An Economic Framework for Evaluating Biomarkers Used to Target CVD Prevention

评估用于预防 CVD 的生物标志物的经济框架

• 批准号: 8181126
• 负责人: MICHAEL P PIGNONE
• 金额: $ 19.28万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-21 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8181126
• 关键词: Address; Adopted; Adverse effects; Advisory Committees; Age; Area; Aspirin; Biological Markers; Calcium; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Clinical; Coronary; Cost Savings; Data; Decision Analysis; Decision Making; Disease; Economics; Effectiveness; Evaluation; Event; Framingham Heart Study; Future; Generic Drugs; Genetic Markers; Guidelines; Health; Health Care Costs; Intervention; Ionizing radiation; Knowledge; Low-Density Lipoproteins; Measurement; Measures; Medicine; Modeling; Myocardial Infarction; Outcome; Output; Patients; Persons; Pharmaceutical Preparations; Policy Making; Prevention; Preventive; Preventive Intervention; Price; Primary Prevention; Public Health; Publications; Radiation-Induced Cancer; Relative Risks; Research; Research Personnel; Risk; Risk Estimate; Risk Factors; Science; Screening procedure; Series; Services; Simulate; Stroke; Subgroup; Testing; Translating; Translational Research; Translations; Update; base; cardiovascular disorder prevention; cardiovascular disorder risk; cardiovascular risk factor; clinical care; clinical practice; cost; cost effective; cost effectiveness; economic impact; health economics; heart imaging; high risk; improved; models and simulation; novel; prevent; sex; systematic review; tool

DESCRIPTION (provided by applicant): Guidelines recommend calculation of global cardiovascular (CVD) risk in order to target effective prevention interventions such as aspirin and statins to those most likely to benefit and to limit adverse effects and costs by not treating those at low risk. Improving our ability to predict who will suffer future CVD events through use of novel biomarkers should help us improve targeting of preventive interventions and thereby improve health outcomes. Many such markers have been identified over recent years, and some have been studied extensively; however, a widely-acknowledged "critical gap" in knowledge exists that has hindered effective decision-making about whether such biomarkers should be adopted in clinical practice. It is our view that this critical gap is the result of a lack of evidence about the net health and economic impact of biomarker targeting strategies. To address this gap, we propose to develop a decision analysis/cost-effectiveness modeling framework for evaluating any biomarker that could be used to target use of aspirin and statins for primary prevention of CVD (Aim 1). For this task, we will use the UNC/RTI CHD Prevention Model, an established model focusing on the cost-effectiveness of aspirin and statin prescribing for prevention of CHD and stroke. The model will be updated via a series of systematic reviews to incorporate the latest data on effectiveness and adverse effects of aspirin and statins, and then restructured to allow "Test-and-Treat" strategies based on biomarker measurements (requiring parallel modeling of 4 different "sub-scenarios" to allow for 3 possible Test-and-Treat treatment thresholds), and to facilitate comparison of Test-and-Treat strategies with Treat All and Treat None (strategies not incurring the cost and any adverse effects associated with the test itself). This framework will then be used to evaluate coronary calcium (Aim 2). This extremely controversial biomarker is a strong independent predictor of CHD risk, but it is expensive to measure and exposes the patient to ionizing radiation. We will undertake a systematic evaluation of different coronary calcium treatment thresholds in a comprehensive set of clinical scenarios varied in terms of age, sex, LDL level and CVD risk, and compared in terms of cost and health impact, and incremental cost-effectiveness. Finally, we will build an online interface allowing users to screen ANY biomarker for use in targeting aspirin and statin therapy (in a relatively ideal scenario) by inputting information commonly available in biomarker publications, and allowing users to vary key parameters such as the cost of statins (Aim 3). Our project would close the critical gap in knowledge on CVD biomarker use, produce key evidence for coronary calcium that could be used immediately to drive rational policy-making, an online tool allowing researchers and policymakers to screen other biomarkers for use in this setting, and a roadmap for evaluating use of biomarker targeted prevention in other settings. PUBLIC HEALTH RELEVANCE: "Heart scans" for coronary calcium and other newly discovered tests ("biomarkers") can help identify persons at risk for heart attacks and stroke who should be treated with medications to lower their risk. By estimating how many heart attacks, strokes and deaths could be prevented by using these tests routinely in the U.S. and how much money this would cost, our study will help policymakers decide when doctors should order a heart scan or other biomarker test.

描述（由申请人提供）：指南建议计算全球心血管（CVD）风险，以靶向有效的预防干预措施，例如阿司匹林和他汀类药物，以使最有可能受益的人通过不给予低风险的人来限制不良影响和成本。提高我们通过使用新型生物标志物来预测谁将遭受未来CVD事件的能力应有助于我们改善预防性干预措施的靶向，从而改善健康状况。近年来，已经确定了许多这样的标记，有些是经过广泛研究的。但是，存在一个广泛的知识中存在的“关键差距”，这阻碍了关于在临床实践中是否应采用这种生物标志物的有效决策。我们认为，这一关键差距是缺乏有关靶向策略的净健康和经济影响的证据的结果。 为了解决这一差距，我们建议开发一个决策分析/成本效益建模框架，以评估任何可用于靶向使用阿司匹林和他汀类药物以初级预防CVD的生物标志物（AIM 1）。对于此任务，我们将使用UNC/RTI CHD预防模型，这是一个既定的模型，旨在侧重于阿司匹林和他汀类药物处方的成本效益，以预防CHD和中风。 The model will be updated via a series of systematic reviews to incorporate the latest data on effectiveness and adverse effects of aspirin and statins, and then restructured to allow "Test-and-Treat" strategies based on biomarker measurements (requiring parallel modeling of 4 different "sub-scenarios" to allow for 3 possible Test-and-Treat treatment thresholds), and to facilitate comparison of Test-and-Treat strategies with Treat All and Treat None (strategies不产生与测试本身有关的成本和任何不利影响）。然后，该框架将用于评估冠状动脉钙（AIM 2）。这种极具争议性的生物标志物是CHD风险的强大独立预测指标，但是测量和暴露患者处于电离辐射方面是昂贵的。我们将在一组全面的临床方案中对不同的冠状动脉治疗阈值进行系统评估，在年龄，性别，LDL水平和CVD风险方面有所不同，并在成本和健康影响方面进行比较，以及逐步的成本效益。最后，我们将构建一个在线界面，允许用户通过输入在生物标志物出版物中常见的信息来筛选用于靶向阿司匹林和他汀类药物疗法的任何生物标志物（在相对理想的情况下），并允许用户改变关键参数，例如汀类药物的成本（AIM 3）。 我们的项目将缩小有关CVD生物标志物使用知识的关键差距，为冠状动脉钙提供关键证据，可立即用于推动理性的决策制定，一种在线工具，允许研究人员和决策者在此设置中筛选其他生物标志物，以及用于评估在其他设置中使用生物标志物预防的路线图。 公共卫生相关性：冠状动脉钙和其他新发现的测试（“生物标志物”）的“心脏扫描”可以帮助识别有患心脏病和中风风险的人，应接受药物治疗以降低风险。通过估计有多少心脏病发作，可以通过常规在美国使用这些测试来预防中风和死亡，这将花费多少钱，我们的研究将有助于决策者决定何时医生订购心脏扫描或其他生物标志物测试。