ModifiedCentenePolicy CP.PMN.120

Ibuprofen/Famotidine (Duexis) - Clinical Policy

Coverage and prior authorization criteria for ibuprofen/famotidine (Duexis) for reduction of NSAID-induced gastric ulcers in patients with rheumatoid arthritis or osteoarthritis and related authorization rules for other uses.

Policy Summary

PayerCentene

PolicyIbuprofen/Famotidine (Duexis) - Clinical Policy

Policy CodePolicy CP.PMN.120

Change TypeMaterial revisions to approval durations, step therapy, and generic redirection

Effective DateJun 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation that initial/continuation criteria are met, including diagnosis, age, prior step therapy failures, trial of individual components, and dose within limits.

SourceLink

POLICY UPDATE CHANGES

Extended initial approval duration from 6 to 12 months during 2Q 2026 annual review.

Clarified that generic famotidine-ibuprofen applies to the policy (2Q 2025).

Added step therapy bypass for Illinois health improvement measures per IL HB 5395 (06.27.25).

Revised continued approval duration to 12 months (2Q 2025 entry reflected prior to 2Q 2026 change).

Added redirection to generic product in continued therapy in multiple annual reviews (2022, 2024).

12 monthsapproval duration

≤2400 mgmax daily dose

≥18minimum age

800/26.6 mg

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2Q 2026recent review

ICHRAline of business added

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for Rheumatoid Arthritis or Osteoarthritis:

Initial Approval Criteria - RA/OA

Indication and age: Prescribed to decrease the risk of developing NSAID-induced gastric ulcers in patients with rheumatoid arthritis or osteoarthritis; age >= 18 years.
Step therapy failures: Failure of a H2RA (e.g., ranitidine) in combination with an NSAID (e.g., ibuprofen), unless contraindicated or clinically significant adverse effects are experienced; AND failure of three PPIs in combination with three different NSAIDs, unless clinically significant adverse effects are experienced or all are contraindicated.
Illinois HIM requests exempt from step therapy as of 1/1/2026 per IL HB 5395.
Use of individual components: Member must instead use the individual components (famotidine and ibuprofen) concurrently unless contraindicated or clinically significant adverse effects are experienced.
GI risk factor requirement: Member has at least one risk factor for NSAID-induced gastric ulcers: age > 65 years; history of peptic ulcer disease; or concurrent use of antiplatelets, corticosteroids, or anticoagulants.
Brand/generic and dosing limits: If request is for brand Duexis, member must use generic ibuprofen/famotidine unless contraindicated; dose must not exceed 2,400 mg ibuprofen/79.8 mg famotidine (3 tablets) per day.

Other Indications

Other diagnoses/indications:

Other Indications: If the drug has had a recent label change (within the last 6 months) not yet reflected in this policy, follow the applicable no-coverage or non‑formulary policy for the line of business; OR if the requested use is not listed under section III and no recent label change applies, refer to the off‑label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for HIM/ICHRA, CP.PMN.53 for Medicaid).

Continuation Therapy

Continuation/renewal criteria for members already receiving therapy:

Continuation Criteria - RA/OA

Current enrollment or prior approval: Member is currently receiving medication via Centene benefit, has previously met initial approval criteria, or is in a continuity of care situation per state regulations.
Response and ongoing risk: Member is responding positively to therapy and continues to have at least one GI risk factor for NSAID-induced gastric ulcers (age > 65 years; history of peptic ulcer disease; or concurrent use of antiplatelets, corticosteroids, or anticoagulants).
Brand/generic and dose: If request is for brand Duexis, member must use generic ibuprofen/famotidine unless contraindicated; dose increases must not exceed 2,400 mg ibuprofen/79.8 mg famotidine (3 tablets) per day.
Approval duration: 12 months.

Requests for uses that are not FDA‑approved and are not specifically addressed in this policy will be excluded unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies. Relevant off‑label policies include CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace/ICHRA), and CP.PMN.53 (Medicaid).

For Medicaid members, state Medicaid coverage provisions supersede this clinical policy when there is a conflict. Providers should follow the applicable state Medicaid manual and coverage determinations in those circumstances.

Use of ibuprofen/famotidine for non‑FDA approved indications that lack adequate supporting evidence or that do not comply with the applicable off‑label use policies is not authorized. Providers must supply the documentation required by the off‑label policies cited (CP.CPA.09, HIM.PA.154, CP.PMN.53) to support any request for an off‑label indication.

