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PERSPECTIVEImplantable Cardioverter Defibrillators: An Excellent Case Study
Numerous randomized controlled trials have shown that implantable cardioverter defibrillators (ICDs) reduce mortality from sudden cardiac death. Evidence-based medicine can elucidate the benefits of treatment and inform Medicare policy when applied in a consistent and nonselective manner. The use of cost-effectiveness data to determine Medicare coverage—and therefore access to a therapy—involves many practical challenges. Cost-effectiveness analysis may be more useful as a tool to guide marketplace decision making than as a regulatory mechanism. Medicare coverage does not mandate use of a therapy; it allows the discussion to occur between a patient and his or her doctor.
The paper by Mark Hlatky and colleagues provides a stimulating overview and analysis of the challenges of applying evidence-based medicine (EBM) to real-life policy making.1 The authors also suggest a possible role for cost-effectiveness analysis in coverage decisions with respect to medical technology. The case study selected for review is the implantable cardioverter defibrillator (ICD). This device was originally reimbursed for use in the United States in 1986 for the treatment of ventricular tachyarrhythmia, the major cause of sudden cardiac death. Sudden cardiac death and ICDs. People with a history of heart disease and especially those with heart damage are at the greatest risk for sudden cardiac death. Only 5 percent of people without an ICD who experience sudden cardiac death outside the hospital will survive. U.S. estimates of sudden cardiac deaths range from 150,000 to more than 400,000 each year.2 In both primary and secondary prevention studies, ICDs have been shown to reduce mortality in patients with a history of heart disease and impaired left ventricular function. This level of effectiveness for ICDs versus optimal drug therapy and placebo was demonstrated in numerous well-designed, randomized controlled trials (RCTs) during the past two decades.3 ICDs are already recognized in specialty society guidelines as first-line therapy to prevent sudden cardiac arrest.4 Recent results from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), a large landmark trial sponsored by the National Institutes of Health (NIH), confirm that ICD therapy provides a major mortality benefit to selected patients with heart failure. EBM and coverage decisions. Patients’ access to therapies such as ICDs requires physician education and training, strong referral networks, and the establishment of adequate insurance coverage, particularly by Medicare. In theory, clinical data concerning what works and what does not can be used to guide the use of new therapies. In practice, many questions remain about how evidence-based principles are applied to coverage decisions. This ultimately influences whether the private sector invests in the development and clinical study of innovative technologies that are designed to improve health. A question that device manufacturers might reasonably ask is, Which technologies will be subject to evidence-based decision making? Beyond ICDs, no other device therapy has been examined under the microscope via critical analysis over such a long period of time and at such expense. Another question is, What evidence will be considered acceptable to decisionmakers? Although numerous organizations have developed positions on levels of evidence, a uniform standard does not exist, and the strength of clinical evidence required for coverage has not been established.5 In the case of ICDs, a plethora of RCTs have been conducted and published in leading peer-reviewed journals.6 Medical progress is highly valued in America, and to ensure that adequate investment is made in new medical technologies, criteria for coverage should be simple and transparent and be based on timely data. Coverage processes must also be flexible enough to allow policies—and patients’ access—to evolve with innovation. Medicare’s local coverage process has been critical in this regard. Economic considerations and coverage decisions. Considering the compelling number of large RCTs of ICDs that have been conducted, it is reasonable to ask why the therapy has received such unparalleled scrutiny. The cost of the therapy is the standard response. But this rationale requires further assessment. Concern about cost may relate to the unit cost of devices, overall budgetary impact on Medicare, or efficiency (cost-effectiveness). ICDs are considered an expensive technology, with unit costs of approximately $25,000. However, the budgetary impact of ICDs on Medicare is not disproportionate; it is, in fact, relatively low compared with the cost of other treatments. Approximately $1.2 billion was spent on ICDs and the associated implant costs in 2002 for people age sixty-five and older. In contrast, Medicare spending on coronary stents and bypass surgery was $6.2 billion and $7.7 billion, respectively.7 ICDs have been available for well over a decade, but it is estimated that less than 15 percent of people who would benefit from an ICD actually receive one.8 This suggests limitations on the diffusion of this technology. The market also can play an important role in placing constraints on spending, since the costs of new technology tend to decline over time, especially with rapid innovation and competition among suppliers. The evolution of ICDs is an excellent case study of the value that innovation provides patients, caregivers, hospitals, and the health care system. Initially, implantable defibrillators required an open-chest procedure for epicardial lead placement, an abdominal implant for the device, general anesthesia, and a hospital stay of almost twelve days. Perioperative mortality was about 4 percent, and costs for the initial hospitalization were estimated to be almost $100,000.9 Today, ICDs are the size of a small pager (which is about one-sixth the size of earlier versions) and are implanted through a small subcutaneous pocket in the pectoral region of the chest. Perioperative mortality is now well under 1 percent. Some procedures are even performed on an outpatient basis. In addition, today’s ICDs treat not only ventricular arrhythmias but also bradycardia, atrial fibrillation, and heart failure. Hlatky and his colleagues describe the cost-effectiveness analyses of ICDs and support the use of cost-effectiveness criteria in decisions about coverage, despite being forthcoming about some of the limitations of this approach. Others have acknowledged both the controversies and obstacles inherent in using cost-effectiveness criteria in coverage decisions.10 Objections include concerns that standards of cost-effectiveness will be used to ration care, the physician-patient relationship will be threatened, and the methodology is still too immature. Moreover, cultural and social factors may limit its acceptance in the United States.11 Cost-effectiveness analysis also requires solid clinical evidence and thus involves many of the same challenges mentioned above. The lack of a de facto standard for the threshold or maximum that one should be willing to pay to improve health also makes it difficult to rank interventions and therefore set priorities for coverage. For example, cost-effectiveness ratios greater than $100,000 per life year gained may be considered economically unattractive. However, many commonly accepted medical practices, such as the use of statin drugs for the primary prevention of heart disease, exceed this threshold but are nonetheless covered by payers. Given these difficulties, I believe that cost-effectiveness analysis is not yet ready to be used as a tool for medical coverage decisions regarding new technologies. Restricting access to innovative medical technologies through inconsistent or selective use of evidence-based or cost-effectiveness criteria has the potential to do more harm than good by denying access to appropriate treatments in a timely manner. For most medical devices, multiple treatment choices exist, which allows the marketplace to help guide the optimal use of resources. Cost-effectiveness analysis may be more useful as a tool to guide marketplace decision making than as a regulatory mechanism. Although, on the surface, using a regulatory mechanism to limit access to devices might appear to be cost-saving, the medical marketplace has proved its worth in the case of ICDs by bringing down costs and introducing innovation without government intervention. The advantage in relying on the market to convey value is that the central role of the physician-patient relationship in medical decision making is preserved. Coverage does not mandate use of a therapy; it allows the discussion to occur between the patient and his or her doctor.
Marshall Stanton (marshall.stanton{at}medtronic.com) is vice president and medical director, Medtronic Cardiac Rhythm Management, in Minneapolis, Minnesota. The author thanks Joseph Menzin for his critical review and analysis of this commentary.
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