Vowst Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Vowst will be approved when ALL of the following are met:

1. The requested medication will be used to prevent the recurrence of Clostridioides difficile infection (CDI)
   AND

2. The patient has had a confirmed diagnosis of recurrent CDI as defined by greater than or equal to 3 episodes of CDI in a 12 month period
   AND

3. The patient has completed a standard of care antibiotic regimen (e.g., vancomycin, fidaxomicin) for recurrent CDI at least 2 to 4 days before initiating treatment with the requested medication
   AND

4. The patient will NOT be using the requested medication in combination with any antibiotic regimen for any indication
   AND

5. The patient is within the FDA labeled age for the requested medication
   AND

6. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., infectious disease, gastroenterologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND

7. ONE of the following:

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

   2. BOTH of the following:

      1. The requested quantity (dose) is greater than the program quantity limit
         AND
      2. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months