Determinants and risks of use and overuse of expensive oncology drugs

描述(申请人提供)：过去十年见证了多种新疗法的引入，用于癌症患者的治疗和支持性护理。然而，研究表明，一些癌症患者没有接受这些更新的、更有效的治疗，而另一些癌症患者则接受了这些昂贵的治疗，但没有生存或生活质量好处的证据。虽然在可能挽救生命的手术和化疗的背景下，使用不足在一定程度上得到了评估，但对过度使用的评估很少。我们小组以前有丰富的经验，使用SEER-Medicare数据库来探索被证明有效的癌症治疗的使用模式。我们现在建议扩大我们的研究，以评估这些新的、昂贵的疗法的过度使用。由于经济学的影响，有关适当使用和过度使用昂贵的癌症新疗法和技术的问题非常令人感兴趣。我们建议使用关联监测、流行病学和最终结果(SEER)-医疗保险数据库来评估几种重要的新的昂贵疗法的“适当使用”、“过度使用”、益处和毒副作用的模式。我们将研究的治疗方法已经公布了循证临床指南，建议适当使用：(1)静脉注射双膦酸盐(帕米磷酸/唑来膦)治疗多发性骨髓瘤或实体瘤骨转移患者；(2)在几种常见癌症中使用红细胞刺激剂(ESA)；(3)在高级别和低级别淋巴瘤患者中使用第一种抗肿瘤抗体利妥昔单抗(利妥昔单抗)。此外，对于每一种药物，我们将确定患者(种族、年龄、社会经济地位)、肿瘤(阶段、级别)、卫生系统(教学医院、癌症中心)和医生特征(专业、年龄、性别)对使用模式、使用时间和非标签使用的影响。这项研究将采用回溯性队列设计，使用最新的SEER-Medicare和美国医学会主文件。为了在控制医疗成本的同时改善绩效结果和医疗质量，我们需要了解医疗模式，以便能够实施有针对性的干预措施，以提高质量。所获得的信息将有助于指导政策制定者改进对癌症治疗越来越多的治疗选择的使用的监管。表演现场(S)纽约哥伦比亚大学医学中心。在过去的十年里，为癌症患者的治疗和支持性护理引入了多种新的疗法。然而，研究表明，一些癌症患者没有接受这些新的、有效的治疗，而另一些人则在没有证据的情况下接受了这些昂贵的治疗。我们建议使用关联监测、流行病学和最终结果(SEER)-医疗保险数据库来评估几种重要的新的昂贵疗法的“适当使用”、“过度使用”、益处和毒副作用的模式。与公共卫生相关：过去十年见证了多种新疗法的引入，用于癌症患者的治疗和支持性护理。然而，研究表明，一些癌症患者没有接受这些新的、有效的治疗，而另一些人则在没有证据的情况下接受了这些昂贵的治疗。我们建议使用关联监测、流行病学和最终结果(SEER)-医疗保险数据库来评估几种重要的新的昂贵疗法的“适当使用”、“过度使用”、益处和毒性的模式

DESCRIPTION (provided by applicant): The past decade has witnessed the introduction of multiple new therapies for the treatment and supportive care of cancer patients. However, studies suggest that some cancer patients do not receive these newer, more effective treatments while others are offered these costly treatments without evidence of survival or quality-of-life benefit. While under-use has been evaluated to some degree in the setting of potentially life- saving surgery and chemotherapy, there has been very little evaluation of over-use. Our group has previously had extensive experience using the SEER-Medicare database to explore the utilization patterns of cancer treatments proven to be efficacious. We now propose to extend our studies to evaluate over-use of these newer, costly therapies. Because of the economc implications, issues concerning the appropriate use and over-use of expensive new cancer treatment and technology is of great interest. We propose to use the linked Surveillance, Epidemiology and End Results (SEER)-Medicare database to evaluate several important new costly therapies for their patterns of "appropriate use", over-use", benefits and toxicities. The treatments we will investigate have published evidence-based clinical guidelines advising appropriate use: (1) use of IV bisphosphonates (pamidronate/zoledronate) in patients with multiple myeloma or solid tumors with bone metastases; (2) use of erythrocyte stimulating agents (ESA's) in several common cancers; (3) use of the first anti-tumor antibody, rituximab (Rituxan), in patients with high and low grade lymphoma. In addition, for each of these agents we will identify the impact of patient (race, age, socioeconomic status), tumor (stage, grade), health system (teaching hospital, cancer center) and physician characteristics (specialty, age, gender) on the patterns of use, length of use and off-label use. This study will use a retrospective cohort design using the most updated SEER-Medicare and the American Medical Association Master file. In order to improve performance outcomes and quality of care while controlling health care costs, we need to understand patterns of care so that targeted interventions to improve quality can be implemented. The information obtained will help guide policy makers to improve the reglation of the use of the increasing cadre of treatment options for cancer treatments. PERFORMANCE SITE(S) Columbia University Medical Center, NY, NY. The past decade has witnessed the introduction of multiple new therapies for the treatment and supportive care of cancer patients. However, studies suggest that some cancer patients do not receive these newer, effective treatments while others are offered these costly treatments without evidence of benefit. We propose to use the linked Surveillance, Epidemiology and End Results (SEER)-Medicare database to evaluate several important new costly therapies for their patterns of "appropriate use", over-use", benefits and toxicities. PUBLIC HEALTH RELEVANCE: The past decade has witnessed the introduction of multiple new therapies for the treatment and supportive care of cancer patients. However, studies suggest that some cancer patients do not receive these newer, effective treatments while others are offered these costly treatments without evidence of benefit. We propose to use the linked Surveillance, Epidemiology and End Results (SEER)-Medicare database to evaluate several important new costly therapies for their patterns of "appropriate use", "over-use", benefits and toxicities