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

Initial criteria

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

Approval duration

12 months (one course per 12 months)