CurrentCentenePolicy CP.PMN.117

Naproxen/Esomeprazole (Vimovo) coverage and medical necessity

Defines medical necessity, prior authorization and coverage criteria for naproxen/esomeprazole (Vimovo) for Centene lines of business (Commercial, HIM/ICHRA, Medicaid) including eligible indications, age/weight limits, step therapy and dosing limits.

Policy Summary

PayerCentene

PolicyNaproxen/Esomeprazole (Vimovo) coverage and medical necessity

Policy CodePolicy CP.PMN.117

Key ActionSubmit prior authorization with clinical documentation showing the member meets all approval criteria (age, weight, indication, step therapy, risk factors, and dose limits).

Change TypeNo material change

Effective DateJun 1, 2018

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12min age

≥38 kgmin weight

12 monthsapproval duration

2max tablets/day

3 PPIs+3 NSAIDsstep therapy

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Initial therapy (Medical necessity for Vimovo)

Covered when ALL of the following are met:

FDA indication and patient factors: 1) Prescribed to decrease the risk of developing NSAID-induced gastric ulcers in patients with rheumatoid arthritis, juvenile idiopathic arthritis (JIA), osteoarthritis, or ankylosing spondylitis; 2) Age ≥ 12 years; 3) Weight ≥ 38 kg.

Step therapy and component use: 4) Failure of three 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 (esomeprazole and naproxen) concurrently, unless contraindicated or clinically significant adverse effects are experienced; prior authorization may be required for esomeprazole.

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

Risk factors required: 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.

Brand and dosing restrictions: If request is for brand Vimovo, member must use generic naproxen/esomeprazole unless contraindicated or clinically significant adverse effects are experienced; dose must not exceed listed maximums per weight group.See dosing thresholds for adults and adolescents (≥50 kg: 1,000 mg naproxen/40 mg esomeprazole per day and 2 tablets/day; 38 to <50 kg: 750 mg naproxen/40 mg esomeprazole per day and 2 tablets/day).

Continuation/renewal criteria

Covered when ALL of the following are met:

Continuation eligibility: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria, or qualifies under continuity of care regulations; 2) Member is responding positively to therapy; 3) Member continues to have at least one of the risk factors for developing 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 Vimovo, member must use generic naproxen/esomeprazole unless contraindicated or clinically significant adverse effects are experienced; 5) If request is for a dose increase, the new dose must not exceed the maximums specified for the applicable weight group.Approval duration: 12 months.

Non‑FDA approved indications not addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with applicable off‑label use policies (for example, CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, or CP.PMN.53 for Medicaid).

Vimovo is not recommended for initial treatment of acute pain because the product causes delayed absorption of naproxen compared with other naproxen formulations; therefore initial acute pain indications are not supported by this policy.

Dosing, Quantity and Eligibility Limits

Maximum daily naproxen/esomeprazole — dosing limits by weight/age

Adults and adolescents ≥50 kg — maximum daily naproxen/esomeprazole1,000 mg naproxen / 40 mg esomeprazole per day

Adolescents 38 to <50 kg — maximum daily naproxen/esomeprazole750 mg naproxen / 40 mg esomeprazole per day

Typical dosing regimens supporting limitsOne tablet PO BID of either 375 mg naproxen/20 mg esomeprazole or 500 mg naproxen/20 mg esomeprazole (doses correspond to the stated maximums)

Maximum tablets per day — policy limit

Policy limit — maximum tablets per day2 tablets per day

Adult/adolescent regimen exampleOne tablet PO BID (two tablets daily) of 375 mg naproxen/20 mg esomeprazole or 500 mg naproxen/20 mg esomeprazole

Dose increase constraintAny dose increase must not exceed the 2 tablets/day limit per weight-based maximums

Age/weight eligibility — minimum age and weight requirements

Minimum age for therapy12 years or older

Minimum weight for therapyAt least 38 kg

Indication age/weight contextFDA indication applies to adult and adolescent patients ≥12 years and ≥38 kg requiring naproxen and esomeprazole

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vimovo (naproxen/esomeprazole) and requests are subject to review. Approval duration for continued therapy is 12 months. Policy updates and historical notes are tracked in the references/revision history; providers should verify state-specific exceptions.

