Die Gesundheitsreform in den Niederlanden: Ein Modell für Deutschland? (German Edition)
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The authors adopted the societal perspective without consideration of indirect costs and used a lifetime horizon for their evaluation. The target population consisted of 55 year-old patients with chest pain and angiographically determined intermediate stenosis without documented myocardial ischemia.
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The analysis was restricted to patients with single-vessel disease. Results were presented as discounted incremental cost-utility ratios ICUR of the FFR-strategy as compared with the two other strategies. Data for diagnostic test performance were derived from two diagnostic studies, data for treatment efficacy from a meta-analysis, the duration of treatment effects from two randomized clinical trials, mortality associated with the procedures from a large cohort study, and utilities from one cross-sectional study.
The estimate of the remaining life expectancy was based on the results of a published decision analysis performed in Cost data were based on the published literature, manufacturer information, professional fee tables, and hospital accounting data. After discounting, the FFR-based strategy resulted in Hence, universal PCI was dominated by both the FFR strategy and the nuclear stress test strategy because it was more costly and less effective.
The authors concluded that measurement of FFR as a guide for decisions regarding PCI in patients with an intermediate coronary lesion and no prior functional test may lead to significant cost savings as compared with the performance of nuclear stress imaging or universal PCI in all patients.
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This study employed a straightforward approach and a simple decision tree, utilizing quality-adjusted life expectancy as a health outcome and relying on several simplifying assumptions. A particular strength of this study was the inclusion of a noninvasive imaging test as an alternative to FFR testing and sensitivity analyses of the diagnostic performance of both tests.
Overall this study is the first decision analysis in this area. It should be replicated for other countries using a more detailed modeling approach with actual units and prices. Because this study was performed in the US healthcare context where price patterns of coronary stents differ significantly from Germany, these results are only of limited value for a German assessment. It was thus necessary to develop a decision-analytic model for the German healthcare context.
The model combines a decision tree for diagnostic and short-term outcomes with a seven-state Markov model for long-term events. Cycle length was one year. We adopted the societal perspective and a lifetime analytic time horizon. Prevalence data and data for short-term treatment outcomes were based on a randomized clinical trial with a two-year follow-up.
Data on progression and incidence of revascularizations, short- and long-term mortality of interventions, and utilities were extracted from published studies. In addition, we performed extensive univariate and multivariate sensitivity analyses and subgroup analyses gender, age: 30 to 70 years. Subgroup analyses demonstrated no decision-relevant differences by gender but provided evidence that the results differ across age groups. One-way sensitivity analyses for re-stenosis risk in the target lesion, PCI-related peri-procedural mortality, effects of the PCI on long-term survival, relative mortality risk for functional versus nonfunctional stenosis, and coronary stent price are robust under conservative assumptions bias against FFR testing.
The most influential sensitivity analysis parameters were 1 the relative reduction in long-term mortality after PCI in patients with non-functional stenosis and 2 the prevalence prior probability of functional stenoses. For a PCI-related mortality reduction of Based on our decision analysis, the use of FFR measurement to guide the decision on PCI should result in better health outcomes than universal use of PCI in patients with chest pain and single-vessel disease without documented myocardial ischemia.
The FFR-based strategy should also be cost-effective when compared to other well-accepted medical interventions. We identified only one other published study that investigated the cost-effectiveness of FFR measurement in CAD patients, though it was performed for the US healthcare context. This study showed greater clinical benefit associated with FFR measurement than was demonstrated in our study.
This can be explained by the fact that the US study was based on a decision tree analysis with simplifying assumptions, whereas our decision analysis used a Markov model. This allowed us to explicitly and transparently model the effects of interventions on the long-term course of the disease, the progression of angina and quality of life. Our model was built on explicit and extremely conservative assumptions in favor of the long-term benefit of PCI bias against FFR measurement. This can be explained by our conservative long-term assumptions in favor of universal PCI as well as by lower stent prices in Germany as compared to the US.
The most relevant limitations of our study are that data are currently available only for short time horizons and are not stratified by functional versus non-functional stenoses when reported.
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In addition, essential parameters are derived from a single RCT with limited numbers of patients. Given that we have used extremely conservative model assumptions, we expect that the real effect of FFR measurement as a guide for decisions about PCI is more beneficial and cost-effective than our estimates suggest. Our literature search did not yield any publications addressing ethical, social or legal aspects of the FFR technology relevant to the research questions of this HTA-report.
