Initial Public Comments on Implantable Cardiac Defibrillators
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Comment One
May 25-June 25, 2004
Comment #1:
Name: Barbara J. Calvert
Organization: Guidant Corporation
Date: June 25, 2004
Guidant Corporation welcomes the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) reconsideration of the national coverage determination for implantable defibrillators. This letter is in direct reply to the CMS request for comment regarding the results of the COMPANION trial and how these results should impact Medicare's review of the coverage decision for implantable defibrillators.
Headquartered in Indianapolis, Indiana, with manufacturing and/or research and development facilities in the states of Minnesota, California and Washington, as well as in Puerto Rico and Ireland, Guidant Corporation is a leading designer and manufacturer of medical technologies used primarily to treat cardiovascular and vascular illnesses.
The COMPANION trial, sponsored solely by Guidant, was a prospective, multi-center, randomized study of patients with advanced heart failure.(1) The patients studied in this trial had diminished function of the left ventricle (an ejection fraction at or below 35 percent), a wide QRS complex (>120 milliseconds) and advanced heart failure. The trial included 1,520 patients at 128 centers in the United States. All patients received optimal heart failure drug therapy. The COMPANION trial used cardiac resynchronization therapy pacemakers in one patient group and cardiac resynchronization therapy defibrillators in another patient group. The third patient group received optimal drug therapy only.
While previous clinical studies demonstrated cardiac resynchronization therapy devices improve exercise performance and quality of life only, the COMPANION trial yielded the following results, each as compared to optimal drug therapy alone:
• A 20 percent risk reduction in combined all-cause mortality or first all-cause hospitalization for heart failure patients assigned to receive cardiac resynchronization therapy defibrillators
• A 36 percent risk reduction in all-cause mortality for heart failure patients assigned to receive Guidant as cardiac resynchronization therapy defibrillators
• Cardiac resynchronization therapy with defibrillation reduced symptoms and improved quality of life
COMPANION was the largest prospective, randomized, controlled trial conducted to evaluate the benefits of resynchronization therapy and resynchronization therapy defibrillators, and was the only trial powered to test the impact of these therapies on mortality. The most statistically rigorous intention-to-treat design was used to assure that the results would be unambiguous. The mortality benefit seen with resynchronization therapy defibrillators in this population of advanced heart failure patients is striking (an absolute mortality benefit exceeding 10% just 18 months into therapy), and the improvements in quality of life and exercise tolerance are completely consistent with the positive results seen in other trials. These results have been broadly peer-reviewed and are now published in the New England Journal of Medicine.
Coverage of NYHA Class IV Patients
Our understanding is that a decision by CMS to modify the national coverage decision for ICDs to cover the SCD-HeFT population would result in coverage for cardiac resynchronization therapy defibrillators for NYHA Class III COMPANION patients, subject to possible further discretion by local Medicare contractors. COMPANION patients with NYHA Class IV, however, are not included in the SCD-HeFT population and therefore may not be addressed during the review process. In order to assure access to life-saving and enhancing therapy for Class IV patients, Guidant recommends that if national coverage is not to be extended to these patients at this time that CMS allow for local coverage of cardiac resynchronization therapy defibrillators in NYHA Class IV heart failure patients who fit the COMPANION criteria. To accomplish this, we recommend that CMS consider including the following language in its revised national coverage determination for AICDs:
•All other indications remain non-covered except in Category B IDE clinical trials (42 CFR Part 405) or as a routine cost in clinical trials defined under CIM 30-1, or for certain patients with NYHA class IV, LVEF < 35%, LVEDD > 60 mm, QRS > 120 ms, PR interval of > 150 ms who are on optimal medical therapy. Final coverage decisions for these patients are subject to the discretion of local carriers and fiscal intermediaries.
Appropriate Defibrillator for Specific Populations
CMS has requested comments regarding the appropriate defibrillator for specific patient populations. The COMPANION and SCD-HeFT populations share some of the same patients, and as such, could possibly be indicated for an ICD or a cardiac resynchronization therapy defibrillator. Guidant believes that the revised coverage decision should continue to provide physicians the discretion to select the type of ICD that is appropriate for each patient based on individual medical need.
Lastly we recommend that CMS focus on prospective endpoints in analyzing the trial evidence and use caution in drawing any conclusions from retrospective subgroup analysis. Hypotheses derived from such analysis become valid reasons to conduct future trials, but should not, we believe, be used for the purposes of determining coverage.
We appreciate CMSA effort to pursue a timely and comprehensive reconsideration of the medical necessity of ICD therapy based on new and important clinical science. We look forward to the opportunity to continue to work closely with you throughout this reconsideration process.
(1) Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac- resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350 (21):2140-50. http://content.nejm.org/cgi/reprint/350/21/2140.pdf
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see also:
Nonischemic Dilated Cardiomyopathy Comment
Initial Public Comments on Implantable Guidant Pacemaker RecallGuidant Pacemaker: Public comments on the dangerous recall
Breaking News
Guidant Defibrillator Recall: Breaking NewsBreaking News About Guidant Defibrillator Recall Lawsuits
News & Warnings
Guidant Defibrillator - Public Commentary on Defibrillators and the Guidant RecallGuidant defibrillator recall public comment. FREE lawsuit information
