COST-EFFECTIVENESS OF MONOCLONAL-ANTIBODIES TO GRAM-NEGATIVE ENDOTOXIN IN THE TREATMENT OF GRAM-NEGATIVE SEPSIS IN ICU PATIENTS

Objective-To evaluate the fiscal impact and the cost-effectiveness of monoclonal antibodies against gram-negative endotoxin (MAbGNE) in the treatment of presumed gram-negative sepsis. Design.-A decision analysis model was developed from (1) data from two phase ill trials that studied the E5 or HA-1A MAbGNE, and (2) financial data from 1405 septic patients who required intensive care at a large tertiary hospital. Setting.-Intensive care unit (ICU) patients with presumed gram-negative sepsis. Patients.-The E5 trial evaluated 468 patients, and the HA-1A study enrolled 543 patients with presumed gram-negative sepsis. Interventions.-The addition of MAbGNE to standard regimens or standard regimens alone. Main Outcome Measures.-Total expected charges and the expected probability of survival were determined for each option. Cost-effectiveness and marginal cost-effectiveness ratios were also derived. Multiple sensitivity and Monte Carlo analyses were performed to test the underlying assumptions. Results.-MAbGNE therapy always resulted in higher expected charges; however, these differences were less than its acquisition cost by $870. The cost-effectiveness ratio for MAbGNE, for $2000 and $4000 acquisition costs, was $71 674 and $74 900 per probability of survival, respectively. Sensitivity analysis showed that cost-effectiveness was most affected by diagnostic accuracy, patient selection, and acquisition cost. Monte Carlo analysis showed that MAbGNE was more costly for 71 % of simulations, yet the most efficacious option for 79% of simulations. Conclusions.-From the perspective of acute care institutions, MAbGNE is expensive and cannot be justified on a cost-saving basis. However, it may be cost-effective throughout a reasonable range of assumptions.