Viberzi (eluxadoline)

POLICY NUMBER

L.5.01.497

Viberzi (eluxadoline)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan. Samples will not be considered as stable therapy.

DESCRIPTION

Viberzi (eluxadoline) is a mu-opioid receptor agonist that stimulates the mu-opioid receptors in the GI tract, leading to decreased muscle contractility, inhibition of water and electrolyte secretion, and increased rectal sphincter tone. Viberzi (eluxadoline) is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

Quantity Limits

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Initial Criteria

Viberzi (eluxadoline) may be considered medically necessary when ALL of the following are met:

1. The individual is 18 years of age or older;

2. The individual has a documented diagnosis of irritable bowel syndrome with diarrhea (IBS-D) with symptoms for at least 3 months;

3. BOTH of the following:

   1. The individual has documented failure of conventional dietary changes (including fiber), or stress reduction, or behavioral changes (see definition of Lifestyle and Medication Failure in Policy Guidelines section); AND

   2. The individual has documented failure (see definition of Lifestyle and Medication Failure in Policy Guidelines section), contraindication, or intolerance to TWO of the following medications from different drug classes: 

      1. Antispasmodic agent (i.e. dicyclomine);

      2. Antidiarrheal agent (i.e. loperamide, colestipol); OR

      3. Tricyclic antidepressant (i.e. amitriptyline);

4. The individual does not have ANY of the following contraindications:

   1. Previous gallbladder removal;

   2. Known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction;

   3. Alcoholism, alcohol abuse, alcohol addiction, or drink more than 3 alcoholic beverages/day;

   4. History of pancreatitis, structural diseases of the pancreas, including known or suspected pancreatic duct obstruction;

   5. Known hypersensitivity reaction to the requested agent;

   6. Severe hepatic impairment (Child Pugh Class C);

   7. History of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction; AND

5. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.  

Length of Approval: 6 months

Renewal Criteria

Viberzi (eluxadoline) may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has previously been approved for therapy with the requested agent through the BCBSMS PA process;

2. The individual has documented clinical improvement (i.e., decrease in symptom severity and/or frequency);

3. The individual is tolerating therapy and continues to follow dietary and physical activity recommendations;

4. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

5. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.  

Length of Approval: 12 months

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Lifestyle and Medication Failure

Lifestyle modification failure is defined as disease progression despite changes diet (including fiber), or stress reduction, or behavioral changes for ≥3 months. Documentation such as a daily dietary journal may be requested to support conventional non-medication interventions.

Medication failure is defined as disease progression at generally accepted doses (for ≥3 months use) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.

BCBSMS determines individual medication trials and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If individual is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the individual and/or requesting provider to obtain said records and submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

07/01/2016: New policy added. Policy number L.5.01.497.

11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

08/15/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

07/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Criteria for initial approval of Viberzi updated to state the following: 1) The patient has documented failure of conventional dietary changes (including fiber), or stress reduction, or behavioral changes 2) The patient has documented failure (≥3 months use), contraindication, or intolerance to TWO of the following. Removed statement that reauthorization will be made for 12 months.

08/06/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy section updated to add that prior authorization is required and that the use of samples by a member will not be considered current or stable therapy for purposes of Medical Policy review. Medically necessary criteria updated to reference the Policy Guidelines for the definition of Failure. Updated renewal criteria. Policy Guidelines updated to define medication failure and regarding BCBSMS determination of patient medication trials and adherence. Sources updated.

07/13/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding quantity limits. Medically necessary statement updated regarding contraindications and prescribed dosage. Revised renewal criteria. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Added information regarding BCBSMS request for medical records and defined lifestyle and medication failure. Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

10/01/2024: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy language updated to change "member" to "individual." Sources updated.

09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy section revised with minor changes for clarity purposes; intent unchanged. Sources updated.

SOURCE(S)

Viberzi prescribing information. Allergan, Inc. July 2024. Last accessed July 2025.

CODE REFERENCE

None