CurrentmhnPolicy CP.PMN.117

Naproxen/Esomeprazole (Vimovo)

Criteria and coverage guidance for use of the fixed-combination naproxen/esomeprazole (Vimovo) for members meeting FDA-approved indications and payer-specific step therapy and dosing limits.

Policy Summary

Payermhn

PolicyNaproxen/Esomeprazole (Vimovo)

Policy CodePolicy CP.PMN.117

Change TypeNo material changes

Effective DateJun 1, 2018

Next Review Date

Key ActionProvider must submit clinical documentation supporting that the member meets all approval criteria (age ≥12, weight ≥38 kg, indication, risk factors, and prior therapy failures).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12Minimum age for coverage

≥38 kgMinimum weight for coverage

Fail 3 PPIs+3 NSAIDsStep therapy requirement

12 moApproval duration

2Product strengths

Coverage Criteria

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inv-01: Initial Authorization Criteria

Covered when ALL of the following are met

FDA-approved indication: Prescribed to decrease the risk of developing NSAID-induced gastric ulcers in patients with rheumatoid arthritis, juvenile idiopathic arthritis (JIA), osteoarthritis, or ankylosing spondylitis

Age and weight: Age ≥ 12 years AND weight ≥ 38 kg

Step therapy: 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

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

Use of individual components when required: Member must use the individual components (esomeprazole and naproxen) concurrently when specified unless contraindicated or clinically significant adverse effects are experienced

Prior authorization may be required for esomeprazole

Risk factor for NSAID-associated ulcer: Member has at least one risk factor: age > 65 years, history of peptic ulcer disease, or concurrent use of antiplatelets, corticosteroids, or anticoagulants

Brand vs generic: If request is for brand Vimovo, member must use generic naproxen/esomeprazole unless contraindicated or clinically significant adverse effects are experienced

Dose limit: Dose does not exceed the specified limits by weight category

For ≥50 kg: maximum 1,000 mg naproxen/40 mg esomeprazole per day (2 tablets per day); for 38 kg to <50 kg: maximum 750 mg naproxen/40 mg esomeprazole per day (2 tablets per day)

inv-02: Continuation Therapy Criteria

Continuation therapy — Covered when ALL of the following are met

Continuation or continuity: Member is currently receiving medication via Centene benefit or previously met initial approval criteria, or member is enrolled in a state/product with continuity of care regulations

Refer to state-specific continuity of care addendums

Clinical response: Member is responding positively to therapy

Ongoing risk factor: Member continues to have at least one risk factor for developing NSAID-induced gastric ulcers: age > 65 years, history of peptic ulcer disease, or concurrent use of antiplatelets, corticosteroids, or anticoagulants

Brand vs generic for continuation: If request is for brand Vimovo, member must use generic naproxen/esomeprazole unless contraindicated or clinically significant adverse effects are experienced

Requests for use of naproxen/esomeprazole (Vimovo) for non‑FDA approved indications that are not specifically 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 (e.g., CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, or CP.PMN.53 for Medicaid) or unless coverage is supported by the member’s evidence of coverage documents.

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Providers should refer to the applicable state Medicaid manual for any state‑specific coverage determinations that govern this product.

Use of Vimovo for indications outside the FDA‑approved labeling may be considered not medically necessary unless there is supporting clinical evidence per the applicable off‑label use policies noted in this document. Additionally, the product has documented limitations of use (for example, it should not be substituted with separate single‑ingredient naproxen and esomeprazole products and is not recommended for initial treatment of acute pain) which should be considered when evaluating off‑label requests.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must demonstrate that member meets all approval criteria including age (≥12 years), weight (≥38 kg), indication to decrease NSAID‑induced gastric ulcers, required risk factors, and step‑therapy requirements where applicable. Provider must submit supporting clinical documentation (e.g., office notes, labs) to show criteria are met.

Prior authorization required showing criteria met (age ≥12, weight ≥38 kg, indication to decrease NSAID‑induced gastric ulcers, risk factors, dosing limits).
Provider must submit clinical documentation supporting that member meets all approval criteria (office chart notes, lab results, etc.).

