CurrentmhnPolicy CP.PMN.120

Clinical Policy: Ibuprofen/Famotidine (Duexis)

This policy governs medical necessity and prior authorization criteria for ibuprofen/famotidine (Duexis) for members in the payer's lines of business, including commercial, HIM/ICHRA, and Medicaid.

Policy Summary

Payermhn

PolicyIbuprofen/Famotidine (Duexis) coverage criteria

Policy CodePolicy CP.PMN.120

Change TypeNo material changes

Effective DateJun 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating the member meets all approval criteria including diagnosis, age ≥18, prior therapy failures, and dose within limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=18minimum age for initial approval

12 moapproval duration

3 tabs/daymax daily dosing

800/26.6 mgtablet strength

Coverage Criteria

Initial Therapy

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Initial Approval Criteria for RA or OA: 1) Prescribed to decrease the risk of developing NSAID-induced gastric ulcers in patients with rheumatoid arthritis or osteoarthritis; 2) Age >= 18 years; 3) Failure of an H2RA antagonist (e.g., ranitidine) in combination with an NSAID (e.g., ibuprofen), unless contraindicated or clinically significant adverse effects are experienced; 4) Failure of three proton pump inhibitors (PPIs) (e.g., omeprazole, pantoprazole, lansoprazole) in combination with three different NSAIDs, unless clinically significant adverse effects are experienced or all are contraindicated; 5) Member must instead use the individual components (famotidine and ibuprofen) concurrently, unless contraindicated or clinically significant adverse effects are experienced; 6) Member has at least one of the following risk factors for developing NSAID-induced gastric ulcers: a) Age > 65 years; b) History of peptic ulcer disease; c) Concurrent use of antiplatelets, corticosteroids, or anticoagulants; 7) If request is for brand Duexis, member must use generic ibuprofen/famotidine unless contraindicated or clinically significant adverse effects are experienced; 8) Dose does not exceed 2,400 mg ibuprofen/79.8 mg famotidine (3 tablets) per day.

Approval duration: 12 months

Continuation Therapy

Covered when ALL of the following are met (requirements for ongoing coverage):

Continuation Therapy Criteria: 1) Member meets one of the following: a) Currently receiving medication via Centene benefit or previously met initial approval criteria; or b) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy; 3) Member continues to have at least one risk factor for developing NSAID-induced gastric ulcers: a) Age > 65 years; b) History of peptic ulcer disease; c) Concurrent use of antiplatelets, corticosteroids, or anticoagulants; 4) If request is for brand Duexis, member must use generic ibuprofen/famotidine unless contraindicated or clinically significant adverse effects are experienced; 5) If request is for a dose increase, new dose does not exceed 2,400 mg ibuprofen/79.8 mg famotidine (3 tablets) per day.

Approval duration: 12 months

Other Diagnoses/Indications

Other/off-label uses and exclusions:

Other indications: 1) If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow the applicable formulary/no-coverage or non-formulary policies for the relevant line of business as specified (see CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16); 2) If the requested use (diagnosis, age, dosing) is not listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for ICHRA/HIM, CP.PMN.53 for Medicaid).

See listed cross-reference policies

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for HIM/ICHRA, and CP.PMN.53 for Medicaid) or unless coverage is otherwise specified in the member’s evidence of coverage documents.

Use of ibuprofen/famotidine for non‑FDA approved indications that lack adequate supporting evidence is not authorized unless the request is supported by sufficient documentation of efficacy and safety as required by the referenced off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or by the member’s evidence of coverage.

Initial Therapy Criteria

Initial Therapy

Initial coverage criteria for RA or OA — ALL conditions must be met:

Initial Therapy: See Initial Approval Criteria for RA or OA (must meet all): prescribed to decrease NSAID-induced gastric ulcer risk; age >= 18 years; failure of H2RA + NSAID unless contraindicated; failure of three PPIs each with different NSAIDs unless contraindicated; use of individual components (famotidine + ibuprofen) unless contraindicated; at least one GI risk factor present; generic required before brand unless contraindicated; dose <= 2,400 mg ibuprofen/79.8 mg famotidine per day.

Approval duration: 12 months

Initial therapy duration

Administrative history and specified approval durations:

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

Initial approval duration: 12 months

Continuation Therapy Criteria

Continuation Therapy

Continuation therapy — ALL conditions must be met:

Continuation: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria or has continuity of care; 2) Member is responding positively to therapy; 3) Member continues to have at least one GI risk factor (age >65, prior peptic ulcer, or concurrent antiplatelet/corticosteroid/anticoagulant use); 4) Generic required before brand unless contraindicated; 5) Dose must not exceed 2,400 mg ibuprofen/79.8 mg famotidine per day.

Approval duration: 12 months

Continued therapy administrative updates

Documented administrative updates affecting continued therapy:

continued therapy notes: Redirection to generic product applied to continued therapy in past reviews; continued approval duration revised to 12 months as of 2Q 2025 review.

See policy history for dates and P&T actions

Step Therapy Requirements

Prior Authorization

Prior Authorization and Documentation Requirements

Prior authorization is required for ibuprofen/famotidine (Duexis and generics). Prior authorization requirements and operational rules may be updated administratively; providers should confirm current prior auth forms and criteria before submitting. Coverage is conditional on the member's benefit plan; benefits documents determine final coverage and any applicable member cost-sharing. Requests lacking required documentation or when the indication is non‑FDA (off‑label) may be denied; provide full clinical justification when requesting coverage for non‑FDA indications.

