Economic Evaluations of Emerging Genomic Tests for Early Stage Breast Cancer

描述（由申请人提供）：新兴的医疗技术正在大大改善我们的医疗保健选择，但往往在相当大的额外成本。成本效益和可负担性被描述为新医疗技术的第四和第五个障碍，仅次于传统的三个许可要求：安全性，有效性和质量。人类基因组计划提供了充分的机会，通过创新的基因组技术来改善人类健康，这些技术只是最近才出现的。已经开发了许多基因组预后和预测测试，以帮助医生为早期乳腺癌（ESBC）患者提供更好的治疗。这些新兴基因组检测的临床应用不仅取决于检测的准确性，还取决于其对社会的经济影响。本研究的目的是使用经济评价的方法，以检查药物基因组学预后和预测测试的性能和它们的成本之间的关系，在一个合理的范围内的测试性能和成本的背景下ESBC的妇女的成本效益和负担能力。具体目标如下： 1.比较使用药物基因组学预后检测与目前治疗ESBC的实践的成本效益 2.评估使用药物基因组学预测试验与目前治疗ESBC的实践的成本效益 3.评价药物基因组学预后和预测性检测与目前治疗ESBC的实践相结合的成本效益 4.估计新兴药物基因组学预后和/或预测检测的预算影响

DESCRIPTION (provided by applicant): Emerging medical technologies are substantially improving our health care options, but often at considerable added cost. Cost-effectiveness and affordability are described as the fourth and fifth hurdles for new medical technologies, following the traditional three hurdles for licensing requirements: safety, efficacy, and quality. The Human Genome Project offers ample opportunity to improve human health through innovative genome-based technologies that have only recently become available. A number of genomic prognostic and predictive tests have been developed to assist physicians in providing better treatment for patients with early-stage breast cancer (ESBC). Clinical use of these emerging genomic tests will depend not only on the accuracy of the tests but also on their economic impacts to the society. The purpose of this study is to use methods of economic evaluation to examine the relationship between the performance of pharmacogenomic prognostic and predictive tests and their costs over a plausible range of test performance and costs for women with ESBC in the context of costeffectiveness and affordability. The specific aims are the following: 1. To compare the cost-effectiveness of using pharmacogenomic prognostic tests versus current practices in the treatment of ESBC 2. To assess the cost-effectiveness of using pharmacogenomic predictive tests versus current practices in the treatment of ESBC 3. To evaluate the cost-effectiveness of using a combination of pharmacogenomic prognostic and predictive tests versus current practices in the treatment of ESBC 4. To estimate the budgetary impact of the emerging pharmacogenomic prognostic and/or predictive tests