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CLINICAL NEWS American College of Cardiology Extended Learning ACCEL interviews and topical summaries of cardiology’s most interesting research areas The Conundrum of Cost-effective but Unaffordable Care: The Plight of High-tech New Interventional Therapies W e’re not #1! At least when it comes to health expenditures, the U.S. per capita rate of $9,146 is third (third!!) to Norway’s lead at $9,715 and Switzerland’s per capita rate of $9,276. (The World Bank lists the data [in U.S. dollars] from the World Health Organization Global Health Expenditure database: data.worldbank.org/indicator/SH.XPD.PCAP ) Granted, these are much smaller countries. If you’re feeling competitive or miss no longer being first in per capita health care expenditures, then you will be happy to know that among major countries we remain #1 in total health expenditure as a percent of gross domestic product (GDP) (TABLE). However, we miss being #1 among all nations, beat out by tiny Tuvalu (formerly known as the Ellice Islands), a Polynesian island nation located midway between Hawaii and Australia. There you will find health care expenditures that are 19.7% of their GDP. You probably have seen older graphics showing the U.S. as a resounding #1 in both categories, which certainly was the case. Our descent to #3 is a recent phenomenon; as of 2010, the U.S. was spending more per capita than either Norway or Switzerland—or anyone else, for that matter. And that had been the case since about 1980. Also, you likely have seen the trends in deaths considered amenable to health care in people younger than 75 years. In an analysis of the U.S. and 18 other industrialized countries, investigators reported such deaths account, on average, for 23% of total mortality in this age group among males and 32% among females. The decline in amenable mortality in all countries averaged 16% between 1997-98 and 2002-03. The U.S. was an outlier, with a decline of only 4%. Had the U.S. To listen to an reduced amenable mortality to interview with the average rate achieved in the David J. Cohen, three top-performing countries MD, on the costs of new interventional (France, Japan, and Australia), therapies, scan the then the U.S. would have realcode. The interview ized 101,000 fewer deaths per was conducted by Deepak L. Bhatt, MD. year by the end of the study period. CONUNDRUM This brings us to what has been called the current crisis in technology: cost-effective 26 CardioSource WorldNews (based on historical measures) yet unaffordable care. Here are some numbers: if ICDs were used in patients shown to benefit in MADIT-II, the price-tag would be $15 billion per year. For left atrial appendage occlusion (LAAO), based on PROTECT-AF, the applicable annual cost for expanding use would TABLE true “value” of medical technology. Dr. Cohen also noted that even the current economic environment will continue to support innovation over iteration: technologies that provide substantial benefit and fill truly unmet clinical needs are most likely to be covered and reimbursed. International Comparison of Spending on Health (2013) Per capita total healthcare expenditure Health expenditure as a % of GDP United States Australia Canada France Germany Japan United Kingdom $9,146 $6,110 $5,718 $4,864 $5,006 $3,966 $3,598 17.1 9.4 10.9 11.7 11.3 10.3 9.1 Data: The World Bank and the World Health Organization All figures are $U.S. dollars. GDP = gross domestic product be $13 billion. Throw in more patients receiving drug-eluting stents (DES; an extra $2.4 billion based on SIRIUS) and a wider use of transcatheter aortic valve replacement (PARTNER data and an additional cost of $3 billion), then these four interventional therapies would add $33.4 billion to annual healthcare costs. These numbers apply to expanding established interventional technologies, but this problem is not confined to high-tech devices. Consider the new lipid-lowering agents, known as PCSK9 inhibitors: with approximately 2.6 million U.S. individuals who could potentially receive a PCSK9 inhibitor over the next 5 years, the total budgetary impact over that time period would be $19 billion (for those with familial hypercholesterolemia), $15 billion (for those who have CVD but are statinintolerant), and $74 billion (if used for individuals with CVD but not at their low-density lipoprotein cholesterol target). According to David J. Cohen, MD, director of cardiovascular research at Saint Luke’s Mid America Heart Institute, Kansas City, KS, there is already informal rationing in cardiovascular care, including limiting use of LV assist devices, carotid stenting, and transcatheter heart valves. Coming soon, he said, you might see limits placed on the use of PCI in stable coronary artery disease, renal stenting, LAAO, and perhaps others. From a public health standpoint, there are data to support further expansion of spending on health care over many other areas, but there is a need for continued education of the public regarding the He added that study designs should emphasize clinical benefit and focus on identification of optimal populations. Also, there should be a demonstration of economic value through “real world” studies that focus on outcomes that are relevant to patients and payers (survival, QOL, and lower costs of care). Dr. Cohen added that treatments are not ‘cost effective’ unless they are truly effective. And for truly transformative technologies, the true value may not be immediately apparent. REFERENCES: 1. Nolte E, McKee CM. Health Aff (Millwood). 2008;27:58-71. Take-aways • Costs for health care continue to increase but, on a per capita basis, the United States is no longer the most expensive place in the world for healthcare expenditures. • In interventional cardiology there are a number of cost-effective but unaffordable technologies that has led to an informal rationing of care that will likely expand. • There is a great need to understand the true “value” of medical technology—which may require changes in how clinical trials are designed and evaluated—so that technologies can be demonstrated to provide substantial benefit and fill truly unmet clinical needs based on outcomes relevant to patients and payers. May 2016