Read Pharmacy Medical Necessity Guidelines: Xifaxan (rifaximin) text version

Pharmacy Medical Necessity Guidelines Xifaxan (rifaximin)

Document ID#: Subject: Effective Date:

2100491 Xifaxan (rifaximin) March 13, 2012

Type of Review - Case Management Type of Review ­ Clinical Review RX Administrative Process (Internal Use Only) LPN

Clinical Documentation and Prior Authorization Required Not Covered Pharmacy (RX) or Medical (MED) Benefit

Note: This pharmacy medical necessity guideline applies to commercial products. For Tufts Health Plan Medicare Preferred members, please refer to the Tufts Medicare Preferred Prior Authorization Criteria. Background, applicable product and disclaimer information can be found on the last page.

Overview

FDA-approved indications: Rifaximin 200 mg tablets is indicated for travelers diarrhea caused by noninvasive strains of E.coli in adults and adolescents 12 years of age and older. Rifaximin 550 mg tablets is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients 18 years of age

Pharmacy Coverage Guidelines

Tufts Health Plan may authorize coverage of Xifaxan (rifaximin) for Members when the following criteria are met: For Traveler's Diarrhea 1. The Member has a documented diagnosis of traveler's diarrhea caused by noninvasive strains of Escherichia coli For Hepatic Encephalopathy 1. The member has a physician-documented diagnosis of hepatic encephalopathy. AND 2. The member has had an inadequate response or has a contraindication to lactulose (Constulose, Duphalac, Enulose, Generlac).

For Inflammatory Bowel Disease 1. The member has a documented diagnosis of Inflammatory Bowel Disease (IBD). AND

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2. The member has failed to respond to or has a contraindication to standard antibiotic treatment (e.g., ® ® ciprofloxacin [Cipro ], metronidazole [Flagyl ])

Limitations

1. Xifaxan (rifaximin) would not be covered in the following instances:

Prevention of traveler's diarrhea 2. For traveler's diarrhea, coverage is limited to a 3-day course of therapy (9 tablets) of the 200 mg tablets in any 30-day period. 3. For Hepatic Encephalopathy, coverage is limited to 60 tablets per 30 days of the 550 mg tablets.

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Treatment of diarrhea caused by pathogens other than E. coli Treatment of diarrhea complicated by fever or bloody stools Treatment of Irritable Bowel Syndrome

Codes

None.

References

1. Manufacturer's Web Site: www.salix.com/products/products_xifaxan.asp, 2006. 2. American Hospital Formulary Service/AHFS website: www.ahfs.org, Copyright ©1997-2005, American Society of Health-System Pharmacists, Inc. 3. Facts and Comparisons 4.0 online, http://online.factsandcomparisons.com, 2006 4. Manufacturer's Web Site: www.Xifaxan550.com, 2010 5. Xifaxan [Package insert]. Morrisville, NC: Salix Pharmaceuticals, Inc.; 2010.

Approval History

Reviewed by the Pharmacy and Therapeutics Committee on August 8, 2006. Subsequent Endorsement Date(s) and Changes Made:

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July 10, 2007 1. Added limitation "Pharmacy Coverage Guidelines for Xifaxan (rifaximin) apply to the Tufts Health Plan Generic Focused Formulary only." September 11, 2007 1. Removed limitation "Pharmacy Coverage Guidelines for Xifaxan (rifaximin) apply to the Tufts Health Plan Generic Focused Formulary only." 2. Added reference table outlining applicable Tufts Health Plan products. July 8, 2008: 1. Added coverage criteria for the diagnosis of hepatic encephalopathy. 2. Added coverage criteria for the diagnosis of Inflammatory Bowel Disease (IBD). 3. Added limitation, that Xifaxan will not be covered for the treatment of bacterial overgrowth. 4. Removed limitation that Xifaxan would not be covered for the treatment of hepatic encephalopathy. 5. Clarified limitation, that Xifaxan coverage is limited to a 3-day course of therapy (9 tablets) in any 30-day period for traveler's diarrhea. July 14, 2009: No changes.

