Diffusion /Outcomes of Marketed /Unmarketed Cancer Drugs

已上市/未上市抗癌药物的扩散/结果

• 批准号: 7028437
• 负责人: Scott J Johnson
• 金额: $ 2.78万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-09 至 2006-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7028437
• 关键词: Medicare /Medicaid; antineoplastics; behavioral /social science research tag; clinical research; ethics; health care cost /financing; health care quality; health related legal; health services research tag; human data; motivation; neoplasm /cancer chemotherapy; outcomes research; patient care; physicians; public health

DESCRIPTION (provided by the applicant): Understanding the roles that physician financial incentives and manufacturer promotion play in the diffusion and use of new technology is of central interest to policy makers. By using an innovative means to identify off label use in SEER-Medicare panel data with over 500,000 patients from 1991 to 2002, three specific research aims will be pursued in informing that understanding. First, the research will quantify the descriptive statistics of off-label use of anticancer drugs. Off-label drugs are those drugs prescribed for diagnoses other than those for which there is FDA-qualified evidence of safety and efficacy. Despite assumptions that fifty percent of anti-cancer uses are off-label, there has never been a valid descriptive quantification of their actual use by physicians on patients. Second, the candidate will address whether reimbursement for chemotherapy drugs influences their patterns of use, and if so, whether such use contributes to outcomes. Profit per chemo administration varies significantly across drugs, time, Medicare carrier jurisdiction, and product label. By exploiting variation across Medicare carriers' coverage policies and reimbursement levels for off-label chemotherapeutics in the 1990's, the candidate will test how financial incentives affected physician use and patient outcomes. Third, the candidate will address whether the prohibition on promoting medical technology for which there is unsatisfactory evidence of safety and efficacy from a regulatory perspective affects patterns of use and quality of care. The candidate will use a court ruling in 1999 that caused a relaxation of this policy to test how it affected off-label drug administrations and outcomes. Patterns of use in the second and third research aims will be estimated with a conditional logit discrete choice model where the dependent variable consists of all drug choices for a physician at a point in time. Outcomes will be estimated using a Cox proportional hazard model, where the dependent variable is patient mortality at a point in time. The overall objective of this research is to further our understanding of the benefits and costs of FDA and CMS policy that respectively restrict off-label detailing but allow for its reimbursement. This research has the capacity to inform policies dealing with product promotion regulation and physician financial incentives, especially in the war on cancer.

描述（由申请人提供）：了解医生经济激励和制造商促销在新技术的传播和使用中所发挥的作用是政策制定者的核心利益。通过使用创新的方法来识别 1991 年至 2002 年间超过 500,000 名患者的 SEER-Medicare 面板数据中的超说明书使用情况，我们将追求三个具体的研究目标来传达这种理解。 首先，该研究将量化抗癌药物超说明书使用的描述性统计数据。标签外药物是指为诊断而开具的药物，但有 FDA 合格的安全性和有效性证据的药物除外。尽管假设百分之五十的抗癌用途是标签外用途，但医生对患者的实际使用情况从未有过有效的描述性量化。其次，候选人将讨论化疗药物的报销是否影响其使用模式，如果是，这种使用是否有助于结果。每次化疗的利润因药物、时间、医疗保险承运人管辖范围和产品标签的不同而存在显着差异。通过利用 20 世纪 90 年代 Medicare 承保政策和标签外化疗药物报销水平的变化，候选人将测试经济激励如何影响医生的使用和患者的治疗结果。第三，候选人将讨论禁止推广从监管角度来看安全性和有效性证据不令人满意的医疗技术是否会影响使用模式和护理质量。候选人将利用 1999 年法院的一项裁决（该裁决导致该政策放宽）来测试其对超说明书用药管理和结果的影响。 第二个和第三个研究目标的使用模式将使用条件 Logit 离散选择模型进行估计，其中因变量包括医生在某个时间点的所有药物选择。结果将使用 Cox 比例风险模型进行估计，其中因变量是某个时间点的患者死亡率。 这项研究的总体目标是进一步了解 FDA 和 CMS 政策的收益和成本，这些政策分别限制标签外细节，但允许其报销。这项研究有能力为有关产品促销监管和医生经济激励的政策提供信息，特别是在抗击癌症方面。