ModifiedCentenePolicy CP PMN.120

Ibuprofen/Famotidine (Duexis) coverage

Defines medical necessity and authorization criteria for coverage of the combination product ibuprofen/famotidine (Duexis) for treatment of rheumatoid arthritis or osteoarthritis and prevention of NSAID‑induced upper GI ulcers for Centene lines of business.

Policy Summary

PayerCentene

PolicyIbuprofen/Famotidine (Duexis) coverage

Policy CodePolicy CP PMN.120

Change TypeClarified generic applicationapproval duration revisionsstep therapy bypass for IL

Effective DateJun 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation showing failures of required step-therapy and medical justification for inability to use individual components.

SourceLink

POLICY UPDATE CHANGES

Clarified that generic famotidine-ibuprofen applies to the policy and revised continued approval duration to 12 months.

Revised initial and continued approval durations from 12 months to 6 months (earlier change described) and added requirement that inability to use individual components 'must use' language.

Added redirection to generic product in continued therapy.

6 monthsInitial approval duration

12 monthsContinuation approval

≥18Age requirement

2,400 mg

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Coverage Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Approval: 1) Prescribed to decrease the risk of developing NSAID-induced gastric ulcers in patients with rheumatoid arthritis or osteoarthritis; 2) Diagnosis: rheumatoid arthritis or osteoarthritis; 3) Age > 18 years; 4) Failure of an H2RA (ranitidine) in combination with an NSAID (ibuprofen), unless contraindicated or clinically significant adverse effects; 5) Failure of three proton pump inhibitors (e.g., omeprazole, pantoprazole, lansoprazole) in combination with three different NSAIDs unless contraindicated or clinically significant adverse effects; 6) Member must use the individual components (famotidine and ibuprofen) concurrently unless contraindicated or clinically significant adverse effects; 7) If brand Duexis is requested, member must use generic ibuprofen/famotidine unless contraindicated or clinically significant adverse effects; 8) 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).approval duration 6 months

For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

inv-02: Continuation Therapy

Covered when ALL of the following are met:

Continued Therapy: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria; 2) Member is responding positively to therapy; 3) Member continues to have 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); 4) If request is for brand Duexis, member must use generic ibuprofen/famotidine unless contraindicated or clinically significant adverse effects; 5) Dose increase requests must not exceed 2,400 mg ibuprofen / 79.8 mg famotidine per day.approval duration 12 months

Continuity of care provisions referenced.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 for Commercial, HIMPA.154 for Health Insurance Marketplace, and CP PMN.53 for Medicaid, or unless coverage is supported by the plan's evidence of coverage documents.

Initial Therapy Criteria

inv-16: Initial Therapy

Initial authorization requirements

Initial Therapy Nodes: Prescribed to decrease risk of NSAID-induced gastric ulcers in rheumatoid arthritis or osteoarthritis; age >18 years; failure of ranitidine (H2RA) in combination with an NSAID (ibuprofen) unless contraindicated or clinically significant adverse effects; failure of three PPIs each in combination with three different NSAIDs unless contraindicated or clinically significant adverse effects; member must use individual components (famotidine and ibuprofen) concurrently unless contraindicated or clinically significant adverse effects; generic ibuprofen/famotidine required before brand Duexis unless contraindicated or clinically significant adverse effects; member has at least one GI risk factor (age ≥65 years, prior peptic ulcer disease, or concurrent use of antiplatelets, corticosteroids, or anticoagulants).approval duration 6 months

Policy history: 2Q 2021 clarified 'must use' language for individual components and revised approval durations (see policy history).

inv-17: Initial therapy

Initial approval considerations (historical edits captured)

Continuation / Renewal Criteria

inv-18: Continuation Therapy

Continuation criteria for members already on therapy

Continued Therapy Nodes: Member currently receiving medication via Centene benefit or previously met initial criteria; member responding positively to therapy; ongoing presence of 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); generic use required over brand unless contraindicated or clinically significant adverse effects; dose limit applies (does not exceed 2,400 mg ibuprofen / 79.8 mg famotidine per day).

