doi: 10.1161/CIRCULATIONAHA.105.546010
(Circulation. 2006;114:1736-1744.)
© 2006 American Heart Association, Inc.
Controversies in Cardiovascular Medicine |
Will drug-eluting stents bankrupt the healthcare system?
Are Drug-Eluting Stents Cost-Effective?
It Depends on Whom You Ask
From the Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Mass (J.R.), and Saint Luke’s Mid America Heart Institute, Kansas City, Mo (D.J.C.).
Correspondence to David J. Cohen, MD, MSc, Cardiovascular Research, Saint Luke’s Mid America Heart Institute, 4401 Wornall Rd, Kansas City, MO 64111. E-mail dcohen{at}saint-lukes.org
 |
Introduction |
|---|
 Top Introduction What Is the Clinical...Economic Impact of RestenosisEconomic Impact of DESDistinction Between "Cost...Cost-Effectiveness Analyses of...Hospital PerspectiveHow Has the Introduction...Future ConsiderationsReferences |
|---|
Since their commercial introduction in 2003, drug-eluting stents (DES) have rapidly altered the management of coronary artery disease. Before their development, the percutaneous management of coronary artery disease was performed predominantly by implantation of bare metal stents (BMS) made of either surgical stainless steel or metal alloys. Although such stents represented a considerable advance over balloon angioplasty alone, they remained limited by restenosis resulting from neointimal proliferation. As a result,
15% to 20% of patients treated with BMS required 
1 repeat revascularization procedure within the 6 to 12 months after stent implantation.1 Despite numerous attempts at systemic pharmacotherapy, device modification, and even use of ionizing radiation, the rate of restenosis after BMS implantation remained largely unaffected.
Response by Eisenberg p 1744
Over the past 5 years, effective DES have become the first device to substantially reduce the incidence of restenosis after stent implantation. By delivering high concentrations of either antiproliferative or immunomodulatory compounds directly to the site of arterial injury and by controlling this delivery through polymer-based drug release, both sirolimus- and paclitaxel-eluting stents have safely and effectively inhibited the proliferative process that results in in-stent restenosis. In pivotal clinical trials, both sirolimus- and paclitaxel-eluting stents have reduced rates of angiographic restenosis by 70% to 90% compared with conventional BMS designs, with parallel reductions in the need for clinically driven target vessel revascularization (TVR).2–4 As a result, in April 2003, DES were approved for use in clinical practice in the United States. Within 9 months of their introduction, DES made up 35% of all stent implantations in the United States,5 and their use has increased rapidly since that time. At our own institution, DES comprised >85% of all stents implanted during the past year, and national estimates are that >90% of all percutaneous coronary intervention (PCI) procedures currently performed in the United States involve 1 DES.
Given current procedural volumes (>1 million PCI procedures were performed in the United States in 2004)6 and costs (DES are generally 3 to 4 times more expensive than BMS), the rapid growth of this technology has raised important concerns about cost from both a hospital and a societal perspective.7,8 Because annual increases in US healthcare expenditures consistently outpace inflation,9 there is increasing interest in formally evaluating the economic impact of new technologies both before and immediately after their introduction. The aim of the present report is to summarize the economic consequences of current DES use and to explore the possible future impact of DES on US healthcare expenses.
|
What Is the Clinical and Economic Impact of Restenosis? |
|---|
|
TopIntroductionWhat Is the Clinical...Economic Impact of RestenosisEconomic Impact of DESDistinction Between "Cost...Cost-Effectiveness Analyses of...Hospital PerspectiveHow Has the Introduction...Future ConsiderationsReferences |
|---|
The major benefit of DES is a reduction in the rate of restenosis after PCI. Therefore, to understand the clinical and economic impact of DES, the overall scope and consequences of coronary restenosis must first be appreciated. Unlike native coronary artery stenoses in which plaque rupture and in situ coronary thrombosis can lead to acute myocardial infarction or death, in-stent restenosis is largely a nonfatal condition.10 Luminal narrowing after BMS implantation occurs from neointimal hyperplasia and vascular remodeling mainly at the stent margins.11 This process causes gradual, progressive loss of arterial diameter, resulting most commonly in recurrent myocardial ischemia and anginal symptoms. Given the gradual nature of the disease process, progression to myocardial infarction or sudden cardiac death is very rare.10
Several clinical studies confirm the relatively benign long-term prognosis of patients who experience coronary restenosis. Weintraub and colleagues12 followed-up >3300 patients treated with successful balloon angioplasty who subsequently underwent angiographic restudy to assess for restenosis. Both unadjusted and adjusted comparisons of 6-year survival failed to demonstrate any excess mortality among those patients with restenosis. Similar insights may be derived from randomized comparisons of PCI with bypass surgery.13,14 Although rates of restenosis requiring repeat revascularization are consistently higher among patients treated with PCI in these trials (both balloon angioplasty and BMS implantation), in general, these studies have demonstrated little to no difference in long-term survival. These observations thus confirm that restenosis itself and its subsequent treatment generally do not increase mortality—at least among the vast majority of patients who currently undergo PCI procedures. One may thus infer that, although DES may dramatically reduce restenosis rates for patients treated with PCI, they are unlikely to have a major impact on long-term mortality.
