XIFAXAN (rifaximin)

ORAL ADMINISTRATION

Indications for Prior Authorization:
  • Treatment of patients at least 12 years of age with traveler's diarrhea caused by noninvasive strains of Escherichia coli
  • Reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients at least 18 years of age
  • Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults
Patients must meet the following criteria for the indication(s) above (supported by chart note documentation):
  • Travelers' diarrhea
    • Patient is 18 years of age or older with travelers' diarrhea, AND failure or clinically significant adverse effects to ciprofloxacin or azithromycin OR
    • Patient is 12-17 years of age with travelers' diarrhea
  • Hepatic Encephalopathy
    • Treatment or prophylaxis of hepatic encephalopathy, AND failure or clinically significant adverse effects to lactulose
  • Small Intestinal Bacterial Overgrowth (SIBO)
    • Patient has a diagnosis of SIBO as confirmed by chart note documentation, AND
    • Patient meets one of the following:
      • Trial and failure of one of the following: amoxicillin/clavulanate, ciprofloxacin, trimethoprim-sulfamethoxazole, metronidazole, doxycycline, tetracycline, OR
      • Methane-predominant bacterial overgrowth and will be used in combination with neomycin
  • Crohn's Disease
    • Patient has Crohn's Disease, AND failure or clinically significant adverse reaction to metronidazole OR ciprofloxacin
  • Irritable Bowel Syndrome with Diarrhea (IBS-D)
    • Patient has IBS-D, AND failure of or clinically significant adverse effects to TWO of the following:
      • Bulk forming agent (e.g., psyllium)
      • Anti-diarrhea agent (e.g., bismuth subsalicylate, loperamide)
      • Antispasmodic agent (e.g., diphenoxylate-atropine, dicyclomine, hyoscyamine, hyoscyamine/atropine/scopolamine/phenobarbital)
The following conditions do not meet the criteria for use as established by WHA P&T committee:
  • Any condition not listed above in the indications section (examples below)
    • C. difficile infection
    • Diverticulitis and inflammatory bowel disease
Dosing:
  • Traveler's Diarrhea
    • Adults and children at least 12 years of age: 200 mg orally three times daily for 3 days (authorization limit 9 tablets/month)
  • Hepatic Encephalopathy
    • 550 mg orally twice daily
  • SIBO
    • 200 mg orally three times daily for 7 days OR
    • 550 mg orally three times daily for 14 days
  • IBS with SIBO
    • 550 mg orally three times daily for 7 days
  • Crohn's disease
    • 200 mg orally three times daily (authorization limit 12 weeks) OR
    • 800 mg orally twice daily (authorization limit 12 weeks)
  • IBS-D
    • 550 mg orally three times daily (authorization limit 550 mg orally three times daily for 14 days; patients who experience recurrence can be retreated up to two times with the same regimen)
Approval:
  • Hepatic Encephalopathy: 1 year
  • IBS-D
    • Initial: 1 treatment
    • Recurrence: 2 treatments
  • Crohn's disease: 3 months
  • All other approved indications: 1 treatment

Last review date: May 19, 2020