XIFAXAN (rifaximin)

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