The Economics of ICDs
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《新英格兰医药杂志》
On September 28, 2004, the Centers for Medicare and Medicaid Services (CMS) proposed new reimbursement guidelines for implantable cardioverter–defibrillators (ICDs) used for the prevention of sudden death from cardiac causes. The new guidelines dramatically increase the number of patients for whom prophylactic implantation of an ICD would be covered by Medicare. Among other things, the CMS dispensed with the controversial "QRS restriction" on patients like those who participated in the second Multicenter Automatic Defibrillator Implantation Trial — so-called MADIT-II patients. In this trial, which was reported in the Journal in 2002, ICD therapy conferred a striking survival benefit as compared with drug therapy in patients with healed myocardial infarction and an ejection fraction of less than 30 percent.1 But when the CMS announced its coverage guidelines in June 2003, it decided, despite the unanimous recommendation of its own advisory committee, to restrict reimbursement for ICDs to patients who not only met the criteria for inclusion in MADIT II but also had evidence of an intraventricular conduction abnormality (namely, a QRS duration of more than 120 msec).
That decision, based on a post hoc subgroup analysis of MADIT II, disturbed many cardiologists, who believed that the restriction was simply a way to limit the use of an expensive medical device. Others regarded the decision as an intrusion by policymakers into the realm of clinical decision making. For their part, the major cardiology societies, including the American Heart Association, the American College of Cardiology, and the North American Society for Pacing and Electrophysiology (now called the Heart Rhythm Society), published clinical guidelines embracing the results of MADIT II without any caveats.
In addition to lifting the QRS restriction, the CMS proposed extending Medicare coverage of ICDs for the first time to patients with nonischemic cardiomyopathy. During the past year, several trials have demonstrated impressive survival benefits for the prophylactic implantation of ICDs in this population. The Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial showed that patients who received ICD therapy had an 80 percent reduction in the relative risk of death due to arrhythmia as compared with those who received medical therapy.2 The landmark Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), whose results were announced earlier this year but have not yet been published, showed that in a group of 2521 patients with moderate heart failure, half of whom had nonischemic cardiomyopathy, the use of ICDs reduced the rate of death by 23 percent over a period of five years as compared with standard medical therapy with or without amiodarone.3 These and other results led to a prediction in the Journal last May that recent trials "will increase the pressure on large payers (especially Medicare) to expand coverage for these devices."4
However, the new ICD guidelines still include restrictions. To be eligible for Medicare coverage, patients would have to have an ejection fraction of less than 30 percent (the cutoff in SCD-HeFT was 35 percent); would have to receive a relatively inexpensive, single-lead device, unless a case could be made for a more advanced model; and would have to be enrolled in a clinical trial or national registry. Although some cardiologists welcomed these proposals, others argued that they were unnecessarily restrictive and, in particular, that required enrollment in a registry would be cumbersome and would make it more difficult to provide ICD therapy to all eligible patients.
The central issue in this debate, of course, is money. How will the government pay for all these devices? In 2003, approximately 150,000 defibrillators were implanted in patients in the United States (Figure 1). With no QRS restriction placed on MADIT-II patients, that number could easily double. If patients who met the inclusion criteria for SCD-HeFT were included, the number could double once again. (It is estimated that several hundred thousand additional patients would be eligible for ICDs if only the SCD-HeFT criteria were applied.) If the "penetration" of ICDs into the eligible population, currently estimated at about 25 percent, were to increase, as it probably will after the dissemination of the available trial data, the number of implantations could rise still further. The findings reported by Hohnloser et al. in this issue of the Journal5 will further complicate the matter. These investigators found that among patients with recent myocardial infarction and an ejection fraction of 35 percent or less, ICD implantation resulted in a substantial reduction in death due to cardiac arrhythmia, which was offset by an equivalent increase in the rate of death from nonarrhythmic causes. Thus, ICD therapy had no effect on overall mortality among these high-risk patients.
Figure 1. Increase in the Use of Implantable Cardioverter–Defibrillators (ICDs) in the United States.
Data are from Medtronic; data for 2004 through 2006 are estimates.