On the other hand, quality of life (QOL) is clearly affected by restenosis. For example, in the Optimum Percutaneous Coronary Angioplasty With Routine Stent Strategy (OPUS-1) trial of universal versus provisional bare metal stenting, patients without restenosis had less frequent angina, fewer physical limitations, and improved QOL scores at a 6-month follow-up compared with patients with restenosis.15 Similarly, in the Stent Primary Angioplasty for Myocardial Infarction (Stent-PAMI) trial, significant differences in QOL scores at 6 months were observed in BMS patients compared with those who received balloon angioplasty16; these differences were driven predominantly by lower rates of clinical and angiographic restenosis associated with BMS implantation. Although no studies to date have directly compared QOL scores between DES and BMS patients, one can reasonably assume that lower rates of restenosis associated with DES will result in improved QOL—at least in the short to intermediate term. There are no data, however, to suggest that these benefits will persist beyond the first year of follow-up once the restenosis process has completed its course and any necessary additional revascularization procedures have been performed.
|
Economic Impact of Restenosis |
|---|
|
TopIntroductionWhat Is the Clinical...Economic Impact of RestenosisEconomic Impact of DESDistinction Between "Cost...Cost-Effectiveness Analyses of...Hospital PerspectiveHow Has the Introduction...Future ConsiderationsReferences |
|---|
To fully characterize the economic impact of restenosis on the US healthcare system, one must consider both the frequency of this adverse event and the cost of each episode. The cost of restenosis is not a single value, however, and varies considerably depending on both the setting of care and, in particular, on the underlying patient population. Much of the available data on the cost and frequency of restenosis within the US healthcare system are derived from clinical trials. For example, in the Enhanced Suppression of Platelet Receptor Glycoprotein IIb/IIIa Using Integrilin Trial (ESPRIT) of patients undergoing predominantly elective coronary stenting, the mean cost for each TVR event (which occurred in 14% of the study cohort) was $11 913.17 Thus, the economic burden of restenosis within the ESPRIT population was $1675 (ie, $11 913x14%). This value represents the potential savings to the healthcare system that could be derived from a hypothetical intervention that completely eliminated restenosis for this population. Other patient populations have higher costs associated with restenosis. For example, among patients undergoing PCI for in-stent restenosis in the Gamma-1 trial, the overall economic burden of restenosis was
5-fold higher than in ESPRIT, reflecting both the higher frequency of restenosis in this challenging patient population and the higher treatment costs per episode of restenosis.18 The economic burden of restenosis is similarly high among patients undergoing multivessel PCI.19 Given the substantial variability in both the frequency and cost of restenosis across differing populations of PCI patients, it is clear that population-based data are required to fully characterize the economic burden of restenosis within the US healthcare system. We recently published such an analysis based on data from the Medicare program.20 Among US patients undergoing coronary stent implantation in 1999 (before the introduction of DES), the overall incidence of repeat revascularization in the first year after stent implantation was 16.9%, and the need for repeat revascularization was associated with excess costs (to the Centers for Medicare and Medicaid Services) of $19 074. By assuming, on the basis of previously published data, that 85% of procedures during this time were for treatment of restenosis,21 we estimated that the true frequency of TVR (ie, clinical restenosis) in the Centers for Medicare and Medicaid Services population was 14.4% and that the overall economic burden of restenosis to the US healthcare system during the BMS era was roughly $2500 per PCI patient.
|
Economic Impact of DES |
|---|
|
TopIntroductionWhat Is the Clinical...Economic Impact of RestenosisEconomic Impact of DESDistinction Between "Cost...Cost-Effectiveness Analyses of...Hospital PerspectiveHow Has the Introduction...Future ConsiderationsReferences |
|---|
There are currently no population-based data on the overall clinical or economic outcomes of DES within the US healthcare system. In the absence of such data, the results of the aforementioned Medicare study can provide important preliminary insights into the potential economic impact of the introduction and widespread adoption of DES. When the sirolimus-eluting stent was first available commercially in the United States, its list price was about $3200 per stent. With increasing competition and volume discounts, many US centers currently pay roughly $2200 per DES (prices are even lower in Canada and Europe, where even more devices are routinely available). Compared with an average acquisition cost of approximately $600 per BMS, the incremental cost of each DES is currently about $1600 per stent. Because many PCI procedures require >1 stent (both to cover long lesions and to treat multiple lesions and vessels), this number does not represent the true incremental cost of DES use. Given current stent use of
1.6 per DES procedure,22,23 complete conversion of the current PCI population from BMS to DES would be predicted to increase costs by about $2500 per procedure. From a population perspective, however, this upfront increase in cost with DES would be offset to some degree by savings from reduced repeat revascularization procedures and other concomitant medically associated costs. To estimate the balance between these 2 effects, we have developed a computer-simulation model of PCI within the US healthcare system.24 Although the model originally was designed to reflect patients undergoing single-vessel PCI, we have recently updated the model to capture the full spectrum of PCI patients, including contemporary outcomes and costs for BMS based on published data from the Medicare program.20 Key model assumptions thus include the overall BMS clinical restenosis (TVR) rate of 14%, an incremental stent cost of $1600 per DES, and average use of 1.6 stents per PCI procedure.
