OBJECTIVES: Clostridium difficile infection (CDI) is the most common known cause of nosocomial diarrhea associated with antibiotic use and 20 to 30% of the patients have recurrences. Its incidence has been increasing over the last few decades with a considerable morbidity and mortality as well as healthcare resource use from CDI patients. This study assesses the cost-effectiveness of bezlotoxumab, a new antitoxin agent + standard of care (SoC) compared with SoC alone in patients who are at risk for CDI recurrence.

METHODS: A state-transition Markov model was developed to simulate the natural history of CDI, over a lifetime horizon from the societal perspective. Patient characteristics and recurrence rates were taken from pooled data of the two Phase 3 clinical trials. The analysis was conducted in the entire clinical trial population representing the patients at risk of CDI recurrence. Costs and outcomes were estimated from Portuguese sources, and discounted annually at 5%, as recommended by national guidelines. Model outputs included discounted and undiscounted life years, quality-adjusted life years (QALYs), costs and incremental cost-effectiveness ratios (ICERs).

RESULTS: In the base case analysis, the model predicted that treating patients with bezlotoxumab in addition to SoC, when compared to SoC alone, reduced CDI total recurrences by 38.0% with increments of 0.1301 discounted life years gained and 0.0839 discounted QALYs gained per patient. The incremental discounted costs were 2,296.00 €. Incremental discounted cost-effectiveness ratios were estimated at 17.643,77 € per life year gained and 27.373,07 € per QALY gained. Key influential parameters include CDI-specific mortality, cost of recurrences, quality of life multipliers and underlying recurrence rate.

CONCLUSIONS: The analysis suggests that bezlotoxumab in combination with SoC is a cost-effective treatment in the Portuguese setting, reducing the disease and economic burden associated with CDI, through the prevention of recurrence of CDI in patients at risk for recurrence.