Approval duration 12 months.

inv-19: Continued therapy

Continued approval duration and product redirection

Continued therapy requirements: Continued approval duration revised to 12 months (per 2Q 2025 review); continued therapy may be redirected to a generic famotidine-ibuprofen product; providers must supply medical justification when inability to use individual components is claimed.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit clinical documentation (e.g., office/chart notes, lab results) supporting that the member meets all approval criteria. Requests lacking required documentation or evidence for the indicated diagnosis may be denied.

Prior authorization required for ibuprofen/famotidine (Duexis) per policy CP PMN.120
Include office notes, labs, prior medication trials, and rationale for therapy choice

Documentation Required

Medical Justification Required

Providers must supply documentation that the member cannot use the individual components (famotidine and ibuprofen) together when requesting combination product therapy. Failure to provide medical justification for inability to use individual components may result in denial.

Medical justification must explain contraindication, intolerance, or clinically significant adverse effects to individual components

Step Therapy Requirements

Step	Requirement
1	Failure of an H2‑receptor antagonist (ranitidine) in combination with an NSAID (ibuprofen), unless contraindicated or clinically significant adverse effects occurred; and failure of three proton pump inhibitors (e.g., omeprazole, pantoprazole, lansoprazole) each in combination with three different NSAIDs unless contraindicated or clinically significant adverse effects occurred.
2	Member must have used the individual components (famotidine and ibuprofen) concurrently unless contraindicated or clinically significant adverse effects occurred; if request is for brand Duexis, member must use generic ibuprofen/famotidine unless contraindicated or clinically significant adverse effects are experienced.
Illinois HIM exemption	For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395.

State	Step therapy bypass / effective date
Illinois	Step therapy bypass added for Illinois HIM requests per IL HB 5395; step therapy requirements do not apply as of 1/1/2026.

Coding and Dose Limits

Maximum daily dose

Maximum daily dose2,400 mg ibuprofen / 79.8 mg famotidine per day

Equivalent tablet limitMaximum corresponds to 3 tablets per day (800 mg ibuprofen / 26.6 mg famotidine per tablet)

Dose increase restrictionRequests for dose increases must not exceed this maximum

Definitions

Duexis (ibuprofen/famotidine)

ProductDuexis — fixed‑dose combination of ibuprofen (NSAID) and famotidine (H2‑receptor antagonist)

IndicationsRelief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of upper GI ulcers in patients taking ibuprofen

Clinical trial limitsTrials primarily enrolled patients <65 years and did not extend beyond 6 months

Duexis dosing

Strength per tablet800 mg ibuprofen / 26.6 mg famotidine

Recommended dosingOne tablet orally three times daily (one tablet PO TID) for rheumatoid arthritis or osteoarthritis

Background

Duexis is a fixed‑dose combination of an NSAID and an H2‑receptor antagonist — ibuprofen/famotidine — formulated to relieve signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of upper gastrointestinal ulcers in patients taking ibuprofen for those conditions. The product is supplied as a tablet containing 800 mg ibuprofen / 26.6 mg famotidine, with the labeled regimen for arthritis of one tablet orally three times daily (TID) and a maximum daily exposure of 2,400 mg ibuprofen / 79.8 mg famotidine. Clinical trial experience predominantly enrolled patients under age 65 without prior GI ulcer history and did not extend beyond six months, which informs the policy's age, risk‑factor, and authorization duration considerations.

Quantity Limits

Duexis — Quantity limit

Quantity limit (Duexis)3 tablets per day

RationaleAligns with maximum daily dose of 2,400 mg ibuprofen / 79.8 mg famotidine

Applies toAll formulations of ibuprofen/famotidine covered under this policy

ibuprofen/famotidine tablet — Quantity

Quantity (per tablet)3 tablets per day

Unit strengthEach tablet contains 800 mg ibuprofen and 26.6 mg famotidine

Daily maximum equivalence3 tablets = 2,400 mg ibuprofen / 79.8 mg famotidine