OBJECTIVES: CAZ-AVI, a fixed-combination drug containing ceftazidime and avibactam, has been approved in Europe for cIAI, cUTI, HAP including VAP, and aerobic Gram-negative infections with limited treatment options (LTO). The objective of this study is to quantify the budgetary impact of adding CAZ-AVI to a hospital formulary in Italy.

METHODS: A model was developed to estimate budget impact of adding CAZ-AVI to a hospital formulary over 3 years. Number of eligible patients were estimated from Italian epidemiological data. Cure and adverse event rates were extracted from clinical trials. Hospital length of stay associated with treatment cures/failures was derived from clinical trials of CAZ-AVI. Cost inputs were retrieved from published Italian Tariff lists. Current and future market shares were based on market research data and manufacturer’s forecast model. Given uncertainty around market share estimates in aerobic Gram-negative infections with LTO, analysis for this indication was not included.

RESULTS: The introduction of CAZ-AVI was estimated to carry a marginal impact to the hospital budget. The total cost per treated patient, prior to CAZ-AVI introduction, was estimated to be €12,102 [€4,309 (cUTI), €15,208 (cIAI), €17,975 (HAP/VAP)] and €12,168 [€4,360 (cUTI), €15,282 (cIAI), €18,051 (HAP/VAP)] after the introduction of CAZ-AVI, an average of 0.5% increase in the budget. Reduction in hospital bed days and hospitalization costs was estimated with introduction of CAZ-AVI. Hospitalization costs represented the largest component of the total costs (93%) while pharmacy and adverse event costs made up 6% and 1%, respectively. The budget impact remained marginal even in sensitivity analysis of lower resistance rates (90% decrease in resistance rates resulted in 0.7% increase in total budget).

CONCLUSIONS: The analysis suggested that adding CAZ-AVI to a hospital formulary in Italy would lead to a marginal increase in the hospital budget and a reduction in hospital bed days.