CurrentCentenePolicy CP PHAR.115

Pegloticase (Krystexxa)

Coverage and prior authorization criteria for pegloticase (Krystexxa) for treatment of chronic gout in members of Centene-affiliated health plans (commercial, HIM, Medicaid). Applies to providers requesting coverage under Centene benefits.

Policy Summary

PayerCentene

PolicyPegloticase (Krystexxa)

Policy CodePolicy CP PHAR.115

Change TypeNo material changes

Effective Date06.01.13

Next Review Date

Key ActionSubmit prior authorization with clinical documentation showing failure to normalize serum uric acid to <6 mg/dL after trials of allopurinol and febuxostat and trial of a uricosuric agent.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8 mgdose (mg)

<6serum uric acid target

≥3flares criterion

G6PDcontraindication

3disclaimer sections

Coverage Criteria

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Initial Approval Criteria

Covered when ALL of the following are met for chronic gout:

Initial Criteria: 1) Diagnosis of chronic gout; 2) Age >= 18 years; 3) Symptomatic disease evidenced by at least one of the following: >= 3 gout flares in the previous 18 months, chronic gouty arthritis, or at least 1 gout tophus; 4) Failure to normalize serum uric acid to < 6 mg/dL with allopurinol and febuxostat at maximally indicated doses, each used for at least 3 months unless clinically significant adverse effects occur or the agent is contraindicated; 5) Failure of one uricosuric agent (e.g., probenecid or losartan) at maximally indicated doses in combination with allopurinol or febuxostat unless clinically significant adverse effects occur or contraindicated; 6) Krystexxa is not prescribed concurrently with oral urate-lowering agents (e.g., allopurinol, febuxostat, probenecid); 7) Dose does not exceed 8 mg (uricase protein) every 2 weeks.

Approval duration: Medicaid/HIM 6 months; Commercial 6 months or to member's renewal date.

Initial Therapy — dosing

Initial therapy and dosing requirements:

Initial Therapy: Diagnosis of chronic gout in adults (>=18) with symptomatic disease as defined in initial criteria; documented failure to normalize serum uric acid to < 6 mg/dL on allopurinol and febuxostat each used at maximally indicated doses for >=3 months unless intolerant or contraindicated; failure of one uricosuric agent in combination with a xanthine oxidase inhibitor unless intolerant/contraindicated; Krystexxa must not be co-prescribed with oral urate-lowering agents; recommended dosing: 8 mg IV (uricase protein) every 2 weeks.

Approval duration: Medicaid/HIM 6 months; Commercial 6 months or to member's renewal date. Product available as 8 mg/mL vial; IV administration (infusion center).

Continuation (Renewal) Criteria

Covered for continued therapy when member meets one of the following and other conditions:

Continuation Criteria: a) Member is currently receiving the medication via Centene benefit or has previously met initial approval criteria; b) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations.

Member must be responding positively to therapy as evidenced by a decrease in plasma uric acid levels; Krystexxa must not be prescribed concurrently with oral urate-lowering agents. Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to member's renewal date.

Requests for coverage of indications that are not FDA‑approved and not addressed in this policy will not be authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (Health Insurance Marketplace), or CP PMN.53 (Medicaid).

Coverage decisions are governed by the member's benefit documents and applicable laws. Coverage determinations under this policy are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance) and to Health Plan administrative policies and state or federal requirements.

Use of Krystexxa (pegloticase) for asymptomatic hyperuricemia is not recommended and is a limitation of use; the policy does not authorize therapy for this indication.

This clinical policy is intended to guide medical necessity determinations and assist coverage decisions; it is not medical advice and does not replace clinical judgment. Providers remain responsible for the medical advice and treatment of their patients and must exercise professional medical judgment when diagnosing and treating members. The policy does not constitute a contract or guarantee of payment.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Krystexxa. This policy guides medical necessity determinations used to assist coverage decisions and prior authorization review.

