Guidant Applauds Decision That Will Expand Defibrillator Coverage to Thousands More Medicare Beneficiaries.
Guidant Corporation (NYSE:GDT) today applauds the proposed national coverage determination by the Centers for Medicare and Medicaid Services (CMS) to expand implantable defibrillator coverage to thousands of patients at risk for sudden cardiac death. CMS has determined that recent clinical evidence is adequate to conclude that implantable defibrillator therapy is reasonable and necessary for the following patients:
--Patients with ischemic dilated cardiomyopathy (IDCM), documented prior myocardial infarction (MI) and measured left ventricular ejection fraction (LVEF) less than or equal to 30%.
--Patients with nonischemic dilated cardiomyopathy (NIDCM) greater than 9 months and measured LVEF less than or equal to 30%.
According to CMS, this expansion of coverage will increase the number of Medicare beneficiaries eligible for an implantable defibrillator by one-third, to nearly 500,000. As part of the decision, CMS will work closely with Guidant and other product manufacturers and clinical experts, including the National Institutes of Health, to develop a practical registry that can track the progress of patients who receive the devices and help develop additional evidence to better identify who is most likely to benefit from them.
"We commend the Centers for Medicare and Medicaid Services for moving to recognize results from the latest well-controlled randomized clinical trials," said Joseph Smith, M.D., Ph.D., FACC, chief medical officer, Cardiac Rhythm Management, Guidant Corporation. "The evidence from SCD-HeFT, in concert with that from MADIT II, COMPANION and DEFINITE, provides pivotal clinical science for extending device therapy to broad segments of the population suffering from heart disease."
"This proposed decision by CMS effectively extends the potential of defibrillator therapy to tens of thousands of new patients each year in the United States," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "As a consistent sponsor of foundational clinical science for defibrillator therapy, we are excited that the benefits are now being extended to more patients who struggle with heart failure or are at risk of sudden cardiac death."
The proposed coverage decision is open to a 30-day public comment period, and is scheduled to take effect at the end of this year. During the comment period, Guidant and others will engage on several elements of the proposed decision, including the proposed practical registry, the full consideration of the COMPANION trial results and the potential to further enhance the broad availability of appropriate defibrillator therapy.
"The use of post-market registries is particularly appealing when considered with the concept of broad national coverage immediately upon FDA approval, based on the safety and efficacy of the therapy," said Ronald W. Dollens, president and chief executive officer, Guidant Corporation. "This national coverage determination holds an even larger potential to pioneer new mechanisms for fast, sure market availability and patient access of novel medical technology."
The company does not expect to revise its previously provided guidance as a result of this announcement.
Heart failure is a debilitating condition that affects not only a patient's quality of life, but also life expectancy. It is a condition in which the heart weakens and gradually loses the ability to pump blood effectively. Nearly five million Americans and more than six million Europeans currently suffer from heart failure. Nearly one million new cases of heart failure are diagnosed annually worldwide, making it the most rapidly growing cardiovascular disorder.
Sudden cardiac death is the abrupt loss of heart function, usually due to a potentially fatal electrical rhythm malfunction in the heart called ventricular fibrillation. Each year, sudden cardiac death claims the lives of as many as 460,000 people in the United States alone. More people die from sudden cardiac death each year than from lung cancer, breast cancer and AIDS combined. Immediate defibrillation therapy is the only proven treatment for sudden cardiac death.
Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 12,000 employees, develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life's most threatening medical conditions. For more information visit www.guidant.com.
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The CMS decision was based on the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), which was sponsored by the National Institutes of Health and also funded by Medtronic and Wyeth Pharmaceuticals. The results of SCD-HeFT confirm and extend the results of previous trials that demonstrated the benefits of implantable defibrillator therapy.
SCD-HeFT demonstrated that ICD therapy reduced overall mortality by 23 percent in patients with moderate heart failure. The SCD-HeFT trial was designed to determine whether implantable defibrillator therapy with conventional heart failure drug therapy improves overall survival when compared to conventional drug therapy and a placebo in patients with clinical symptoms of heart failure and an ejection fraction of less than or equal to 35 percent.
The Multicenter Automatic Defibrillator Implantation Trial (MADIT) II, sponsored by Guidant, demonstrated that ICD therapy reduced overall mortality by 31 percent in patients who had experienced a previous heart attack and had an ejection fraction of less than or equal to 30 percent. MADIT II was designed to determine whether implantable defibrillator therapy with conventional medical therapy improves overall survival when compared to conventional therapy alone. In 2003, CMS provided reimbursement for only a subset of Medicare and Medicaid beneficiaries who met the MADIT II criteria. This proposed reimbursement for the SCD-HeFT population encompasses a large portion of the MADIT II population
The landmark Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial, sponsored by Guidant, demonstrated for the first time that cardiac resynchronization therapy reduces the risk of death or time to first hospitalization in patients with advanced heart failure. Additionally, COMPANION demonstrated that resynchronization therapy defibrillators reduced overall mortality by 36 percent in patients with moderate to severe heart failure. COMPANION included patients with moderate to severe heart failure (NYHA class III and IV) despite optimal medical therapy, who also had a wide QRS and an ejection fraction less than or equal to 35 percent.
The DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial, sponsored by St. Jude Medical, was the first major trial to exclusively focus on the potential mortality benefits of implantable defibrillators as primary prevention therapy in non-ischemic patients. DEFINITE included patients with mild to moderate heart failure with an ejection fraction of less than or equal to 35 percent and either an intermittent too-rapid heart beat or frequent abnormal or premature ventricular contractions. Although the trial design called for a 50 percent all-cause mortality reduction, the final results revealed a non-significant reduction of 35 percent. A pre-specified secondary analysis did reveal a significant 80 percent reduction in the risk of sudden cardiac death.
This release includes forward-looking statements concerning reimbursement, covered patients, and guidance. The statements are based on assumptions about many important factors, including the proposal becoming final in the form and on the timeline described, penetration of the therapy in the covered population, and other factors identified on Exhibit 99 to the company's most recent 10-Q. Actual results may differ materially. The company does not undertake to update its forward-looking statements.