OBJECTIVE: To assess the cost-effectiveness of the HA-1A monoclonal antibody for the treatment of gram-negative bacteremia. DESIGN:Cost-effectiveness analysis of a randomized, double-blind, placebo-controlled trial using clinical efficacy data reported in the medical literature. SETTING:Hospitalized patients with sepsis. PATIENTS: 543 patients with sepsis and suspected gram-negative infection. Patients enrolled in the study met strict criteria for sepsis, including fever or hypothermia (less than 35.6 degrees C or greater than 38.3 degrees C), tachycardia (greater than 90 beats per minute), tachypnea (greater than 20 breaths per minute), and hypotension or two of six signs of systemic toxicity. INTERVENTION: HA-1A vs placebo in addition to usual care. MAIN OUTCOME MEASURES: We determined the range of possible cost-effectiveness ratios for HA-1A therapy, using modeling techniques when clinical or economic variables were unknown. We subjected the model to rigorous sensitivity analysis. We calculated the incremental cost of care and years of life saved for patients with sepsis and modeled two different treatment strategies: treat all patients with sepsis or test and then treat only patients with positive test results. $24,100 per year of life saved based on the treat strategy and $14,900 based on the test strategy. In sensitivity analysis the ratios ranged from $5200 to $110,200 per year of life gained. Annual costs of care for these two strategies are $1.3 billion for the test strategy and $2.3 billion for the treat strategy. CONCLUSION: Economic assessment of new technologies early in their development can be used to guide their efficient clinical introduction.
RCT Entities:
OBJECTIVE: To assess the cost-effectiveness of the HA-1A monoclonal antibody for the treatment of gram-negative bacteremia. DESIGN: Cost-effectiveness analysis of a randomized, double-blind, placebo-controlled trial using clinical efficacy data reported in the medical literature. SETTING: Hospitalized patients with sepsis. PATIENTS: 543 patients with sepsis and suspected gram-negative infection. Patients enrolled in the study met strict criteria for sepsis, including fever or hypothermia (less than 35.6 degrees C or greater than 38.3 degrees C), tachycardia (greater than 90 beats per minute), tachypnea (greater than 20 breaths per minute), and hypotension or two of six signs of systemic toxicity. INTERVENTION: HA-1A vs placebo in addition to usual care. MAIN OUTCOME MEASURES: We determined the range of possible cost-effectiveness ratios for HA-1A therapy, using modeling techniques when clinical or economic variables were unknown. We subjected the model to rigorous sensitivity analysis. We calculated the incremental cost of care and years of life saved for patients with sepsis and modeled two different treatment strategies: treat all patients with sepsis or test and then treat only patients with positive test results. $24,100 per year of life saved based on the treat strategy and $14,900 based on the test strategy. In sensitivity analysis the ratios ranged from $5200 to $110,200 per year of life gained. Annual costs of care for these two strategies are $1.3 billion for the test strategy and $2.3 billion for the treat strategy. CONCLUSION: Economic assessment of new technologies early in their development can be used to guide their efficient clinical introduction.