Bezlotoxumab (Zinplava™)

• Bezlotoxumab (Zinplava® ) intravenous infusion for administration by a healthcare professional

• To reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at high risk for CDI recurrence 
• Limitation of use: Not for treatment of CDI and to be used only in conjunction with antibacterial drug treatment of CDI

The restricted product(s) may be considered medically necessary when the following criteria are met: 

1. The patient is 1 year of age or older; AND
2. The patient has a diagnosis of Clostridioides difficile infection (CDI); AND 
3. The patient will be receiving the requested agent to reduce recurrence of CDI; AND
4. The patient has a confirmed CDI, as defined by BOTH of the following:
   1. Passage of three or more loose stools within ≤ 24 hours; AND
   2. Positive stool test for toxigenic Clostridium difficile from a stool sample collected not more than 14 days prior to scheduled infusion with the requested agent [medical record documentation required]; AND 
5. The patient is currently receiving antibacterial therapy for CDI; AND 
6. The patient is at high risk for CDI recurrence, as defined by one or more of the following [medical record documentation required]: 
   1. Age 65 years or older with a history of CDI in the past 6 months; OR
   2. Immunocompromised state; OR
   3. Severe CDI at presentation; OR
   4. Presence of Clostridium difficile ribotype 027; AND 
7. The requested agent will NOT be used as first-line therapy for CDI; AND
8. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).

Duration of Approval: 30 days (one-time approval for single infusion)

^{^}Safety and efficacy of repeat administration has not been studied in patients with CDI

*Maximum units allowed for duration of approval

All information referenced is from FDA package insert unless otherwise noted below. 

1. Christina M, Surawicz MD, Lawrence J, et al. Guidelines for diagnosis, treatment, and prevention of clostridium difficile infections. Am J Gastroenterol. 2013;108:478-498. 
2. Yang Z, Ramsey J, Hamza T, et al. Mechanisms of protection against clostridium difficile infection by the monoclonal antitoxin antibodies actoxumab and bezlotoxumab. Infect Immun. 2015;83(2):822-831. 
3. Zar FA, Bakkanagari SR, et al. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity. Clin Infect Dis. 2007;45(3):302-307.

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

March 2025: Criteria change: Extended timeframe requirement for confirmed positive stool test for toxigenic Clostridium difficile to no more than 14 days prior to Zinplava infusion (previously no more than 7 days).

January 2024: Criteria change: Expanded indication to patients 1 year of age and older per FDA label update. Adjusted maximum units according to FDA label for clarity.

June 2021: Criteria change: Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.

Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy