CurrentAnthemPolicy CC-0057

Krystexxa (pegloticase) - Medical Drug Clinical Criteria

Medical necessity and prior authorization criteria for use of Krystexxa (pegloticase) for treatment of chronic gout under Anthem's medical benefit; affects providers requesting authorization and patients meeting clinical criteria.

Policy Summary

PayerAnthem

PolicyKrystexxa (pegloticase) - Medical Drug Clinical Criteria

Policy CodePolicy CC-0057

Change TypeNo material change

Effective DateJul 23, 2025

Next Review Date

Key ActionObtain prior authorization and document baseline serum uric acid ≥6 mg/dL and prior trial/failure or intolerance to conventional urate-lowering therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum age for therapy

>=6 mg/dLserum uric acid threshold

2quantity limit (vials/28d)

J2507HCPCS code

≥3 flares/18mdefinition: refractory gout

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Initial Therapy

Initial requests may be approved when ALL of the following are met:

Initial approval criteria: I. Individual is 18 years of age or older;

Diagnosis of chronic gout (one or more required): II. Diagnosis of chronic gout demonstrated by one or more of: A. Three or more gout flares in the previous 18 months; OR B. One or more tophus present; OR C. History of chronic gouty arthropathy (clinical or radiographic joint damage due to gout).

Reference: Sundy 2011

Baseline serum uric acid: III. Documentation is provided that individual has a baseline serum uric acid ≥ 6 mg/dL prior to initiating Krystexxa (pegloticase).>= 6 mg/dL

Reference: FitzGerald 2020

Prior therapy requirement: IV. Documentation the individual has failed to respond to, is intolerant of, or has a medical contraindication to one or more conventional therapies (e.g., a xanthine oxidase inhibitor such as allopurinol or febuxostat, or combination therapy of a xanthine oxidase inhibitor with a uricosuric agent).

Reference: FitzGerald 2020; ACR guidance

Concomitant therapy: V. Krystexxa (pegloticase) will be administered in combination with weekly methotrexate and folic acid/folinic acid supplementation unless contraindicated or not clinically appropriate.

Methotrexate co-administration recommended to reduce anti-drug antibodies

Continuation Therapy

Continuation requests may be approved when ALL of the following are met:

Clinical response: I. There is clinically significant improvement in clinical signs and symptoms of disease (including but not limited to reduction in serum uric acid level, gout flare reduction, tophus resolution, or reduction in joint pain).

Concomitant therapy for continuation: II. Krystexxa (pegloticase) will be administered in combination with weekly methotrexate and folic acid/folinic acid supplementation unless contraindicated or not clinically appropriate.

Monitoring and discontinuation consideration: Note: Monitor serum uric acid prior to infusions; consider discontinuing treatment if levels increase above 6 mg/dL, particularly when two consecutive levels > 6 mg/dL are observed.> 6 mg/dL (two consecutive)

Reference: product safety guidance for infusion monitoring

Do not administer Krystexxa (pegloticase) to individuals with a known glucose-6-phosphate dehydrogenase (G6PD) deficiency due to reports of hemolysis and methemoglobinemia. Krystexxa is not approved for asymptomatic hyperuricemia. The medication should not be used in combination with oral urate-lowering therapy (including but not limited to allopurinol, febuxostat, or probenecid). Requests for indications outside the specified criteria or when these exclusions apply may not be approved.

Use of Krystexxa is considered not medically necessary when the policy criteria are not met. This includes use for asymptomatic hyperuricemia, administration to individuals with a known G6PD deficiency, concurrent use with oral urate-lowering therapies, or continuation requests when the two most recent serum uric acid measurements are >= 6 mg/dL. Requests lacking required documentation or clinical justification consistent with the coverage criteria may be denied.

Provider Requirements, Limits, and Denial Risks

Prior Authorization

Prior Authorization and Quantity Limit

Prior authorization is required for Krystexxa (pegloticase). Quantity is limited to 2 vials per 28 days (8 mg/mL single-dose vial).

