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Assessing Social Value in Economic Evaluation to Scale Up Novel TB Drug Regimens

评估经济评价中的社会价值以扩大新型结核病药物治疗方案

基本信息

批准号：
8870516
负责人：
Maria Weston Merritt
金额：
$ 30.23万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-07-21 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8870516
关键词：
Accounting Benefits and Risks Bioethics Consultants Cause of Death Cessation of life Cost Effectiveness Analysis Country Critiques Data Data Collection Decision Analysis Decision Making Disease Elements Ethics Funding Funding Agency Future Goals HIV Health Health Personnel Health Policy Health Professional Health system Human Infection Intervention Life Low income Malawi Measures Methodology Methods Modeling Morals Outcome Patient Representative Patients Pharmaceutical Preparations Phase Phase III Clinical Trials Play Population Process Public Health Recommendation Regimen Research Rural Scientist Social Justice Social Values Societies South Africa Techniques Time Treatment Cost Treatment Protocols Tuberculosis Uganda authority base civil society cost design disability-adjusted life years economic evaluation experience flexibility innovation member novel programs scale up social theories tool tuberculosis drugs tuberculosis treatment

项目摘要

DESCRIPTION (provided by applicant): Assessing Social Value in Economic Evaluation to Scale up Novel TB Drug Regimens The goal of the proposed 3-year interdisciplinary multi-method project is to develop an innovative methodology to enhance traditional economic evaluation, using novel drug regimens for tuberculosis (TB) as a paradigm case. Over 400,000 people living with HIV (PLHIV) die of tuberculosis (TB) every year, accounting for 25% of the world's HIV-related deaths, most of them in low-income countries. TB treatment has changed little since the 1980s, requiring months of burdensome, often-toxic therapy. Prospects for developing novel TB drug regimens to alleviate treatment-induced suffering, however, are more promising now than at any time in the past 40 years. The emergence of novel TB drug regimens presents policymakers with decisions of far-reaching consequence regarding which novel regimens to implement at the population level (that is, to scale up) in specific settings. Economic evaluation is a critical component of the scale-up decision-making process for novel TB drug regimens. The most common form of economic evaluation is cost-effectiveness analysis (CEA). Traditional CEA compares the costs of interventions against health outcomes such as lives saved, years of life gained, or disability-adjusted life years (DALYs) averted. To be sure, such considerations have ethical importance, but decision-making processes that focus narrowly on them will deliver recommendations that fail to account for other human concerns of comparable ethical importance. This is a longstanding general problem in the ethics of health policy. A powerful ethical critique targets the inability of traditional CEA to incorporate central elements f social justice. Moreover, CEA does not take into account the perspectives of key stakeholders such as patients and healthcare providers, yet without their support no health intervention can be successfully scaled up. Our proposed methodology will enable decision makers to assess incremental social value - an innovative measure incorporating not only traditional cost-effectiveness analysis, but also norms of social justice and key stakeholders' perspectives - for a range of promising novel TB drug regimens. We will develop this methodology by accomplishing 3 specific aims: (1) using philosophical methods, we will demonstrate how to quantify the greatest gains or losses to social justice posed by the scale-up of novel TB drug regimens in a range of settings where the poorest members of society are most burdened by TB, often together with HIV; (2) using empirical data collection with patients, healthcare providers, and public health policymakers in 3 HIV-endemic, high TB-burden settings, we will demonstrate how to incorporate data on stakeholders' perspectives into economic evaluation; and (3) using formal modeling techniques, we will develop a flexible decision analysis model so that users can "plug and play," inserting parameters that reflect their settings and obtaining locally relevant assessments of incremental social value. Our overarching objective is to support scale-up decision-making processes (with potential application to research program design as well) that are more ethically responsible than they would be using traditional CEA.

描述（由申请人提供）：评估经济评估的社会价值，以扩大新型结核病药物方案拟议的3年跨学科多方法项目的目标是开发一种创新的方法，以加强传统的经济评估，使用结核病（TB）的新型药物方案作为范例。每年有超过40万艾滋病毒感染者（PLHIV）死于结核病（TB），占世界艾滋病毒相关死亡人数的25%，其中大多数发生在低收入国家。自20世纪80年代以来，结核病治疗几乎没有变化，需要数月的繁重，往往有毒的治疗。然而，开发新的结核病药物疗法以减轻治疗引起的痛苦的前景现在比过去40年中的任何时候都更有希望。新型结核病药物治疗方案的出现为决策者提供了在特定环境下在人群水平上实施（即扩大规模）何种新型治疗方案的具有深远影响的决定。经济评估是扩大新型结核病药物治疗方案决策过程的关键组成部分。最常见的经济评估形式是成本效益分析（CEA）。传统的CEA将干预措施的成本与健康结果进行比较，如挽救的生命、增加的寿命或避免的残疾调整生命年（DADs）。诚然，这些考虑具有伦理重要性，但狭隘地关注这些考虑的决策过程将提供无法考虑具有类似伦理重要性的其他人类关切的建议。这是卫生政策伦理学中一个长期存在的普遍问题。一个强有力的伦理批评的目标是传统的CEA无法纳入社会正义的核心要素。此外，CEA没有考虑到患者和医疗保健提供者等关键利益相关者的观点，但没有他们的支持，任何健康干预措施都无法成功扩大。我们提出的方法将使决策者能够评估一系列有前途的新型结核病药物治疗方案的增量社会价值--这是一种创新措施，不仅纳入了传统的成本效益分析，还纳入了社会正义规范和关键利益相关者的观点。我们将通过实现3个具体目标来发展这一方法：（1）使用哲学方法，我们将展示如何量化在一系列环境中扩大新型结核病药物治疗方案对社会正义造成的最大收益或损失，这些环境中最贫穷的社会成员受结核病（通常与艾滋病毒一起）的负担最重;（2）在3个艾滋病流行、结核病负担高的环境中，通过对患者、医疗服务提供者和公共卫生政策制定者的经验数据收集，我们将演示如何将利益相关者观点的数据纳入经济评估;以及（3）使用正式建模技术，我们将开发一个灵活的决策分析模型，以便用户可以“即插即用”，插入反映其设置的参数，并获得与本地相关的增量社会价值评估。我们的总体目标是支持规模扩大的决策过程（具有潜在的应用程序，以及研究项目设计），这是更道德的责任比他们将使用传统的CEA。