Scott Ramsey, M.D., Ph.D., an associate member of Fred Hutchinson's Public Health Sciences Division and an associate professor of medicine at the University of Washington, led the cost analysis, which was based on data from the National Emphysema Treatment Trial, or NETT, the largest randomized clinical trial to date of lung-volume-reduction surgery versus medical therapy to treat severe emphysema.
The results of NETT, together with those of the NETT Cost Effectiveness Study led by Ramsey in collaboration with investigators at clinical-study sites nationwide, will be posted May 20 on the New England Journal of Medicine Web site (www.nejm.org) in tandem with their presentation at the American Thoracic Society's 99th International Conference in Seattle.
This unprecedented parallel evaluation of the medical benefits and cost-effectiveness of a surgical procedure will inform Medicare's decision next month regarding whether to reinstate coverage for lung-volume-reduction surgery, which was suspended in 1996 due to insufficient evidence regarding benefits, concern over high operative mortality rates and high costs.
The surgery alone costs about $35,000 per person. If coverage is reinstated and only 1 percent of the 2 million people with emphysema in the United States were eligible for the procedure, Medicare costs during the first year could exceed $300 million, Ramsey said.
NETT investigators found that those who benefited most from the surgery in terms of survival and quality of life were those with upper-lobe emphysema who had low exercise capacity prior to surgery.
These results were based on three-year post-surgical follow-up data. Costs during this period were very high, largely due to the expense of the surgery and the substantial number of patients who had very long postoperative hospital stays. If the benefits of surgery among these patients were sustained for 10 or more years, projected cost-effectiveness of the procedure would approach levels consistent with other treatments considered to be a good value, Ramsey said.
Economists express cost-effectiveness values for a medical procedure as a dollar amount per quality-adjusted year of life gained, a ratio calculated using medical expenses, survival data and quality-of-life factors. Lower ratios are preferred to higher ones; a procedure is generally considered to be cost-effective if it has a value on the order of $50,000 per quality-adjusted year of life gained.
The NETT investigators found that three years after surgery, the cost-effectiveness was $190,000 per quality-adjusted life-year gained. For the subgroup of patients who responded well after surgery, the cost-effectiveness of surgery in year three was $98,000.
Based on their 10-year projections, the researchers calculated that the overall cost- effectiveness for the surgery would be $53,000 per quality-adjusted life-year gained and $21,000 for the subgroup that responded well to the surgery.
"I'm cautiously optimistic about the long-term cost-effectiveness of this procedure, particularly for the subgroup of patients who responded well to the surgery," Ramsey said. "But because of the expense of conducting this type of clinical trial, this is the best data that will ever exist on this procedure. Future randomized trials specifically evaluating the favorable subgroup found in this trial are unlikely, and 10-year follow-up of the patients in this trial is unlikely. That makes it difficult to predict with confidence whether lung-volume-reduction surgery will be cost- effective long term."
The Fred Hutchinson Cancer Research Center, home of two Nobel Prize laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical technology to eliminate cancer and other potentially fatal diseases. Fred Hutchinson receives more funding from the National Institutes of Health than any other independent U.S. research center. Recognized internationally for its pioneering work in bone-marrow transplantation, the center's four scientific divisions collaborate to form a unique environment for conducting basic and applied science. Fred Hutchinson, in collaboration with its clinical partners, the University of Washington Academic Medical Center and Children's Hospital and Regional Medical Center, is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest and is one of 39 nationwide. For more information, visit the center's Web site at www.fhcrc.org. Advancing Knowledge, Saving Lives
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New England Journal of Medicine