CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Viberzi (eluxadoline) prior authorization for IBS-D

Defines prior authorization coverage criteria for Viberzi (eluxadoline) for treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults under CVS Caremark criteria as used by the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyViberzi (eluxadoline) prior authorization for IBS-D

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required for Viberzi and will be approved only when the patient is an adult with IBS-D and none of the listed exclusionary conditions are present.

POLICY UPDATE CHANGES

No material clinical/coverage changes.

1Indication covered

6Exclusionary conditions

Coverage Summary & Criteria

Covered with criteria: defines prior authorization coverage for Viberzi (eluxadoline) for treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults under CVS Caremark criteria. Viberzi is FDA-approved for the treatment of IBS-D in adults.

Initial Prior Authorization - Coverage Criteria

Covered when ALL of the following are met:

ALL of the following

The requested drug is being prescribed for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in an adult patient
ALL of the following
- ANY of the following: A history of cholecystectomy
- ANY of the following: A history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction
- ANY of the following: Known or suspected biliary duct obstruction; or sphincter of Oddi disease or dysfunction
- ANY of the following: A history of pancreatitis; or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction
- ANY of the following: Severe hepatic impairment (Child-Pugh Class C)
- ANY of the following: Alcoholism, alcohol abuse or alcohol addiction, or a patient who drinks more than 3 alcoholic beverages per day

Provider Requirements & Prior Authorization

Prior Authorization

Prior authorization required for Viberzi

Prior authorization is required for coverage of Viberzi (eluxadoline) and will be approved only when the patient is an adult with IBS-D and none of the listed exclusionary conditions are present.

Documentation Required

Document absence of exclusionary conditions

Provider must document diagnosis of IBS-D in an adult and explicitly document that the patient does not have any listed exclusionary conditions (e.g., prior cholecystectomy, pancreatitis, severe hepatic impairment, alcoholism, biliary obstruction, severe constipation or mechanical GI obstruction, pancreatic structural disease).

Cholecystectomy
Pancreatitis
Severe hepatic impairment (Child-Pugh Class C)
Alcoholism, alcohol abuse, or alcohol addiction (or >3 alcoholic beverages per day)
Biliary duct obstruction or sphincter of Oddi disease/dysfunction
Severe chronic constipation or known/suspected mechanical gastrointestinal obstruction
Structural disease of the pancreas (including known or suspected pancreatic duct obstruction)

Clinical Evidence & References

Primary reference: Viberzi package insert, Allergan USA, Inc; June 2020.

Other referenced sources listed: Micromedex (IBM Watson Health) and an additional 2022 reference noted in the policy.

The package insert is used as the primary source for safety information per the policy references.

Background

Viberzi (eluxadoline) is FDA-approved for treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. The policy references the Viberzi package insert and other sources (e.g., Micromedex) for safety information.

Indication covered1

Exclusionary conditions6