Subject: Xifaxan 550mg PA Policy 681-A 04-2021

Drug

XIFAXAN 550MG ONLY

Policy:

FDA-APPROVED INDICATIONS  
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Xifaxan and other antibacterial drugs, Xifaxan when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Hepatic Encephalopathy
Xifaxan is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.
In the trials of Xifaxan for HE, 91% of the patients were using lactulose concomitantly. Differences in the treatment effect of those patients not using lactulose concomitantly could not be assessed.
Xifaxan has not been studied in patients with MELD (Model for End-Stage Liver Disease) scores > 25, and only 8.6% of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction.
Irritable Bowel Syndrome with Diarrhea
Xifaxan is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. 

COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
      •  The requested drug is being prescribed to reduce the risk of overt
          hepatic encephalopathy (HE) recurrence
          AND
               ο  The requested drug is being used as add-on therapy to lactulose
OR
      •   The patient has the diagnosis of irritable bowel syndrome with diarrhea
           (IBS-D)
           AND
           ο  If the patient has previously received treatment with the requested
               drug, the patient is experiencing a recurrence of symptoms AND
           ο  The patient has not already received an initial 14-day course of
               treatment AND two additional 14-day courses of treatment with the
               requested drug

Place of Service:

Outpatient

The above policy is based on the following references:

1. Xifaxan [package insert]. Bridgewater, NJ: Salix Pharmaceuticals, Inc; October 2020.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, OH: UpToDate, Inc.; 2021; Accessed March 5, 2021.
3. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. https://www.micromedexsolutions.com. Accessed March 2, 2021.
4. Vilstrup H, Amodio P, Bajaj J, et al. Hepatic encephalopathy in chronic liver disease: 2014 Practice Guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014;60(2):715-735.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 06, 2021