ModifiedCentenePolicy CP.PMN.57

Febuxostat (Uloric)

This policy defines medical necessity and prior authorization criteria for febuxostat (Uloric) for Centene-affiliated health plans (HIM, Medicaid) and specifies documentation and approval durations.

Policy Summary

PayerCentene

PolicyFebuxostat (Uloric)

Policy CodePolicy CP.PMN.57

Change TypeMaterial updates (criteria, generic redirect, boxed warning)

Effective DateAug 1, 2013

Next Review DateN/A

Key ActionSubmit prior authorization with supporting chart notes and recent serum urate results to demonstrate criteria are met.

SourceLink

POLICY UPDATE CHANGES

For Illinois HIM per IL HB 5395, added criterion for failure of allopurinol aligning with FDA labeling.

Added redirection to generic febuxostat; generic requires prior authorization.

Updated boxed warning wording to 'cardiovascular death' to align with prescriber information.

For Medicaid, changed approval duration from length of benefit to 12 months.

≥18Minimum age for coverage

≥6 mg/dLSerum urate threshold

80 mgMaximum daily dose

12 moApproval duration

Azathioprine/MP

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Coverage Criteria for Febuxostat (Uloric)

inv-02: Continuation Therapy

Covered when ALL of the following are met:

Continued Therapy Criteria: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or has previously met initial approval criteria; OR (b) member is currently receiving medication and is enrolled in a state and product with continuity of care regulations; 2. Member must use generic febuxostat unless contraindicated or clinically significant adverse effects are experienced; 3. Member is responding positively to therapy as evidenced by improvement such as: (a) reduced frequency of gout attacks; or (b) serum urate level < 6 mg/dL; 4. Request does not exceed health plan-approved quantity limit, if applicable; 5. If request is for a dose increase, new dose does not exceed: (a) 80 mg per day; or (b) 1 tablet per day.see node text

Approval duration: Medicaid/HIM - 12 months

Non‑FDA approved indications that are not specifically addressed in this clinical policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (see HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for specific coverage rules and follow those requirements when they differ from this policy.

Use of Uloric (febuxostat) for asymptomatic hyperuricemia is not recommended or authorized. Requests for treatment of non‑FDA indications will be considered only when the provider supplies adequate supporting documentation of efficacy and safety consistent with the Health Plan's off‑label use policies and any applicable evidence of coverage.

Product Availability, Doses, and Coding

Product Availability / StrengthsNDC

40 mg	Tablet strength available
80 mg	Tablet strength available

inv-07: Serum urate threshold — Initial

Initial serum urate requirementCurrent (within the last 30 days) serum urate ≥ 6 mg/dL

Treatment goal notedTreatment goal for many patients: serum urate < 6 mg/dL (per ACR guidance; some contexts cite < 6.8 mg/dL as minimum threshold)

Age requirement tied to thresholdApplies for members aged ≥ 18 years as part of initial approval criteria

inv-08: Dose limit

Maximum daily doseDose does not exceed 80 mg per day

Tablet limitOr 1 tablet per day (per dosing limits)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for febuxostat (Uloric) prior to initiation or continuation of therapy. Approval duration is 12 months for Medicaid/HIM lines of business. Providers must follow the Health Plan's medical necessity guidelines and benefit documents when requesting coverage; prior authorization decisions are governed by the member's coverage documents and applicable state and federal law.

Prior authorization required — approval duration: Medicaid/HIM 12 months
Requests governed by Health Plan medical necessity guidelines and member coverage documents; follow applicable state/federal requirements and Health Plan administrative policies

Documentation Required

Required Documentation

Providers must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, relevant laboratory results (e.g., serum urate), prior medication trials and response, and any documentation of contraindications or adverse reactions.

