CurrentCentenePolicy CP.PMN.170

Eluxadoline (Viberzi) Coverage

Policy governs medical necessity criteria and prior authorization requirements for eluxadoline (Viberzi) for treatment of irritable bowel syndrome with diarrhea (IBS-D) for Centene-affiliated lines of business.

Policy Summary

PayerCentene

PolicyEluxadoline (Viberzi) Coverage

Policy CodePolicy CP.PMN.170

Change TypeStep therapy bypass addedapproval duration revised

Effective Date12.01.18

Next Review Date

Key ActionSubmit prior authorization with documentation of IBS-D diagnosis, age ≥18, prior failures of anti-diarrheal and antispasmodic therapy (unless contraindicated or intolerant), and dosing that does not exceed 200 mg/day and 2 tablets/day.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.

Corrected numbering of criteria.

≥ 18Minimum age for coverage

200 mg/dayMaximum daily dose

2Max tablets/day

12 moApproval duration (Medicaid/HIM)

75 mg, 100 mgProduct strengths

Policy Summary

PayerCentene

PolicyEluxadoline (Viberzi) Coverage

Policy CodePolicy CP.PMN.170

Change TypeStep therapy bypass addedapproval duration revised

Effective Date12.01.18

Next Review Date

SourceLink

On This Page

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for Initial Approval (IBS‑D):

Initial IBS-D criteria: 1. Diagnosis of irritable bowel syndrome with diarrhea (IBS‑D).

Age requirement: 2. Age ≥ 18 years.

Anti-diarrheal step: 3. Failure of an anti-diarrheal agent (e.g., loperamide) at up to maximally indicated doses, unless clinically significant adverse effects occur or all such agents are contraindicated.

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

Antispasmodic step: 4. Failure of an antispasmodic agent (e.g., dicyclomine) at up to maximally indicated doses, unless clinically significant adverse effects occur or all such agents are contraindicated.

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

Dose limits: 5. Requested dose does not exceed both: (a) 200 mg per day; and (b) 2 tablets per day.<= 200 mg/day; <= 2 tablets/day

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy (IBS‑D):

Eligibility: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations.

Refer to state-specific continuity of care addendums where applicable.

Clinical response: 2. Member is responding positively to therapy.

Dose increase limits: 3. If the request is for a dose increase, the new dose does not exceed both: (a) 200 mg per day; and (b) 2 tablets per day.<= 200 mg/day; <= 2 tablets/day

Approval duration: Medicaid/HIM - 12 months; Commercial - 12 months or duration of request, whichever is less.

Coverage is not authorized for non‑FDA approved indications that are not addressed in this policy unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or other applicable evidence of coverage documents. Patients who meet any listed contraindications (for example: absence of a gallbladder, biliary duct obstruction or sphincter of Oddi disease/dysfunction, alcoholism or alcohol abuse, history of pancreatitis or structural pancreatic disease, severe hepatic impairment, severe constipation or mechanical gastrointestinal obstruction, or known hypersensitivity to Viberzi) are excluded from coverage.

Use of eluxadoline (Viberzi) for non‑FDA approved indications without submission of adequate clinical evidence is considered not authorized. Providers must follow the referenced off‑label use policies and submit supporting documentation of efficacy and safety for the requested off‑label indication to be considered for coverage.

Coding and Dosing Information

Age

Age requirementMember must be ≥ 18 years of age.

Applicable populationAdults diagnosed with irritable bowel syndrome with diarrhea (IBS‑D).

Maximum daily dose

Maximum daily milligram dose200 mg per day (maximum).

Maximum tablets per dayNo more than 2 tablets per day.

Dose limit sourceListed as part of initial approval criteria and dosing section (maximum 200 mg/day).

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria for Eluxadoline (Viberzi). Approval is contingent upon documentation of diagnosis, age, prior therapy trials, and dosing limits.

Applicable diagnosis: IBS‑D (Irritable Bowel Syndrome with Diarrhea)
Age requirement: ≥ 18 years
Dose limit: ≤ 200 mg per day and ≤ 2 tablets per day

Step Therapy

Step Therapy Required (IL HIM Bypass)

Step therapy requires documented failure of both an anti‑diarrheal (e.g., loperamide) and an antispasmodic (e.g., dicyclomine) given at up to maximally indicated doses, unless clinically significant adverse effects occur or all are contraindicated. For Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395 (step therapy bypass).

Definitions

IBS‑D

DefinitionIrritable bowel syndrome with diarrhea (IBS‑D).

FDA‑approved indicationViberzi (eluxadoline) is indicated in adults for the treatment of IBS‑D.

PopulationAdults (policy age requirement applies: ≥ 18 years).

Background

Eluxadoline (Viberzi) is a mu‑opioid receptor agonist indicated for treatment of adults with irritable bowel syndrome with diarrhea (IBS‑D). The usual dosing regimen is 100 mg orally twice daily; a reduced dose of 75 mg orally twice daily is recommended for patients who are intolerant of the 100 mg dose, those receiving OATP1B1 inhibitors, patients with mild to moderate hepatic impairment, or patients with moderate to severe renal impairment. The maximum daily dose is 200 mg per day and no more than 2 tablets per day. Contraindications include patients without a gallbladder, known or suspected biliary duct obstruction or sphincter of Oddi disease/dysfunction, alcoholism or alcohol abuse, history of pancreatitis or structural pancreatic disease, severe hepatic impairment (Child‑Pugh Class C), history of chronic or severe constipation or mechanical gastrointestinal obstruction, and known hypersensitivity to Viberzi.

Revision History

2026-01-06administrative_correction

Corrected numbering of criteria.

2025-07-14annual_review_material_change

4Q 2025 annual review: added step therapy bypass for Illinois HIM per IL HB 5395; references reviewed and updated.

2021-10-18policy_revision

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.