Zinplava

Drug - Zinplava™ (bezlotoxumab) [Merck]

June 2017

Therapeutic Area - Gastrointestinal/Infectious Disease

Approval criteria

Patient must be 18 years of age or older AND
Patient must be prescribed Zinplava by, or in consultation with, a gastroenterologist or an infectious disease specialist AND
Patient must have a diagnosis of Clostridium difficile (C. difficile) infection (CDI) confirmed by documentation of positive Clostridium difficile toxin B test AND
Patient has had at least TWO episodes of CDI recurrence (or THREE CDI episodes) in the previous 6 months AND
Patient has been treated with at least one of the following:
- Metronidazole: 500 mg orally three times per day for 10-14 days
- Vancomycin: 125 mg orally four times per day for 10 days AND
Patient has been treated with one course of pulsed vancomycin:
- Pulse vancomycin: 125 mg four times daily for 10 days, followed by 125 mg daily pulsed every 3 days for 10 doses AND
Patient will receive or is currently receiving concomitant antibiotic treatment for CDI

Quantity limit

Single dose of 10 mg/kg for one time dose and cannot be renewed
Patient’s weight must be submitted at time of request

Background information

Zinplava should only be used in conjunction with antibacterial drug treatment of CDI. The safety and efficacy of repeated administration of Zinplava has not been established. Zinplava is not covered through the MHCP fee-for-service pharmacy benefit and must be submitted as a medical claim.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411