Cost-effectiveness of monoclonal antibodies to gram-negative endotoxin in the treatment of gram-negative sepsis in ICU patients
D. B. Chalfin, M. E. Holbein, A. M. Fein and G. C. Carlon
Division of Pulmonary and Critical Care Medicine, Winthrop University Hospital, Mineola, NY 11501.
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 III 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.
