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SCD-HeFT Cost-Effectiveness Study - SCD-HeFT Cost-Effectiveness Study
Description:
SCD-HeFT was a randomized multicenter three-arm primary prevention trial of single-chamber implantable cardioverter defibrillator (ICD) therapy, amiodarone, or placebo for the treatment of patients with stable heart failure (both ischemic and nonischemic in origin). This prespecified substudy analysis examined the cost-effectiveness of these therapies.
Hypothesis:
ICD therapy would be cost-effective in the treatment of patients with New York Heart Association (NYHA) class II-III congestive heart failure (CHF).
Study Design
Patients Enrolled: 2,521
NYHA Class: Class II and III
Mean Follow Up: Five years
Mean Patient Age: Mean 60 years
Female: 23
Mean Ejection Fraction: Mean of 25%
Patient Populations:
Patients 18 years of age or older; symptomatic heart failure (NYHA class II or III) due to ischemic or nonischemic dilated cardiomyopathy for at least three months, treated with a vasodilator; and left ventricular ejection fraction ≤35% within three months of enrollment
Exclusions:
Ventricular arrhythmias or history of cardiac arrest, other comorbid conditions, or contraindication to either amiodarone or ICD
Primary Endpoints:
Cost-effectiveness of ICD therapy over placebo
Drug/Procedures Used:
As previously described, randomization to a single-chamber ICD, amiodarone 200-400 mg/day, or placebo
Concomitant Medications:
Standard therapy for CHF
Principal Findings:
A total of 2,521 patients were enrolled in the study; 52% of patients had ischemic cardiomyopathy. In the overall study population, there was no effect of amiodarone on survival (the primary endpoint), while there was a highly significant 23% reduction in mortality among patients randomized to ICD therapy.
The cost-effectiveness substudy assessed 2003 US dollar costs to the health care system in an intent-to-treat analysis. Costs assessed were resource use, hospitalization costs (from billing data), physician costs (based on Medicare rates), outpatient medication costs, and ICD costs (mean of $17,500). Five-year total costs were $49,444 for amiodarone, $43,077 for placebo, and $61,967 for ICD therapy (p=0.078 for amiodarone vs. placebo; p<0.001 for ICD vs. placebo).
The benefits of the various therapies over placebo were modeled from a societal perspective (not including nonmedical and productivity costs) over the lifetime of the study, given the assumptions that the benefit of a given therapy would be constant over time. Using this model, the life expectancy in the placebo arm was 8.4 years, while it was 10.8 years in the ICD arm. Thus, the cost-effectiveness of ICD therapy was $27,718 per life-year (undiscounted) or $33,192 (discounted 3%).
The cost-effectiveness of amiodarone therapy was not calculated, given that amiodarone was more costly than placebo without a survival benefit. The cost-effectiveness of ICD therapy appeared robust in sensitivity analyses, and was similar among patients with ischemic versus nonischemic cardiomyopathy. The cost per life-year was slightly greater among patients with NYHA class III heart failure than among patients with NYHA class II heart failure.
Interpretation:
The SCD-HeFT trial demonstrated a survival benefit of a single-chamber ICD over placebo and amiodarone for patients with CHF. In this prespecified cost-effectiveness analysis, ICD therapy was demonstrated to be a cost-effective intervention (interventions costing <$40,000-50,000 are generally considered to be cost-effective from a societal perspective). Although ICD therapy was more costly than treatment with placebo, the survival benefit associated with ICD therapy appeared to offset the increased cost from a societal perspective.
References:
Mark DB, Nelson CL, Anstrom KJ, et al. Cost-effectiveness of defibrillator therapy or amiodarone in chronic stable heart failure: results from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Circulation. 2006 Jul 11;114(2):135-42.
Presented by Daniel B. Mark at the American Heart Association Scientific Sessions, November 2004, New Orleans, LA.
Keywords: Cost-Benefit Analysis, Cardiomyopathies, Life Expectancy, Heart Failure, Stroke Volume, Medicare, Defibrillators, Implantable, Cardiomyopathy, Dilated, Vasodilator Agents
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