CurrentMass General Brigham Health PlanPolicy N/A

Xifaxan 550mg (rifaximin)

Pharmacy benefit prior-authorization policy for Xifaxan (rifaximin) 550 mg for adult indications: reduction in risk of overt hepatic encephalopathy (HE) recurrence and treatment of irritable bowel syndrome with diarrhea (IBS-D). Defines eligibility, required prior trials/contraindications, quantity limits, and approval durations.

Policy Summary

PayerMass General Brigham Health Plan

PolicyXifaxan 550mg (rifaximin)

Policy CodePolicy N/A

Change TypeRevised criteria and added approval durations

Effective DateApr 1, 2025

Next Review Date

Key ActionProviders must obtain prior authorization through the plan's pharmacy prior authorization process for Xifaxan 550 mg and document diagnosis, age, and prior trials or contraindications per indication.

SourceLink

POLICY UPDATE CHANGES

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

Added approval durations for indications.

2Covered Indications

12 moHE Approval Duration

30 daysIBS-D Approval Duration

>=18Age Requirement

Coverage Summary

This pharmacy benefit prior-authorization policy covers Xifaxan (rifaximin) 550 mg for adults for two indications: reduction in risk of overt hepatic encephalopathy (HE) recurrence and treatment of irritable bowel syndrome with diarrhea (IBS-D). Coverage stance: covered_with_criteria. Age requirement: 18 years or older. Approval durations: HE — 12 months; IBS-D — 30 days. Quantity limits summarized: HE dosing and quantity limit expressed as 550 mg twice daily; 60 tablets per 30 days; IBS-D dosing and quantity limit expressed as 550 mg three times daily for 14 days; 42 tablets per 14 days; may be treated up to 2 times. Providers must obtain prior authorization unless the member is new to the plan within the past 90 days and currently receiving therapy (excluding samples or manufacturer assistance).

Quick Reference

Age Requirement>= 18 years

Covered IndicationsHE; IBS-D

HE Approval Duration12 months

IBS-D Approval Duration30 days

HE Quantity Limit550 mg BID; 60 tabs/30 days

IBS-D Quantity Limit550 mg TID x14 days; 42 tabs/14 days; up to 2 courses

General Authorization Conditions

Authorization may be granted for members who meet one of the following:

ANY of the following

Authorization when ALL of the following are met
- Member is new to the plan within the past 90 days and is currently receiving treatment with the requested medication (excluding product obtained as samples or via manufacturer's patient assistance programs).
- Indication-specific criteria met (see Hepatic Encephalopathy or Irritable Bowel Syndrome sections).

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Hepatic Encephalopathy (HE) - Approval Criteria

Authorization will be granted when ALL of the following criteria are met:

ALL of the following

Documented diagnosis of hepatic encephalopathy.
Member is 18 years of age or older.
Documentation has had an inadequate response, adverse reaction, or contraindication to lactulose.

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Irritable Bowel Syndrome with Diarrhea (IBS-D) - Approval Criteria

Authorization will be granted when ALL of the following criteria are met:

ALL of the following

Documented diagnosis of Irritable Bowel Syndrome with Diarrhea (IBS-D).
Member is 18 years of age or older.
Trial or contraindication to ONE of the following
- Loperamide (documentation of inadequate response or contraindication).
- Diphenoxylate/atropine (documentation of inadequate response or contraindication).

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required through the plan's pharmacy prior authorization process for Xifaxan 550 mg. Do not submit prior authorization for members who are new to the plan within the past 90 days and are currently receiving the requested medication (this exception excludes product obtained as samples or via manufacturer patient assistance programs). Submit prior authorization via the plan's pharmacy prior authorization process; for Medical and Specialty medications use the plan contact phone/fax provided by the plan.

