Good for the heart - and the wallet: African-American heart failure drug is cost-effective

December 12, 2005

Health care costs often increase when newer, more effective therapies are introduced to the marketplace, placing a financial burden on patients and insurers that can last for years. However, the same may not be true for a drug recently shown to greatly improve outcomes in African-American heart failure patients. According to a report in today's issue of Circulation: Journal of the American Heart Association, this heart failure drug is not only a promising treatment option, but one that is cost-effective as well.

A team of researchers led by Derek Angus, M.D., M.P.H., professor of critical care medicine at the University of Pittsburgh School of Medicine, examined data from the African-American Heart Failure Trial (A-HeFT) study in order to determine the trial participants' ongoing health care costs. AHeFT, the results of which were published November 2004 in the New England Journal of Medicine, compared outcomes in patients who took a medication with two active drug ingredients, isosorbide dinitrate and hydralazine (ISDN/HYD), to those in patients receiving a placebo regimen. The trial demonstrated the effectiveness of ISDN/HYD for treating heart failure in African-American patients.

According to the new analysis, total health care costs for the AHeFT participants who were treated with ISDN/HYD were 22 percent lower. Their total health care costs - those resulting from hospitalizations, doctors visits for any conditions or illnesses, but not including the cost of the drug itself - averaged $15,384 over the course of the 12-month trial. Such costs for patients who did not receive the drug averaged $19,728. Health care costs specifically related to heart failure were almost 34 percent lower on average, $5,997 versus $9,144. When the cost of the drug was factored in, there was still an average savings of 6 percent, or $533, on heart failure-related costs for ISDN/HYD patients compared to those who didn't receive the drug, and a 9 percent, or $1,730, average savings on total health care costs.

"This medication clearly decreased healthcare costs for AHeFT participants during the course of the clinical trial, even when the cost of the drug itself was taken into account," Dr. Angus said. "Based on the savings we've seen for one year and our modeling that projects future health care cost expenditures, it's likely that the cost-effectiveness of this drug will bear out in the long term as well."

Dr. Angus and his colleagues developed a model to predict costs over the course of the patient's lifespan beyond the 12-month trial period. Even under the most pessimistic assumption - that, over time, the drug would no longer provide therapeutic benefits - the model predicted that for 95 percent of patients, health care costs would still amount to less than what is considered to be a reasonable threshold for cost-effectiveness. Specifically, the model found the incremental cost-effectiveness ratio would be better than $50,000 per life-year gained, an amount widely regarded as the ceiling for costs that are acceptable to society. Researchers define the cost-effectiveness ratio as the additional health care costs incurred per life-year gained as a result of a treatment. Essentially, it represents the additional costs to society brought about by use of the drug.

"Using very conservative restrictions, our model suggests that this drug, even if used for lifetime courses over many years, should be very cost-effective," Dr. Angus said. "The key will be appropriate patient selection and careful attention to compliance with treatment. Our findings apply to the types of individuals, African-Americans with moderate to severe heart failure, who were enrolled in AHeFT. We do not know whether similar benefits would be found in other groups of patients."

The cost analysis incorporated actual data, such as frequency and length of hospitalization, office and emergency room visits and physician services during the 12-month clinical trial, and projections for the long-term model. Medicare guidelines were used to estimate and calculate costs.

"Because we relied on the actual data regarding health care resource use, our primary findings are likely to be very robust, as robust as the overall clinical trial results from AHeFT," said Dr. Angus.

During the study, 994 hospitalizations occurred, with 43 percent of these related to heart failure. Patients treated with ISDN/HYD had 30 percent fewer hospitalizations, and their hospital stays were one day shorter compared to the placebo group, resulting in a 41 percent reduction in the number of days spent in the hospital for heart failure. The ISDN/HYD group also had fewer hospitalizations for any reason, and the length of stay for all hospitalizations was shorter.

A-HeFT involved 1,050 African-American patients at 11 sites with New York Heart Association Class III or Class IV failure, which is defined as moderate to severe heart failure resulting in significant limitations to physical activity. AHeFT participants were randomly assigned to receive ISDN/HYD or a placebo in addition to their regular heart failure therapy. The patients' age averaged 56.8 years, and 40 percent of the patients were women. The patients were followed for an average of 12.8 months, and the study ended prematurely when a preliminary analysis showed that patients treated with ISDN/HYD had a significantly lower mortality - 6.2 percent compared to 10.2 percent. Last June, the drug won approval by the U.S. Food and Drug Administration for the treatment of heart failure in African-American patients and is now being marketed as BiDil® by NitroMed, Inc., of Lexington, Mass.
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In addition to Dr. Angus, other authors of the cost-effectiveness study were Jalal K. Ghali, M.D., Louisiana State University Health Sciences Center; Walter T. Linde-Zwirble, of consulting firm ZD Associates, Perkasie, Pa.; S. William Tam, Ph.D., Michael L. Sabolinski, M.D. and Manuel Worcel, M.D., NitroMed, Inc., Lexington Mass.; Victor G. Villagra, M.D., Health & Technology Vector, Inc., Farmington, Conn.; and Wolfgang C. Winkelmayer, M.D., Sc.D., Brigham and Women's Hospital in Boston.

The study was funded by NitroMed, which also sponsored the African-American Heart Failure Clinical Trial.

University of Pittsburgh Medical Center

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