CurrentCentenePolicy CP.PMN.117

Naproxen/Esomeprazole (Vimovo) Coverage Criteria

Policy governing medical necessity and prior authorization requirements for naproxen/esomeprazole (Vimovo) for commercial, HIM, and Medicaid lines of business; affects providers prescribing Vimovo for patients age ≥12 years and ≥38 kg.

Policy Summary

PayerCentene

PolicyNaproxen/Esomeprazole (Vimovo) Coverage Criteria

Policy CodePolicy CP.PMN.117

Change TypeNo material change

Effective DateJun 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation showing age, weight, indication, prior therapy trials, risk factors, and dosing within specified limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsApproval duration

≥12 yrsMinimum age

≥38 kgMinimum weight

1,000 mgMax adult dose

2Max tablets/day

Coverage Criteria

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inv-01: Initial Approval

Covered when ALL of the following are met

ALL of the following

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.
FDA Indication and demographics: Patient is >= 12 years of age and weight >= 38 kg.
Prior therapy: Failure of three proton pump inhibitors (e.g., omeprazole, pantoprazole, lansoprazole) in combination with three different NSAIDs unless clinically significant adverse effects are experienced or all are contraindicated (Illinois HIM exception: step therapy does not apply as of 1/1/2026 per IL HB 5395).
Risk factors: Member has at least one risk factor for developing NSAID-induced ulcers such as history of peptic ulcer disease, advanced age, or concurrent use of antiplatelets, corticosteroids, or anticoagulants.
Formulation preference: If request is for brand Vimovo, member must use generic naproxen/esomeprazole unless contraindicated or clinically significant adverse effects occur.
Dosing limits: Dose does not exceed specified limits by weight: for adults and adolescents >= 50 kg — 1,000 mg naproxen/40 mg esomeprazole per day (2 tablets/day); for adolescents 38 kg to < 50 kg — 750 mg naproxen/40 mg esomeprazole per day (2 tablets/day).

inv-02: Continued Therapy

Covered when ALL of the following are met

ALL of the following

Continuation eligibility: Member is currently receiving medication via Centene benefit or has previously met initial approval criteria; or member is in a state/product with continuity of care regulations.
Response: Member is responding positively to therapy.
Risk factors continue: Member continues to have at least one risk factor for developing NSAID-induced gastric ulcers (history of peptic ulcer disease; concurrent use of antiplatelets, corticosteroids, or anticoagulants).
Formulation preference: If request is for brand Vimovo, member must use generic naproxen/esomeprazole unless contraindicated or clinically significant adverse effects occur.

Requests for indications that are not FDA‑approved and are not specifically addressed in this clinical policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the Health Plan’s off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other applicable evidence of coverage.

For members covered under Medicaid, state Medicaid coverage provisions take precedence when they conflict with the coverage provisions in this clinical policy. Providers should consult the applicable state Medicaid manual for specific coverage rules that apply to Medicaid members.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must obtain prior authorization and submit documentation demonstrating that all approval criteria are met, including age, weight, indication, prior therapy trials (see step therapy requirements), dose limits, and risk factors for NSAID‑induced gastric ulcers. Prior authorization approvals are limited to the durations specified in the policy (e.g., initial approval: 12 months).

Prior authorization may be required for esomeprazole when submitted separately.
For Illinois HIM requests, step therapy requirements do not apply as of 01/01/2026 per IL HB 5395.

Denial Risk

Non‑FDA Indications

Requests for non–FDA approved (off‑label) indications that are not specifically addressed by this policy will be denied unless the provider submits sufficient supporting 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, CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Documentation Required

Clinical Documentation Required

Provider must submit supporting clinical documentation with the prior authorization request or claim. Acceptable documentation includes office chart notes, relevant laboratory results, medication trial history, and any other information that demonstrates the member meets all policy criteria (age, weight, indication, prior therapy trials, contraindications, adverse effects, and presence of risk factors for NSAID‑induced ulcers). Failure to provide sufficient documentation may result in denial.

Step Therapy

Step Therapy / Trial of Individual Components

Member must have tried the individual components (esomeprazole and naproxen concurrently) unless contraindicated or clinically significant adverse effects are experienced. The policy also requires failure of three different PPIs in combination with three different NSAIDs prior to approval unless contraindicated or adverse effects preclude their use. If a brand product is requested, the member must use the generic naproxen/esomeprazole formulation unless contraindicated or adverse effects are experienced.

Failure of three PPIs (e.g., omeprazole, pantoprazole, lansoprazole) in combination with three different NSAIDs is required prior to approval unless contraindicated or clinically significant adverse effects are experienced.
Member must use individual components (esomeprazole and naproxen) concurrently prior to approval unless contraindicated.
Brand requests require trial of generic formulation unless contraindicated.

