CurrentNeighborhood Health Plan of Rhode IslandPolicy Viberzi PA Policy 1287-A, 1271-A UDR 10-2023

Viberzi (eluxadoline) prior authorization

Defines prior authorization requirements for coverage of Viberzi (eluxadoline) for adults with irritable bowel syndrome with diarrhea (IBS-D) under Neighborhood Health Plan/CVS Caremark.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyViberzi (eluxadoline) prior authorization

Policy CodePolicy Viberzi PA Policy 1287-A, 1271-A UDR 10-2023

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization showing the patient is an adult with IBS-D and documentation that none of the listed contraindications are present.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Adult IBS-DIndication required

6 itemsContraindications

12–36 moDuration of approval

Coverage Criteria for Viberzi (eluxadoline)

Initial Prior Authorization Criteria

Covered when ALL of the following are met

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Eligibility and contraindication criteria: 1) The requested drug is being prescribed for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in an adult patient; AND 2) The patient does not have any of the following: A) a history of cholecystectomy, B) a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction, C) known or suspected biliary duct obstruction or sphincter of Oddi disease or dysfunction, D) a history of pancreatitis or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction, E) severe hepatic impairment (Child-Pugh Class C), F) alcoholism, alcohol abuse or alcohol addiction, or a patient who drinks more than 3 alcoholic beverages per day.

See Duration of Approval for policy-specific DOA.

Patients with any of the listed conditions are excluded from coverage under this authorization policy. Specifically, prior authorization for eluxadoline (Viberzi) will not be approved if the patient has any of the following: a history of cholecystectomy; a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction; known or suspected biliary duct obstruction or sphincter of Oddi disease or dysfunction; a history of pancreatitis or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction; severe hepatic impairment (Child-Pugh Class C); or alcoholism, alcohol abuse or addiction, or consumption of more than 3 alcoholic beverages per day.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Viberzi and will be approved when the patient is an adult with irritable bowel syndrome with diarrhea (IBS-D) and does not have any listed contraindications. Duration of approval varies by policy code.

Prior authorization required
Approval when prescribed for IBS-D in an adult and no contraindications present
Duration of approval: 1287-A — 36 months; 1271-A — 12 months

Documentation Required

Required Documentation

Documentation must show the drug is prescribed for treatment of IBS-D in an adult and must include clinical information confirming the absence of contraindications listed in this policy (see denial conditions).

Clinical indication: diagnosis of IBS-D in an adult
Documentation confirming absence of listed contraindications (see denial-risk callout)

Denial Risk

Contraindications Causing Denial

Prior authorization will be denied if the patient has any of the following contraindications: history of cholecystectomy; history of chronic or severe constipation or sequelae from constipation; known or suspected mechanical gastrointestinal obstruction; known or suspected biliary duct obstruction or sphincter of Oddi disease/dysfunction; history of pancreatitis or structural pancreatic disease (including pancreatic duct obstruction); severe hepatic impairment (Child-Pugh Class C); alcoholism, alcohol abuse or alcohol addiction, or current consumption of more than 3 alcoholic beverages per day.

History of cholecystectomy
Chronic or severe constipation or sequelae, or mechanical GI obstruction
Biliary duct obstruction or sphincter of Oddi disease/dysfunction
History of pancreatitis or structural pancreatic disease
Severe hepatic impairment (Child-Pugh Class C)
Alcoholism, alcohol abuse/addiction, or >3 alcoholic drinks/day

Key Definitions

Irritable bowel syndrome with diarrhea (IBS-D) — clinical indication for Viberzi per FDA labeling

IndicationTreatment of irritable bowel syndrome with diarrhea (IBS-D) in adults (FDA-approved).

Contraindication: cholecystectomyHistory of cholecystectomy is listed as a condition that must NOT be present.

Contraindication: constipation/obstructionHistory of chronic or severe constipation or sequelae from constipation, or known/suspected mechanical gastrointestinal obstruction.

Contraindication: biliary/Sphincter of OddiKnown or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction.

Contraindication: pancreatic diseaseHistory of pancreatitis or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction.

Contraindication: hepatic impairmentSevere hepatic impairment (Child-Pugh Class C) is listed as a contraindication.

Contraindication: alcohol useAlcoholism, alcohol abuse or addiction, or consumption of more than 3 alcoholic beverages per day.

Background

Eluxadoline (Viberzi) is FDA-approved for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. Safety concerns limit its use in patients with certain conditions; the policy excludes patients with prior cholecystectomy, pancreatitis or structural pancreatic disease, biliary duct or sphincter of Oddi dysfunction, severe hepatic impairment (Child-Pugh Class C), severe or mechanical gastrointestinal obstruction/constipation sequelae, and patients with significant alcohol use (more than 3 alcoholic beverages per day or history of alcohol abuse).