Coverage is subject to the specific terms of the member's benefit plan.
Bezlotoxumab (Zinplava) may be considered medically necessary to reduce the recurrence of CDI in individuals who meet
of the following:
The individual has had at least two (2) episodes of diarrhea with a positive stool test for C.difficile toxin within the last year;
The individual has had at least one (1) previous episodes of diarrhea with a positive stool test for C.difficile toxin within the last year and one of the following:
C. difficile infection was severe (defined as ZAR score greater than or equal to two (2);
- The individual is immunocompromised.
Note: Zinplava will only be approved for one dose per active CDI. Zinplava will not be approved for any repeat doses for recurrence of the same active infection.
The use of bezlotoxumab (Zinplava) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.