Definitions

Vimovo (naproxen/esomeprazole magnesium)

ProductVimovo (naproxen/esomeprazole magnesium)

CompositionFixed combination of naproxen (NSAID) and esomeprazole magnesium (PPI)

Indication summaryProvides naproxen for symptomatic relief of arthritis and esomeprazole to decrease risk of naproxen-associated gastric ulcers

Health Plan

DefinitionHealth Plan: a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC or an affiliate; policy statements govern coverage determinations for that Health Plan.

ApplicabilityProviders, members, and their representatives are bound to the terms and conditions expressed in the clinical policy per their contracts

Proprietary noteUnauthorized copying, use, and distribution of this clinical policy is strictly prohibited.

Initial Therapy Criteria

inv-18: Initial Therapy Criteria

Initial approval requires demonstration of FDA-indicated use, demographics, prior therapy failure, risk factors, and dosing limits

ALL of the following

Age/weight: Patient is >= 12 years of age and weight >= 38 kg.
Indication: Prescribed to decrease the risk of developing NSAID-induced gastric ulcers in the FDA-approved arthritis indications (rheumatoid arthritis, JIA, osteoarthritis, ankylosing spondylitis).
Prior therapy: Failure of three PPIs (e.g., omeprazole, pantoprazole, lansoprazole) in combination with three different NSAIDs unless contraindicated or clinically significant adverse effects are experienced; for Illinois HIM requests, step therapy does not apply as of 1/1/2026 per IL HB 5395.
Risk factor: Member must have at least one risk factor for NSAID-induced ulcers (e.g., history of peptic ulcer disease; concurrent use of antiplatelets, corticosteroids, or anticoagulants).
Dose limits: Dose must not exceed specified limits by weight: adults/adolescents >=50 kg — 1,000 mg naproxen/40 mg esomeprazole per day (2 tablets/day); adolescents 38 kg to <50 kg — 750 mg naproxen/40 mg esomeprazole per day (2 tablets/day).
Formulation: If request is for brand Vimovo, member must use generic naproxen/esomeprazole unless contraindicated or clinically significant adverse effects occur.

weight requirement: A weight requirement per the prescribing information was added to the policy criteria (document history notes weight requirement added).

use of individual components: Medical justification was revised to require trial of individual components (concurrent use of esomeprazole and naproxen or separate agents) prior to approval of the combination product in some cases.

inv-19: Initial Therapy

Initial therapy considerations reflected in policy history

weight requirement: A weight requirement per the prescribing information was added to the policy criteria (document history notes weight requirement added).

use of individual components: Medical justification revised to require that the member must use individual components (trial of separate naproxen and esomeprazole) prior to combination product in some cases.

Continued Therapy Criteria

inv-20: Continued Therapy Criteria

Continuation requires evidence of prior authorization or current receipt and continued benefit

ALL of the following

Prior authorization or prior approval: Member is currently receiving medication via Centene benefit or has previously met initial approval criteria.
Clinical response: Member is responding positively to therapy.
Risk factors: Member continues to have at least one risk factor for developing NSAID-induced gastric ulcers (history of peptic ulcer disease; concurrent use of antiplatelets, corticosteroids, or anticoagulants).
Formulation preference: If request is for brand Vimovo, member must use generic naproxen/esomeprazole unless contraindicated or clinically significant adverse effects occur.

inv-21: Continued Therapy

Continued therapy provisions and formulation preferences in policy history

continued therapy clarification: Continued therapy language was updated to indicate requests may be for generic formulation; for commercial line of business, approval duration updated to 12 months and generic formulation added to continued therapy.

continued therapy: Template and wording changes clarified continued therapy requirements and continuity-of-care provisions per state-specific addendums.

Step Therapy Requirements

Step	Requirement	Notes
1	Required prior to approval except where state law (Illinois HIM) exempts as of 1/1/2026	Failure of three PPIs in combination with three different NSAIDs is required unless contraindicated or clinically significant adverse effects occur; IL HB 5395 exempts Illinois HIM requests from these step therapy requirements effective 1/1/2026.

Step	Requirement	Notes
1	Member must use individual components (esomeprazole and naproxen) prior to combination product request	Policy history revised medical justification to require trial of individual components prior to combination product; exception applies if contraindicated or clinically significant adverse effects occur.

OpenPayer

Naproxen/Esomeprazole (Vimovo) Coverage Criteria

Coverage Criteria

Coding and Dosing Parameters

Provider Actions and Requirements

Background

Definitions

Initial Therapy Criteria

Continued Therapy Criteria

Step Therapy Requirements

Quantity Limits