title: Cost-effectiveness of HA-1A monoclonal antibody for gram-negative sepsis. Economic assessment of a new therapeutic agent.
abstract: OBJECTIVE
  To assess the cost-effectiveness of the HA-1A monoclonal antibody for the treatment of gram-negative bacteremia.
  
  
  METHODS
  Cost-effectiveness analysis of a randomized, double-blind, placebo-controlled trial using clinical efficacy data reported in the medical literature.
  
  
  METHODS
  Hospitalized patients with sepsis.
  
  
  METHODS
  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.
  
  
  METHODS
  HA-1A vs placebo in addition to usual care.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Economic assessment of new technologies early in their development can be used to guide their efficient clinical introduction.
authors.affiliation: Department of Medicine, University of Pennsylvania, Philadelphia.
authors.forename: K A
authors.initials: KA
authors.lastname: Schulman
authors.forename: H A
authors.initials: HA
authors.lastname: Glick
authors.forename: H
authors.initials: H
authors.lastname: Rubin
authors.forename: J M
authors.initials: JM
authors.lastname: Eisenberg
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D016470:Bacteremia / Q000191:economics* / Q000628:therapy*; D003362:Cost-Benefit Analysis; D016527:Drug Costs / Q000706:statistics & numerical data; D016905:Gram-Negative Bacterial Infections / Q000191:economics* / Q000628:therapy*; D017048:Health Care Costs / Q000706:statistics & numerical data*; D006760:Hospitalization / Q000191:economics*; D006801:Humans; D008875:Middle Aged; D009426:Netherlands; D012680:Sensitivity and Specificity; D026712:Value of Life
chemical_list: D000911:Antibodies, Monoclonal