fecal microbiota spores, live-brpk caps — Blue Cross Blue Shield of Texas

Initial criteria

• 1. Requested agent will be used to prevent the recurrence of Clostridioides difficile infection (CDI)
• 2. Diagnosis of recurrent CDI as defined by ALL of the following: A. ≥3 episodes of CDI in a 12-month period; B. A positive C. difficile stool sample; C. A CDI episode of diarrhea ≥3 unformed stools per day for at least 2 consecutive days
• 3. 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
• 4. Patient has had an adequate clinical response to a standard of care oral antibiotic regimen (e.g., vancomycin, fidaxomicin) as defined by <3 unformed stools in 24 hours for 2 or more consecutive days
• 5. Patient will NOT use the requested agent in combination with any antibiotic regimen for any indication
• 6. If patient has an FDA approved indication, then ONE of the following: A. Patient’s age is within FDA labeling for the requested indication and agent OR B. There is support for using the requested agent for the patient’s age for the requested indication
• 7. Prescriber is a specialist in the area of the patient’s diagnosis (e.g., infectious disease, gastroenterologist) or has consulted with such specialist
• 8. Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months