Prior authorization required — see policy number CP.PMN.117
Approval duration for continuation: 12 months
Policy updates and P&T review history documented in References section

Documentation Required

Providers must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, laboratory results, and other clinical information demonstrating that the member meets all approval criteria.

Office chart notes detailing diagnosis and prior treatments
Laboratory results or imaging as applicable
Medication history showing trials and failures or contraindications

Denial Risk

Incomplete Requests May Be Delayed or Denied

Requests that do not include the required documentation or clinical information to support that approval criteria are met may be delayed or denied. Providers should ensure all required fields and supporting records are provided at time of submission.

Incomplete requests lacking office notes, medication history, or lab data may not be processed
Provide clear documentation of prior PPI and NSAID trials or documented contraindications/adverse effects

Step Therapy

Step Therapy Requirement and Bypass

Step therapy applies: failure of three proton pump inhibitors (e.g., omeprazole, pantoprazole, lansoprazole) in combination with three different NSAIDs is required unless clinically significant adverse effects are experienced or all are contraindicated. For Illinois HIM requests, step therapy requirements do not apply per IL HB 5395 effective 01/01/2026; see state-specific guidance for continuity.

Step therapy: documented failure of 3 PPIs + 3 different NSAIDs required unless contraindicated
IL HIM (Illinois) step therapy bypass per IL HB 5395 effective 01/01/2026 — do not apply step therapy for IL HIM requests

Note

References to Prescribing Information and Drug Databases

References to prescribing information and drug databases may be used to support clinical rationale and documentation. Relevant references include the Vimovo Prescribing Information, Micromedex, and Clinical Pharmacology.

Use Vimovo PI and drug databases to corroborate dosing, indications, and contraindications
Cite relevant reference when documenting contraindications or adverse effects

Product Background

Vimovo is a fixed‑combination product containing naproxen (a nonsteroidal anti‑inflammatory drug) and esomeprazole magnesium (a proton pump inhibitor) intended to provide symptomatic relief of arthritic conditions while decreasing the risk of NSAID‑associated gastric ulcers.

The product is indicated for use in adults and adolescents 12 years of age and older weighing at least 38 kg who require naproxen therapy and have risk factors for NSAID‑induced gastric ulcers; controlled clinical studies of the combination do not extend beyond 6 months.

Because naproxen absorption from Vimovo is delayed compared with other naproxen products, Vimovo is not recommended for initial treatment of acute pain and should be used primarily when the goal includes reduction of NSAID‑associated gastric ulcer risk alongside naproxen therapy.

Product Definitions and Safety Notes

Vimovo — fixed combination composition and indication summary

CompositionFixed combination product containing naproxen (NSAID) and esomeprazole magnesium (PPI)

Available tablet strengths / regimensTablets available as 375 mg naproxen/20 mg esomeprazole and 500 mg naproxen/20 mg esomeprazole (dosed PO BID to achieve daily maxima)

Primary indication summaryIndicated to provide symptomatic relief of arthritis (osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and JIA in adolescents) and to decrease risk of naproxen-associated gastric ulcers

Contraindications/Boxed warnings — hypersensitivity, CABG, cardiac and other boxed warnings

Contraindication — hypersensitivity and NSAID allergyHypersensitivity to naproxen, esomeprazole magnesium, substituted benzimidazoles, or any component; history of asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs

Contraindication — CABGUse in the setting of coronary artery bypass graft (CABG) surgery is contraindicated

Contraindication — drug interactionsConcurrent use of rilpivirine-containing products is contraindicated

Boxed warning — cardiovascular riskNSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke

Boxed warning — gastrointestinal riskNSAIDs, including naproxen, increase the risk of serious GI adverse events including bleeding, ulceration, and perforation

OpenPayer

Naproxen/Esomeprazole (Vimovo) coverage and medical necessity

Coverage and Medical Necessity Criteria

Dosing, Quantity and Eligibility Limits

Prior Authorization, Documentation, and Step Therapy

Product Background

Product Definitions and Safety Notes