IBS-D – Essential Formulary

Restriction applies to brand and generic products

• Lotronex® (alosetron) 
• Viberzi® (eluxadoline) 
• Xifaxan® (rifaximin)

Lotronex: 

• For the treatment of women with severe diarrhea-predominant IBS who have chronic IBS symptoms (generally lasting 6 months or longer), have had anatomic or biochemical abnormalities of the GI tract excluded, and who have not responded adequately to conventional therapy.

Viberzi: 

• For the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

Xifaxan:

• For the reduction in risk of overt hepatic encephalopathy recurrence in adults
• For the treatment of moderate to severe irritable syndrome without constipation in adults 
• For the treatment of traveler’s diarrhea caused by noninvasive strains of Escherichia coli in adult and pediatric patients ≥ 12 years of age.

1. Requests for Lotronex or alosetron (generic Lotronex): 
   1. The patient has a diagnosis of irritable bowel syndrome with severe diarrhea (IBS-D), with onset of symptoms starting at least 6 months prior; AND 
   2. The patient exhibits at least ONE of the following:
      1. Frequent and severe abdominal pain/discomfort; OR
      2. Frequent bowel urgency or fecal incontinence; OR 
      3. Disability or restriction of daily activities due to IBS; AND
   3. The patient will not be using the requested agent in combination with Viberzi or Xifaxan for IBS-D; AND
   4. The patient was assigned female at birth; OR
      1. The prescriber has provided information that the requested agent is medically appropriate for the patient’s gender; AND
   5. The patient has had anatomic or biochemical abnormalities of the gastrointestinal tract excluded; AND
   6. The patient has not responded adequately to conventional therapy; OR
2. Requests for Viberzi: 
   1. The patient has a diagnosis of irritable bowel syndrome with severe diarrhea (IBS-D), with onset of symptoms starting at least 6 months prior; AND
   2. The patient will not be using the requested agent in combination with Lotronex or Xifaxan for IBS-D; OR
3. Requests for Xifaxan: 
   1. ONE of the following:
      1. The patient has a diagnosis of irritable bowel syndrome with severe diarrhea (IBS-D), with onset of symptoms starting at least 6 months prior; AND
         1. The patient will not be using the requested agent in combination with Lotronex or Viberzi for IBS-D; OR 
      2. The patient is at risk of recurrent overt hepatic encephalopathy; AND
         1. ONE of the following: 
            1. The patient will be using the requested agent in combination with lactulose; OR 
            2. The patient has a contraindication/intolerance to lactulose; OR
      3. The patient has a diagnosis of traveler’s diarrhea; AND
         1. The traveler’s diarrhea is caused by noninvasive strains of Escherichia coli; AND
         2. The patient does not have diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli; AND
   2. The requested dosage strength is FDA approved for the requested FDA labeled diagnosis; OR
      1. The prescriber has provided information in support of the requested dosage strength for the requested FDA labeled diagnosis; AND
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies. 

Duration of Approval:

Traveler’s Diarrhea: 30 days

Hepatic Encephalopathy: 3 years

IBS-D: Lotronex, Viberzi: 3 years, Xifaxan: 1 year

Quantity limitations apply to brand and associated generic products.

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed). 

Duration of Approval:

Traveler’s Diarrhea: 30 days

Hepatic Encephalopathy: 3 years

IBS-D: Lotronex, Viberzi: 3 years, Xifaxan: 1 year

All information referenced is from FDA package insert unless otherwise noted below.

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

March 2025: Criteria update: Updated duration of approval for Lotronex and Viberzi for IBS-D to 3 years. Updated duration of approval for Xifaxan for recurrent hepatic encephalopathy to 3 years.

January 2025: Criteria change: Added requirement of taking Xifaxan with lactulose for recurrent overt hepatic encephalopathy. Removed criteria points excluding use if member has an FDA labeled contraindication.

December 2023: Criteria update: Formatting changes only.

November 2022: Criteria update: Annual criteria review. No changes to policy.      

October 2021: Original utilization management policy issued.