Determinants and risks of use and overuse of expensive oncology drugs

描述（由申请人提供）：在过去的十年中，已经引入了多种新疗法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，更有效的治疗，而其他人则提供这些昂贵的治疗，没有证据表明生存或生活质量的好处。虽然在可能挽救生命的手术和化疗的背景下对使用不足进行了一定程度的评价，但对过度使用的评价很少。我们的小组以前有广泛的经验，使用SEER医疗保险数据库，探索利用模式的癌症治疗被证明是有效的。我们现在建议扩展我们的研究，以评估这些新的，昂贵的疗法的过度使用。由于其经济意义，关于适当使用和过度使用昂贵的新癌症治疗和技术的问题引起了极大的兴趣。我们建议使用相关的监测、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”、益处和毒性模式。我们将研究的治疗方法已发表循证临床指南，建议适当的用途：（1）在多发性骨髓瘤或伴有骨转移的实体瘤患者中使用IV双膦酸盐（帕米膦酸盐/唑来膦酸盐）;（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（Rituxan）。此外，对于这些药物中的每一种，我们将确定患者（种族、年龄、社会经济地位）、肿瘤（分期、等级）、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、使用时长和超说明书使用的影响。本研究将采用回顾性队列设计，使用最新的SEER-Medicare和美国医学会主文件。为了提高绩效结果和护理质量，同时控制医疗保健成本，我们需要了解护理模式，以便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善对越来越多的癌症治疗方案的使用的监管。性能地点：哥伦比亚大学医学中心，纽约州纽约市。在过去的十年中，已经出现了多种新疗法，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，有效的治疗，而其他人提供这些昂贵的治疗没有证据的好处。我们建议使用相关的监测、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”、益处和毒性模式。公共卫生相关性：在过去的十年中，已经出现了多种新疗法，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，有效的治疗，而其他人提供这些昂贵的治疗没有证据的好处。我们建议使用相关的监测、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