Duexis (ibuprofen and famotidine)

Indications for Prior Authorization

Duexis (ibuprofen/famotidine)
  • For diagnosis of Osteoarthritis, rheumatoid arthritis, and gastrointestinal ulcers
    Indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and /or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months.

Criteria

Brand Duexis, generic ibuprofen-famotidine

Prior Authorization

Length of Approval: 3 Month(s)

  • One of the following diagnoses:
    • Osteoarthritis
    • Rheumatoid Arthritis
    AND
  • One of the following [2]:
    • History of peptic ulcer disease
    • History of gastrointestinal (GI) bleeding, obstruction, or perforation
    • Erosive esophagitis
    • Used in combination with aspirin
    AND
  • History of a minimum 30 day trial and failure, contraindication or intolerance to two of the following generics:
    • etodolac
    • fenoprofen
    • flurbiprofen
    • ibuprofen
    • indomethacin
    • ketoprofen
    • ketorolac
    • meloxicam
    • nabumetone
    • naproxen
    • oxaprozin
    • piroxicam
    • sulindac
    • tolmetin
    • diclofenac
    AND
  • History of a minimum 30 day trial and failure, or intolerance to two of the following generic H2-receptor antagonists:
    • cimetidine
    • famotidine
    • nizatidine
    • ranitidine
    AND
  • Physician has provided rationale for needing to use fixed-dose combination therapy with brand Duexis or generic ibuprofen-famotidine instead of taking individual products in combination
P & T Revisions

2025-02-06, 2024-02-14, 2023-01-31, 2022-06-08, 2022-01-28, 2021-08-26, 2021-03-12, 2020-08-25, 2020-01-22

  1. Duexis [prescribing information]. Deerfield, IL: Horizon Medicines, LLC; April 2021.
  2. Solomon C. Upper Gastrointestinal Bleeding Due to a Peptic Ulcer. N Engl J Med. 2016;374:2367-2376.

  • 2025-02-06: Removed NF criteria
  • 2024-02-14: 2024 Annual Review - no changes
  • 2023-01-31: 2023 Annual Review
  • 2022-06-08: Removed submission of medical records requirement from prior authorization criteria
  • 2022-01-28: 2022 Annual Review: No changes to criteria, updated NF background information.
  • 2021-08-26: New generic, mirrored brand and added to PA and NF sections
  • 2021-03-12: Updated GL name
  • 2020-08-25: added drug specific non formulary criteria and added document requirements
  • 2020-01-22: no changes to criteria