CurrentMass General Brigham Health PlanPolicy N/A

Xifaxan (rifaximin) 550 mg coverage

Defines prior authorization, quantity limits, and clinical criteria for coverage of rifaximin 550 mg for hepatic encephalopathy and IBS-D for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyXifaxan (rifaximin) 550 mg coverage

Policy CodePolicy N/A

Change TypeCriteria revisions and added approval durations

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, age ≥18, and prior inadequate response, adverse reaction, or contraindication to required therapies.

SourceLink

POLICY UPDATE CHANGES

Updated criteria to require documentation of diagnoses and previous trials; updated hepatic encephalopathy criteria to remove allowance for approval if member is currently on therapy.

Added approval durations for hepatic encephalopathy (12 months) and IBS-D (30 days) and clarified quantity limits per indication.

2Indications covered (HE, IBS-D)

12mAuth duration HE

30dAuth duration IBS-D

550 mgProduct strength

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Hepatic Encephalopathy

Covered when ALL of the following are met

HE coverage: Member has a documented diagnosis of hepatic encephalopathy; member is 18 years of age or older; documentation of inadequate response, adverse reaction, or contraindication to lactulose; OR member is new to the plan within the past 90 days and is currently receiving the requested medication (excluding when the product was obtained as samples or via manufacturer's patient assistance programs).

Approval duration: 12 months; quantity limit: 550 mg twice daily, 60 tablets per 30 days.

Irritable Bowel Syndrome with Diarrhea (IBS-D)

Covered when ALL of the following are met

IBS-D coverage: Member has a documented diagnosis of irritable bowel syndrome with diarrhea (IBS-D); member is 18 years of age or older; documentation of inadequate response or contraindication to ONE antidiarrheal (loperamide or diphenoxylate/atropine) AND documentation of inadequate response or contraindication to a bile acid sequestrant (e.g., cholestyramine, colestipol, or colesevelam); OR member is new to the plan within the past 90 days and is currently receiving the requested medication (excluding when the product was obtained as samples or via manufacturer's patient assistance programs).

Approval duration: 30 days; quantity limit: 550 mg three times daily, 42 tablets per 14 days; may be treated up to 2 times.

Authorization is required for rifaximin. Authorization may be granted for members who are new to the plan within the past 90 days and are currently receiving treatment with the requested medication, provided the medication was not obtained as samples or through the manufacturer's patient assistance program. For all other requests, authorization will be granted only when the specific coverage criteria for the applicable indication are met.

Use of rifaximin is considered not medically necessary when the required indication-specific criteria are not met. Examples include: absence of a documented diagnosis for the requested indication, the patient being younger than 18 years, or missing documentation of required prior therapy trials or documented contraindications/adverse reactions (for example, lack of documented trial or intolerance to lactulose for hepatic encephalopathy, or lack of documented trial or intolerance to an antidiarrheal and a bile acid sequestrant for IBS‑D). Requests lacking these elements are subject to denial.

Coding and Quantity Limits

Pharmacy coding guidanceNDC

NDC not listed

No NDC codes specified in document

Quantity limits (reference)mixed

HE: 550 mg twice daily	Hepatic Encephalopathy quantity limit: 60 tablets per 30 days; approval duration: 12 months.
IBS-D: 550 mg three times daily	Irritable Bowel Syndrome with Diarrhea quantity limit: 42 tablets per 14 days; may be treated up to 2 times; approval duration: 30 days.

Quantity limits per indication

Hepatic encephalopathy (HE)60 tablets per 30 days (550 mg twice daily)

IBS-D (Irritable bowel syndrome with diarrhea)42 tablets per 14 days (550 mg three times daily)

IBS-D repeat treatment limitMay be treated up to 2 times with this regimen

Provider Actions, Requirements, and Denial Risk

Prior Authorization

Prior Authorization Required

Prior authorization is required for Xifaxan (rifaximin) 550 mg. Authorization may be granted without meeting the clinical criteria for members who are new to the plan within the past 90 days and are currently receiving treatment with the requested medication (excludes samples and manufacturer's patient assistance programs).

Applies to new-to-plan members ≤ 90 days who are currently receiving therapy
Does not apply to products obtained as samples or through manufacturer assistance programs

Step Therapy

Step Therapy Requirements

For IBS-D, step therapy requires documentation of an inadequate response or contraindication to at least one first-line antidiarrheal agent and to a bile acid sequestrant prior to approval of rifaximin 550 mg.

Required trial of ONE antidiarrheal: loperamide or diphenoxylate/atropine (document inadequate response or contraindication)
Required trial of a bile acid sequestrant (e.g., cholestyramine, colestipol, colesevelam) with documentation of inadequate response or contraindication

Documentation Required

Required Clinical Documentation

Clinical documentation must be submitted with the prior authorization request. This should include diagnosis, member age, and documentation of prior therapies and responses or contraindications.

Documented diagnosis: hepatic encephalopathy OR Irritable Bowel Syndrome with Diarrhea (IBS-D)
Member is ≥ 18 years of age
For hepatic encephalopathy: documentation of inadequate response, adverse reaction, or contraindication to lactulose
For IBS-D: documentation of inadequate response or contraindication to ONE antidiarrheal (loperamide or diphenoxylate/atropine) AND to a bile acid sequestrant (e.g., cholestyramine, colestipol, colesevelam)

Denial Risk

Requests may be denied if authorization criteria are not met. Also, members who are not new to the plan within the past 90 days must meet all clinical criteria for approval; otherwise the request is at risk for denial.

Denial possible if required clinical criteria, age, diagnosis, or prior therapy trials/contraindications are not documented
Denial possible for members not new to plan within 90 days unless currently receiving therapy

Definitions

IBS-D definition

DefinitionIrritable bowel syndrome with diarrhea (IBS-D) as indicated in the policy for adults.

PopulationAdults (≥18 years), per coverage criteria requirements.

Indication contextCovered when all policy criteria are met, including documented diagnosis and required prior therapy trials or contraindications.

HE definition

DefinitionHepatic encephalopathy (overt HE) for reduction in recurrence risk in adults.

PopulationAdults (≥18 years), per coverage criteria requirements.

Approval duration12 months when coverage criteria are met.

Revision History and Policy Changes

2025-04-01policy effective dateLatest

Operational changes effective 04/01/2025: criteria updated to require documentation of diagnoses and prior therapy trials; hepatic encephalopathy criteria revised to remove allowance for approval solely because member is currently on therapy; added approval durations and clarified quantity limits per indication.

2024-01-01approval duration added

Approval durations were added (noted in Oct 2023 update) with an effective date of 01/01/2024 per review history entry for Oct P&T.

2023-10-11review and update

Reviewed and updated for Oct P&T; added approval duration (effective 01/01/24).

2022-11-16review

Reviewed for Nov P&T; separated out MassHealth vs Commercial/Exchange plans (no clinical changes).

2021-07-21review

Reviewed at July P&T with reference updates (no clinical changes).

2019-06-19review

Policy reviewed (recorded in review history).