Based on the diagnostic meta-analysis in this report, FFR should be a valid test with a good diagnostic performance. The only published RCT that investigated the clinical benefit of FFR measurement showed that, in patients without documented myocardial ischemia, an FFR-based strategy is at least as effective as universal PCI in all patients. The only economic evaluation demonstrated that, in the US healthcare context, an FFR-based strategy is more effective and less costly than universal PCI. Due to different cost structures, the US results cannot be transferred to the German context.
Based on our decision analysis in patients with chest pain and single-vessel disease without documented myocardial ischemia, FFR measurement as a guide for decisions regarding PCI should be effective and cost-effective in the German context. This HTA-report demonstrates that diagnostic studies of test performance, RCT assessing short-term clinical benefits, epidemiologic studies examining long-term outcomes, quality-of-life studies determining patient preferences, and economic studies cannot be judged in isolation.
All data relevant to the decision problem and the time horizon of interest must be critically assessed for their quality and then incorporated in a decision-analytic model that evaluates the short- and long-term clinical benefit and cost-effectiveness in the healthcare context of interest. This must also be accompanied by a comprehensive uncertainty assessment such as that of a sensitivity analysis. This HTA-report has several limitations. Most of the diagnostic studies have failed to apply a valid gold standard as a reference. Many of the studies also have the potential of further bias, for example, progression bias.
This RCT did not prove the superiority of either of the compared strategies with statistical significance. German Edition Free download.
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German Edition Bookeveryone. This Book have some digital formats such us :paperbook, ebook, kindle, epub, fb2 and another formats. German Edition Pocket Guide.
Defining hospital markets — an application to the German hospital sector Lueschen G et al. Log in to Wiley Online Library The RCT that investigated the clinical benefit of an FFR-based treatment strategy was a multicenter study of patients who had no documented history of myocardial ischemia. Thus the history of such regulation is that it does not really lower cost to consumers. Moreover, regulatory authorities are not czars. They must observe the due process requirements of the Administrative Procedures Act and the Fifth Amendment.follow link
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They must hold hearings, consider arguments, and base conclusions on evidence—all of which can be costly. Such global budgets would raise a whole maze of paradoxes and conundrums: Would they be equal per capita across states, and if unequal, on what basis? How would one deal with high- versus low-cost states? Could one justify locking Massachusetts and Arkansas, with a nearly twofold difference in per capita spending, into the same percentage rate of increase forever?
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Who decides? Finally, for managed competition to work well, the managed care industry must make a great deal of investment in corporate restructuring, service expansion, and information and reporting systems, all of which are much less likely to appear attractive if government threatens to set prices and expropriate the return on investment.
How then should government respond? The answer is that the managed competition framework gives government a number of tools to use to influence the outcome. These would be market-determined global budgets and would encompass all publicly supported and tax-subsidized national health expenditures. Government could then decide on a public policy that sets a target for this global budget relative to GNP.
If the global budget grows faster than the target, the president and Congress should direct the National Health Board to develop and implement a set of targeted interventions designed to reduce health spending based on solid and current data. The list might include, for example, reducing covered benefits; raising copayments and deductibles except for the poor ; removing from coverage and inclusion in the uniform effective covered benefit package those drugs and other technologies of very high cost in relation to the benefits produced with protection against tort litigation for providers who comply ; antitrust action against local cartels; and possibly taxing the excess of premiums over the premiums of the low-cost benchmark plan in each area.
In other words, government should examine the causes of excess spending and apply specific remedies, rather than trying to sweep the problems under the carpet of a national global budget. Managed competition is not a lot of things it has been called by people who do not understand it or who prefer central governmental controls to decentralized markets.
A free market does not and cannot work in health insurance and health care. If not corrected by a careful design, this market is plagued by problems of free riders, biased risk selection, segmentation, and other sources of market failure. Managed competition uses market forces within a framework of carefully drawn rules. In managed competition, sponsors work actively to perfect the market.
Everyone is given an opportunity to enroll. It is new rules, not no rules. On the contrary, managed competition emphasizes the importance of individual not employer choice of plans. Many systems and styles would be able to compete effectively, including familiar solo doctor styles in some selective individual practice models.
However, managed competition does make people bear the economic consequences of their choices. On the contrary, far more often than not, quality and economy in medical care go hand-in-hand. The correct diagnosis done promptly, and the appropriate procedure done by someone very proficient, without errors or complications, is best for the patient and the payer.