Vowst — Blue Cross Blue Shield of Montana
prevention of recurrence of Clostridioides difficile infection (CDI)
Initial criteria
- The requested agent will be used to prevent the recurrence of Clostridioides difficile infection (CDI)
- The patient has a diagnosis of recurrent CDI as defined by ALL of the following: (A) ≥ 3 episodes of CDI in a 12‑month period AND (B) a positive C. difficile stool sample AND (C) a CDI episode of diarrhea ≥ 3 unformed stools per day for at least 2 consecutive days
- The patient has completed a standard of care oral antibiotic regimen (e.g., vancomycin, fidaxomicin) for recurrent CDI at least 2 to 4 days before initiating treatment with the requested agent
- The patient has had an adequate clinical response to a standard of care oral antibiotic regimen (e.g., vancomycin, fidaxomicin) as defined by fewer than 3 unformed stools in 24 hours for 2 or more consecutive days
- The patient will NOT be using the requested agent in combination with any antibiotic regimen for any indication
- If the patient has an FDA approved indication, then ONE of the following: (A) The patient’s age is within FDA labeling for the requested indication for the requested agent OR (B) There is support for using the requested agent for the patient’s age for the requested indication
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g., infectious disease, gastroenterologist) or has consulted with a specialist
- The patient does NOT have any FDA labeled contraindications to the requested agent
Approval duration
1 course per 12 months