Arbor Research Collaborative for Health, Ann Arbor, MI, USA.
University of Michigan, College of Pharmacy, Ann Arbor, MI, USA.
Am J Transplant. 2018 Jul;18(7):1764-1773. doi: 10.1111/ajt.14722. Epub 2018 Mar 31.
The transplant community is divided regarding whether substitution with generic immunosuppressants is appropriate for organ transplant recipients. We estimated the rate of uptake over time of generic immunosuppressants using US Medicare Part D Prescription Drug Event (PDE) and Colorado pharmacy claims (including both Part D and non-Part D) data from 2008 to 2013. Data from 26 070 kidney, 15 548 liver, and 6685 heart recipients from Part D, and 1138 kidney and 389 liver recipients from Colorado were analyzed. The proportions of patients with PDEs or claims for generic and brand-name tacrolimus or mycophenolate mofetil were calculated over time by transplanted organ and drug. Among Part D kidney, liver, and heart beneficiaries, the proportion dispensed generic tacrolimus reached 50%-56% at 1 year after first generic approval and 78%-81% by December 2013. The proportion dispensed generic mycophenolate mofetil reached 70%-73% at 1 year after generic market entry and 88%-90% by December 2013. There was wide interstate variability in generic uptake, with faster uptake in Colorado compared with most other states. Overall, generic substitution for tacrolimus and mycophenolate mofetil for organ transplant recipients increased rapidly following first availability, and utilization of generic immunosuppressants exceeded that of brand-name products within a year of market entry.
移植界对于是否应使用通用免疫抑制剂替代器官移植受者的药物存在分歧。我们利用美国医疗保险处方药物事件（PDE）和科罗拉多州药房（包括 Part D 和非 Part D）数据，从 2008 年至 2013 年，估计了通用免疫抑制剂的使用率随时间的变化情况。对来自 Part D 的 26070 例肾移植、15548 例肝移植和 6685 例心脏移植患者以及来自科罗拉多州的 1138 例肾移植和 389 例肝移植患者的数据进行了分析。按移植器官和药物，计算了 PDE 或通用和品牌名他克莫司或吗替麦考酚酯的用药数据随时间的变化比例。在接受 Part D 治疗的肾、肝和心脏受益患者中，通用他克莫司的使用率在首次获得通用批准后 1 年内达到 50%-56%，到 2013 年 12 月达到 78%-81%。通用吗替麦考酚酯的使用率在进入通用市场后 1 年内达到 70%-73%，到 2013 年 12 月达到 88%-90%。通用药物的使用存在州际差异，科罗拉多州的使用速度快于其他大多数州。总体而言，在首次上市后，他克莫司和吗替麦考酚酯的通用替代方案迅速增加，通用免疫抑制剂的使用量在进入市场后一年内超过了品牌产品。
