indicated as an intravenous urate-lowering therapy for adult patients with chronic gout refractory to conventional therapy (patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at maximally appropriate doses). The FDA labeling also notes the limitation that Krystexxa is not recommended for asymptomatic hyperuricemia.

Definitions and Terminology

inv-22: Symptomatic gout

DefinitionHistory of ≥ 2 gout flares in the previous 12 months OR at least 1 gouty tophus OR chronic gouty arthropathy

ContextRequired as part of initial therapy criteria for chronic gout refractory to conventional therapy

Source guidanceRefers to Coverage Rationale criteria for Krystexxa (pegloticase)

inv-23: Treatment failure

Definition of treatment failureFailure to normalize serum uric acid to < 6 mg/dL after 3 months of therapy at the maximally medically appropriate dose

Applies toBoth allopurinol and febuxostat must have history of contraindication, intolerance, or treatment failure

Policy Summary

PayerUnitedHealthcare

PolicyKrystexxa (Pegloticase) — Medical Benefit Drug Policy

Policy CodePolicy 2025D0082H

Change TypeEditorial updatesreferences refreshed

Effective DateNov 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation of diagnosis, baseline serum uric acid > 6 mg/dL, and prior treatment failure or intolerance to allopurinol and febuxostat.

SourceLink

On This Page

Reflects ACR 2020 guidance on when to switch to pegloticase.

Check member-specific benefit plan and applicable federal/state mandates
Medicare: confirm Medicare Part B "incident to" rules and any MAO-specific step therapy programs
In event of conflict, member-specific benefit plan document governs

Step Therapy

Step Therapy Requirement

Step therapy requires prior trial and failure, intolerance, or contraindication to both allopurinol and febuxostat. Failure is defined as inability to normalize serum uric acid to < 6 mg/dL after at least 3 months of therapy at maximally medically appropriate doses. Providers must document trials and outcomes for both agents unless a contraindication or intolerance is documented.

Required prior therapies: Allopurinol and Febuxostat
Minimum trial duration: ≥ 3 months at maximally medically appropriate dose (unless contraindicated/intolerant)
Failure threshold: persistent serum uric acid ≥ 6 mg/dL

Note

Step Therapy Positioning

Pegloticase is positioned for patients with chronic gout who are refractory to conventional urate-lowering therapy — i.e., those who have failed to normalize serum uric acid and whose signs/symptoms remain inadequately controlled despite maximally appropriate xanthine oxidase inhibitor therapy or for whom these agents are contraindicated. Not recommended as first-line therapy.

Indicated for chronic gout refractory to conventional therapy
Not recommended as first-line therapy per ACR guidance

Denial Risk

Potential Denial Triggers

Potential denial may occur if documentation is incomplete or does not demonstrate prior failure/intolerance/contraindication to both allopurinol and febuxostat after adequate trials, if baseline serum uric acid is not > 6 mg/dL, or if prescriber attestation for uric acid monitoring is missing. Requests for indications other than chronic gout refractory to conventional therapy or for asymptomatic hyperuricemia will be denied as not medically necessary.

Denial triggers: lack of documented trials of allopurinol and febuxostat (≥ 3 months at max appropriate dose)
Denial triggers: missing baseline serum uric acid > 6 mg/dL
Denial triggers: absent prescriber attestation for pre-infusion uric acid monitoring
Not covered: asymptomatic hyperuricemia or non-refractory indications

Documentation Required

Coverage Indication Limits

Coverage is limited to the treatment of chronic gout refractory to conventional therapy. Krystexxa is not covered for asymptomatic hyperuricemia or indications outside chronic refractory gout. For continuation, documentation of clinical benefit (e.g., serum uric acid < 6 mg/dL, tophus reduction) and no two consecutive uric acid levels > 6 mg/dL after initiating therapy is required for reauthorization (reauthorizations also limited to ≤ 12 months).

Covered indication: chronic gout refractory to conventional therapy only
Not covered: asymptomatic hyperuricemia or other non-refractory uses
Continuation criteria: evidence of clinical response and uric acid control; reauthorization ≤ 12 months

Documentation Required

Coverage Decision Documentation

When submitting prior authorization requests, include member-specific benefit references and any applicable federal or state mandates. For Medicare Advantage reviews, reference CMS guidance regarding Part B coverage and any MAO step therapy programs. Maintain clear documentation of prior therapies, laboratory results, prescriber specialty (rheumatologist or nephrologist preferred), and FDA-aligned dosing/titration.

Required documentation: member benefit plan reference and applicable mandates
Prescriber specialty: Rheumatologist or Nephrologist preferred
Clinical documentation: prior therapy trials, baseline and ongoing serum uric acid values, dosing plan per FDA labeling

Documentation expectationRecords should show 3 months of therapy at maximally medically appropriate dose prior to deeming failure

inv-24: Gout refractory to conventional therapy

DefinitionPatients who have failed to normalize serum uric acid and whose signs and symptoms remain inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose, or for whom these drugs are contraindicated

IndicationFDA-indicated population for Krystexxa: chronic gout refractory to conventional therapy

Policy applicationCoverage requires documented failure or contraindication to XOIs and persistent signs/symptoms despite conventional therapy