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The economic impact and cost-effectiveness of monoclonal antibody therapy for sepsis.

Monoclonal antibodies directed against the endotoxins produced by gram-negative organisms have been developed for the treatment of patients with sepsis. Phase 3 clinical trials in which two of these agents, E5 and HA-1A, have been evaluated have suggested possible benefit in terms of improved survival and reversal of organ dysfunction for certain subgroups. Since monoclonal antibodies are expected to be expensive, cost-effectiveness analysis is necessary to assess the joint clinical and economic impact. Cost-effectiveness studies based on the clinical data from these phase 3 trials have suggested that monoclonal antibodies may represent a cost-effective approach to the treatment of sepsis. However, an increase in the number of questions concerning the clinical efficacy of these agents and their ultimate impact on survival mandates the need for further clinical and economic investigation.