RAFT Study Shows Cost-Effectiveness of CRT-D in Mildly Symptomatic Heart Failure Patients
May 11, 2012 — Medtronic Inc. announced findings from an economic analysis of the landmark RAFT (Resynchronization/Defibrillation in Ambulatory Heart Failure Trial) trial demonstrating that cardiac resynchronization therapy with defibrillation (CRT-D) is a cost-effective treatment for mildly symptomatic heart failure patients. The findings showed a $33,025 cost per quality adjusted life year (QALY) gained using Medtronic CRT-Ds in a mild, New York Heart Association (NYHA)-designated Class II-III heart failure patient population, substantially lower than the benchmark for therapy cost effectiveness of other serious chronic conditions that cost at least $50,000 per QALY gained.(1) QALY is a measure of the quantity and quality of life.
In the RAFT economic analysis, patients who received CRT-D were estimated to gain more than one quality-adjusted life year (1.07) at an additional cost of $35,308 over a lifetime horizon, the typical time period commonly cited by health economists.
"The large-scale RAFT trial has provided us with a wealth of clinical insight into the overall benefits of CRT-D in treating mild heart failure, proving that this advanced therapy significantly decreases mortality and reduces heart failure hospitalization rates with an economic value to the healthcare system as a whole," said George Wells, Ph.D., University of Ottawa Heart Institute, Ottawa, Canada.
Approximately 6 million people in the United States suffer from heart failure, and the estimated cost for treating the life-threatening condition is almost $40 billion per year.(2) In line with numerous clinical trials showing that CRT-D is a cost-effective treatment approach in treating moderate-to-severe disease, this new data confirms it is also associated with a cost-effectiveness benefit per QALY gained in mild heart failure patients.
Last month, the U.S. Food and Drug Administration (FDA) approval expanded the indication for Medtronic's CRT-D devices to treat NYHA Class II heart failure patients with a left ventricular ejection fraction (LVEF) of less than or equal to 30 percent, left bundle branch block (LBBB), and a QRS duration greater than or equal to 130 milliseconds. The expanded indication fulfills a serious unmet need by enabling treatment with CRT-D in indicated patients in the earlier stages of heart failure, before their symptoms start impacting their quality of life.
The economic analysis assessed the healthcare-related costs and QALYs of 1,798 patients randomized to receive CRT-D or ICD therapy extrapolated across a lifetime horizon, which was facilitated by an economic model that combined RAFT patient data with long-term data on the longevity of the medical devices. Cost in regard to QALYs was discounted at 3 percent per year. Healthcare-related costs examined included the treatment device (plus any replacements), hospitalization (both cardiovascular and non-cardiovascular related), pharmaceutical treatments, physician visits and long-term care, and were calculated using U.S. expenditures.
About the RAFT Trial The RAFT trial, sponsored by the Canadian Institutes of Health Research and Medtronic, is a double-blinded, randomized, controlled trial, and showed that CRT-D significantly reduced mortality for mildly symptomatic heart failure patients (NYHA Class II): 29 percent when compared to patients treated with guideline-recommended implantable ICDs and medical therapy (p=0.006; HR=0.71). The study also demonstrated a significant reduction (30 percent) in heart failure hospitalizations for this Class II population (p=0.003; HR=0.70), consistent with previously published studies. It involved 1,798 patients in Canada, Europe and Australia. All patients were followed for at least 18 months, and had an average follow-up of 40 months, making it the longest follow-up and largest patient months-of-experience of any randomized controlled trial of CRT therapy.
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(1) The Economic Argument for Disease Prevention: Distinguishing Between Value & Savings. Partnership for Prevention. February 2009. Retrieved on April 9, 2012 from www.prevent.org.
(2) American Heart Association / American Stroke Association, Heart Disease and Stroke Statistics, 2010 Update.