Figure 1 summarizes the results of this model in terms of the relationship between the restenosis relative risk reduction achieved by DES and the net 1-year cost difference between DES- and BMS-based strategies. Unless DES provide restenosis relative risk reductions >95% compared with BMS, our model projects that using DES will increase the aggregate cost of PCI within the US healthcare system. At current levels of efficacy (70% to 75% relative risk reduction),25 the net 1-year cost associated with replacing BMS with DES is estimated to be $600 per PCI patient. Given current procedural volumes of 1 million PCI procedures, we project that the overall impact of substituting DES for all US PCI patients is about $600 million in increased annual healthcare spending.
|
|
Distinction Between "Cost Saving" and "Cost-Effective" |
|---|
|
TopIntroductionWhat Is the Clinical...Economic Impact of RestenosisEconomic Impact of DESDistinction Between "Cost...Cost-Effectiveness Analyses of...Hospital PerspectiveHow Has the Introduction...Future ConsiderationsReferences |
|---|
As we have shown, given current stent prices, use patterns, and outcomes, it is unlikely that drug-eluting stents will result in meaningful net cost savings for the current PCI population. This does not necessarily imply that the treatment is not worthwhile. In fact, many new medical procedures and drugs are associated with a net increase in healthcare expenditures. Under these conditions, formal cost-effectiveness analysis can be used to examine the relationship between the costs and clinical benefits of a medical device or procedure and to provide insight into those conditions under which the benefits of the device or procedure justify any long-term increase in costs.26 In formal economic analysis, the "value" of a new medical therapy is expressed in terms of an incremental cost-effectiveness ratio, which is calculated by dividing the net cost of the treatment under evaluation (relative to standard of care) by its net benefits (also relative to standard of care): equation
|
|
In principle, costs are measured in monetary terms, and any valued clinical outcome may be used as a measure of health benefits. The standard approach, however, is to assess long-term health outcomes in terms of quality-adjusted life-years (QALYs),26 a metric that combines years of life and QOL into a single value. Each time interval in a given state of health is weighted by the "utility" of that health state; utility is a theoretical construct that represents an individual’s preference for that health state on a scale ranging from 0 to 1, where 1 represents perfect health and 0 represents death. Thus, years of life in good health yield more QALYs than years when health status is poor.
Once a cost-effectiveness ratio is calculated, it typically is compared with cost-effectiveness ratios for other therapies in a "league table." The threshold for determining whether a therapy is economically attractive varies with the available healthcare budget. In the United States, for example, cost-effectiveness ratios <$50 000 per QALY gained are generally viewed as favorable, and ratios between $50 000 and $100 000 per QALY gained are frequently considered to be in a "gray zone." In contrast, cost-effectiveness ratios >$100 000 per QALY saved are generally viewed as economically unattractive.27 These standards do not necessarily apply to other healthcare systems, however. In particular, countries that spend considerably less on healthcare than the United States would appropriately have more stringent (ie, lower) thresholds.
Although the use of QALYs as an outcome measure in cost-effectiveness analysis is widely accepted, several pragmatic issues limit the attractiveness of this end point for valuing treatments in which the principal benefit is preventing restenosis after PCI. Because there is no evidence that restenosis affects survival after PCI, one would not expect treatments with the sole benefit of reducing restenosis (such as DES) to improve population-level life expectancy. Furthermore, although restenosis is clearly associated with reduced QOL,27 empirical data as to the overall impact of restenosis on quality-adjusted life expectancy are limited.
Given these limitations, several recent studies have used a disease-specific cost-effectiveness ratio: cost per repeat revascularization avoided.13,18,28,29 The advantages of this end point are that it is simple to measure, can be integrated easily into standard data collection for clinical trials or registries, and is readily interpreted by both clinicians and patients. The primary limitation of this end point is that it is specific to coronary revascularization and cannot be compared directly with cost-effectiveness ratios for other conditions or against cost-effectiveness analyses using different outcome measures. Thus, determination of an appropriate cost-effectiveness threshold may be challenging.
Within a specific healthcare system, however, comparison with other established technologies that can prevent coronary restenosis may serve as a useful benchmark. For example, within the US healthcare system, several technologies with cost-effectiveness ratios <$10 000 per repeat revascularization avoided (eg, brachytherapy for in-stent restenosis, elective coronary stenting versus balloon angioplasty) have been widely adopted and are currently reimbursed by most third-party payers.18,29 These observations suggest that other therapies with cost-effectiveness ratios <$10 000 per repeat revascularization avoided may be considered reasonably attractive within the US healthcare system. Of note, several recent studies using the contingent valuation (ie, "willingness to pay") technique suggest that at least in hypothetical scenarios, US patients undergoing cardiac procedures may assign even higher values to therapies that reduce restenosis.30
|
Cost-Effectiveness Analyses of DES |
|---|
|
TopIntroductionWhat Is the Clinical...Economic Impact of RestenosisEconomic Impact of DESDistinction Between "Cost...Cost-Effectiveness Analyses of...Hospital PerspectiveHow Has the Introduction...Future ConsiderationsReferences |
|---|
As noted previously, because clinical trials are often performed relatively early in the development process for medical devices, they often represent a unique opportunity to study the cost-effectiveness of such devices under controlled conditions. The first prospective economic evaluation of drug-eluting stents was performed alongside the RAndomized study with the sirolimus-eluting Bx VELocity balloon-expandable stent in the treatment of patients with de novo native coronary artery lesions (Cypher; RAVEL) trial.4,31 In this trial, sponsored by Cordis, 238 patients undergoing PCI of a single, de novo coronary lesion were randomized to receive either sirolimus-eluting stents or a comparable BMS. Clinical outcomes demonstrated that the sirolimus-eluting stent completely eliminated both angiographic and clinical restenosis among this highly select patient population. Economic analysis from the Dutch healthcare perspective demonstrated that initial procedural costs were increased by 1284
, whereas follow-up costs were reduced to a similar extent. The net 1-year cost increment with DES was thus only 54 per patient. This study is of limited relevance to the US healthcare system, however, because both stent prices and the costs associated with repeat revascularization procedures differ substantially between the Netherlands and the United States. Moreover, the RAVEL economic analysis also is limited by the performance of protocol-mandated angiographic follow-up. This practice is well known to inflate rates of repeat revascularization procedures (and their associated costs) through the "oculostenotic reflex."28,32 As a result, one should be particularly cautious in interpreting the results of economic analyses derived from clinical trials that incorporate a primary angiographic end point.
