Bezlotoxumab (Zinplava) (CPB 0914, reviewed 2026-01-07)
Summary
Aetna considers bezlotoxumab (Zinplava) medically necessary to reduce recurrence of C. difficile infection in members who are receiving antibacterial drug treatment for CDI and are at high risk for CDI recurrence. Criteria include age 1 year or older, a confirmed CDI diagnosis with 3 or more loose bowel movements in 24 or fewer hours, a positive toxigenic C. difficile stool test from a sample collected no more than 7 days prior, and at least one high-risk factor: age 65 or older, long term use of systemic antibacterial drugs, 1 or more CDI episodes in the previous 6 months, immunocompromise, clinically severe CDI (Zar score of 2 or greater), or a hypervirulent strain (ribotypes 027, 078 or 244). Bezlotoxumab is given in conjunction with standard of care antibiotics during the antibacterial treatment course, and other indications, combinations with other human monoclonal antibodies to C. difficile toxin, and repeat administration are considered experimental, investigational or unproven.
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