Quantity limit: 2 vials per 28 days (8 mg/mL single-dose vial).
Affected HCPCS: J2507 (Injection, pegloticase, 1mg [Krystexxa]).

Step Therapy

Step Therapy Requirement

Approval requires documentation of trial, failure, intolerance, or medical contraindication to conventional urate-lowering therapies prior to initiating Krystexxa.

Required trials: at least one xanthine oxidase inhibitor (allopurinol or febuxostat) OR combination therapy of a xanthine oxidase inhibitor with a uricosuric agent (e.g., probenecid).
Documentation should state if therapy was not tolerated or is contraindicated.

Documentation Required

Required Documentation

Documentation must include baseline and prior-therapy information prior to authorization. Provide baseline serum uric acid and details of previous urate-lowering therapies and outcomes.

Baseline serum uric acid level ≥ 6 mg/dL documented prior to initiating treatment.
Medical record documentation of prior urate-lowering therapies tried (drug names, doses, duration) and reason for discontinuation or failure.
For continuation requests, documentation of clinically significant improvement (e.g., reduction in serum uric acid, fewer gout flares, tophus resolution) and ongoing co-administration with methotrexate and folic acid/folinic acid unless contraindicated.

Denial Risk

Common Denial Triggers

Be aware of common denial triggers and contraindications that will result in non-approval.

Asymptomatic hyperuricemia is not an approved indication.
Do not prescribe Krystexxa to individuals with known G6PD deficiency; screening recommended for at-risk populations.
Concomitant use with oral urate-lowering therapy (including allopurinol, febuxostat, probenecid) is not allowed.
For continuation, two most recent serum uric acid levels ≥ 6 mg/dL may lead to denial.
Lack of documentation of prior therapy trials or baseline serum uric acid ≥ 6 mg/dL may result in denial.

Background

Krystexxa (pegloticase) is a recombinant uricase enzyme that lowers serum uric acid by converting uric acid to the more soluble metabolite allantoin, facilitating uric acid removal. It is FDA-approved for use in patients with chronic gout refractory to conventional therapy. Because of the risk of infusion reactions and immunologic adverse events, Krystexxa administration should occur in a healthcare setting with preparedness to manage anaphylaxis and infusion reactions; pretreatment with antihistamines and corticosteroids and monitoring of serum uric acid prior to infusions are recommended. Screening for G6PD deficiency is required prior to initiation due to risk of hemolysis and methemoglobinemia in affected individuals.

Revision History

2025-07-23Policy publish/effective dateLatest

Policy CC-0057 published with effective date 07/23/2025.

2025-06-09Annual review

Annual review completed; document status marked as Reviewed on 06/09/2025.

2024-05-17Annual review

Annual review performed on 05/17/2024 with no changes noted to coding or policy content at that time.

2024-04-01Policy change

Quantity limit for Krystexxa (8 mg/mL single-dose vial) was added effective 04/01/2024.

2023-05-19Policy change

Added requirement for combination use with methotrexate and clarified criteria for not approving combination use with oral urate-lowering therapy and for repeated elevated serum uric acid levels (05/19/2023).

2022-05-20Annual review

Annual review with wording and formatting changes (05/20/2022).

2021-08-01Administrative update

Administrative update to add documentation (08/01/2021).

2021-05-21Annual review

Annual review with updated guideline references (05/21/2021).

2020-05-15Annual review

Annual review including addition of continuation criteria (05/15/2020).

2019-05-17Annual review

Annual review with wording and formatting changes (05/17/2019).

2018-11-16Initial P&T review

Initial Pharmacy & Therapeutics review of Krystexxa with updates to criteria and off-label references (11/16/2018).

M1A.00X0-M1A.9XX1	Chronic gout
M10.00-M10.9	Gout

OpenPayer

Krystexxa (pegloticase) - Medical Drug Clinical Criteria

Coverage Criteria for Krystexxa (pegloticase)

Coding and Clinical Thresholds

Provider Requirements, Limits, and Denial Risks

Background

Definitions

Revision History