Prior Authorization Required: Submit PA request with supporting documentation.
PA Affected by Administrative Updates: Operational rules (forms, fax/electronic submission, contact) may change; verify at time of submission.
Coverage Conditional on Benefit Documents: Actual coverage determined by member benefit plan.
Documentation Insufficiency or Non‑FDA Indication: Insufficient documentation or non‑FDA indications require supporting clinical rationale; may result in denial.

Step Therapy Requirements
No results

Step Therapy Bypass (Jurisdictional)
No results

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization must show all approval criteria are met

Prior authorization requests must include documentation that demonstrates all approval criteria are met, including applicable diagnosis (RA or OA), age ≥18 years, prior therapy failures or contraindications, presence of NSAID‑ulcer risk factors, use of generic before brand when required, and dosing within stated limits.

Confirm diagnosis of rheumatoid arthritis or osteoarthritis when applicable.
Verify age ≥18 years and that dose does not exceed 2,400 mg ibuprofen/79.8 mg famotidine per day.
Document prior therapy failures or contraindications per step therapy requirements and generic-product use when brand requested.

Documentation Required

Submit chart notes, labs, or clinical information with PA request

Providers must submit supporting clinical documentation such as office chart notes, laboratory results, or other clinical information demonstrating the member has met all approval criteria.

Include relevant chart notes documenting prior therapies, adverse effects, or contraindications.
Attach lab results or other clinical data as applicable to support risk factors or response to therapy.

Denial Risk

Insufficient documentation or non‑FDA indication may lead to denial

Requests that lack sufficient documentation showing the member meets approval criteria, or requests for non‑FDA approved indications without adequate off‑label justification per the referenced off‑label policies, may be denied.

Non‑FDA indications require sufficient documentation of efficacy and safety per off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or applicable evidence of coverage.
Incomplete clinical documentation demonstrating prior therapy trials, contraindications, or risk factors risks denial.

Documentation Required

Follow Health Plan administrative policies and retain professional judgment

Providers should follow Health Plan–level administrative policies and procedures and exercise professional medical judgment; this clinical policy is a guide to medical necessity but does not guarantee payment.

Adhere to plan-specific authorization workflows and retain documentation per administrative rules.
This policy is not medical advice and does not replace provider judgment.

Note

Coverage contingent on member benefit documents and state law

Coverage is subject to the member's evidence of coverage, contract terms, exclusions, limitations, and applicable state and federal requirements; state Medicaid provisions supersede this policy where conflicts exist.

Verify member eligibility and benefit terms before authorizing treatment.
When state Medicaid rules conflict with this policy, follow the state Medicaid manual.

Prior Authorization

PA workflows may be affected by prior administrative updates

Prior authorization processes and programmatic details have been updated over time (for example: redirection to generic product, changes to approval durations, and addition of ICHRA line of business) and may affect authorization workflows.

Policy history documents redirection to generic product and revision of approval durations (initial and continued) in prior reviews.
Plan operational rules may reflect these administrative updates; consult plan-specific guidance.

Definitions

Duexis (ibuprofen/famotidine) — Combination product

DefinitionCombination product of ibuprofen (a non‑steroidal anti‑inflammatory drug, NSAID) and famotidine (a histamine H2‑receptor antagonist).

Drug class(es)NSAID with H2‑receptor antagonist combination; components: ibuprofen and famotidine.

Common trade nameDuexis (ibuprofen/famotidine).

FDA approved indication

Indication (FDA)Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers (gastric and/or duodenal) in patients taking ibuprofen for those indications.

Population noteClinical trials primarily enrolled patients <65 years and did not extend beyond 6 months.

LimitationIntended for patients taking ibuprofen for RA or OA to reduce risk of NSAID‑induced gastric/duodenal ulcers.

Duexis — Tablet strength / description

Tablet strengthIbuprofen 800 mg / Famotidine 26.6 mg per tablet.

Dosing regimen (reference)One tablet PO three times daily (one tablet TID) for RA or OA; maximum 2,400 mg ibuprofen/79.8 mg famotidine per day.

Product formOral tablet (brand and referenced generic equivalent).

Background

Duexis is a fixed‑dose combination tablet containing ibuprofen (800 mg) and famotidine (26.6 mg). It combines an NSAID (ibuprofen) to treat the signs and symptoms of rheumatoid arthritis and osteoarthritis with an H2‑receptor antagonist (famotidine) intended to reduce the risk of upper gastrointestinal ulcers associated with NSAID therapy.

Clinical trial populations for the product evaluated symptomatic relief in RA and OA patients and the combination’s effect on NSAID‑associated gastric/duodenal ulcer risk; dosing is provided as the combination tablet and quantity limits and dose thresholds in this policy reflect the tablet strength and recommended maximum of 3 tablets per day (equivalent to a maximum of 2400 mg ibuprofen / 79.8 mg famotidine per day when used at the upper limit).

Quantity Limits

ibuprofen/famotidine (Duexis) — Quantity limit

Quantity limit (per day)3 tablets per day (maximum dosing: 2,400 mg ibuprofen / 79.8 mg famotidine per day).

Per‑dose instructionTypical regimen: one tablet PO TID (one tablet three times daily).

Approval duration tie‑inDose must not exceed this limit for initial or continuation approvals (approval duration: 12 months).

Policy Summary

Payermhn

PolicyIbuprofen/Famotidine (Duexis) coverage criteria

Policy CodePolicy CP.PMN.120

Change TypeNo material changes

Effective DateJun 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating the member meets all approval criteria including diagnosis, age ≥18, prior therapy failures, and dose within limits.

SourceLink

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