The first study to examine the economic impact of DES from the perspective of the US healthcare system was performed alongside the SIRIUS trial (a Cordis-sponsored trial of the sirolimus-coated Bx Velocity stent [Cypher]).22 In this trial, 1058 patients undergoing single-vessel PCI for moderately complex coronary stenoses were randomized to receive either sirolimus-eluting stents or BMS and were followed up for both clinical and economic outcomes for 1 year. Initial hospital costs were approximately $2800 higher with the sirolimus-eluting stent compared with the BMS ($11 345 versus $8464; P<0.001). Much of this difference in initial costs was offset by lower follow-up costs ($5468 versus $8040; P<0.001), however, mainly because of a reduced requirement for repeat revascularization procedures. Thus, at 12 months, the DES strategy cost an average of $309 per patient more than the BMS strategy, yielding cost-effectiveness ratios of $1650 per repeat revascularization avoided and $27 500 per QALY gained (based on externally derived utility weights). These findings suggest that, for patients at moderate to high risk of restenosis (the population selected for the SIRIUS trial), sirolimus-eluting stents are reasonably cost-effective within the context of the US healthcare system. Of note, this study was conducted in 2004 and assumed an incremental cost of $2000 per DES versus BMS. If the study were to be repeated using 2006 US costs (with an incremental cost per DES of $1600), the resulting outcome would most likely be modest cost savings with the DES strategy.
More recently, we completed an economic analysis based on the TAXUS-IV trial of paclitaxel-eluting stents versus BMS for patients undergoing planned single-vessel PCI.33 The general design of the TAXUS-IV trial and its economic analysis were similar to those of the SIRIUS trial. In TAXUS-IV, use of the paclitaxel-eluting stent increased initial hospitalization costs by $2028. This was partially offset by a reduction in 1-year follow-up costs of $1456 in the DES arm, so mean 1-year costs were $572 higher among DES patients ($14 583 versus $14 011; P<0.001). The overall cost-effectiveness ratio for the paclitaxel-eluting stent was $4678 per repeat revascularization avoided and $47 798 per QALY gained. In contrast to the previous studies, TAXUS-IV was the first randomized trial to incorporate a large, prespecified cohort of patients who were managed according to standard clinical practice without mandatory angiographic follow-up. In this 582-patient subset, economic outcomes were actually somewhat more favorable than those for the trial as a whole. The net 1-year cost increment for DES versus BMS in this subgroup was only $97 per patient, with a resulting cost-effectiveness ratio of $760 per repeat revascularization avoided and $5105 per QALY gained. Thus, these findings confirm that, for patients at moderate to high risk of restenosis who are undergoing single-vessel PCI, use of DES represents an economically attractive investment within the US healthcare environment.
The most recent economic evaluation of DES versus BMS was performed alongside the BAsel Stent Kosten Effektivitäts Trial (BASKET).34 In BASKET, 826 "unselected" patients undergoing PCI were randomized to receive sirolimus-eluting stents, paclitaxel-eluting stents, or cobalt-chromium stents (BMS). In contrast to both SIRIUS and TAXUS-IV, BASKET enrolled a relatively diverse patient population, including patients undergoing treatment for acute myocardial infarction and patients undergoing multivessel PCI, and used a pragmatic "real-world" design without angiographic follow-up. At the 6-month follow-up, randomization to either DES was associated with a significant reduction in TVR. An economic analysis performed from the perspective of the Swiss healthcare system demonstrated that aggregate 6-month costs were increased by 905 with DES implantation (10 544 versus 9639 ). The incremental cost-effectiveness ratio was 18 311 per repeat revascularization avoided or 72 283 per QALY gained. Given that clinical restenosis after BMS implantation frequently manifests over a 9 to 12 months,21 however, it is unclear whether these relatively unfavorable results relate primarily to the relatively brief analytic time horizon or to other differences in the patient population and management of restenosis in European versus US practice.
To overcome the limitations inherent in these trial-based economic analyses, we have developed a decision-analytic model to evaluate the cost-effectiveness of DES for patients undergoing PCI from the perspective of the US healthcare system. Although the original model was based on published data from the medical literature, we have recently updated the model assumptions to reflect population-based PCI outcomes and costs from the Medicare database as previously described.20 Key assumptions of the current PCI model thus include an average TVR rate for BMS of 14%,27 an incremental cost of $1600 per DES,29 and average stent use of 1.6 per procedure.35 Under these baseline conditions and assuming that DES reduce clinical restenosis by 70%,25 the model projects that 1-year aggregate costs with DES would be $691 per patient higher than with BMS, with an incremental cost-effectiveness ratio of $5422 per repeat revascularization avoided. Sensitivity analyses demonstrated that DES would be cost saving for patient populations in which the expected BMS TVR rate is >19% and economically attractive (at a threshold of $10 000 per repeat revascularization avoided) as long as BMS TVR rates were >11% (Figure 2). These results provide credible evidence that, at least on average, use of a DES rather than a BMS may be considered an economically attractive healthcare investment within the context of the US healthcare system.
