CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Krystexxa (pegloticase) IV for chronic gout

Policy defines coverage, authorization length, dosing, prior authorization clinical criteria, renewal requirements, billing codes, units limits, and covered ICD-10 diagnoses for Krystexxa (pegloticase) for Medicaid, Commercial, and Medicare members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKrystexxa (pegloticase) IV for chronic gout

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionProviders must submit documentation of age, baseline serum uric acid >=7 mg/dL, G6PD screening result (no deficiency), prior trials/intolerance of xanthine oxidase inhibitors when applicable, evidence of gout severity, and concomitant methotrexate plan or contraindication.

POLICY UPDATE CHANGES

No material clinical or coverage changes were reported in this brief.

6 monthsAuthorization length

16Max billable units

>=7 mg/dLBaseline uric acid requirement

<6 mg/dLRenewal uric acid target

>=18Minimum age

Coverage Summary

Scope: This policy defines coverage for Krystexxa (pegloticase) IV for chronic gout across Medicaid, Commercial, and Medicare members and specifies authorization length, dosing, prior authorization clinical criteria, renewal requirements, billing codes/units limits, and covered ICD-10 diagnoses. Coverage stance: covered with criteria. Indication summary: Pegloticase (Krystexxa) is indicated for chronic gout refractory to conventional therapy. Effective date: 01/01/2020; Last review: 05/21/2025.

Key thresholds

Authorization duration6 months

Baseline serum uric acid>= 7 mg/dL

Renewal serum uric acid< 6 mg/dL (documented prior to scheduled infusion)

Billing unit limit16 billable units/28 days (HCPCS J2507; 1 unit = 1 mg)

Minimum age>= 18 years

Initial Therapy Criteria

Initial Approval Criteria

Coverage is provided when ALL of the following are met:

ALL of the following

Patient is at least 18 years of age
Patient must not have glucose-6-phosphate dehydrogenase (G6PD) deficiency
Patients at increased risk for G6PD deficiency should be screened prior to starting Krystexxa
Documentation of baseline serum uric acid level >= 7 mg/dL>=7 mg/dL
Current lab reports are required for renewal
Universal therapy restriction:

Medicare Exception to Step Therapy

Medicare exception to Step Therapy

Medicare members who have previously received this medication within the past 365 days are not subject to step therapy requirements

Member is Medicare and has received Krystexxa within the past 365 days

Continuation / Renewal Criteria

Provider Actions

Prior Authorization

Prior authorization required with clinical documentation

Providers must submit documentation of patient age, baseline serum uric acid >= 7 mg/dL, G6PD screening result showing no deficiency, prior trial/intolerance or failure of xanthine oxidase inhibitors when applicable, evidence of gout severity (e.g., two or more gout flares per year, nonresolving subcutaneous tophus, or radiographic damage), and either a plan for concomitant methotrexate or documentation that methotrexate is contraindicated or not clinically appropriate.

J2507

Documentation Required

Baseline and ongoing lab documentation

Submit baseline serum uric acid documentation >= 7 mg/dL. For renewals, submit serum uric acid < 6 mg/dL prior to the scheduled infusion and document absence of unacceptable toxicity.

Applicable Codes

HCPCS (drug billing)HCPCSCovered

J2507

Injection, pegloticase, 1 mg (1 billable unit = 1 mg)

NDC (product identification)NDC

75987-0080-xx

Krystexxa 8 mg/mL single-dose vial (xx = variable package code)

Billable unit definition: Per J2507, 1 billable unit = 1 mg pegloticase. Maximum billing: 16 billable units every 28 days. Providers should report pegloticase using HCPCS code J2507 with the unit-to-milligram mapping as specified.

Clinical Evidence & References

Clinical trials demonstrated significant reductions in serum uric acid, improvements in tophi (tophus resolution), and reductions in gout flares; common adverse events reported include infusion reactions and gout flares (also nausea and bruising). Examples of serious toxicities referenced for renewal include anaphylaxis, infusion reactions, exacerbation of congestive heart failure, and hemolytic reactions (including methemoglobinemia and hemolysis).

Package insert: Krystexxa [package insert], April 2025; Key RCTs/guidelines cited: Sundy et al. JAMA 2011; ACR 2020 Guideline; EULAR 2016 recommendations; MIRROR study (2021).

Background

Pegloticase (Krystexxa) is a PEGylated uric acid–specific enzyme indicated for the treatment of chronic gout in adult patients who are refractory to conventional therapy. The mechanism is enzymatic uric acid degradation via a PEGylated uricase. Clinical trials demonstrated marked reductions in serum uric acid, tophus improvement/resolution, and reduced frequency/severity of gout flares. Main adverse events include gout flares and infusion reactions; other reported reactions include nausea and contusion/ecchymosis. Serious toxicities cited in renewal criteria include anaphylaxis, infusion reactions, exacerbation of congestive heart failure, and hemolytic reactions (including methemoglobinemia and hemolysis).

Revision History

2020-01-01effective_date

Policy effective

2025-05-21last_reviewLatest

Last review

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKrystexxa (pegloticase) IV for chronic gout

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review DateN/A

On This Page

Will not be given in combination with other urate lowering therapies such as allopurinol, febuxostat, probenecid, lesinurad, etc.

Chronic gout indication – ONE of the following must be present

Documented contraindication, intolerance, or clinical failure (inability to reduce serum uric acid to 6 mg/dL) after a minimum 3-month trial on previous therapy with maximum tolerated dose of xanthine oxidase inhibitor (e.g., allopurinol or febuxostat)
Two or more gout flares per year that were inadequately controlled by colchicine, NSAIDs, or oral/injectable corticosteroids
At least one nonresolving subcutaneous tophus
Evidence of radiographic damage attributable to gout

Concomitant methotrexate requirement

Used in combination with methotrexate
Used as single agent if methotrexate is contraindicated or clinically not appropriate

Documentation Required

G6PD screening requirement

Document that the patient does not have glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to initiating pegloticase; screen patients at increased risk for G6PD deficiency.

Billing Rule

Units and HCPCS billing

Report HCPCS code J2507 for pegloticase. Billing is per mg: 1 billable unit = 1 mg. Maximum 16 billable units every 28 days.

J2507
1 billable unit = 1 mg

Note

Authorization length and renewal

Length of authorization is six months; eligible for renewal if renewal criteria are met.