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January 1, 2010: Removal of Tufts Medicare Preferred language (separate criteria have been created specifically for Tufts Medicare Preferred). July 13, 2010: 1. Removed, "Rifaximin tablets are indicated for the treatment of traveler's diarrhea caused by noninvasive strains of E.coli in adults and adolescents 12 years of age or older at a dose of 200 mg 3 times a daily for 3 days. Rifaximin was not found to be effective in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than E.coli. Rifaximin is not effective and should not be used for the treatment of traveler's diarrhea caused by Campylobacter jejuni and has not been proven effective in traveler's diarrhea caused by Shigella spp. and Salmonella spp." 2. Added FDA-approved indications for rifaximin 200 mg and 550 mg tablets. 3. Removed, "The member must be 12 years of age or older" for Traveller's diarrhea indication. 4. Under Hepatic Encephalopthy: Removed, "The member has failed to respond to or has a contraindication to lactulose (Constulose, Duphalac, Enulose, Generlac); replaced with "The member has had an inadequate response or contraindication to lactulose (Constulose, Duphalac, Enulose, Generlac). 5. Clarified the limitation for Travelers diarrhea that it applies to the 200 mg strength. 6. Added a limitation for Hepatic encephalopathy that "coverage is limited to a 30-day supply (60 tablets) of the 550 mg tablets May 10, 2011: 1. Removed the overview section and replaced with FDA-approved indications. 2. Removed the limitation on Bacterial Overgrowth Syndrome. 3. Added limitation of Irritable Bowel Syndrome. March 13, 2012: No changes.

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Background, Product and Disclaimer Information

Pharmacy Medical Necessity Guidelines have been developed for determining coverage for Tufts Health Plan benefits and are published to provide a better understanding of the basis upon which coverage decisions are made. They are used in conjunction with a Member's benefit document and in coordination with the Member's physician(s). Tufts Health Plan makes coverage decisions on a case-by-case basis considering the individual Member's health care needs. Pharmacy Medical Necessity Guidelines are developed for selected therapeutic classes or drugs found to be safe, but proven to be effective in a limited, defined population of patients or clinical circumstances. They include concise clinical coverage criteria based on current literature review, consultation with practicing physicians in the Tufts Health Plan service area who are medical experts in the particular field, FDA and other government agency policies, and standards adopted by national accreditation organizations. Tufts Health Plan revises and updates Pharmacy Medical Necessity Guidelines annually, or more frequently if new evidence becomes available that suggests needed revisions. Pharmacy Medical Necessity Guidelines apply to all fully insured Tufts Health Plan offerings unless otherwise noted in this policy or the Member's benefit document. Check the applicable formulary in the Pharmacy section of our Website at www.tuftshealthplan.com to determine if the drug requires you to get prior authorization. This Pharmacy Medical Necessity Guideline does not apply to Uniformed Services Family Health Plan Members or to certain delegated service arrangements. Unless otherwise noted in the Member's benefit document or applicable Pharmacy Medical Necessity Guideline, Pharmacy Medical SM Necessity Guidelines do not apply to CareLink Members. For self-insured plans, drug coverage may vary depending on the terms of the benefit document. If a discrepancy exists between a coverage guideline and a self-insured Member's benefit document, the provisions of the benefit document will govern. Applicable state or federal mandates will take precedence. For Tufts Medicare Preferred, please refer to Tufts Medicare Preferred Prior Authorization Criteria.

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Treating providers are solely responsible for the medical advice and treatment of Members. The use of this policy is not a guarantee of payment or a final prediction of how specific claim(s) will be adjudicated. Claims payment is subject to Member eligibility and benefits on the date of service, coordination of benefits, referral/authorization and utilization management guidelines when applicable, and adherence to plan policies and procedures and claims editing logic.

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Pharmacy Medical Necessity Guidelines: Xifaxan (rifaximin)