CurrentCentenePolicy CP PMN.57

Clinical Policy: Febuxostat (Uloric)

Defines medical necessity criteria, prior authorization requirements, dosing limits, continuation criteria, exclusions, and related formulary/redirection guidance for febuxostat (brand Uloric and generic) for Centene lines of business (HIM, Medicaid).

Policy Summary

PayerCentene

PolicyClinical Policy: Febuxostat (Uloric)

Policy CodePolicy CP PMN.57

Change TypeAnnual review / template updates / clarifications (2022-2025)

Effective Date08.01.13

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) to support that the member meets all approval criteria including diagnosis, recent serum urate, prior therapy trials/intolerance, and dosing.

POLICY UPDATE CHANGES

1Q 2025 annual review: added febuxostat to 'febuxostat and Uloric are medically necessary when the following criteria are met' standard template language as generic requires authorization; references reviewed and updated.

1Q 2024 annual review: added redirection to generic febuxostat; updated boxed warning with 'cardiovascular death' to align with prescriber information; references reviewed and updated.

Clarified requirement for trial of probenecid/colchicine as 'probenecid-containing product'.

1Covered Indication(s) (gout-related hyperuricemia)

2Tablet strengths available

80 mg/dayMaximum daily dose

≥ 6 mg/dL

Coverage Summary

Febuxostat (brand Uloric) is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout who have an inadequate response or intolerance to allopurinol or when allopurinol is not advisable. The product is available in 40 mg and 80 mg tablet strengths with a maximum labeled dose of 80 mg/day.

The prescribing information contains a boxed warning for an increased risk of cardiovascular death, and Uloric should not be prescribed concurrently with azathioprine or mercaptopurine. Per policy and formulary guidance, members are generally redirected to the generic febuxostat product unless contraindicated or clinically significant adverse effects occur.

Scope: This coverage criteria defines medical necessity and prior authorization requirements for febuxostat (Uloric and generic) for hyperuricemia associated with gout, including initial approval requirements (diagnosis, recent serum urate threshold, prior therapy trials/intolerance, dosing limits), continuation criteria (evidence of response or continuity of care exceptions), explicit dose constraints (no more than 1 tablet/day and ≤ 80 mg/day), exclusions (non‑FDA indications not supported by off‑label policies), and redirection to generic formulations when appropriate.

Thresholds and Quick Facts

Serum urate for initiation≥ 6 mg/dL

Continuation response target< 6 mg/dL

Maximum dose≤ 80 mg/day

Tablet strengths available40 mg, 80 mg

Covered indication count1

Coverage Criteria (Initial & Continuation)

Product Availability / Dosing Codes

Product availability / dosingmixed

40 mg	Tablet strength 40 mg
80 mg	Tablet strength 80 mg

Provider Actions & Requirements

Prior Authorization

Prior authorization required with documentation

Provider must submit documentation (office chart notes, lab results, or other clinical information) showing the member meets all approval criteria, including diagnosis of hyperuricemia with gout, a recent serum urate, prior therapy trials or intolerance, and dosing within limits.

Documentation Required

Lab documentation of serum urate

Provide a current serum urate level (within the last 30 days). For initiation, documented serum urate ≥ 6 mg/dL is required. For continuation, provide evidence of response such as reduction in serum urate to < 6 mg/dL or other documented clinical improvement (for example, reduced frequency of gout attacks).

Background, Evidence & Definitions

Febuxostat (Uloric) is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom allopurinol is not advisable. The approved dosing regimen is 40 mg or 80 mg PO once daily with a maximum dose of 80 mg/day.

The product labeling includes a boxed warning for cardiovascular death. The policy lists contraindications including concomitant use with azathioprine or mercaptopurine.

Formulary/redirection context: the policy reflects redirection to generic febuxostat when available and authorizations may be for the generic product; brand Uloric remains referenced in the policy but generic use is required unless contraindicated or clinically significant adverse effects are documented.

Source	Citation
FDA prescribing information	Uloric Prescribing Information; Takeda; April 2023
Guideline reference	2020 ACR guidelines: target serum urate thresholds and management guidance cited

Definitions: Hyperuricemia is defined in this policy as elevated serum urate. The laboratory thresholds used by the policy are a serum urate of ≥ 6 mg/dL for initiation and a response target of < 6 mg/dL for continuation/response.

Revision History

04.06.22clarification

Clarified requirement for trial of probenecid/colchicine as 'probenecid-containing product'.

02.241Q 2024 annual review update

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

02.251Q 2025 annual review updateLatest

Added febuxostat to 'febuxostat and Uloric are medically necessary when the following criteria are met' standard template language as generic requires authorization; references reviewed and updated.