Documentation Required

Brand vs Generic Requirement

If the request is for brand Vimovo, the member must use the individual generic components (naproxen + esomeprazole) or the generic naproxen/esomeprazole product unless contraindicated or clinically significant adverse effects are documented. Prior authorization may be required for esomeprazole.

Brand Vimovo requests require trial/use of generic naproxen/esomeprazole unless contraindication or adverse reaction documented.
Prior authorization may be required for esomeprazole.

Step Therapy

Step Therapy and Illinois Bypass

Step therapy requirements apply: member must have failed three PPIs (for example, omeprazole, pantoprazole, lansoprazole) in combination with three different NSAIDs unless clinically significant adverse effects are experienced or all are contraindicated. For Illinois HIM line of business, the step therapy requirements do not apply per IL HB 5395 (effective 1/1/2026) — a step therapy bypass was added for IL HIM.

Failure of three PPIs in combination with three different NSAIDs required prior to approval unless contraindicated or adverse effects.
Illinois HIM: step therapy bypass per IL HB 5395 (effective 01/01/2026).

Note

Coverage Governance and Clinical Judgment

Coverage decisions are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable state and federal requirements. This policy is guidance to assist medical necessity determinations and does not guarantee payment. Providers are expected to exercise professional medical judgment.

Coverage governed by evidence of coverage, certificate of coverage, policy/contract, and applicable law.
Non‑FDA indications not addressed by this policy may be denied unless supported by off‑label use policies or evidence of coverage documents.

Background

Vimovo is a fixed‑combination product that contains naproxen (a nonsteroidal anti‑inflammatory drug) and esomeprazole magnesium (a proton pump inhibitor). It is formulated as delayed‑release tablets combining enteric‑coated naproxen with immediate‑release esomeprazole to provide symptomatic relief of arthritis while reducing the risk of naproxen‑associated gastric ulcers in patients who require naproxen therapy.

The FDA‑labeled population includes adults and adolescents 12 years of age and older weighing at least 38 kg. Indications for the naproxen component include osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis in adolescents, while the esomeprazole component is intended to reduce NSAID‑associated gastric ulcer risk.

Clinicians should note boxed warnings and contraindications associated with NSAIDs: increased cardiovascular and gastrointestinal risk, and specific contraindication of Vimovo in patients undergoing coronary artery bypass graft (CABG) surgery. Dosing is available in two delayed‑release tablet strengths (375 mg/20 mg and 500 mg/20 mg naproxen/esomeprazole), with weight‑based maximum daily naproxen limits specified in the policy.

Definitions and Safety Notes

inv-21: Vimovo (naproxen/esomeprazole) — key definition and indication summary

DefinitionVimovo is a fixed combination of naproxen (an NSAID) and esomeprazole magnesium (a PPI)

Indication summaryIndicated for adults and adolescents ≥12 years and ≥38 kg who require naproxen for symptomatic relief of arthritis while reducing the risk of naproxen-associated gastric ulcers (osteoarthritis, rheumatoid arthritis, ankylosing spondylitis; JIA in adolescents)

Components rolesNaproxen provides analgesic/anti-inflammatory effects; esomeprazole reduces risk of NSAID-associated gastric ulcers

inv-22: NSAID boxed warnings / contraindications — cardiovascular and GI risks; contraindicated in CABG

Boxed warningsNSAIDs (including naproxen) carry boxed warnings for increased risk of serious cardiovascular thrombotic events (including MI and stroke) and serious gastrointestinal events (bleeding, ulceration, and perforation)

Contraindication: CABGVimovo is contraindicated in the setting of coronary artery bypass graft (CABG) surgery

Other contraindicationsHypersensitivity to naproxen, esomeprazole magnesium, substituted benzimidazoles, aspirin/NSAID allergy, or concurrent use of rilpivirine-containing products

OpenPayer

Naproxen/Esomeprazole (Vimovo)

Coverage Criteria

Coding and Product Strengths

Provider Actions and Prior Authorization

Background

Definitions and Safety Notes