Prior authorization required for Krystexxa
Policy used to guide medical necessity and coverage decisions

Documentation Required

Provider must submit documentation (such as office chart notes, laboratory results, medication history, and other relevant clinical information) supporting that the member has met all approval criteria. Lack of submitted documentation may result in denial of the request.

Include office chart notes and recent laboratory results (e.g., serum uric acid levels)
Document prior medication trials, doses, durations, and reasons for discontinuation
Provide history of gout flares, tophi, and other clinical manifestations

Denial Risk

Non‑FDA Indications

Requests for non‑FDA approved (off‑label) indications are not authorized by this policy unless sufficient documentation of efficacy and safety is provided per the applicable off‑label use policies or evidence of coverage documents. Insufficient documentation for non‑FDA indications may lead to denial.

Commercial off‑label policy: CP CPA.09
Health Insurance Marketplace off‑label policy: HIM.PA.154
Medicaid off‑label policy: CP PMN.53

Note

Policy Guides Prior Authorization

Providers remain responsible for medical advice and treatment decisions. Coverage determinations remain subject to the terms, conditions, exclusions, and limitations of the member's benefit documents and applicable laws and regulations.

Coverage subject to member's benefit terms, exclusions, and limitations
Providers must exercise independent medical judgment

Initial Therapy Criteria

Initial Therapy — dosing (repeat emphasis)

Initial therapy and dosing (emphasis):

Initial Therapy: Krystexxa dosing for chronic gout: 8 mg IV (uricase protein) administered every 2 weeks. Krystexxa may be used alone when concomitant methotrexate is contraindicated; if used with methotrexate, an example co-administration is weekly oral methotrexate 15 mg. Dose increases must not exceed 8 mg every 2 weeks.

Product available as 8 mg/mL vial; IV administration (infusion center).

Required prior trials (each at maximally indicated dose)	Minimum duration / notes
Allopurinol — failure to normalize serum uric acid to < 6 mg/dL	At least 3 months at maximally indicated dose unless intolerant or contraindicated
Febuxostat — failure to normalize serum uric acid to < 6 mg/dL	At least 3 months at maximally indicated dose unless intolerant or contraindicated
One uricosuric agent (e.g., probenecid or losartan) in combination with allopurinol or febuxostat — failure	Used at maximally indicated dose unless intolerant or contraindicated
Additional requirements	Diagnosis of chronic gout in adults (≥18) with symptomatic disease (≥3 flares in 18 months, chronic gouty arthritis, or ≥1 tophus); Krystexxa not co‑prescribed with oral urate‑lowering agents; dose ≤ 8 mg IV every 2 weeks

Definitions

inv-19: Pegloticase — PEGylated uric acid-specific enzyme (Krystexxa)

Drug name (generic/brand)Pegloticase (Krystexxa)

Mechanism / classPEGylated uric acid-specific enzyme (urate-oxidizing enzyme)

IndicationTreatment of chronic gout refractory to conventional therapy

Dosing noteRecommended IV dose: 8 mg (uricase protein) every 2 weeks; product supplied as 8 mg/mL vial

inv-20: G6PD deficiency — contraindication to Krystexxa due to risk of hemolysis and methemoglobinemia

ContraindicationGlucose-6-phosphate dehydrogenase (G6PD) deficiency is a contraindication to Krystexxa

Reason for contraindicationRisk of hemolysis and methemoglobinemia in G6PD-deficient patients

Boxed warningG6PD deficiency-associated hemolysis and methemoglobinemia listed in Appendix C boxed warnings

inv-21: Health Plan — definition of health plan that adopted policy

DefinitionHealth Plan: a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates

RoleClinical policy provides guidance for medical necessity determinations to assist coverage decisions and administering benefits

LimitationsCoverage decisions are subject to all terms, conditions, exclusions, and limitations of the coverage documents and applicable law

OpenPayer

Pegloticase (Krystexxa)

Coverage Criteria

Provider Actions & Requirements

Coding

Initial Therapy Criteria

Continuation (Renewal) Criteria

Site of Care & Administration

Definitions

Background