Initial Therapy Criteria

Initial Therapy

Initial authorization criteria for Rheumatoid Arthritis or Osteoarthritis:

Indication and age: Prescribed to decrease the risk of developing NSAID-induced gastric ulcers in patients with rheumatoid arthritis or osteoarthritis; age >= 18 years.
Step therapy failures: Failure of a H2RA (e.g., ranitidine) in combination with an NSAID (e.g., ibuprofen), unless contraindicated or clinically significant adverse effects are experienced; AND failure of three PPIs in combination with three different NSAIDs, unless clinically significant adverse effects are experienced.
Illinois HIM requests exempt from step therapy as of 1/1/2026 per IL HB 5395.
Use of individual components: Member must instead use the individual components (famotidine and ibuprofen) concurrently unless contraindicated or clinically significant adverse effects are experienced.

Continuation / Renewal Criteria

Continuation Therapy

Continuation criteria for existing users:

Current enrollment or prior approval: Member is currently receiving medication via Centene benefit or has previously met initial approval criteria; or member is in a continuity of care situation per state regulations.
Response and ongoing risk: Member is responding positively to therapy and continues to have at least one GI risk factor (age > 65 years; history of peptic ulcer disease; or concurrent use of antiplatelets, corticosteroids, or anticoagulants).
Brand/generic and dose: If request is for brand Duexis, member must use generic ibuprofen/famotidine unless contraindicated; dose must not exceed 2,400 mg ibuprofen/79.8 mg famotidine (3 tablets) per day.
Continued approval duration: 12 months; prior reviews added redirection to generic products.

Provider Actions & Administrative Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria, including diagnosis, age, prior treatment failures, risk factors for NSAID‑induced gastric ulcers, and dosing information.

Initial and continued approval durations: 12 months (initial and continued).
If request is for brand Duexis, generic ibuprofen/famotidine must be used unless contraindicated or clinically significant adverse effects are experienced.
Dose limit: ≤ 2,400 mg ibuprofen / 79.8 mg famotidine (3 tablets) per day.

Denial Risk

Non‑FDA Indications

Requests for non‑FDA approved (off‑label) indications that are not addressed in this policy may be denied unless sufficient clinical documentation of efficacy and safety is provided in accordance with applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace/ICHRA), and CP.PMN.53 (Medicaid), or per the member's evidence of coverage.

Step Therapy Requirements

Step	Requirement	Notes
1	Failure of an H2RA (e.g., ranitidine) in combination with an NSAID (e.g., ibuprofen)	Required prior to approval unless contraindicated or clinically significant adverse effects
1	Failure of three PPIs (e.g., omeprazole, pantoprazole, lansoprazole) each in combination with three different NSAIDs	Required prior to approval unless contraindicated or clinically significant adverse effects
1	Use of individual components concurrently (famotidine + ibuprofen) instead of the combination product	Must be tried unless contraindicated or clinically significant adverse effects
—	Dose must not exceed 2,400 mg ibuprofen / 79.8 mg famotidine per day (3 tablets)	Applies to approval and continuation

State	Policy change	Effective / Legislative reference
Illinois (HIM)	Step therapy bypass added for Illinois; step therapy requirements do not apply for Illinois HIM requests	Per IL HB 5395; exemption noted as of 1/1/2026 (policy entry dated 06.27.25)

Coding, Dose Limits & Quantity Limits

Maximum daily dose — dosing limits

Maximum daily dose (ibuprofen)2,400 mg ibuprofen per day

Maximum daily dose (famotidine)79.8 mg famotidine per day

Tablet equivalenceEquals 3 tablets of Duexis (800 mg ibuprofen / 26.6 mg famotidine each)

Quantity limit — ibuprofen/famotidine (Duexis)

Quantity limit3 tablets per day

Rationale3 tablets/day corresponds to the policy maximum dose of 2,400 mg ibuprofen / 79.8 mg famotidine

Approval duration (related)

Definitions & Safety Information

Duexis (ibuprofen/famotidine) — product description

Product classCombination product of ibuprofen (NSAID) and famotidine (H2-receptor antagonist)

Indication (FDA)Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper GI ulcers in patients taking ibuprofen for those indications

Clinical trial noteControlled trials did not extend beyond 6 months and primarily enrolled patients <65 years without prior GI ulcer history

Duexis formulation — tablet strength

Tablet strength800 mg ibuprofen / 26.6 mg famotidine per tablet

Dosing regimen exampleRheumatoid arthritis or osteoarthritis: One tablet PO TID (total 3 tablets/day)

Background

Duexis is a combination product of ibuprofen (an NSAID) and famotidine (an H2‑receptor antagonist) used to relieve signs and symptoms of rheumatoid arthritis and osteoarthritis and to reduce the risk of NSAID‑associated upper gastrointestinal ulcers in patients taking ibuprofen for those indications. Clinical use for other diagnoses is governed by the policy’s coverage criteria and off‑label use requirements.

