NEW ORLEANS — Treatment with a single-chamber, implantable cardioverter defibrillator is cost-effective for patients with moderate to severe heart failure and a left ventricular ejection fraction of 35% or less, according to results of the Sudden Cardiac Death in Heart Failure Trial.
An economic analysis of the results of SCD-HeFT showed that placing an implantable cardioverter defibrillator in all patients who met entry criteria would cost about $33,000 for each added life-year, Daniel B. Mark, M.D., reported at the annual scientific sessions of the American Heart Association.
This means that ICD treatment for these patients is cost-effective and “economically attractive” because the cost for each additional year of life saved was less than the consensus maximum in the United States of $50,000 per added life-year, the cost of Medicare's dialysis program, said Dr. Mark, director of the outcomes research and assessment group at Duke University, Durham, N.C.
Still, actually putting these devices in all U.S. patients who fit the clinical profile would rack up a staggering cost of perhaps as much as $50 billion a year, said William Weintraub, M.D., director of the Center for Outcomes Research at Emory University, Atlanta.
SCD-HeFT enrolled 2,521 patients with stable heart failure with symptoms that placed them into either New York Heart Association class II or III; 70% had class II disease. On top of standard heart failure treatment, patients were randomized to receive 200-400 mg/day amiodarone, treatment with an ICD, or placebo, and they were followed for a mean of 46 months. The trial, and the economic analysis, were sponsored by Medtronic Inc., maker of the ICD used.
During follow-up, mortality was about 36% in both the placebo and amiodarone groups and about 28% in the ICD group, a statistically significant 23% relative drop.
The mean 5-year cost per patient on amiodarone exceeded the $43,077 cost with placebo, so amiodarone is not an economically viable alternative. The mean 5-year cost in the ICD group was $61,967, but because ICD treatment saved lives, compared with placebo, the cost increment could be subjected to a cost-effectiveness analysis. The mean life expectancy in the placebo group was about 8.4 years, compared with 10.9 years in the ICD group, yielding an average gain of nearly 2.5 years for each patient who got an ICD.
When ICD therapy cost was calculated using a 3% discount for all costs and life expectancy, the result was $33,192 per added life-year. The cost of ICD therapy per added life-year generally remained below the $50,000 maximum even using different cost assumptions. For example, the cost per added life-year remained less than $40,000 whether or not treatment was limited to patients with left ventricular ejection fractions of 30% or less, to patients aged 65 years or older, or to patients with a QRS interval of 120 msec or more.
ICD therapy was as cost-effective in patients with ejection fractions of 30%-35% as in patients with ejection fractions below 30%.
The Centers for Medicare and Medicaid Services recently removed several exclusions for ICD coverage, including those for patients with high QRS intervals, or left ventricular ejection fractions of 30%-35% (INTERNAL MEDICINE NEWS, Feb. 15, 2005, p. 1). CMS previously focused on the fact that during 5 years of follow-up, ICDs saved seven lives for every 100 patients who received ICDs, and the agency had sought to avoid paying for ICDs in the 93% of patients who seemed to get no benefit, Dr. Mark said.
SCD-HeFT was not designed to identify criteria to easily distinguish responders from nonresponders, he noted. Even so, “seven lives saved for 100 patients treated is a huge therapeutic impact. Very few treatments in cardiology have this impact,” he said.