|
Further insights into the optimal patient population for DES implantation may be derived from statistical models to predict restenosis after BMS implantation. Several previous studies have demonstrated that smaller reference vessel diameter, greater lesion length, and the presence of treated diabetes mellitus are consistently associated with higher rates of angiographic and clinical restenosis after BMS implantation.21 By incorporating the predicted rates of clinical restenosis based on such a statistical model into our population-based economic outcomes model, we can estimate the projected cost-effectiveness of DES versus BMS for treatment of specific patient subsets (Table). If one considers a cost-effectiveness ratio <$10 000 per repeat revascularization avoided to be acceptable within the US healthcare system, our model suggests that DES are reasonably cost-effective for virtually all diabetic patients. On the other hand, despite their proven clinical benefits, for many nondiabetic patients with reference vessel diameters 3.5 mm, our model suggests that DES are not particularly efficient healthcare investments given the relatively low rates of clinical and angiographic restenosis seen with BMS implantation in these subsets. Whether appropriate guidelines and reimbursement policies can be developed to encourage such a tailored approach is currently unknown.
|
|
Hospital Perspective |
|---|
|
TopIntroductionWhat Is the Clinical...Economic Impact of RestenosisEconomic Impact of DESDistinction Between "Cost...Cost-Effectiveness Analyses of...Hospital PerspectiveHow Has the Introduction...Future ConsiderationsReferences |
|---|
It is important to note that our discussion thus far has focused on costs as assessed from a societal (or healthcare system) perspective. From these perspectives, the initial higher cost of DES implantation can be recouped, at least in part, through downstream cost savings resulting from a reduction in the need for subsequent revascularization procedures. The situation is quite different when viewed from the perspective of a typical US hospital, however, which is paid for each episode of care and does not realize any direct financial benefits related to improved long-term outcomes. From the perspective of the hospital, economic attractiveness is simply the difference between reimbursement and the cost of the episode of care. Although the Centers for Medicare and Medicaid Services have provided incremental hospital reimbursement (in the form of diagnosis-related group payments) for implantation of DES since their approval in 2003, the difference in reimbursement rates between DES and BMS implantation is approximately $1800,36 which is less than the difference in cost for the 2 procedures. Thus, regardless of the specific cost structure of a hospital, it is clear that profitability is diminished by using drug-eluting stents. Moreover, under the current diagnosis-related group–based reimbursement system, the more stents that are required to treat a specific patient, the greater the financial burden is that is imposed on hospitals by DES adoption.
Insufficient third-party reimbursement accounts for only part of the financial challenge faced by hospitals resulting from the introduction of DES, however. Given the benefits of DES in reducing restenosis, hospitals face further loss of revenue resulting from the expected downstream reduction in the need for repeat revascularization procedures.
Finally, hospitals have had to face an important loss of revenue resulting from the substitution of less remunerative DES procedures for bypass surgery—traditionally one of the best reimbursed and most profitable procedures for many tertiary hospitals. An analysis based on historical data from Duke University Medical Center projected that the introduction of DES (with 85% penetration over a 5-year period) would reduce overall hospital revenue by more than $5 million per year despite the availability of higher Medicare reimbursements for DES procedures—mainly because of erosion of coronary artery bypass grafting (CABG) volumes.7
|
How Has the Introduction of DES Affected Overall Healthcare Expenditures? |
|---|
|
TopIntroductionWhat Is the Clinical...Economic Impact of RestenosisEconomic Impact of DESDistinction Between "Cost...Cost-Effectiveness Analyses of...Hospital PerspectiveHow Has the Introduction...Future ConsiderationsReferences |
|---|
Although our analyses suggest that use of DES compared with BMS is reasonably cost-effective within the context of the US healthcare system, the underlying framework of cost-effectiveness analysis is based predominantly on the concept of economic efficiency and does not directly address the critical issues of the overall impact of technology on healthcare spending (ie, global budget impact) or the source for any incremental funds required to implement the program. As we have outlined above, when the analysis is restricted to the current US PCI population, universal adoption of DES is unlikely to reduce net healthcare costs. In fact, with a projected long-term incremental cost of about $600 per PCI patient, one can readily project that use of DES in >90% of PCI recipients would increase annual PCI-related costs by >$500 million.