Revision History

2026-03-30annual_reviewLatest

Extended initial approval duration from 6 to 12 months and added ICHRA line of business during 2Q 2026 annual review; references reviewed and updated.

2025-06-27policy_update

Added step therapy bypass for Illinois Health Improvement Measures per IL HB 5395 (effective 06.27.25).

2025-01-16annual_review

Clarified that generic famotidine-ibuprofen applies to the policy and revised continued approval duration to 12 months during 2Q 2025 annual review; references reviewed and updated.

Policy Summary

PayerCentene

PolicyIbuprofen/Famotidine (Duexis) - Clinical Policy

Policy CodePolicy CP.PMN.120

Change TypeMaterial revisions to approval durations, step therapy, and generic redirection

Effective DateJun 1, 2018

Next Review Date

SourceLink

On This Page

GI risk factor requirement: Member has at least one risk factor for NSAID-induced gastric ulcers: age > 65 years; history of peptic ulcer disease; or concurrent use of antiplatelets, corticosteroids, or anticoagulants.

Brand/generic and dosing limits: If request is for brand Duexis, member must use generic ibuprofen/famotidine unless contraindicated; dose must not exceed 2,400 mg ibuprofen/79.8 mg famotidine (3 tablets) per day.

Initial therapy duration

Initial approval duration (updated):

initial approval duration: Initial approval duration was extended from 6 to 12 months (2Q 2026 annual review).12 months

2Q 2026 annual review: extended initial approval duration from 6 to 12 months; added ICHRA line of business.

Continued therapy

Continued therapy edits and generic-product redirection applied in prior reviews:

Continued therapy duration: Continued approval duration revised to 12 months per prior reviews and 2Q 2025/2Q 2026 entries.12 months

Policy history documents redirection to generic product in multiple annual reviews and clarified application of generic famotidine-ibuprofen to the policy.

Documentation Required

Documentation and Administrative Responsibilities

Providers must follow applicable Health Plan‑level administrative policies and procedures and document medical necessity in the medical record. The Health Plan’s coverage decisions are subject to the member’s coverage documents and applicable law. Providers are responsible for exercising professional judgment and for maintaining and submitting supporting documentation (e.g., office notes, labs, prior treatment records) when requested.

Step Therapy

Step Therapy Requirements

Step therapy requirements must be met prior to approval unless contraindicated or clinically significant adverse effects are experienced. For initial approval in rheumatoid arthritis or osteoarthritis (all must be met): failure of an H2RA antagonist (e.g., ranitidine) in combination with an NSAID (e.g., ibuprofen); and failure of three PPIs (e.g., omeprazole, pantoprazole, lansoprazole) each in combination with three different NSAIDs. Member should instead use the individual components (famotidine + ibuprofen) concurrently unless contraindicated.

Step therapy requires documented trials and failures or contraindications to the specified agents.
Member must have at least one risk factor for NSAID‑induced gastric ulcers (age >65, history of peptic ulcer disease, or concurrent use of antiplatelets/corticosteroids/anticoagulants).

Step Therapy

Step Therapy Bypass — Illinois

Per Illinois HB 5395, step therapy requirements for Illinois HIM (Health Insurance Marketplace/ICHRA) requests do not apply as of the effective dates noted (1/1/2026 for the step therapy bypass). When applicable, providers should document the member’s line of business and apply the statutory bypass.

IL HIM step therapy bypass effective 01/01/2026 per IL HB 5395.
Policy history reflects addition of IL step therapy bypass on 06/27/2025.

Approval duration: 12 months (per policy)

Daily max restatement3 tablets per day = 2,400 mg ibuprofen / 79.8 mg famotidine

Contraindications and boxed warnings — Duexis

HypersensitivityContraindicated in individuals with hypersensitivity to ibuprofen or famotidine

Aspirin/NSAID allergyHistory of asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs is a contraindication

CABG surgeryContraindicated in the setting of coronary artery bypass graft (CABG) surgery

Boxed warningsBoxed warnings for increased risk of serious cardiovascular and gastrointestinal events (MI, stroke, GI bleeding, ulceration, perforation)

2024-01-18annual_review

Added redirection to generic product in continued therapy during 2Q 2024 annual review; references reviewed and updated.

2022-01-18annual_review

Added redirection to generic product and applied template changes to other diagnoses/indications and continued therapy during 2Q 2022 annual review; references reviewed and updated.