For release: March 15, 2000
Contact: Kimberly Lynch, ACCP
(847) 498-8341
[email protected]
REPLACEMENT THERAPY FOR SEVERE EMPHYSEMA CALLED A COST-EFFECTIVE WAY TO REDUCE OVERALL MORTALITY
Human alpha1-antitrypsin ("1-AT) replacement therapy for patients with severe chronic obstructive pulmonary disease (COPD), caused by significant "1-AT deficiency, is safe, cost-effective, slows the decline of lung function, and reduces overall mortality, according to a report published in the March issue of CHEST.
Writing in the peer-reviewed journal of the American College of Chest Physicians (ACCP), Stephan A. Alkins, M.D., of the Pulmonary and Critical Care Medicine Service, Walter Reed Army Medical Center, Washington, DC, along with an associate, points out that "1-AT deficiency is associated with the premature development of emphysema by early middle age (40's), especially in smokers.
A protein produced in the body, "1-AT prevents an enzyme called neutrophil elastase from damaging the connective tissue in the walls of the tiny air sacs of the lungs (alveoli). First identified in 1963 and usually found in individuals of Northern European ancestery, "1-AT deficiency affects one out of 10,000 people, making it one of the most common serious genetic diseases. Replacement therapy with pooled "1-AT is used to treat the genetically- determined problem. The therapy is safe and has been approved by the U.S. Food and Drug Administration.
Based on National Institutes of Health (NIH) Registry data for patients with this disorder, replacement therapy reduces the mortality rate over five years by 55 percent for a patient with severe emphysema. Mortality was lowered from 33 percent in the untreated group to 15 percent in the treated group.
The researchers calculated that the yearly cost-effectiveness associated with the intervention per year of life saved was $13,971 for a 154-pound (70 kilograms), "1-AT- deficient individual with severe emphysema who receives weekly replacement therapy. The cost of therapy per year for that individual would be approximately $52,000. All costs will vary based on patient age, sex, and smoking status. Replacement therapy costs were calculated from the payer's perspective based on Medicare part B reimbursement rates as reported in 1998 U.S. dollars.
The NIH Registry data for those on replacement therapy described a slower decline in lung function when initial respiratory tests were between 35 and 49 percent of their normal predicted value.
The investigators point out that survival in patients with "1-AT deficiency varies depending on the initial lung function test results and their cigarette use. The average overall survival time for those with "1-AT deficiency is 52 years for smokers and 67 years for nonsmokers.
"Assuming that the mortality rate reduction associated with "1-AT replacement therapy in the NIH Registry is valid," said Dr. Alkins, "this cost analysis suggests that
"1-AT replacement is cost-effective for severely deficient patients with severe COPD."
According to the researchers, cost-effectiveness thresholds are value judgements used to define the use of scarce societal resources. For example, the annual cost per life
saved by renal dialysis, which prolongs life for end-stage kidney disease patients and is a procedure accepted by U.S. communities, runs approximately $40,000 to $50,000 per year.
Therefore, a therapy being considered for its cost-effectiveness can be compared, for example purposes, to the annual cost of renal dialysis, since it too is reimbursed by Medicare, according to Dr. Alkins.
CHEST is published by the American College of Chest Physicians which represents 15,000 members who provide clinical, respiratory, and cardiothoracic patient care in the U.S. and throughout the world.
Reporters may wish to contact Kimberly Lynch of the ACCP at (847) 498-8341 for a full copy of this article. She can also be reached by fax at (847) 498-5460 or by e-mail at [email protected]. Dr. Alkins can be reached by phone at (202) 782-6745.
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