CurrentColorado Rocky Mountain Health Plans | UnitedHealthcare Pharmacy Clinical Pharmacy ProgramsPolicy 2025 P 2081-13

Viberzi® (eluxadoline) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Prior authorization and medical necessity criteria for Viberzi (eluxadoline) for treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults under UnitedHealthcare commercial plans; includes initial and reauthorization criteria, authorization duration, and notes about automated approvals and supply limits.

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare Pharmacy Clinical Pharmacy Programs

PolicyViberzi® (eluxadoline) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 2081-13

Change TypeRevised

Effective DateJul 1, 2025

Next Review Date

Key ActionPrior authorization is required and will be approved only when initial authorization criteria are met (IBS-D diagnosis and history of failure/contraindication/intolerance to a tricyclic antidepressant).

SourceLink

POLICY UPDATE CHANGES

Effective Date set to 7/1/2025 and program listed as Prior Authorization/Medical Necessity for Viberzi.

Initial authorization criteria require IBS-D diagnosis and failure/contraindication/intolerance to a tricyclic antidepressant.

1Required prior step (TCA)

12 monthsAuthorization duration

AdultsCovered population

Coverage Summary

Viberzi (eluxadoline) is indicated for treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. This policy applies to UnitedHealthcare commercial plans as a Prior Authorization/Medical Necessity program (Program Number 2025 P 2081-13), effective 7/1/2025. Coverage stance: covered_with_criteria. Authorization duration: 12 months.

Policy number2025 P 2081-13

Effective date2025-07-01

Last review2025-04-01

Authorization duration12 months

Covered populationAdults

Initial Authorization Criteria

Initial Authorization

Viberzi will be approved based on all of the following criteria:

ALL of the following

Diagnosis of irritable bowel syndrome with diarrhea (IBS-D)
Prior step: History of failure, contraindication or intolerance to a tricyclic antidepressant (e.g., amitriptyline)

Operational note: This policy references the AbbVie Viberzi Prescribing Information (July 2024) and relevant professional guidelines (ACG 2021 and AGA 2022). Automated approvals may be used per program processes (see Provider Actions and Additional Clinical Rules) and UnitedHealthcare may approve based on prior claim/medication history, diagnosis codes (ICD-10) and/or claim logic.

Reauthorization / Continuation Criteria

Reauthorization

Viberzi will be approved based on the following criterion:

Response: Documentation of positive clinical response to Viberzi therapy

Positive clinical response: Not explicitly defined in the policy document; however, the policy requires submission of documentation demonstrating improvement on Viberzi therapy for reauthorization.

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required and will be approved only when initial authorization criteria are met (IBS-D diagnosis and history of failure/contraindication/intolerance to a tricyclic antidepressant).

Documentation Required

Reauthorization documentation

For reauthorization, submit documentation of positive clinical response to Viberzi therapy.

Applicable Codes

Applicable diagnosisICD-10Covered

K58.0 / K58.9

Irritable bowel syndrome with diarrhea (IBS-D) - document listed diagnosis type in policy text

Applicable diagnosisICD-10Covered

K58.0 / K58.9

Irritable bowel syndrome with diarrhea (IBS-D) - document listed diagnosis type in policy text

Clinical Evidence & References

Evidence: Prescribing information — Viberzi Prescribing Information, AbbVie, July 2024; Guidelines — ACG Clinical Guideline: Management of Irritable Bowel Syndrome, Am J Gastroenterol 2021; AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome with Diarrhea, Gastroenterology 2022.

Background

Background: Viberzi is a mu-opioid receptor agonist indicated for IBS-D in adults. The policy references the AbbVie prescribing information and professional society guidelines (ACG and AGA) to inform coverage criteria.

Revision History

2025-07-01policy_effectiveLatest

Effective Date set to 7/1/2025; program listed as Prior Authorization/Medical Necessity for Viberzi. P&T approval dates updated through 4/2025; annual review references updated (non-material).

2024-03-01material_change

Material change: Reauthorization requires documentation of positive clinical response; authorization length increased to 12 months (3/2024 update).