Economic Evaluation of Cefiderocol for the Treatment of Confirmed MBL-Producing Pathogens in Italy
Author(s)
Maria Laura Notarianni, MSc1, Davide Andretta, MSc2.
1Shionogi, Rome, Italy, 2Shionogi, London, Italy.
1Shionogi, Rome, Italy, 2Shionogi, London, Italy.
OBJECTIVES: Cefiderocol is an antibiotic launched in Italy in 2021. The objective of this economic evaluation was to assess the cost-effectiveness of cefiderocol compared to colistin from the Italian Healthcare perspective in patients with severe gram-negative infections caused by MBL-producing pathogens.
METHODS: A decision-tree economic model was developed. Microbiological test results are assumed to be available at treatment initiation; therefore, pathogen strain and its antimicrobial susceptibility profile are known at the time patients enter the model. The outcome measure used to inform the movement of patients in the decision-tree model was the rate of all-cause mortality (ACM) at day 28 associated with the MBL-pathogens, obtained from the published patient-level information on MBL-producing bacterial infections from two phase 3, randomized, prospective, clinical studies investigating the efficacy and safety of cefiderocol (CREDIBLE-CR and APEKS-NP). Overall day 28 ACM was 12.5% among cefiderocol-treated patients and 50.0% for patients who received other agents. A weighted average of three infection sites populations (cUTI, pneumonia and BSI/sepsis) was included in the model. The distribution among infection sites was informed by prevalence data from Italy. The evaluation was performed using a 5-year time horizon with a discount rate of 3% for costs and benefits (as AIFA and ISPOR Guidelines recommend). The threshold for cost-effectiveness considered was €40,000 per additional quality-adjusted life year. Deterministic and probabilistic sensitivity analyses were conducted to assess the impact of bias on the model results.
RESULTS: In a confirmed carbapenem-resistant MBL population, the base-case analysis resulted in an ICER of €8,599/QALY when cefiderocol is compared against colistin-based regimens. Results from the probabilistic sensitivity analysis showed that cefiderocol was cost-effective in 100% of all simulations.
CONCLUSIONS: The analysis confirmed the economic value of cefiderocol versus colistin-based regimens for the treatment of critically ill patients with severe infections caused by gram-negative bacteria producing metallo-B-lactamases.
METHODS: A decision-tree economic model was developed. Microbiological test results are assumed to be available at treatment initiation; therefore, pathogen strain and its antimicrobial susceptibility profile are known at the time patients enter the model. The outcome measure used to inform the movement of patients in the decision-tree model was the rate of all-cause mortality (ACM) at day 28 associated with the MBL-pathogens, obtained from the published patient-level information on MBL-producing bacterial infections from two phase 3, randomized, prospective, clinical studies investigating the efficacy and safety of cefiderocol (CREDIBLE-CR and APEKS-NP). Overall day 28 ACM was 12.5% among cefiderocol-treated patients and 50.0% for patients who received other agents. A weighted average of three infection sites populations (cUTI, pneumonia and BSI/sepsis) was included in the model. The distribution among infection sites was informed by prevalence data from Italy. The evaluation was performed using a 5-year time horizon with a discount rate of 3% for costs and benefits (as AIFA and ISPOR Guidelines recommend). The threshold for cost-effectiveness considered was €40,000 per additional quality-adjusted life year. Deterministic and probabilistic sensitivity analyses were conducted to assess the impact of bias on the model results.
RESULTS: In a confirmed carbapenem-resistant MBL population, the base-case analysis resulted in an ICER of €8,599/QALY when cefiderocol is compared against colistin-based regimens. Results from the probabilistic sensitivity analysis showed that cefiderocol was cost-effective in 100% of all simulations.
CONCLUSIONS: The analysis confirmed the economic value of cefiderocol versus colistin-based regimens for the treatment of critically ill patients with severe infections caused by gram-negative bacteria producing metallo-B-lactamases.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE377
Topic
Economic Evaluation
Disease
Infectious Disease (non-vaccine)