Budget Impact Analysis of Aztreonam-Avibactam (ATM-AVI) for the Treatment of Infections Caused by Confirmed and Suspected Metallo Β-Lactamase (MBL)-Producing Enterobacterales in Italy

OBJECTIVES: ATM-AVI is approved in Europe in adult patients for the treatment of complicated intra-abdominal infection (cIAI); hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP); complicated urinary tract infection (cUTI), including pyelonephritis and for infections due to aerobic Gram-negative organisms with limited treatment options (LTO). This analysis evaluates the budget impact of introducing ATM-AVI ± metronidazole for the treatment of infections caused by confirmed and suspected MBL-producing Enterobacterales (MBL-CREs) including cIAI, HAP/VAP, cUTI and those with limited treatment options (LTO) in the Italian setting.

METHODS: We compared two scenarios (‘world with’ and ‘world without’ ATM-AVI) to assess the budget impact of introducing ATM-AVI for the treatment of MBL-CRE infections including cIAI, HAP/VAP, cUTI and LTO over a 3-year time horizon. In the ‘World without ATM-AVI’, patients are assumed to receive either cefiderocol or colistin-based regimes. The number of patients for each treatment is based on the market share and total eligible patients in Italy. Treatment response rates were taken from REVISIT & CREDIBLE-CR. REVISIT included cIAI and HAP/VAP patients, thus overall results from the trial were extrapolated to cUTI and LTO. The impact of resistant pathogens and risk of nephrotoxicity (NTX) from recent literature were included.

RESULTS: In the ‘World with ATM-AVI’, there were 780 additional cures, with 281 fewer deaths and 4,056 fewer bed days. There is an increase in drug acquisition costs, but this is largely offset by the reduced costs associated with hospitalization, NTX and resistance of ATM-AVI. The total budget impact for suspected and documented MBL-CRE infections including cIAI, HAP/VAP, cUTI and LTO is €6,837,527 over 3 years, equivalent to €356 per patient.

CONCLUSIONS: The introduction of ATM-AVI in the hospital formulary can be expected to have marginal impact on the total healthcare budget with significant benefits in terms of additional cures, lives saved and healthcare costs.