CurrentHealth NetPolicy CP PMN.47

Clinical Policy: Rifaximin (Xifaxan)

Clinical policy defining medical necessity criteria, initial and continuation approval requirements, dosing limits, approved indications (HE, IBS-D, Travelers' diarrhea), select off-label SIBO criteria, coverage exclusions and prior authorization documentation requirements for Health Net/Centene lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerHealth Net

PolicyClinical Policy: Rifaximin (Xifaxan)

Policy CodePolicy CP PMN.47

Change TypeRevised (concurrent lactulose added)

Effective DateNov 1, 2011

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added requirement for concurrent lactulose and rifaximin to initial criteria for HE per guidelines.

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.

Deleted off-label Crohn's disease criteria as unsupported by guidelines.

Template changes to other diagnoses/indications and continued therapy sections.

3FDA-approved indications covered

1Off-label indication (SIBO)

4Lines of Business referenced

Coverage Summary

Coverage stance: covered with criteria. Supported/approved indications: hepatic encephalopathy (HE), irritable bowel syndrome with diarrhea (IBS‑D), and travelers' diarrhea (TD). The policy also addresses an off‑label indication: small intestinal bacterial overgrowth (SIBO) as a covered-with-criteria off‑label use. Scope: clinical policy defining medical necessity, initial and continuation requirements, dosing limits, prior authorization and documentation requirements for Centene/Health Net lines of business. Effective date: 2011-11-01. Last review date: 2024-11-01.

Continuation Therapy Criteria

Continued Therapy (Reauthorization) Criteria

Member must meet one of the following and indication-specific requirements

Member eligibility for continuation

Currently receiving medication via Centene benefit or member has previously met initial approval criteria
Member is receiving benefit from the referenced states for applicable product and regulation (refer to state-specific addendums)

Other Diagnoses / Off-Formulary / Non‑Formulary Uses

Other Diagnoses/Off-Formulary/Non-Formulary Uses

If requested use is not addressed by this policy or drug status varies by formulary, follow applicable Centene policies

For drugs on formulary/PDL use no coverage criteria policy for applicable line of business: CP.CPA.190 (Commercial), HIM.PA.33 (Health Insurance Marketplace), CP PMN.255 (Medicaid)

For drugs NOT on formulary/PDL use non-formulary policy: CP.CPA.190 (Commercial), HIM.PA.103 (Health Insurance Marketplace), CP PMN.16 (Medicaid)

If requested use is not listed under section III and criterion 1 above does not apply, refer to off-label use policies: CP.CPA.09 (Commercial), HIMPA.154 (Health Insurance Marketplace), CP.PMN.53 (Medicaid)

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required for Xifaxan

Providers must obtain prior authorization for Xifaxan. Requests will be reviewed against the policy's initial and continued therapy criteria (indication-specific clinical requirements, age limits, required concurrent lactulose for HE, and dose limits). Re-authorization is not permitted for Travelers' Diarrhea; other continuation rules apply per indication.

Initial and continuation criteria (indication-specific) will be used to determine approval
HE requires concurrent lactulose unless contraindicated
Re-authorization is not permitted for Travelers' Diarrhea

Documentation Required

Support clinical criteria with documentation

Provider must submit office chart notes, lab results, or other clinical information supporting that member meets all approval criteria.

Billing Rule

Dose limits enforced

Claims exceeding the policy's indication-specific maximum daily doses are not compliant with criteria and may be denied.

Hepatic Encephalopathy (HE): >1100 mg/day
Irritable Bowel Syndrome with Diarrhea (IBS-D): >1650 mg/day
Travelers' Diarrhea (TD): >600 mg/day
Small Intestinal Bacterial Overgrowth (SIBO): >1650 mg/day

Clinical Evidence

Key evidence cited: the 2014 AASLD hepatic encephalopathy guideline recommends rifaximin as an add‑on to lactulose to prevent overt HE recurrence (no solid data support rifaximin alone). A randomized study (Scarpellini et al.) in SIBO showed higher glucose breath test normalization with high‑dose rifaximin: 1,600 mg/day achieved 80% normalization versus 1,200 mg/day 58% (P<0.05).

AASLDHE guideline: rifaximin recommended as add-on to lactulose to prevent HE recurrence

80% vs 58%SIBO GBT normalization: 80% at 1600 mg/day vs 58% at 1200 mg/day (Scarpellini et al.)

Background

Background: Rifaximin (Xifaxan) is a rifamycin antibacterial with FDA approvals for travelers' diarrhea in patients ≥12 years, for IBS‑D in adults, and to reduce risk of overt HE recurrence in adults. Guideline guidance for HE requires rifaximin to be used concurrently with lactulose (AASLD 2014), and most HE trial patients were using lactulose concomitantly. Therapeutic alternatives (e.g., azithromycin for TD; lactulose for HE; antispasmodics, loperamide, etc., for IBS‑D) are provided in the policy appendices. Contraindication: history of hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any components of Xifaxan.

Revision History

Q4 2022 (P&T Approval Date = 11.22; Date = 07.26.22)material_change

Annual review added requirement that rifaximin (Xifaxan) be prescribed concurrently with lactulose in the initial HE criteria per guidelines; references reviewed and updated. P&T Approval Date = 11.22.

11.07.22administrative_update

Template and administrative changes applied to other diagnoses/indications and continued therapy sections (template changes applied 11.07.22).

Jan/May 2022 (Date = 01.20.22; P&T Approval Date = 05.22)revised