News Release

Drotrecogin alfa (activated) is a cost-effective treatment for severe sepsis patients

Compares FaCompares favorably to other widely used life-saving technologiesvorably to Other Widely Used Life-Saving Technologies

Peer-Reviewed Publication

University of Pittsburgh Medical Center

PITTSBURGH, Jan. 30 – The only FDA-approved drug for the treatment of severe sepsis, drotrecogin alfa (activated) (Xigris®), is a cost-effective treatment and has a cost-benefit ratio superior or similar to that of many widely used medical treatments, according to a University of Pittsburgh-led study published in the current issue of the journal Critical Care Medicine (January 2003, Vol. 31, No. 1). In "Cost-effectiveness of Drotrecogin Alfa (Activated) In the Treatment of Severe Sepsis," Derek Angus, M.D., M.P.H., F.C.C.P., associate professor of critical care medicine at the University of Pittsburgh, et al., also report the drug is significantly more cost-effective when used in severe sepsis patients at highest risk of death, and that the drug saves lives without significantly increasing short-term costs or use of medical resources.

Using patient data prospectively collected during the course of the 28-day, multicenter, phase III PROWESS clinical trial, the researchers determined that drotrecogin alfa (activated) costs $48,800 per quality-adjusted life-year (QALY). This figure falls below the widely accepted threshold for cost-effectiveness of $100,000 per QALY. A separate analysis of severe sepsis patients at high risk of death, the group for which the FDA recommended treatment, showed that drotrecogin alfa (activated) cost $27,400 per QALY. Taking into account the estimated lifespan of a patient as well as health status during his/her remaining years of life, the quality-adjusted life-year is widely regarded by health care economists to be the most comprehensive tool used to calculate the cost-effectiveness of medical treatments.

The study also concluded that drotrecogin alfa (activated) is as cost-effective, if not more cost effective, than many commonly used life-saving treatments, including: statins for secondary prevention of coronary artery disease/stroke ($48,000 per QALY); neonatal intensive care ($49,000 per QALY); tissue plasminogen activator therapy for acute myocardial infarction ($60,000 per QALY); lung transplants ($204,000 per QALY); warfarin therapy for stroke ($428,000 per QALY); and resuscitation for cardiac arrest ($603,000 per QALY).

"Our study shows that the cost-effectiveness of drotrecogin alfa (activated) is in line with many other life-saving medical interventions," said Dr. Angus. "Cost-effectiveness, rather than price alone, is the true measure of a drug's value, and ought to be our bottom line when making critical treatment decisions in severe sepsis and other serious conditions."

Importantly, the study also looked at the effect of drotrecogin alfa (activated) on the costs of other aspects of care. The authors found that there was no significant change in other hospital or short-term costs of care: the sole economic impact on hospitals was the acquisition cost for the drug, and there was no effect on other hospital costs, such as duration of ICU care. Previous studies have shown that drotrecogin alfa (activated) improved patients' short- and long-term survival, and that the majority of survivors are discharged directly to home rather than requiring care at another institution.

"Hospitals and pharmacies are certainly faced with painful choices in today's cost-containment environment and, from a practical standpoint, need to find ways to cover the acquisition costs for this therapy," said Dr. Angus. "The recent commitment from Medicare to offset costs should be seen as a great help in this regard."

The Medicare, Medicaid SCHIP Benefits Improvement and Protection Act of 2000 (Section 533(b), Public Law 106554) is designed to address the increased cost to hospitals of new treatments by providing additional payments to hospitals that provide new technologies or services that substantially improve patient outcomes. The Centers of Medicare and Medicaid Services determined that drotrecogin alfa (activated) meets the required criteria and, since October 1, 2002, hospitals have been eligible to receive additional compensation when using the drug for Medicare patients.

In calculating cost-effectiveness figures for drotrecogin alfa (activated), the study team based hospital cost estimates on a subset of the U.S. patients treated in the PROWESS trial. Lifetime projections were modeled from published federal sources (the U.S. Census and the National Center on Health Statistics) and tested in sensitivity analyses.

The results of the cost-effectiveness study are consistent with the conclusions of a Canadian economic evaluation, "An Economic Evaluation of Activated Protein C Treatment for Severe Sepsis" (B.J. Manns et al.), recently published in the New England Journal of Medicine (Sept. 26, 2002, Vol. 347, Number 13), which calculated cost-effectiveness of drotrecogin alfa (activated) to be $47,000 per QALY.

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