One of those important U.S. policy-defining studies just appeared in the Journal of the American College of Cardiology today: "The Cost-Effectiveness of Implantable Cardioverter-Defibrillators: Results from the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II." Researchers from the University of Chicago and University of Rochester along with many of the MADIT-II investigators reported their results of a cost-effectiveness evaluation comparing the incremental cost effectiveness ratio calculated as the difference in discounted costs divided by the difference in discounted life expectancy within the fairly short follow-up period of 3.5 years (the length of the MADIT-II trial).
The bottom line: during the 3.5 year period of the study, the average survival gain for the defibrillator arm was 0.167 years (2 months), the additional costs of the defibrillator arm over the conventional drug-treated arm was $39,200, and the incremental cost-effectiveness ratio was $235,000 per year-of-life saved. Using estimates if the study had been continued for 12 years, the incremental cost-effectiveness ratio would have declined to $78,000 to $114,000 per year-of-life saved (a smaller number implies improved cost-effectiveness). For comparison, studies of dialysis have suggested a cost of $50-80,000 per year-of-life saved. Given the size of the eligible population, this study has profound consequences for US policy makers. These data were also in line with projections made by the Canadians. As the investigators concluded:
"The relatively high estimate if the iCER (incremental cost-effectiveness ratio) is largely the result of the high initial cost of implantation and the relatively small YOLS (years-of-life saved), the latter partially reflecting the underlying heterogeneity of the MADIT-II study population and the significant risks of non-arrhythmic death (40% of the classifiable deaths in conventionally treated patients (without defibrillators) were assigned to other causes."
Look for more pressure on Guidant (now Boston Scientific), Medtronic, and St. Jude to lower their ICD prices, and look for means to risk stratify patients who are high-risk versus low-risk of arrhythmias (like t-wave alternans testing by Cambridge Heart) to become the norm in an attempt to lower costs to the cardiovascular health care system.