Nonetheless, it is possible that DES could eventually result in meaningful long-term cost savings to the healthcare system as a whole. In particular, use of DES for patients who currently undergo bypass surgery (at a cost of $30 000) could result in substantial short- and long-term cost savings, provided the long-term outcomes are not compromised by such a strategy. Indeed, recent data from the Arterial Revascularization Therapy Study (ARTS)–1 and ARTS-2 trials demonstrate that, compared with bypass surgery, DES implantation (with an average of 3.6 DES per patient) led to 1-year cost savings of approximately $5032 per patient compared with bypass surgery ($31 831 versus $36 863; P<0.001).37 Given these cost savings, it is conceivable that conversion of 20% to 30% of CABG procedures to DES could result in sufficient savings to the healthcare system to offset the higher long-term costs of DES for the PCI population. Whether the clinical results of multivessel PCI with DES can match the long-term angina relief and survival benefits of CABG and whether such volume shifts are achievable in practice remain to be seen. Recent data from our own institution have shown a 14% reduction in the rate of referral from coronary angiography to CABG since the introduction of DES, however.38
|
Future Considerations |
|---|
|
TopIntroductionWhat Is the Clinical...Economic Impact of RestenosisEconomic Impact of DESDistinction Between "Cost...Cost-Effectiveness Analyses of...Hospital PerspectiveHow Has the Introduction...Future ConsiderationsReferences |
|---|
Despite such optimistic projections, much about the overall economic impact of DES remains unknown. It is important to recognize that all of the economic projections and estimates summarized in this report represent at best "educated guesses" based on current use patterns, clinical trial results, and costs. Of these factors, device costs represent the greatest source of uncertainty. Although DES acquisition costs have declined by
20% over the 3 years since their initial approval, it is likely that further cost reductions will occur in the near future as additional competitors enter the marketplace. In this case, our economic projections would represent a worst-case scenario, and true cost savings might be realized across much of the current PCI population. On the other hand, development of previously unanticipated new technologies (such as bioabsorbable stents) may further advance the field and command additional price premiums. In addition to changes in pricing or clinical performance, an additional source of uncertainty is the possibility that new indications for DES will emerge. For example, the medical community has recently focused much attention on characterizing and identifying vulnerable plaques.39 Some have speculated that, in the future, cardiologists may be able to identify and treat vulnerable plaques, possibly with DES, to prevent future events, including sudden death and myocardial infarction.40 Obviously, if this were to become common practice, many more DES would be implanted than under the current practice paradigm.
What the sum total effect of these trends will be on US healthcare spending is not yet clear. Most likely, DES will not bankrupt the US healthcare system, especially as stent costs decline over time. Nevertheless, the healthcare marketplace is fluid, and continuous evaluation of outcomes and costs is essential to optimize cost-effectiveness. Only by monitoring use and cost over time can we accurately ascertain the true impact of DES on the US healthcare system.
|
Acknowledgments |
|---|
Disclosures
Dr Cohen received grant support from Cordis Inc and Boston Scientific Inc. Dr Ryan reports no conflicts.
|
References |
|---|
|
TopIntroductionWhat Is the Clinical...Economic Impact of RestenosisEconomic Impact of DESDistinction Between "Cost...Cost-Effectiveness Analyses of...Hospital PerspectiveHow Has the Introduction...Future ConsiderationsReferences |
|---|
- Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, Cleman M, Heuser R, Almond D, Teirstein P, Fish D, Colombo A, Brinker J, Moses J, Shaknovich A, Hirshfeld J, Bailey S, Ellis S, Rake R, Goldberg S, for the Stent Restenosis Study Investigators. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease: Stent Restenosis Study Investigators. N Engl J Med. 1994; 331: 496–501.
[Abstract/Free Full Text] - Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME, for the TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004; 350: 221–231.
[Abstract/Free Full Text] - Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O’Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE, for the SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003; 349: 1315–1323.
[Abstract/Free Full Text] - Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R, for the RAVEL Study Group. Randomized Study With the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions: a randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002; 346: 1773–1780.
[Abstract/Free Full Text] - Tanne JH. Use of drug eluting stents increases in the US but only for some groups. BMJ. 2004; 329: 1205.
[Free Full Text] - Thom T, Haase N, Rosamond W, Howard VJ, Rumsfeld J, Manolio T, Zheng ZJ, Flegal K, O’Donnell C, Kittner S, Lloyd-Jones D, Goff DC Jr, Hong Y, Adams R, Friday G, Furie K, Gorelick P, Kissela B, Marler J, Meigs J, Roger V, Sidney S, Sorlie P, Steinberger J, Wasserthiel-Smoller S, Wilson M, Wolf P, for the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics: 2006 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2006; 113: e85–e151.
[Free Full Text] - Kong DF, Eisenstein EL, Sketch MH Jr, Zidar JP, Ryan TJ, Harrington RA, Newman MF, Smith PK, Mark DB, Califf RM. Economic impact of drug-eluting stents on hospital systems: a disease-state model. Am Heart J. 2004; 147: 449–456.[CrossRef][Medline]
[Order article via Infotrieve]
- Greenberg D, Bakhai A, Cohen DJ. Can we afford to eliminate restenosis? Can we afford not to? J Am Coll Cardiol. 2004; 43: 513–518.
[Abstract/Free Full Text] - Anderson GF, Hussey PS, Frogner BK, Waters HR. Health spending in the United States and the rest of the industrialized world. Health Aff (Millwood). 2005; 24: 903–914.
[Abstract/Free Full Text] - Kimura T, Yokoi H, Nakagawa Y, Tamura T, Kaburagi S, Sawada Y, Sato Y, Yokoi H, Hamasaki N, Nosaka H, Nobuyoshi M. Three-year follow-up after implantation of metallic coronary-artery stents. N Engl J Med. 1996; 334: 561–566.
[Abstract/Free Full Text] - Bennett MR, O’Sullivan M. Mechanism of angioplasty and stent restenosis: implications for design of rational therapy. Pharmacol Ther. 2001; 91: 149–166.[CrossRef][Medline]
[Order article via Infotrieve]
- Weintraub WS, Ghazzal ZM, Douglas JS Jr, Liberman HA, Morris DC, Cohen CL, King SB. Long-term clinical follow-up in patients with angiographic restudy after successful angioplasty. Circulation. 1993; 87: 831–840.
[Abstract/Free Full Text] - Serruys PW, Unger F, Sousa JE, Jatene A, Bonnier HJ, Schonberger JP, Buller N, Bonser R, van den Brand MJ, van Herwerden LA, Morel MA, van Hout BA, for the Arterial Revascularization Therapies Study Group. Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. N Engl J Med. 2001; 344: 1117–1124.
