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Donald B. Chalfin, MD, MS; M. E. Blair Holbein, PhD; Alan M. Fein, MD; Graziano C. Carlon, MD

JAMA. 1993;269(2):249-254.

Abstract
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.

(JAMA. 1993;269:249-254)

Author Affiliations
From the Division of Pulmonary and Critical Care Medicine, and the Pulmonary Research Institute, Winthrop-University Hospital, Mineola, NY (Drs Chalfin and Fein); Surgical Intensive Care Unit (Dr Chalfin) and Division of Pulmonary and Critical Care Medicine (Dr Fein), Health Sciences Center, State University of New York at Stony Brook; Department of Internal Medicine, Presbyterian Hospital, Dallas, Tex (Dr Holbein); and Critical Care Medicine Service and Department of Anesthesiology, Cornell University Medical College, New York, NY (Dr Carlon). Drs Chalfin and Holbein received honoraria for their participation in a seminar series entitled "Focus on New Drugs, E5: A Monoclonal Antibody for the Treatment of Gram-negative Sepsis." These seminars were sponsored by the American College of Clinical Pharmacy and partially funded by an educational grant from Pfizer-Roerig, New York, NY.

Footnotes
Presented, in part, at the 19th Annual Educational and Scientific Symposium of the Society of Critical Care Medicine, San Francisco, Calif, May 29-June 1, 1990.

Reprint requests to Division of Pulmonary and Critical Care Medicine, Winthrop-University Hospital, 222 Station Plaza N, Suite 400, Mineola, NY 11501 (Dr Chalfin).

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