This Article  • References  • Full text PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Contact me when this article is cited  Related Content  • Similar articles in JAMA  Social Bookmarking   What's this?

Economic Assessment of a New Therapeutic Agent

Kevin A. Schulman, MD; Henry A. Glick, MA; Harvey Rubin, MD; John M. Eisenberg, MD

JAMA. 1991;266(24):3466-3471.

Abstract
Objective.
—To assess the cost-effectiveness of the HA-1A monoclonal antibody for the treatment of gram-negative bacteremia.

Design.
—Cost-effectiveness analysis of a randomized, double-blind, placebo-controlled trial using clinical efficacy data reported in the medical literature.

Setting.
—Hospitalized patients with sepsis.

Patients.
—543 patients with sepsis and suspected gram-negative infection. Patients enrolled in the study met strict criteria for sepsis, including fever or hypothermia (<35.6°C or >38.3°C), tachycardia (>90 beats per minute), tachypnea (>20 breaths per minute), and hypotension or two of six signs of systemic toxicity.

Intervention.
—HA-1A vs placebo in addition to usual care.

Main Outcome Measures.
—We determined the range of possible cost-effectiveness ratios for HA-1 A 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.

Results.
—The cost-effectiveness of therapy based on our two models was $24100 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.

Conclusion.
—Economic assessment of new technologies early in their development can be used to guide their efficient clinical introduction.

(JAMA. 1991;266:3466-3471)

Author Affiliations
From the Sections of General Internal Medicine (Drs Schulman and Eisenberg and Mr Glick) and Infectious Diseases (Dr Rubin), Department of Medicine, and the Leonard Davis Institute of Health Economics (Drs Schulman and Eisenberg and Mr Glick), University of Pennsylvania, Philadelphia.

Footnotes
Reprint requests to Department of Medicine, Georgetown University Medical Center, 3800 Reservoir Rd NW, Washington, DC 20007-2197 (Dr Eisenberg).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Impact of Immunomodulating Therapy on Morbidity in Patients with Severe Sepsis
PITTET et al.
Am. J. Respir. Crit. Care Med. 1999;160:852-857.
ABSTRACT | FULL TEXT  

Fair Allocation of Intensive Care Unit Resources
Am. J. Respir. Crit. Care Med. 1997;156:1282-1301.
FULL TEXT  

Magnitude and Duration of the Effect of Sepsis on Survival
Quartin et al.
JAMA 1997;277:1058-1063.
ABSTRACT  

The Relevance of Searching for Effects under a Clinical-trial Lamppost: A Key Issue
Rittenhouse
Med Decis Making 1995;15:348-357.
ABSTRACT  

Projected Impact of Monoclonal Anti-Endotoxin Antibody Therapy
Bates and Lee
Arch Intern Med 1994;154:1241-1249.
ABSTRACT  

Minireview: Therapeutic intervention in sepsis with antibody to endotoxin: is there a future?
Cross and Opal
Innate Immunity 1994;1:57-69.
ABSTRACT  

The Clinical Evaluation of New Drugs for Sepsis: A Prospective Study Design Based on Survival Analysis
Knaus et al.
JAMA 1993;270:1233-1241.
ABSTRACT  

Futility in Practice
Schneiderman and Jecker
Arch Intern Med 1993;153:437-441.
ABSTRACT  

Cost-effectiveness of Monoclonal Antibodies to Gram-negative Endotoxin in the Treatment of Gram-negative Sepsis in ICU Patients
Chalfin et al.
JAMA 1993;269:249-254.
ABSTRACT  

New Drugs: Are We Being Double-Billed?
Meyer
JAMA 1992;267:3153-3154.
ABSTRACT  

Antibody to Endotoxin in the Treatment of Gram-negative Sepsis
Schentag
JAMA 1992;267:2326-2327.
ABSTRACT