CurrentCareSourcePolicy N/A

Krystexxa (pegloticase) — Prior Authorization and Coverage Criteria

Defines prior authorization and medical necessity criteria for Krystexxa (pegloticase) for treatment of chronic gout in adult members of CareSource in Arkansas PASSE benefit; affects providers requesting medical benefit coverage and prior authorization.

Policy Summary

PayerCareSource

PolicyKrystexxa (pegloticase) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeRevision (effective 07/01/2025)

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization; initial approvals granted for 6 months when all criteria are met.

SourceLink

POLICY UPDATE CHANGES

New policy for Krystexxa (pegloticase) created 04/06/2021 and subsequently revised.

Effective date set to 07/01/2025 with revised date 01/15/2025.

6 monthsinitial approval duration

12 monthsreauthorization duration

8 mgvial strength

every 2 weeksdosing interval

>=18minimum age

Coverage Criteria for Krystexxa (pegloticase)

inv-01: Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial Authorization: Medication prescribed by or in consultation with a rheumatologist; Member is at least 18 years of age; Diagnosis of chronic gout with >=2 flares per year OR non-resolving subcutaneous tophi; Trial of a xanthine oxidase inhibitor (e.g., allopurinol or febuxostat) at maximally appropriate dose; Inadequate response (sUA remains > 6 mg/dL) or contraindication to at least 3 months of both a xanthine oxidase inhibitor and a uricosuric agent (e.g., probenecid); Other urate-lowering therapy (allopurinol, febuxostat, probenecid, lesinurad) will be discontinued; Krystexxa will be co-administered with weekly methotrexate 15 mg unless contraindicated or not tolerated; Member does not have G6PD deficiency per screening result; Dosage: 1 single-dose vial (8 mg) IV every 2 weeks, co-administered with weekly methotrexate 15 mg.

If all the above requirements are met, approve for 6 months.

inv-02: Continuation Therapy / Reauthorization

Covered when ALL of the following are met for reauthorization:

Reauthorization:

Policy Summary

PayerCareSource

PolicyKrystexxa (pegloticase) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeRevision (effective 07/01/2025)

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization; initial approvals granted for 6 months when all criteria are met.

SourceLink

On This Page

Member's serum uric acid (SUA) level has been maintained below 6 mg/dL; Chart notes demonstrate a positive clinical outcome from the medication (e.g., reduction of flares or reduction of tophi).

If all the above requirements are met, approve for an additional 12 months.

CareSource considers Krystexxa (pegloticase) not medically necessary for indications not listed in this document. Off‑label use of Krystexxa requires review under the plan's Off‑Label policy and supporting clinical documentation consistent with that policy.

Treatment of conditions not specifically listed in this policy is considered not medically necessary and will not be covered. Providers should consult the Off‑Label policy for requests outside the listed indications.

Initial Authorization Requirements

inv-12: Initial Therapy

Initial authorization requirements

Initial: 1) Medication prescribed by or in consultation with a rheumatologist; 2) Member is >= 18 years of age; 3) Diagnosis of chronic gout with >=2 flares/year OR non-resolving subcutaneous tophi; 4) Trial of a xanthine oxidase inhibitor (e.g., allopurinol or febuxostat) at maximally appropriate dose (allopurinol typically 300–800 mg/day); 5) Inadequate response (sUA remains >6 mg/dL) or contraindication to at least 3 months of both a xanthine oxidase inhibitor and a uricosuric agent (e.g., probenecid); 6) Other urate-lowering therapy will be discontinued (e.g., allopurinol, febuxostat, probenecid, lesinurad); 7) Krystexxa will be co-administered with methotrexate weekly (15 mg) unless contraindicated or not tolerated; 8) Member does not have G6PD deficiency per screening result; 9) Dosage: 1 single-dose vial (8 mg) IV every 2 weeks, co-administered with weekly methotrexate 15 mg.

If all requirements are met, approve for 6 months.

Reauthorization / Continuation Requirements

inv-13: Reauthorization

Reauthorization requirements

Reauthorization: 1) Member's serum uric acid (SUA) level has been maintained below 6 mg/dL; 2) Chart notes demonstrate a positive clinical outcome from treatment (e.g., reduction of gout flares or reduction of tophi).SUA <6 mg/dL

If all the above requirements are met, approve for an additional 12 months.

Provider Requirements and Operational Notes

Prior Authorization

Prior Authorization Required

Krystexxa (pegloticase) is a medical benefit and requires prior authorization. Initial approvals are granted for 6 months when all initial criteria are met. Dosage: 8 mg IV every 2 weeks (1 single‑dose vial) co‑administered with weekly methotrexate 15 mg unless contraindicated. Prior authorization must document specialist involvement (prescribed by or in consultation with a rheumatologist) and that other urate‑lowering therapies will be discontinued.

