Transplant Outcomes Using Generic and Brand Name Immunosuppressants: studying medications used by people who have received kidney and liver transplants

使用通用名和品牌免疫抑制剂的移植结果：研究接受肾脏和肝脏移植的人使用的药物

• 批准号: 8875441
• 负责人: Emily Messersmith
• 金额: $ 49.41万
• 依托单位: ARBOR RESEARCH COLLABORATIVE FOR HEALTH
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-10 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8875441
• 关键词: Transplant; Outcomes; Using; Generic; Brand

7. Abstract/Project Summary Each year since 2009, more than 28,000 people have received organ transplants in the United States. Immunosuppressive medications are critical to reduce rejection and graft loss in transplant recipients. These medications can be expensive and pose a financial burden to patients, leading to non-adherence. Substituting costly brand name medications with therapeutically equivalent, less expensive generic medications is a potential solution to overcome the financial barrier and improve access and adherence to immunosuppressants. However, there are questions regarding the therapeutic equivalence of generic and brand name immunosuppressants. In addition, generic products have not been compared with each other; thus, there is a concern regarding the substitution of one generic for another generic. This uncertainty is problematic for clinicians who seek to provide the best care for their patients. To examine the utility of generic immunosuppressants, we will study recipients of kidney and liver transplants between 2008 and 2013. The first of three specific aims of the project is to describe patterns of generic and brand immunosuppressant use after transplant. These patterns will be examined for patients by time since transplant and also by calendar date, to carefully tease apart changes that occur as patient needs evolve from changes that coincide with changes in the availability of generic immunosuppressants. We will describe patterns at the level of the transplant program, aggregated across patients, to understand program-level factors associated with the speed of generic immunosuppressant adoption. To address our second specific aim, we will compare risks of biopsy-proven and treated rejection and graft failure for patients on generic and brand name immunosuppressants. We will use time-dependent Cox regressions to model these risks, controlling for variability between recipients, organ donors, and characteristics of the transplant surgery. We will carefully examine heterogeneity of treatment effects in patient subgroups, including pediatric patients and adults, racial and ethnic minorities, women and men, and patients with medical complexities or greater- than-average risk for adverse outcomes. Assuming we find no meaningful difference in the effectiveness of generic medications relative to brand name medications, our third aim will be to quantify the costs associated with each type of medication. We will demonstrate the savings to patients and to payers through the use of generic immunosuppressants in place of brand name immunosuppressants. Ultimately, we expect that this study will provide significant new insights regarding the use of generic and brand name immunosuppressants, leading to improved care for transplant recipients.

7. 摘要/项目总结 自2009年以来，美国每年都有超过28,000人接受器官移植。 免疫抑制药物对于减少移植受者的排斥反应和移植物丢失至关重要。这些 药物可能价格昂贵，给患者带来经济负担，导致患者不依从治疗。替代 昂贵的品牌药物与治疗效果相当、较便宜的仿制药相结合是一种选择 克服财务障碍并改善免疫抑制剂的获取和依从性的潜在解决方案。 然而，关于通用名和品牌名的治疗等效性存在问题 免疫抑制剂。此外，通用产品之间尚未进行比较；因此，有一个 关于用一种仿制药替代另一种仿制药的担忧。这种不确定性对于 寻求为患者提供最好护理的临床医生。 为了检验非专利免疫抑制剂的效用，我们将研究肾移植和肝移植的受者 2008 年至 2013 年间。该项目的三个具体目标中的第一个是描述通用和 移植后使用品牌免疫抑制剂。这些模式将按时间对患者进行检查 移植并按日历日期仔细梳理随着患者需求的变化而发生的变化 与通用免疫抑制剂的可用性变化相一致的变化。我们将描述 移植计划层面的模式，跨患者汇总，以了解计划层面 与通用免疫抑制剂采用速度相关的因素。解决我们的第二个具体问题 目的，我们将比较经活检证实和治疗的排斥反应和移植失败的风险。 品牌免疫抑制剂。我们将使用时间相关的 Cox 回归来对这些风险进行建模， 控制受者、器官捐献者和移植手术特征之间的差异。我们 将仔细检查患者亚组（包括儿科患者）治疗效果的异质性 以及成年人、种族和族裔少数群体、女性和男性，以及患有医疗复杂性或更严重的患者- 不良后果的风险高于平均水平。假设我们发现有效性没有显着差异 相对于品牌药物，我们的第三个目标是量化成本 与每种药物相关。我们将通过以下方式向患者和付款人展示节省的费用 使用通用免疫抑制剂代替品牌免疫抑制剂。最终，我们期望 这项研究将为通用名和品牌名的使用提供重要的新见解 免疫抑制剂，从而改善对移植受者的护理。