[Abstract/Free Full Text] - Rihal CS, Raco DL, Gersh BJ, Yusuf S. Indications for coronary artery bypass surgery and percutaneous coronary intervention in chronic stable angina: review of the evidence and methodological considerations. Circulation. 2003; 108: 2439–2445.
[Free Full Text] - Weaver WD, Reisman MA, Griffin JJ, Buller CE, Leimgruber PP, Henry T, D’Haem C, Clark VL, Martin JS, Cohen DJ, Neil N, Every NR. Optimum percutaneous transluminal coronary angioplasty compared with routine stent strategy trial (OPUS-1): a randomised trial. Lancet. 2000; 355: 2199–2203.[CrossRef][Medline]
[Order article via Infotrieve]
- Rinfret S, Grines CL, Cosgrove RS, Ho KK, Cox DA, Brodie BR, Morice MC, Stone GW, Cohen DJ, for the Stent-PAMI Investigators. Quality of life after balloon angioplasty or stenting for acute myocardial infarction: one-year results from the Stent-PAMI trial. J Am Coll Cardiol. 2001; 38: 1614–1621.
[Abstract/Free Full Text] - Cohen DJ, Cosgrove R, Berezin R, O’Shea C, Tcheng J, for the ESPRIT Investigators. Cost-effectiveness of eptifibatide in patients undergoing planned coronary stenting: results from the ESPRIT trial. Circulation. 2001; 104 (suppl I): I-386–I-387.Abstract.
- Cohen DJ, Cosgrove RS, Berezin R, Teirstein P, Leon M, Kuntz R. Cost-effectiveness of gamma radiation for treatment of in-stent restenosis: results from the Gamma-1 trial. Circulation. 2002; 106: 691–697.
[Abstract/Free Full Text] - Reynolds MR, Neil N, Ho KK, Berezin R, Cosgrove R, Lager R, Sirois C, Johnson RG, Cohen DJ. Clinical and economic outcomes of multivessel coronary stenting compared with bypass surgery: a single-center U.S. experience. Am Heart J. 2003; 145: 334–342.[CrossRef][Medline]
[Order article via Infotrieve]
- Clark MA, Bakhai A, Lacey MJ, Pelletier EM, Cohen DJ. Clinical and economic outcomes of percutaneous coronary interventions in the elderly: an analysis of Medicare claims data. Circulation. 2004; 110: 259–264.
[Abstract/Free Full Text] - Cutlip DE, Chauhan MS, Baim DS, Ho KK, Popma JJ, Carrozza JP, Cohen DJ, Kuntz RE. Clinical restenosis after coronary stenting: perspectives from multicenter clinical trials. J Am Coll Cardiol. 2002; 40: 2082–2089.
[Abstract/Free Full Text] - Cohen DJ, Bakhai A, Shi C, Githiora L, Lavelle T, Berezin RH, Leon MB, Moses JW, Carrozza JP Jr, Zidar JP, Kuntz RE, for the SIRIUS Investigators. Cost-effectiveness of sirolimus-eluting stents for treatment of complex coronary stenoses: results from the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) trial. Circulation. 2004; 110: 508–514.
[Abstract/Free Full Text] - Cohen DJ, O’Shea JC, Pacchiana CM, Levine G, Sarembock I, Slater J, Conn E, Smith J, Tcheng JE, for the ESPRIT Investigators. In-hospital costs of coronary stent implantation with and without eptifibatide (the ESPRIT Trial): Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrillin. Am J Cardiol. 2002; 89: 61–64.[CrossRef][Medline]
[Order article via Infotrieve]
- Cohen DJ, Breall JA, Ho KK, Kuntz RE, Goldman L, Baim DS, Weinstein MC. Evaluating the potential cost-effectiveness of stenting as a treatment for symptomatic single-vessel coronary disease: use of a decision-analytic model. Circulation. 1994; 89: 1859–1874.
[Abstract/Free Full Text] - Kastrati A, Dibra A, Eberle S, Mehilli J, Suarez de Lezo J, Goy JJ, Ulm K, Schomig A. Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials. JAMA. 2005; 294: 819–825.
[Abstract/Free Full Text] - Weinstein M, Stason W. Foundations of cost-effectiveness analysis for health and medical practices. N Engl J Med. 1977; 296: 716–721.[Abstract]
- Greenberg D, Cohen DJ. Examining the economic impact of restenosis: implications for the cost-effectiveness of an antiproliferative stent. Z Kardiol. 2002; 91 (suppl 3): 137–143.[Medline]
[Order article via Infotrieve]
- Serruys PW, van Hout B, Bonnier H, Legrand V, Garcia E, Macaya C, Sousa E, van der Giessen W, Colombo A, Seabra-Gomes R, Kiemeneij F, Ruygrok P, Ormiston J, Emanuelsson H, Fajadet J, Haude M, Klugmann S, Morel MA. Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (BENESTENT II). Lancet. 1998; 352: 673–681.[CrossRef][Medline]
[Order article via Infotrieve]
- Cohen DJ, Taira DA, Berezin R, Cox DA, Morice MC, Stone GW, Grines CL. Cost-effectiveness of coronary stenting in acute myocardial infarction: results from the Stent Primary Angioplasty in Myocardial Infarction (Stent-PAMI) trial. Circulation. 2001; 104: 3039–3045.
