CurrentmhnPolicy CP.PHAR.115

Pegloticase (Krystexxa) coverage

Defines medical necessity and prior authorization criteria for pegloticase (Krystexxa) for treatment of chronic gout in adults across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyPegloticase (Krystexxa) coverage

Policy CodePolicy CP.PHAR.115

Change TypeNo material changes

Effective DateJun 1, 2013

Next Review DateFeb 25, 2025

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) showing member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age ≥ 18minimum patient age for coverage

8 mg q2wmaximum dosing regimen

J2507HCPCS code

Medicaid/HIM 6–12 moapproval durations

2013policy year

Coverage Criteria

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inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Approval - Chronic Gout: 1) Diagnosis of chronic gout; 2) Age ≥ 18 years; 3) Symptomatic gout with one or more of the following: (a) ≥3 gout flares in the previous 18 months, (b) ≥1 gout tophus, or (c) chronic gouty arthritis; 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 intolerant/contraindicated; 5) Failure of one uricosuric agent (e.g., probenecid or losartan) at maximally indicated doses in combination with allopurinol or febuxostat unless intolerant/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 two weeks.age >= 18; serum uric acid < 6 mg/dL; dose <= 8 mg q2w

inv-02: Continuation Therapy

Continued coverage when ALL of the following are met:

Continued Therapy - Chronic Gout: 1) Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria, or (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy as evidenced by a decrease in plasma uric acid levels; 3) Krystexxa is not prescribed concurrently with oral urate-lowering agents (e.g., allopurinol, febuxostat, probenecid); 4) If request is for a dose increase, new dose does not exceed 8 mg (uricase protein) every two weeks.dose <= 8 mg q2w

Requests for indications that are not FDA‑approved and that are not specifically addressed in this policy are excluded unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with the coverage provisions in this clinical policy; providers should consult the applicable state Medicaid manual for any state‑specific coverage rules.

Use of Krystexxa (pegloticase) for asymptomatic hyperuricemia is not recommended and is listed as a limitation of use for this product.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Krystexxa. Providers must submit a prior authorization request; detailed PA code requirements are managed through the payer's authorization system.

Prior authorization required

Documentation Required

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

Include relevant chart notes and laboratory results
Document prior use and failure of indicated urate‑lowering therapies when applicable

Note

Follow Coverage Documents

Providers should follow the applicable evidence of coverage, certificate of coverage, policy, contract, and state-specific addendums when submitting requests and determining coverage. Coverage decisions are subject to the terms, conditions, exclusions, and limitations of the coverage documents.

Verify member-specific coverage and benefit limitations prior to requesting authorization
Refer to state-specific continuity of care addendums where applicable

Denial Risk

Non‑FDA Indications

Requests for non‑FDA approved (off‑label) indications may be denied unless there is sufficient documentation of efficacy and safety per the payer's off‑label use policies.

Refer to off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), CP.PMN.53 (Medicaid)

Note

Approval Duration

Initial and continuation approvals are time‑limited. Approval durations vary by line of business and may be limited to the member's renewal date.

Medicaid/HIM: 6 months
Commercial: 6 months or to member renewal date, whichever is longer

Initial Therapy Criteria

inv-20: Initial Therapy

Initial therapy criteria and dosing

Initial Therapy: Diagnosis of chronic gout; age ≥ 18 years; symptomatic gout as defined by ≥3 flares in 18 months, ≥1 tophus, or chronic gouty arthritis; documented failure to normalize serum uric acid to < 6 mg/dL with allopurinol and febuxostat each at maximally indicated doses for at least 3 months unless intolerant/contraindicated; failure of one uricosuric agent (e.g., probenecid or losartan) at maximally indicated dose in combination with allopurinol or febuxostat unless intolerant/contraindicated; Krystexxa must not be prescribed concurrently with oral urate-lowering agents; dose must not exceed 8 mg (uricase protein) IV every 2 weeks. Recommended coadministration with weekly oral methotrexate 15 mg when appropriate; Krystexxa alone may be used if methotrexate is contraindicated or not clinically appropriate.age >= 18; serum uric acid < 6 mg/dL; dose <= 8 mg q2w

Continuation Criteria

inv-21: Continued Therapy

Continued therapy criteria and approval durations

Continued Therapy: Member currently receiving drug via Centene benefit or previously met initial approval criteria, or member receiving drug with applicable continuity of care; member responding positively to therapy as evidenced by decreased plasma uric acid; Krystexxa is not prescribed concurrently with oral urate-lowering agents; requested dose must not exceed 8 mg (uricase protein) IV every 2 weeks.dose <= 8 mg q2w

Step Therapy / Trials and Failures

Required trial or documentation	Details / duration
Failure to normalize serum uric acid to < 6 mg/dL with allopurinol	Allopurinol used at maximally indicated doses for at least 3 months unless intolerant or contraindicated (see therapeutic alternatives dosing in Appendix B).
Failure to normalize serum uric acid to < 6 mg/dL with febuxostat	Febuxostat used at maximally indicated doses for at least 3 months unless intolerant or contraindicated (see therapeutic alternatives dosing in Appendix B).
Failure of one uricosuric agent in combination with allopurinol or febuxostat	Example agents: probenecid or losartan; used at maximally indicated doses in combination with allopurinol or febuxostat unless intolerant/contraindicated. Duration ≥ 3 months per agent as applicable.
Documentation submitted by provider	Office chart notes, laboratory results (serum uric acid), or other clinical information demonstrating trials/failures and meeting initial criteria must be provided.

Definitions

inv-17: Pegloticase (Krystexxa) — definition, indication, contraindications summary

DefinitionPegloticase (Krystexxa) is a PEGylated uric acid–specific enzyme indicated for treatment of chronic gout in adult patients refractory to conventional therapy.

IndicationTreatment of chronic gout in adults refractory to conventional urate‑lowering therapies; not recommended for asymptomatic hyperuricemia.

ContraindicationsContraindicated in patients with glucose‑6‑phosphate dehydrogenase (G6PD) deficiency.

Warnings/risksBoxed warnings include anaphylaxis and infusion reactions; risk of G6PD deficiency–associated hemolysis and methemoglobinemia.

inv-18: Health Plan — definition of 'Health Plan' term

Definition of 'Health Plan''Health Plan' means 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, as applicable.

Purpose in policyDefines the entity responsible for adopting and administering the clinical policy and related administrative procedures.

inv-19: Provider relationship — providers are independent contractors note

Provider relationship statementProviders are independent contractors who exercise independent judgment; they are not agents or employees of the Health Plan.

Implication for controlHealth Plan has no control or right of control over providers' professional judgment and clinical care decisions.

Contractual noteProviders, members, and their representatives are bound to policy terms through contractual relationships or by providing services/submitting claims.

Background

Pegloticase (Krystexxa) is a PEGylated uric acid‑specific enzyme indicated for the treatment of chronic gout in adults refractory to conventional therapy. The product is supplied as an 8 mg vial for intravenous administration (dosing described as 8 mg IV every 2 weeks). Important safety considerations include contraindication in patients with glucose‑6‑phosphate dehydrogenase (G6PD) deficiency and boxed warnings for anaphylaxis, infusion reactions, and G6PD‑associated hemolysis and methemoglobinemia.

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