RESTRICTIONS:

In order for a patient to receive Zinplava, all of the following operational criteria must be met:

1. Outpatient use only (restricted to only outpatient formulary)
2. ID and/or GI consult and approval
3. Prior authorization/payment approval (if required)

 AND

 At least one (1) of the following clinical criteria must be met:

1. Patients who have failed prior fecal microbiota transplant (FMT) excluding difficile reinfection
2. Patient with recurrent difficile infection defined as ≥2 previous episodes (not including current episode) or ≥1 previous episode in the past 6 months (not including the current episode) AND at least one (1) of the following:
   1. Immunocompromising Condition
   2. Inflammatory Bowel Disease
   3. Other patients who may not be candidates for FMT (e.g., based on health status concurrent comorbidities, and toleration of bowel preparation)

Note:  All patients with Congestive Heart Failure (CHF) will be excluded from receiving bezlotoxumab due to an associated 13% increased risk of CHF exacerbation regardless of meeting the operational and clinical criteria.

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