[Abstract/Free Full Text] - van Hout BA, Serruys PW, Lemos PA, van den Brand MJ, van Es GA, Lindeboom WK, Morice MC. One year cost effectiveness of sirolimus eluting stents compared with bare metal stents in the treatment of single native de novo coronary lesions: an analysis from the RAVEL trial. Heart. 2005; 91: 507–512.
[Abstract/Free Full Text] - Greenberg D, Bakhai A, Neumann PJ, Cohen DJ. Willingness to pay for avoiding coronary restenosis and repeat revascularization: results from a contingent valuation study. Health Policy. 2004; 70: 207–216.[CrossRef][Medline]
[Order article via Infotrieve]
- Baim DS, Cutlip DE, Midei M, Linnemeier TJ, Schreiber T, Cox D, Kereiakes D, Popma JJ, Robertson L, Prince R, Lansky AJ, Ho KK, Kuntz RE, for the ASCENT Investigators (ACS Multi-Link Stent Clinical Equivalence in De Novo Lesions Trial). Final results of a randomized trial comparing the MUTLI-LINK stent with the Palmaz-Schatz stent for narrowings in native coronary arteries. Am J Cardiol. 2001; 87: 157–62.[CrossRef][Medline]
[Order article via Infotrieve]
- Bakhai A, Stone G, Mahoney E, Lavelle T, Shi C, Berezin R, Lahue B, Clark M, Lacey M, Russell M, Ellis S, Hermiller J, Cox D, Cohen DJ, for the TAXUS-IV Investigators. Cost-effectiveness of paclitaxel-eluting stents for patients undergoing percutaneous coronary revascularization: results from the TAXUS-IV Trial. J Am Coll Cardiol. 2006; 48: 253–261.
[Abstract/Free Full Text] - Kaiser C, Brunner-La Rocca HP, Buser PT, Bonetti PO, Osswald S, Linka A, Bernheim A, Zutter A, Zellweger M, Grize L, Pfisterer ME, for the BASKET Investigators. Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitäts Trial (BASKET). Lancet. 2005; 366: 921–929.[CrossRef][Medline]
[Order article via Infotrieve]
- Greenberg D, Bakhai A, Neil N, Berezin R, Ho K, Cutlip D, Kuntz R, Cohen DJ. Modeling the impact of patient and lesion characteristics on the cost-effectiveness of drug-eluting stents. J Am Coll Cardiol. 2003; 41 (suppl): 538A. Abstract.
- Centers for Medicare and Medicaid Services Website. Available at: http://www.cms.hhs.gov/. Accessed June 7, 2006.
- Dulisse B, Zhang J, Ryan J, Macaya C, Columbo A, Garcia H, Wittebols K, Van Hout B, Cohen DJ. Cost-effectiveness of PCI with or without drug-eluting stents vs. bypass surgery for treatment of multivessel coronary disease: 1-year results from the ARTS I and ARTS II trials. Abstract presented at: 2005 American Heart Association Scientific Sessions; November 15, 2005; Dallas, Tex.
- Liddicoat J, De La Torre R, Ho K, Nathan S, Levitsky S, Krempin J, Sellke F. Initial impact of drug-eluting stents on coronary artery bypass graft surgery. Ann Thorac Surg. 2006; 81: 1239–1242.
[Abstract/Free Full Text] - Vaina S, Stefanadis C. Detection of the vulnerable coronary atheromatous plaque: where are we now? Int J Cardiovasc Intervent. 2005; 7: 75–87.[CrossRef][Medline]
[Order article via Infotrieve]
- Virmani R, Burke A. Farb A, Kolodgie F. Pathology of the vulnerable plaque. J Am Coll Cardiol. 2006; 47: C13–C18.
[Abstract/Free Full Text]
Response to Ryan and Cohen
Mark J. Eisenberg, MD MPH
Drs Ryan and Cohen nicely summarize the issue of drug-eluting stent (DES) cost-effectiveness. I think that we are in agreement about many points, including the following: (1) Among nondiabetic patients, DES are cost-effective only when reference vessel diameters are small (
3.0 mm) or when coronary lesions are long; (2) among diabetic patients, DES are not cost-effective when reference vessel diameters are large (4.0 mm)1; and (3) The universal use of DES is associated with high incremental costs per patient and a substantial increase in global healthcare costs. These points make it clear that across-the-board use of DES is not cost-effective. The universal use of DES is expensive at current prices and leads to many patients receiving DES with little, if any, clinical benefit. Reserving DES for patients at high risk of restenosis is financially responsible and will have minimal, if any, adverse clinical consequences. I would like to emphasize 1 further point. The universal use of DES will not, by itself, bankrupt the US healthcare system. The indiscriminate use of expensive healthcare interventions that are only borderline cost-effective cannot be sustained indefinitely, however. Healthcare resources are limited; DES use necessarily competes for funding with other healthcare interventions. Examining the cost-effectiveness of DESs in isolation, without taking into account competing healthcare interventions, is naive. If we are not financially responsible in the use of healthcare technology, we can and will eventually bankrupt the healthcare system.
|
Footnotes |
|---|
The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.
This article has been cited by other articles:
 |
|
 |
|
  J. C.J. Sun, J. W. Eikelboom, P. Agostoni, G. M. Sangiorgi, G. G. Biondi-Zoccai, B. Scheller, M. Bohm, and E. Camenzind Treatment of Restenosis with a Paclitaxel-Coated Balloon Catheter N. Engl. J. Med., March 8, 2007; 356(10): 1071 - 1073. [Full Text] [PDF]
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||