Xifaxan Prior Authorization with Quantity Limit Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Xifaxan 550 mg tablet will be approved when ALL of the following are met:

1. The patient has ONE of the following:

   1. A diagnosis of irritable bowel syndrome with diarrhea (IBS-D)
      OR

   2. A diagnosis of hepatic encephalopathy [reduction in risk of overt hepatic encephalopathy (HE) recurrence]
      OR

   3. ALL of the following:

      1. A diagnosis of traveler’s diarrhea (TD)
         AND
      2. The traveler’s diarrhea is caused by noninvasive strains of Escherichia coli
         AND
      3. The patient is within the FDA labeled age for the requested medication
         AND

2. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND

3. ONE of the following:

   1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR

   2. ALL of the following:

      1. The requested quantity (dose) is greater than the program quantity limit
         AND
      2. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit
         AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months