Initial approval duration: 6 months
Dose/limit: 8 mg IV every 2 weeks; co‑administer methotrexate 15 mg weekly unless contraindicated

Step Therapy

Step Therapy Requirement

Step therapy is required before initiating Krystexxa. The provider must document a trial and inadequate response or contraindication to a xanthine oxidase inhibitor (e.g., allopurinol or febuxostat at maximally appropriate dose) AND a uricosuric agent (e.g., probenecid) for at least 3 months. Allopurinol is considered first‑line therapy (typical dosing 300–800 mg/day) when appropriate.

Required prior agents: xanthine oxidase inhibitor (allopurinol or febuxostat) AND a uricosuric agent (probenecid)
Duration: ≥3 months of therapy or documented contraindication/inadequate response (sUA > 6 mg/dL)

Documentation Required

Documentation for Reauthorization

For reauthorization, submit chart notes showing sustained clinical benefit (for example, reduction in gout flares or reduction/resolution of tophi) and documentation that the member's serum uric acid (sUA) has been maintained below 6 mg/dL. If these requirements are met, approval may be extended for an additional 12 months.

Chart notes documenting clinical outcome (e.g., fewer flares, decreased tophi)
Laboratory: sUA < 6 mg/dL maintained

Denial Risk

Denial Risk — Missing Required Documentation

Denial risk is high if there is no documentation of prior use of a xanthine oxidase inhibitor and a uricosuric agent, if specialist consultation is not documented, if G6PD deficiency screening is absent or positive, or if required dosing/contraindication notes (methotrexate co‑administration) are missing. Ensure all required records (trial history, lab results, rheumatologist involvement, G6PD status) are included with the PA submission to avoid denial.

Missing trials of required agents (xanthine oxidase inhibitor and uricosuric) risks denial
Absent chart notes showing positive clinical outcome or sUA < 6 mg/dL risks denial
Missing rheumatology consult or G6PD screening risks denial

Step Therapy Requirements

Step	Requirement	Minimum duration / failure definition
1	Trial of a xanthine oxidase inhibitor (e.g., allopurinol or febuxostat) at maximally appropriate dose	At least 3 months; inadequate response defined as serum uric acid (sUA) remaining above 6 mg/dL
2	Trial of a uricosuric agent (e.g., probenecid) at an appropriate dose	At least 3 months; inadequate response defined as serum uric acid (sUA) remaining above 6 mg/dL

Clinical Targets and Coding-relevant Clinical Values

inv-05: Serum uric acid (SUA) — maintained below 6 mg/dL (clinical target for continuation).

SUA targetSerum uric acid (SUA) maintained below 6 mg/dL for reauthorization

Measurement purposeEvidence of maintained SUA <6 mg/dL required to demonstrate biochemical response for continued therapy

DocumentationChart notes must show SUA values consistent with <6 mg/dL at reauthorization assessment

Quantity Limits and Dosing

inv-15: Krystexxa (pegloticase) — 1 single-dose vial (8 mg).

Vial strength1 single-dose vial (8 mg)

Route and frequencyAdministered as an intravenous infusion every 2 weeks

Quantity limit contextQuantity limit specified as 1 single-dose vial (8 mg) per administration

Site of Care / Administration

Billing Rule

Administer as IV infusion in infusion center (medical benefit)

Krystexxa is administered as an intravenous infusion and is billed as a medical benefit provided in an infusion center setting.

Dosage/administration: 1 single-dose vial (8 mg) given as an IV infusion every 2 weeks.
Site of care: infusion center (medical benefit).

Definitions

inv-11: Chronic gout refractory to conventional therapy — definition including frequent flares (>=2 per year) or non-resolving tophi despite conventional therapy.

DefinitionChronic gout refractory to conventional therapy: adult patients with continued frequent flares (>=2 per year) or non-resolving subcutaneous tophi despite conventional urate-lowering therapies

Patient ageApplies to adults aged >=18 years

Prior treatmentsReserved for patients who have failed or are intolerant/contraindicated to xanthine oxidase inhibitors and uricosurics

Clinical guideline basisUse aligned with ACR guidance recommending pegloticase for patients who have failed other urate-lowering therapies and continue to have frequent flares or non-resolving tophi

Background

Pegloticase (Krystexxa) is a PEGylated, uric acid–specific enzyme indicated for adults with chronic gout refractory to conventional therapy. It is reserved for patients who have failed or are intolerant to standard urate‑lowering treatments and who continue to have frequent gout flares or persistent tophi.

Document History and Revisions

2021-04-06creation

New policy for Krystexxa (pegloticase) created.

2022-07-28revision

Policy revised (document history records a revision on 07/28/2022).

2025-01-15revisionLatest

Policy revised (document history records a revision on 01/15/2025); effective date set to 2025-07-01.