One key question is how cost-effective ICD therapy is. In the United States, renal dialysis has set a sort of standard for cost-effective medical therapy at roughly $50,000 per life-year saved. What is the cost per life-year saved for prophylactic implantation of an ICD? The answer depends on the population being studied. Economic analyses of the first MADIT, which was conducted in patients with ischemic cardiomyopathy and an ejection fraction of less than 35 percent who had spontaneous as well as inducible tachyarrhythmias, showed that ICD therapy cost about $27,000 per life-year saved.6 A similar analysis of the MADIT II results has not yet been published, but it is unlikely that ICD therapy would be as cost-effective in this lower-risk population. A cost-effectiveness analysis of SCD-HeFT, presented at the annual meeting of the American Heart Association last month, showed a cost of about $33,000 per life-year saved7 — not cheap, to be sure, but still justifiable from the standpoint of cost-effectiveness.
A further complication is that economic analyses must be performed over the life span of a defibrillator in order to assess cost-effectiveness properly. Short-term analyses are biased against medical devices, which carry enormous up-front costs. In MADIT II, the study period was only 20 months, and the survival benefit did not become manifest for nearly a year. In DEFINITE, the study period was only 29 months. A national registry could prove very useful in this regard, since it would allow for longer patient follow-up and better real-world estimates of costs and benefits. The CMS is awaiting recommendations from the Heart Rhythm Society on the development of such a registry.
How big a role should economics play in deciding who gets a defibrillator? As doctors, we have been taught not to address issues of social significance at the bedside. Still, as recent history amply demonstrates, economics is at the forefront of the minds of policymakers. Even though reimbursement guidelines for prophylactic use of ICDs are expanding, physicians must remain vigilant about justifying device therapy — with further cost-effectiveness studies, longer trials, and better ways of identifying the patients who will benefit the most — or risk having this therapy taken away from our patients.
Source Information
From the Division of Cardiology, Long Island Jewish Medical Center, New Hyde Park, N.Y.
References
Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346:877-883.
Kadish A, Dyer A, Daubert JP, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med 2004;350:2151-2158.
Bardy G. SCD-HeFT: the Sudden Cardiac Death in Heart Failure Trial. Presented at the Late Breaking Clinical Trials Session of the 53rd Annual Scientific Sessions of the American College of Cardiology, New Orleans, March 7–10, 2004. abstract.
Hlatky MA. Evidence-based use of cardiac procedures and devices. N Engl J Med 2004;350:2126-2128.
Hohnloser SH, Kuck KH, Dorian P, et al. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med 2004;351:2481-2488.
Mushlin AI, Hall WJ, Zwanziger J, et al. The cost-effectiveness of automatic implantable cardiac defibrillators: results from MADIT. Circulation 1998;97:2129-2135.
Mark DB. Cost-effectiveness of ICD therapy in the Sudden Cardia Death in Heart Failure Trial (SCD-HeFT). Presented at the Late Breaking Clinical Trials Session of the Annual Meeting of the American Heart Association, New Orleans, November 10, 2004. abstract(Sandeep Jauhar, M.D., Ph.)
That decision, based on a post hoc subgroup analysis of MADIT II, disturbed many cardiologists, who believed that the restriction was simply a way to limit the use of an expensive medical device. Others regarded the decision as an intrusion by policymakers into the realm of clinical decision making. For their part, the major cardiology societies, including the American Heart Association, the American College of Cardiology, and the North American Society for Pacing and Electrophysiology (now called the Heart Rhythm Society), published clinical guidelines embracing the results of MADIT II without any caveats.
In addition to lifting the QRS restriction, the CMS proposed extending Medicare coverage of ICDs for the first time to patients with nonischemic cardiomyopathy. During the past year, several trials have demonstrated impressive survival benefits for the prophylactic implantation of ICDs in this population. The Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial showed that patients who received ICD therapy had an 80 percent reduction in the relative risk of death due to arrhythmia as compared with those who received medical therapy.2 The landmark Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), whose results were announced earlier this year but have not yet been published, showed that in a group of 2521 patients with moderate heart failure, half of whom had nonischemic cardiomyopathy, the use of ICDs reduced the rate of death by 23 percent over a period of five years as compared with standard medical therapy with or without amiodarone.3 These and other results led to a prediction in the Journal last May that recent trials "will increase the pressure on large payers (especially Medicare) to expand coverage for these devices."4
However, the new ICD guidelines still include restrictions. To be eligible for Medicare coverage, patients would have to have an ejection fraction of less than 30 percent (the cutoff in SCD-HeFT was 35 percent); would have to receive a relatively inexpensive, single-lead device, unless a case could be made for a more advanced model; and would have to be enrolled in a clinical trial or national registry. Although some cardiologists welcomed these proposals, others argued that they were unnecessarily restrictive and, in particular, that required enrollment in a registry would be cumbersome and would make it more difficult to provide ICD therapy to all eligible patients.