Definitions

inv-18: Febuxostat (Uloric)

Drug class and nameFebuxostat (Uloric) — a xanthine oxidase inhibitor

Indication summaryUsed for chronic management of hyperuricemia in patients with gout who have inadequate response or intolerance to allopurinol, or when allopurinol is not advisable

Contraindications and safetyContraindicated in patients being treated with azathioprine or mercaptopurine; carries boxed warning for cardiovascular death due to increased risk of heart-related death versus allopurinol

inv-19: Health Plan

DefinitionHealth 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 its affiliates

Scope of applicationApplies to Health Plans that have adopted this clinical policy; coverage decisions subject to plan terms, state and federal requirements

Background

Febuxostat (Uloric) is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout who have an inadequate response to, are intolerant of, or for whom treatment with allopurinol is not advisable. The FDA label explicitly notes that Uloric is not recommended for asymptomatic hyperuricemia and includes important safety considerations that should be reviewed prior to initiating therapy.

Revision History and Policy Changes

2024-11-12updated_warning_and_redirection

Added redirection to generic febuxostat and updated boxed warning wording to 'cardiovascular death' to align with prescriber information; references reviewed and updated.

2024-10-22template_and_pa_update

Added febuxostat to standard template language noting generic requires prior authorization; references reviewed and updated.

2025-11-06criteria_and_duration_changeLatest

Policy Summary

PayerCentene

PolicyFebuxostat (Uloric)

Policy CodePolicy CP.PMN.57

Change TypeMaterial updates (criteria, generic redirect, boxed warning)

Effective DateAug 1, 2013

Next Review DateN/A

Key ActionSubmit prior authorization with supporting chart notes and recent serum urate results to demonstrate criteria are met.

SourceLink

On This Page

Available strengths referenced

Product available as 40 mg and 80 mg tablets; maximum regimen listed as 40 mg or 80 mg PO QD

Include chart notes and lab results (e.g., current serum urate within 30 days)
Document prior trials of urate-lowering therapy, reasons for discontinuation, and evidence of positive response for continuation requests

Step Therapy

Step Therapy / Trials Required

Initial approvals require documented failure of specified prior therapies (step therapy). For Illinois HIM requests, failure of allopurinol at maximally tolerated doses is required unless contraindicated. For other jurisdictions, one of the following is required: failure of combination urate-lowering therapy (allopurinol plus probenecid) at maximally tolerated doses, or intolerance/contraindication to combination therapy plus failure of allopurinol or probenecid at maximally tolerated doses. Generic febuxostat should be used unless contraindicated.

Illinois HIM: trial and failure of allopurinol (maximally tolerated dose) unless contraindicated
All other jurisdictions: trial and failure of combination therapy (allopurinol + probenecid) OR intolerance/contraindication to combination therapy plus failure of allopurinol or probenecid
Member must use generic febuxostat unless contraindicated

Denial Risk

Triggers for Denial

Coverage may be denied if required documentation is not submitted, if the diagnosis is not gout-associated hyperuricemia, if the request is for asymptomatic hyperuricemia or other non-covered indication, if prior therapy or step requirements are not met, or if the requested dose/quantity exceeds plan limits. Ensure submitted information clearly supports medical necessity per policy criteria.

Denial triggers include: missing clinical documentation; diagnosis not associated with gout; use for asymptomatic hyperuricemia; failure to document required prior therapy trials; dose or quantity exceeds plan limits

Note

Coverage Document and Regulatory Compliance

All prior authorization and coverage determinations are subject to the member's specific coverage documents (e.g., evidence of coverage, certificate of coverage) and applicable state and federal laws. Providers should consult plan-specific administrative policies and state addendums (e.g., continuity-of-care provisions) where applicable.

Decisions subject to member coverage documents and applicable state/federal requirements
Follow Health Plan administrative policies and state-specific addendums for continuity of care when applicable

Non-contractual natureThis clinical policy is a guide to medical necessity and does not constitute a contract or guarantee regarding payment or results

For Illinois HIM (per IL HB 5395) added a failure-of-allopurinol criterion aligning with FDA labeling and changed Medicaid approval duration to 12 months (from length of benefit); references reviewed and updated.