Duexis (ibuprofen and famotidine) - PA, NF
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 F
Prior Authorization
Length of Approval: 3 Month(s)
- One of the following diagnoses:
- Osteoarthritis
- Rheumatoid Arthritis
- 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
- 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
- History of a minimum 30 day trial and failure, or intolerance to two of the following generic H2-receptor antagonists:
- cimetidine
- famotidine
- nizatidine
- ranitidine
- 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
Brand Duexis, generic ibuprofen-famotidine NF
Non Formulary
Length of Approval: 3 Month(s)
- Submission of medical records (e.g., chart notes) documenting one of the following diagnoses:
- Osteoarthritis
- Rheumatoid Arthritis
- Submission of medical records (e.g., chart notes) documenting 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
- Paid claims or submission of medical records (e.g., chart notes) documenting 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
- Paid claims or submission of medical records (e.g., chart notes) documenting history of a minimum 30 day trial and failure, contraindication or intolerance to two of the following generic H2-receptor antagonists:
- cimetidine
- famotidine
- nizatidine
- ranitidine
- 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
2024-02-14, 2023-01-31, 2022-06-08, 2022-01-28, 2021-08-26, 2021-03-12, 2020-08-25, 2020-01-22
References
- Duexis [prescribing information]. Deerfield, IL: Horizon Medicines, LLC; April 2021.
- Solomon C. Upper Gastrointestinal Bleeding Due to a Peptic Ulcer. N Engl J Med. 2016;374:2367-2376.
Revision History
- 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
HEALTHY LIVING