The central issue in this debate, of course, is money. How will the government pay for all these devices? In 2003, approximately 150,000 defibrillators were implanted in patients in the United States (Figure 1). With no QRS restriction placed on MADIT-II patients, that number could easily double. If patients who met the inclusion criteria for SCD-HeFT were included, the number could double once again. (It is estimated that several hundred thousand additional patients would be eligible for ICDs if only the SCD-HeFT criteria were applied.) If the "penetration" of ICDs into the eligible population, currently estimated at about 25 percent, were to increase, as it probably will after the dissemination of the available trial data, the number of implantations could rise still further. The findings reported by Hohnloser et al. in this issue of the Journal5 will further complicate the matter. These investigators found that among patients with recent myocardial infarction and an ejection fraction of 35 percent or less, ICD implantation resulted in a substantial reduction in death due to cardiac arrhythmia, which was offset by an equivalent increase in the rate of death from nonarrhythmic causes. Thus, ICD therapy had no effect on overall mortality among these high-risk patients.
Figure 1. Increase in the Use of Implantable Cardioverter–Defibrillators (ICDs) in the United States.
Data are from Medtronic; data for 2004 through 2006 are estimates.
One key question is how cost-effective ICD therapy is. In the United States, renal dialysis has set a sort of standard for cost-effective medical therapy at roughly $50,000 per life-year saved. What is the cost per life-year saved for prophylactic implantation of an ICD? The answer depends on the population being studied. Economic analyses of the first MADIT, which was conducted in patients with ischemic cardiomyopathy and an ejection fraction of less than 35 percent who had spontaneous as well as inducible tachyarrhythmias, showed that ICD therapy cost about $27,000 per life-year saved.6 A similar analysis of the MADIT II results has not yet been published, but it is unlikely that ICD therapy would be as cost-effective in this lower-risk population. A cost-effectiveness analysis of SCD-HeFT, presented at the annual meeting of the American Heart Association last month, showed a cost of about $33,000 per life-year saved7 — not cheap, to be sure, but still justifiable from the standpoint of cost-effectiveness.
A further complication is that economic analyses must be performed over the life span of a defibrillator in order to assess cost-effectiveness properly. Short-term analyses are biased against medical devices, which carry enormous up-front costs. In MADIT II, the study period was only 20 months, and the survival benefit did not become manifest for nearly a year. In DEFINITE, the study period was only 29 months. A national registry could prove very useful in this regard, since it would allow for longer patient follow-up and better real-world estimates of costs and benefits. The CMS is awaiting recommendations from the Heart Rhythm Society on the development of such a registry.
How big a role should economics play in deciding who gets a defibrillator? As doctors, we have been taught not to address issues of social significance at the bedside. Still, as recent history amply demonstrates, economics is at the forefront of the minds of policymakers. Even though reimbursement guidelines for prophylactic use of ICDs are expanding, physicians must remain vigilant about justifying device therapy — with further cost-effectiveness studies, longer trials, and better ways of identifying the patients who will benefit the most — or risk having this therapy taken away from our patients.
Source Information
From the Division of Cardiology, Long Island Jewish Medical Center, New Hyde Park, N.Y.
References
Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346:877-883.
Kadish A, Dyer A, Daubert JP, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med 2004;350:2151-2158.
Bardy G. SCD-HeFT: the Sudden Cardiac Death in Heart Failure Trial. Presented at the Late Breaking Clinical Trials Session of the 53rd Annual Scientific Sessions of the American College of Cardiology, New Orleans, March 7–10, 2004. abstract.
Hlatky MA. Evidence-based use of cardiac procedures and devices. N Engl J Med 2004;350:2126-2128.
Hohnloser SH, Kuck KH, Dorian P, et al. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med 2004;351:2481-2488.
Mushlin AI, Hall WJ, Zwanziger J, et al. The cost-effectiveness of automatic implantable cardiac defibrillators: results from MADIT. Circulation 1998;97:2129-2135.
Mark DB. Cost-effectiveness of ICD therapy in the Sudden Cardia Death in Heart Failure Trial (SCD-HeFT). Presented at the Late Breaking Clinical Trials Session of the Annual Meeting of the American Heart Association, New Orleans, November 10, 2004. abstract(Sandeep Jauhar, M.D., Ph.)