CurrentCignaPolicy N/A

Gout Medications Step Therapy Policy

Defines step therapy requirements for coverage of gout urate-lowering medications (Step 1 allopurinol; Step 2 febuxostat) for Cigna-administered benefit plans. Affects providers prescribing these drugs and utilization reviewers determining pharmacy coverage.

Policy Summary

PayerCigna

PolicyGout Medications Step Therapy Policy

Policy CodePolicy N/A

Change TypeMinor / No material changes

Effective DateN/A

Next Review DateJan 22, 2025

Key ActionObtain prior authorization showing trial of Step 1 allopurinol or documentation of contraindication before approving Step 2 febuxostat (approvals granted for 1 year).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2step levels (Step 1 → Step 2)

1 yearapproval duration

2products named

01/22/2025review date

Coverage Criteria — Step Therapy for Gout Medications

Step 2 (febuxostat) approval criteria

Covered when ANY of the following are met:

Step therapy approval conditions

Patient has tried one Step 1 Product (allopurinol).
Patient is receiving concomitant medications that have significant drug-drug interactions with the Step 1 Product (allopurinol) which are not noted with febuxostat (examples: cyclosporine, chlorpropamide).

This program requires use of a Step 1 Product (allopurinol) prior to coverage of a Step 2 Product (febuxostat). Any use not meeting the step therapy criteria is considered not medically necessary. Coverage determinations for Step 2 products are made according to the step therapy criteria and approvals are provided for 1 year.

Requests for Step 2 products (febuxostat/Uloric or generic) that do not meet the step therapy criteria will be denied as not medically necessary. The policy requires meeting the specified step therapy conditions at the point of service for authorization.

Policy Summary

PayerCigna

PolicyGout Medications Step Therapy Policy

Policy CodePolicy N/A

Change TypeMinor / No material changes

Effective DateN/A

Next Review DateJan 22, 2025

Key ActionObtain prior authorization showing trial of Step 1 allopurinol or documentation of contraindication before approving Step 2 febuxostat (approvals granted for 1 year).

SourceLink

On This Page

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Step therapy prior authorization required: Step 2 products (febuxostat/Uloric and generics) require that Step 1 criteria are met prior to approval. Approvals are issued for 1 year.

Step 1: allopurinol (Zyloprim, generic)
Step 2: febuxostat (Uloric, generic)

Denial Risk

Denial Risk for Unmet Step Therapy

Coverage of Step 2 products will be determined by the step therapy criteria. If the Step Therapy rule is not met at the point of review, the request may be denied.

Denial risk exists when documentation does not demonstrate prior use of a Step 1 product or an approved exception.
Failures to meet the criteria at point of service may result in coverage being denied.

Documentation Required

Documentation Required to Support Step Exception

Required documentation: submit clinical documentation showing trial and failure or intolerance to one Step 1 product (allopurinol) OR documentation of a contraindication/drug–drug interaction with allopurinol that justifies use of a Step 2 product (examples: concomitant use of cyclosporine or chlorpropamide).

Example acceptable documentation: medication history, lab results, clinical notes describing intolerance or adverse reaction, or evidence of interacting concomitant medications.

Step Therapy

Step Therapy Sequence

Step therapy sequence: Step 1 must be attempted before Step 2 except when an allowed exception applies. When criteria are met, approve Step 2 product for up to 1 year.

Step 1: allopurinol tablets (Zyloprim, generic)
Step 2: febuxostat tablets (Uloric, generic)
Approval duration: 1 year

Step	Product	Requirement for approval
Step 1	allopurinol tablets (Zyloprim, generic)	Must be tried prior to Step 2 unless clinically precluded; trial of one Step 1 product required for Step 2 approval.
Step 2	febuxostat tablets (Uloric, generic)	Approve if patient has tried one Step 1 product OR if patient is receiving concomitant medications with significant drug–drug interactions with allopurinol (examples: cyclosporine, chlorpropamide); approvals provided for 1 year.

Key Definitions — Step Products

inv-09: allopurinol (Zyloprim, generic) — Step 1 Product

Drug (brand/generic)Allopurinol (Zyloprim, generic)

Role in step therapyStep 1 Product — required to be tried prior to Step 2 (febuxostat) unless clinically precluded

Drug classXanthine oxidase inhibitor

Indications (excerpt)Signs and symptoms of primary or secondary gout; cancer therapy–related hyperuricemia; recurrent calcium oxalate calculi with elevated uric acid excretion

Document referencesNamed as Step 1 product in Cigna step therapy program; overview lists clinical indications

inv-10: febuxostat (Uloric, generic) — Step 2 Product

Drug (brand/generic)Febuxostat (Uloric, generic)

Role in step therapyStep 2 Product — covered when patient has tried one Step 1 product (allopurinol) or when allopurinol is clinically precluded (e.g., significant drug–drug interaction)

Drug classXanthine oxidase inhibitor

Indication (policy-aligned)Chronic management of hyperuricemia in adults with gout who have inadequate response or intolerance to allopurinol or when allopurinol is not advisable

Approval durationAuthorizations for Step 2 products are granted for 1 year

Background

Allopurinol and febuxostat are xanthine oxidase inhibitors used to lower serum uric acid in patients with gout. Allopurinol (Zyloprim, generic) is indicated for signs and symptoms of primary or secondary gout and related conditions. Febuxostat (Uloric, generic) is indicated for chronic management of hyperuricemia in adults with gout who have inadequate response or intolerance to allopurinol or when allopurinol is not advisable. The step therapy program is intended to encourage initial use of allopurinol before considering febuxostat.

OpenPayer

Gout Medications Step Therapy Policy

Coverage Criteria — Step Therapy for Gout Medications

Provider Actions and Prior Authorization Requirements

Step Therapy Sequence and Operational Rules

Key Definitions — Step Products

Background