Documentation Required

Document diagnosis and prior therapy

Document the following when requesting authorization: - Diagnosis: specify hepatic encephalopathy (HE) or irritable bowel syndrome with diarrhea (IBS-D). - Member age (must be 18 years or older). - Prior therapy documentation: - For HE: documentation of inadequate response, adverse reaction, or contraindication to lactulose. - For IBS-D: documentation of inadequate response or contraindication to loperamide or diphenoxylate/atropine (trial or contraindication to one of these) and documentation of inadequate response or contraindication to a bile acid sequestrant (e.g., cholestyramine, colestipol, colesevelam).

Applicable Codes

No specific codes provided in policymixed

No codes listed

Clinical Evidence & References

Evidence referenced by this policy includes: Xifaxan (rifaximin) prescribing information, Salix Pharmaceuticals, October 2023; the AASLD/EASL 2014 practice guideline on hepatic encephalopathy; and Lembo et al., Gastroenterology 2016 (repeat treatment with rifaximin in IBS-D).

Background

Background: Xifaxan (rifaximin) is a rifamycin antibacterial indicated for reduction in risk of overt hepatic encephalopathy recurrence in adults and for treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. This policy references clinical guidelines and the product prescribing information.

Policy Metadata

PayerMass General Brigham Health Plan

PolicyXifaxan 550mg (rifaximin)

Effective Date2025-04-01

Last Review2025-01-08

Policy NumberN/A

Definitions

Definitions: New to the plan — Member who has been enrolled in the plan within the past 90 days.

Revision History

01/08/2025revisedLatest

Updated criteria to require documentation of diagnoses and previous trials; updated HE criteria to remove allowance for approval if the member is currently on therapy. Effective 04/01/2025.

01/08/2025revised

Added approval durations: Hepatic Encephalopathy (HE) = 12 months; Irritable Bowel Syndrome with Diarrhea (IBS-D) = 30 days. Effective 04/01/2025.

Policy Summary

PayerMass General Brigham Health Plan

PolicyXifaxan 550mg (rifaximin)

Policy CodePolicy N/A

Change TypeRevised criteria and added approval durations

Effective DateApr 1, 2025

Next Review Date

SourceLink

On This Page

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title___PLEASE_IGNORE_this_field_use_ref_field_above_for_matching__General Authorization Conditions

title___Hepatic Encephalopathy (HE) - Approval Criteria

ref_b2_0__echo_exact_string_required_by_validator__b2_0

title___PLEASE_IGNORE_this_field_use_ref_field_above_for_matching__Hepatic Encephalopathy (HE) - Approval Criteria

title___Hepatic Encephalopathy (HE) - Approval Criteria

Hepatic Encephalopathy (HE) - Approval Criteria

Operational note for Hepatic Encephalopathy: dosing is 550 mg twice daily with a quantity expressed as 60 tablets per 30 days. Standard approval duration for HE is 12 months.

Documentation that member has had an inadequate response or contraindication to a bile acid sequestrant (e.g., cholestyramine, colestipol, colesevelam).

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title___Irritable Bowel Syndrome with Diarrhea (IBS-D) - Approval Criteria

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title___PLEASE_IGNORE_this_field_use_ref_field_above_for_matching__Irritable Bowel Syndrome with Diarrhea (IBS-D) - Approval Criteria

Irritable Bowel Syndrome with Diarrhea (IBS-D) - Approval Criteria

Operational note for IBS-D: dosing is 550 mg three times daily for 14 days with a quantity expressed as 42 tablets per 14 days. Patients may be treated up to 2 times with this regimen. Standard approval duration for IBS-D is 30 days.

Billing Rule

Quantity limits

Quantity limits and dosing expressions: - Hepatic encephalopathy (HE): 550 mg twice daily; quantity expressed as 60 tablets per 30 days. - Irritable bowel syndrome with diarrhea (IBS-D): 550 mg three times daily for 14 days; quantity expressed as 42 tablets per 14 days; may be treated up to 2 times with this regimen.

Documentation Required

New-to-plan exception

New-to-plan exception: Members who are new to the plan within the past 90 days and are currently receiving Xifaxan may be granted authorization. This allowance does not apply if the medication was obtained as samples or through the manufacturer's patient assistance programs.