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）：指南建议计算总体心血管（CVD）风险，以便将有效的预防干预措施（如阿司匹林和他汀类药物）针对最有可能受益的人群，并通过不治疗低风险人群来限制不良反应和成本。通过使用新的生物标志物来提高我们预测谁将遭受未来CVD事件的能力，应该有助于我们提高预防性干预措施的针对性，从而改善健康结果。近年来，许多这样的标志物已被确定，其中一些已被广泛研究;然而，存在一个广泛承认的知识“关键差距”，阻碍了有效的决策是否应在临床实践中采用这样的生物标志物。我们认为，这一关键差距是缺乏关于生物标志物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，用于评估任何可用于靶向使用阿司匹林和他汀类药物进行CVD一级预防的生物标志物（目标1）。在这项任务中，我们将使用ESTA/RTI冠心病预防模型，这是一个已建立的模型，专注于阿司匹林和他汀类药物处方预防冠心病和中风的成本效益。该模型将通过一系列系统评价进行更新，以纳入阿司匹林和他汀类药物有效性和不良反应的最新数据，然后进行重组，以允许基于生物标志物测量的“测试和治疗”策略（需要4种不同“子场景”的并行建模，以允许3种可能的测试和治疗治疗阈值），并便于将测试和治疗策略与全部治疗和不治疗（不产生与测试本身相关的成本和任何不利影响的策略）进行比较。然后，该框架将用于评价冠状动脉钙（目标2）。这种极具争议的生物标志物是CHD风险的一个强有力的独立预测因子，但测量和使患者暴露于电离辐射是昂贵的。我们将在一组全面的临床场景中对不同的冠状动脉钙治疗阈值进行系统评价，这些场景在年龄、性别、LDL水平和CVD风险方面有所不同，并在成本和健康影响以及增量成本效益方面进行比较。最后，我们将建立一个在线界面，允许用户通过输入生物标志物出版物中常用的信息来筛选任何用于靶向阿司匹林和他汀类药物治疗的生物标志物（在相对理想的情况下），并允许用户改变关键参数，如他汀类药物的成本（目标3）。 我们的项目将缩小CVD生物标志物使用知识的关键差距，产生可立即用于推动合理决策的冠状动脉钙的关键证据，允许研究人员和政策制定者筛选其他生物标志物的在线工具在这种情况下使用，以及评估在其他环境中使用生物标志物靶向预防的路线图。 公共卫生关系：冠状动脉钙的“心脏扫描”和其他新发现的测试（“生物标志物”）可以帮助识别有心脏病发作和中风风险的人，他们应该接受药物治疗以降低风险。通过估计在美国常规使用这些测试可以预防多少心脏病发作，中风和死亡，以及这将花费多少钱，我们的研究将帮助政策制定者决定医生何时应该订购心脏扫描或其他生物标志物测试。