Pharmacy Prior Authorization Criteria

AntiGout Agents

Indications for Prior Authorization

Uloric (febuxostat)

• For diagnosis of Gout
  A xanthine oxidase (XO) 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 treatment with allopurinol is not advisable.

  Uloric is not recommended for the treatment of asymptomatic hyperuricemia.

Mitigare (colchicine) capsule

• For diagnosis of Prophylaxis of gout flares
  Indicated for prophylaxis of gout flares in adults.

  Limitation of Use: The safety and effectiveness of Mitigare for acute treatment of gout flares during prophylaxis has not been studied. Mitigare is not an analgesic medication and should not be used to treat pain from other causes.

Colcrys (colchicine) tablet

• For diagnosis of Prophylaxis of Gout Flares
  Indicated for the prophylaxis of gout flares.

• For diagnosis of Treatment of Gout Flares
  Indicated for treatment of acute gout flares when taken at the first sign of a flare.

• For diagnosis of Familial Mediterranean Fever (FMF)
  Indicated in adults and children 4 years or older for treatment of FMF.

Allopurinol

• For diagnosis of Gout
  Indicated in:

  1) the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).

  2) the management of adults and pediatric patient with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels.

  3) the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables). Limitations of use: Allopurinol tablets are not recommended for the treatment of asymptomatic hyperuricemia.

Criteria

generic febuxostat, Uloric

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply), contraindication, or intolerance to generic allopurinol tablets

Mitigare, Brand Colcrys

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure of a minimum 30 days supply within past 180 days, or intolerance to generic colchicine tablets

Brand Allopurinol 200mg tablet

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply), or intolerance to generic allopurinol tablets

P & T Revisions

2025-09-03, 2024-07-04, 2024-01-19, 2024-01-18, 2024-01-18, 2024-01-12, 2023-08-30, 2023-08-02, 2022-11-30, 2022-08-03, 2021-07-27, 2020-08-19, 2020-07-01, 2020-01-30, 2019-09-03

References

1. Uloric Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. April 2023.
2. Mitigare Prescribing Information. Specialty USA Inc. Columbus, OH. May 2024.
3. Colchicine Tablets Prescribing Information. Amneal Pharmaceuticals LLC. Bridgewater, NJ. March 2025.
4. Allopurinol Prescribing Information. Camber Pharmaceuticals, Inc. Piscataway, NJ 08854. June 2024.

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Revision History

• 2025-09-03: 2025 Annual Review - No criteria changes, updated background and references.
• 2024-07-04: 2024 Annual Review. Removed Gloperba as target drug. Updated trial and failure criteria as per UM Comprehensive grid. Updated references.
• 2024-01-19: Updated naming conventions, no change to criteria.
• 2024-01-18: Removed brand Colchicine Capsules as a target from guideline. Brand Colchicine capsule is now a true generic.
• 2024-01-18: Removed brand Colchicine Capsules as a target from guideline. Brand Colchicine capsule is now a true generic .
• 2024-01-12: Removed brand Colchicine Capsules as a target from guideline. Brand Colchicine capsule is now a true generic .
• 2023-08-30: Updated product lists in criteria sections. No change to clinical intent.
• 2023-08-02: Annual review, no changes to criteria.
• 2022-11-30: Added criteria for brand Allopurinol. Updated background and references.
• 2022-08-03: Annual Review, added FDA approved diagnosis requirement to criteria.
• 2021-07-27: Removed obsolete Duzallo and Zurampic products. Updated background, indications, references.
• 2020-08-19: Updated to say Min of 60 day
• 2020-07-01: Update ST criteria in UMCS to specify trial and failure "of 60 days supply within past 180 days" to match Comp UM list coding.
• 2020-01-30: review combined old antigout guideline with colchicine products since criteria was same
• 2019-09-03: Annual review - updated reference no changes to clinical criteria

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