CurrentCommunity-CarePolicy N/A

Krystexxa (pegloticase) — Medical Benefit Coverage Criteria

Defines medical benefit coverage criteria, quantity limits, and authorization periods for pegloticase (Krystexxa) for treatment of chronic gout for members of the payer.

Policy Summary

PayerCommunity-Care

PolicyKrystexxa (pegloticase) — Medical Benefit Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateSep 1, 2024

Key ActionObtain prior authorization documenting diagnosis, specialist involvement, required prior therapy trials, and required serum uric acid measurements.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥3gout flares required (18 mo)

<6 mg/dLurate target for continuation

16 mgmax dose /4 wks

6 moinitial auth period

1 yrcontinuation auth

Coverage Criteria for Pegloticase (Krystexxa)

Initial Therapy

Covered when ALL of the following are met:

Initial Approval for Gout: 1) Diagnosis of chronic gout; 2) Prescribed by, or in consultation with, a rheumatologist, nephrologist, or podiatrist; 3) Does not have G6PD deficiency; 4) Documentation of a recent serum uric acid level > 6 mg/dL within the last 2 months; 5) Has had ≥ 3 gout flares within the previous 18 months; 6) Trial of all of the following was ineffective, contraindicated, or not tolerated: (a) Allopurinol 800 mg/day (or maximally tolerated dose), (b) Febuxostat 120 mg/day (or maximally tolerated dose), (c) A xanthine oxidase inhibitor in combination with a uricosuric.see text

All listed items must be satisfied.

Continuation Therapy

Covered when ALL of the following are met:

Continuation Therapy for Gout: 1) Diagnosis of chronic gout; 2) Member is being monitored and is appropriate to continue therapy with pegloticase (Krystexxa); 3) Documentation of two recent consecutive serum uric acid levels < 6 mg/dL within the last 2 months.

Policy Summary

PayerCommunity-Care

PolicyKrystexxa (pegloticase) — Medical Benefit Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateSep 1, 2024

Key ActionObtain prior authorization documenting diagnosis, specialist involvement, required prior therapy trials, and required serum uric acid measurements.

SourceLink

On This Page

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.

Initial Therapy Requirements

Initial Therapy

Covered when ALL of the following are met:

All listed items must be satisfied.

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required before pegloticase (Krystexxa) is started. The prior authorization must document that all coverage criteria are met and include supporting clinical information.

Prior authorization required for initial and continuation requests
Include documentation that the member meets all listed clinical criteria

Step Therapy

Required Prior Therapy Trials

Before initiating pegloticase, the member must have trials of the following agents unless each is documented as ineffective, contraindicated, or not tolerated.

Allopurinol up to 800 mg/day (or maximally tolerated dose)
Febuxostat up to 120 mg/day (or maximally tolerated dose)
A xanthine oxidase inhibitor in combination with a uricosuric agent

Documentation Required

Required Documentation

Provide the following documentation with the authorization request. Incomplete documentation may delay review or result in denial.

Confirmed diagnosis of chronic gout
Prescriber is a rheumatologist, nephrologist, or podiatrist, or documentation of specialist consultation
Recent serum uric acid result > 6 mg/dL within the last 2 months for initial requests
For continuation requests: two consecutive serum uric acid levels < 6 mg/dL within the last 2 months
Documentation of ≥3 gout flares in the prior 18 months for initial approval
Clinical rationale if any required prior therapy was not tried (ineffective, contraindicated, or not tolerated)

Denial Risk

Triggers for Denial

Requests will be denied if required criteria or documentation are missing, or if exclusionary conditions are present.

Denial triggers: missing required documentation (diagnosis, specialist prescriber/consultation, required lab results)
Exclusion: documented glucose-6-phosphate dehydrogenase (G6PD) deficiency
Denial if prior therapy requirements are not met or not adequately justified
Denial may occur if member does not meet frequency/quantity/authorization-period limits

Step Therapy Requirements

Required prior oral urate‑lowering therapy	Trial details / dosage	Requirement
{"text":"Allopurinol","status":""},{"text":"Up to 800 mg/day (or maximally tolerated dose)","status":""},{"text":"Prior trial must be documented as ineffective, contraindicated, or not tolerated","status":""}
{"text":"Febuxostat","status":""},{"text":"Up to 120 mg/day (or maximally tolerated dose)","status":""},{"text":"Prior trial must be documented as ineffective, contraindicated, or not tolerated","status":""}
{"text":"A xanthine oxidase inhibitor combined with a uricosuric","status":""},{"text":"No specific dose defined (use of a xanthine oxidase inhibitor plus uricosuric)","status":""},{"text":"Prior combination trial must be documented as ineffective, contraindicated, or not tolerated","status":""}

Quantity Limits and Dosing

Pegloticase (Krystexxa) overall quantity limit

Overall quantity limitUp to 2 vials (16 mg) every 4 weeks

Maximum dose per 4 weeks16 mg total per 4 weeks (from up to 2 vials)

Authorization frequencyQuantity specified on a 4‑week basis

Pegloticase (Krystexxa) 8 mg/mL vial

Vial presentation8 mg/mL vial, 2 mL (16 mg)

Quantity limitAuthorized for up to 2 vials (2 mL each) — total 16 mg — every 4 weeks

Per‑period basisLimit applied per 4‑week authorization period

Pegloticase (Krystexxa) 8 mg/50 mL vial

Vial presentation8 mg/50 mL vial (each vial = 100 mL when 2 vials are used) — total 16 mg when 2 vials provided

Quantity limitAuthorized for up to 2 vials (100 mL total when 2 vials) — total 16 mg — every 4 weeks

Note on equivalenceOverall mg limit (16 mg every 4 weeks) applies regardless of vial presentation

Background

Pegloticase (brand name Krystexxa) is a biologic urate-lowering therapy indicated for patients with chronic gout who have not responded to or cannot tolerate conventional urate-lowering treatments. The policy covers pegloticase for members with documented chronic gout who meet specialist involvement, laboratory, and prior-therapy requirements.

For initial approval the policy requires: a documented diagnosis of chronic gout; prescription by or consultation with a rheumatologist, nephrologist, or podiatrist; documentation of a recent serum uric acid level of > 6 mg/dL within the last 2 months; at least ≥ 3 gout flares in the prior 18 months; trials of required prior therapies (allopurinol up to 800 mg/day or maximally tolerated, febuxostat up to 120 mg/day or maximally tolerated, and a xanthine oxidase inhibitor combined with a uricosuric) that were ineffective, contraindicated, or not tolerated; and confirmation that the member does not have G6PD deficiency.

Continuation of therapy requires ongoing monitoring and documentation of clinical benefit, including two consecutive serum uric acid measurements < 6 mg/dL within the most recent 2 months. Quantity limits authorize up to 16 mg (up to 2 vials) every 4 weeks, initial authorizations are for 6 months, and subsequent continuation authorizations are typically for 1 year.

OpenPayer

Krystexxa (pegloticase) — Medical Benefit Coverage Criteria

Coverage Criteria for Pegloticase (Krystexxa)

Initial Therapy Requirements

Continuation (Renewal) Requirements

Coding and Laboratory Thresholds

Provider Requirements and Authorization

Step Therapy Requirements

Quantity Limits and Dosing

Site of Care / Administration

Background

Definitions