Wednesday, July 12, 2006

SCD-HeFT Cost Analysis Finds ICDs "Economically Efficient" as Heart Failure Therapy
By Julie McKeel

Implantable cardioverter-defibrillator (ICD) primary prevention therapy for patients with chronic heart failure can be considered a cost-effective treatment over medication alone by today's standards, according to data analysis of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

Dr. Dan Mark

Based on the trial's primary analysis, those patients who have cardiac disease resulting in a slight limitation of physical activity [“class 2” patients as defined by the New York Heart Association (NYHA) functional classification system] gained the most clinical benefit relative to those in NYHA class 3 (patients with marked limitation of physical activity). The researchers used typical cost standards in which <$50 000 per life-year saved ( LYS ) is considered a "good value" and >$100 000/LYS is an "inadequate value."

[The NYHA classification system is a 4-point index of the functional status of patients with heart failure. NYHA classification is widely accepted and useful clinically because it correlates with quality of life and survival, and can provide a means of tracking disease progression and response to treatment.]

In a report released last year, the 2521-patient SCD-HeFT's primary finding was a 23% drop in the risk of death after five years among ICD patients compared with the study’s control patients. Mark reported the preliminary results of the cost analysis at the American Heart Association 2004 Scientific Sessions .

In this latest report, Mark and his colleagues determined that the lifetime cost-effectiveness ratio for ICDs in SCD-HeFT was as low as $38,389/LYS. But the ratio varied significantly when the "lifetime" exceeded the five-year follow-up period represented by the trial's actual data. The cost per LYS reached $127,503 at five years, $88,657 at eight years, and $58,510 at 12 years.

After adjusting for some underlying assumptions, including initial costs, projected late-complication rates, and battery longevity, the lifetime cost/LYS varied from about $32,000 to about $59,000. SCD-HeFT used single-chamber ICDs programmed to treat with shocks only—a less sophisticated and therefore cheaper device than typically used in clinical practice.

In an accompanying editorial, Dr. Lynne Stevenson (of Brigham and Women's Hospital, Boston, MA) writes that the SCD-HeFT cost analysis provides "exemplary insight" into the challenges of using a formidable yet costly therapy in the many patients eligible for it. However, she expresses concern about the potentially high cost of this particular intervention for the Medicare population.

Stevenson suggests that other heart-failure management programs delivered by specialized multidisciplinary teams might improve hospitalization rates and be more cost effective than the ICDs alone in actual clinical practice as compared with randomized trials. For example, while ICDs can prolong life, they do not impact the course of heart failure nor prevent costly hospitalizations.

Introducing these HF management programs into device clinics could be effective in decreasing the heart-failure disease progression that currently limits the duration of ICD benefit, Stevenson concludes.

The DCRI's Kevin Anstrom, PhD, Patricia Cowper, PhD, Nancy Clapp-Channing, RN, MPH, and Linda Davidson-Ray, MA (from the Outcomes Research Group), Kerry Lee, PhD and Charlotte Nelson, MS (from Statistics), and Sana Al-Khatib, MD, were coauthors for this report.

SCD-HeFT was sponsored by Medtronic, Wyeth-Ayerst Pharmaceuticals, and the National Heart, Lung, and Blood Institute.