CurrentUnitedHealthcarePolicy N/A

Viberzi (eluxadoline) prior authorization

Prior authorization and medical necessity criteria for coverage of Viberzi (eluxadoline) for adults with irritable bowel syndrome with diarrhea (IBS-D) under UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerUnitedHealthcare

PolicyViberzi (eluxadoline) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documented diagnosis of IBS-D and history of failure, contraindication, or intolerance to a tricyclic antidepressant (e.g., amitriptyline).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Adultsindicated population

Prior authprogram type

12 moauthorization duration

2016–2025policy revision history

Coverage Criteria

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Initial Therapy

Covered when ALL of the following are met:

Initial Therapy - Diagnostic and Step Requirements: 1) Diagnosis of irritable bowel syndrome with diarrhea (IBS-D).

Documented diagnosis required for initial authorization

Initial Therapy - Step Therapy Requirement: 2) History of failure, contraindication, or intolerance to a tricyclic antidepressant (e.g., amitriptyline).

Policy specifies prior trial of a tricyclic antidepressant prior to Viberzi initiation

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required

Initial authorization requires a documented diagnosis of irritable bowel syndrome with diarrhea (IBS-D) and evidence the patient has failed, has a contraindication to, or is intolerant of a trial of a tricyclic antidepressant (e.g., amitriptyline). Absence of this documentation may result in denial.

Diagnosis: ICD-10 code(s) supporting IBS-D must be provided
Step requirement: Documentation of failure, contraindication, or intolerance to amitriptyline (or other specified tricyclic antidepressant)
Prior authorization required for initial therapy

Documentation Required

Reauthorization — Documentation of Clinical Benefit Required

Reauthorization will be approved only when documentation shows a positive clinical response to Viberzi therapy. Provide objective or clinician-documented evidence of symptom improvement since initiation of therapy.

Documentation of positive clinical response (symptom reduction, functional improvement, or other clinical measures)
Include treatment dates and monitoring notes supporting continued benefit

Note

Alternate Documentation Routes & Supply Limits

UnitedHealthcare may approve initial or reauthorization requests based on prior claims, medication history, ICD-10 diagnosis codes, and/or claim logic. Automated approval/re-approval processes vary by program or therapeutic class. Supply limits may apply.

Previous claim or pharmacy history demonstrating prior use
ICD-10 diagnosis codes on claims supporting IBS-D
Be aware of potential supply limits applied at approval

Denial Risk

Denial Risk — Missing Step or Diagnosis Documentation

Failure to document the required step therapy (trial and failure, contraindication, or intolerance to amitriptyline) or absence of an IBS-D diagnosis may lead to denial of the request.

Denial risk if no documentation of amitriptyline trial outcome or contraindication
Denial risk if IBS-D diagnosis is not documented

Step	Requirement	Notes
1	Documentation of prior failure, contraindication, or intolerance to a tricyclic antidepressant (example: amitriptyline)	Must be demonstrated prior to approval as the step requirement for initiation of Viberzi (eluxadoline).

Definitions

IBS-D — Definition and Required Documentation

DefinitionIBS-D: irritable bowel syndrome with diarrhea — the documented diagnosis required for authorization.

Required documented diagnosis for authorizationDiagnosis of irritable bowel syndrome with diarrhea (IBS-D) must be documented for initial prior authorization.

Initial authorization supporting requirementHistory of failure, contraindication, or intolerance to a tricyclic antidepressant (example: amitriptyline) is required for initial approval.

Reauthorization documentationDocumentation of positive clinical response to Viberzi therapy is required for renewal (authorization issued for 12 months).

Alternate approval routesUnitedHealthcare may approve initial and re-authorization based on prior claim/medication history, diagnosis codes (ICD-10) and/or claim logic.

Background

Viberzi (eluxadoline) is a mu-opioid receptor agonist indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. Coverage under this policy is limited to patients with a documented diagnosis of IBS-D and is subject to program rules such as prior authorization and potential supply limits. UnitedHealthcare may use prior claim or medication history, diagnosis codes (ICD-10), and claim logic to approve initial or renewal requests where applicable.

Revision History

2016-04-01P&T approval

Initial P&T approval recorded for Viberzi prior authorization policy.

2016-07-01Effective date entry

Policy effective date recorded as 07/2016 (state-specific updates noted).

2016-11-01Administrative update

Added Indiana and West Virginia coverage information.

2017-03-01P&T approval / annual review

Annual review with references updated and state mandate language revised.

2018-03-01P&T approval / annual review

Annual review with references updated.

2018-12-01Administrative update

Added administrative statement regarding use of automated processes.

2019-03-01P&T approval / annual review

Annual review with references updated.

2020-03-01P&T approval / annual review

Annual review with references updated.

2021-03-01P&T approval / annual review

Annual review; removed antispasmodic and antidiarrheal agent as step 1 and updated ACG guidelines.

2022-03-01P&T approval / annual review

Annual review with updated references.

2023-03-01P&T approval / annual review

Annual review with updated references.

2024-03-01P&T approval / policy change

Annual review and increased initial authorization duration to 12 months.

2024-04-01Administrative update

Administrative update: references updated.

2025-03-01P&T approval / annual review

Annual review with updated references recorded (P&T listed for 3/2025 in references).

2025-04-01P&T approvalLatest

P&T approval recorded in April 2025 (listed among P&T approval dates).

Policy Summary

PayerUnitedHealthcare

PolicyViberzi (eluxadoline) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documented diagnosis of IBS-D and history of failure, contraindication, or intolerance to a tricyclic antidepressant (e.g., amitriptyline).

SourceLink

On This Page

OpenPayer

Viberzi (eluxadoline) prior authorization

Coverage Criteria

Initial Therapy

Continuation / Reauthorization

Provider Actions & Documentation Requirements

Step Therapy Requirements

Quantity Limits

Coding

Definitions

Background

Revision History