Friday, November 12, 2004

ICD THERAPY COST-EFFECTIVE FOR MODERATE HEART FAILURE PATIENTS, ANALYSIS SHOWS

Medtronic Inc. said a cost analysis of a trial released earlier this year showed implantable cardioverter-defibrillator (ICD) therapy is a cost-effective means of treating patients with heart failure.

The trial included 2,521 patients who had moderate heart failure (New York Heart Association Class II or Class III) with impaired pumping function of the left ventricle. The patients were randomly assigned to receive an ICD (n=829), placebo (n=847) or the arrhythmia drug amiodarone (n=845). All patients also received optimal conventional heart failure treatment, including ACE inhibitors and beta-blockers.

During an approximate four-year follow-up period, 666 deaths occurred, including 182 in the ICD group (22 percent of patients), 240 in the amiodarone group (28 percent) and 244 in the placebo group (29 percent). Medtronic said this shows ICD therapy reduced the incidence of death by 23 percent as compared with placebo, while amiodarone did not improve survival.

The analysis presented this week showed the cost associated with ICD therapy in order to add one year of life was $33,192. Medtronic said therapies that add a patient-year of life for $50,000 or less are generally considered to be cost-effective.

The cost-effectiveness analysis was presented in New Orleans at the American Heart Association's Scientific Sessions 2004.

Guidant Corp. and St. Jude Medical Inc. also manufacture defibrillators, which analysts have projected could grow to a $4.4 billion market this year, according to Bloomberg News.

Thursday, September 30, 2004

CMS EXPANDS PATIENT POPULATION ELIGIBLE FOR DEFIBRILLATOR COVERAGE

The Centers for Medicare & Medicaid Services proposed expanding insurance coverage for implantable cardioverter defibrillators (ICD), which could raise the number of eligible recipients by one-third to approximately 500,000 people.

The proposal recommends coverage for patients with ischemic dilated cardiomyopathy, prior myocardial infarction and left ventricular ejection fraction (LVEF) of 30 percent or less or in patients with nonischemic dilated cardiomyopathy for more than nine months and LVEF of 30 percent or less. The agency expects to provide 25,000 patients with the device during the first year of coverage, which could save up to 2,500 lives.

CMS said this decision was based on results from the recent SCD-HeFT trial, which demonstrated that ICDs reduced overall mortality by 23 percent in patients with moderate heart failure when compared with placebo or Wyeth's Cordarone (amiodarone hydrochloride). After these findings were released, Medtronic Inc. requested in March 2004 that the agency reconsider its prior decision about ICDs.

"This coverage decision demonstrates our determination to act promptly when convincing medical evidence shows that a biotechnology brand can save and improve lives," said CMS administrator Dr. Mark McClellan.

However, The Wall Street Journal reported that for two years, cardiologists have criticized the government for rationing medical care. The Journal added that CMS "had resisted the expanded coverage, possibly because of the potential billion-dollar price tag the step will carry." The ICDs cost $20,000 or more per device.

Mike Weinstein, a JP Morgan analyst, said the decision could boost the ICD market by between 20 and 25 percent in 2005 and 2006, according to Reuters. Currently, the ICD market is approximately $4.8 billion, Reuters reported.

The agency said it has provided limited coverage for implantable defibrillators since 1986, but expanded coverage in 1991, 1999 and 2003.