Muduma Gorden, Odeyemi Isaac, Pollock Richard Fulton
Astellas Pharma EMEA Limited, Chertsey, UK.
Ossian Health Economics and Communications, GmbH, Bäumleingasse 20, 4051, Basel, Switzerland.
Drugs Real World Outcomes. 2016 Mar;3(1):61-68. doi: 10.1007/s40801-015-0058-x.
As of 2014, there were approximately 8300 patients with a functioning liver transplant in the UK Transplant Registry, with 880 liver transplants performed in 2013-2014 alone. Tacrolimus, typically used in combination with steroids and mycophenolate mofetil, currently represents the cornerstone of post-transplant immunosuppression in liver transplant recipients.
The objective of the present study was to evaluate the cost-effectiveness of prolonged-release (PR) tacrolimus (Advagraf, Astellas Pharma Inc., Tokyo, Japan) versus branded immediate-release (IR) tacrolimus (Prograf, Astellas Pharma Inc., Tokyo, Japan) in liver transplant recipients in the UK.
A model was developed in Microsoft Excel to estimate costs associated with immunosuppressive medications and retransplantation. Three-year patient and graft survival data were taken from a recent retrospective registry analysis and dose data were taken from prescribing information. Costs in 2014 pounds sterling were taken from the British National Formulary and the National Health Service National Tariff.
Over a 3-year time horizon, the numbers needed to treat with PR tacrolimus relative to IR tacrolimus were 14 to avoid one graft loss and 18 to avoid one death. The model was sensitive to dosing assumptions, with incremental cost estimates varying between a saving of £1642 (standard deviation £885) per patient, assuming the same per-kilogram dosing of PR tacrolimus (Advagraf) and IR tacrolimus (Prograf) and an increase of £1350 (£964) using RCT dose data.
Data from a recent analysis of routine clinical practice data in liver transplant recipients on PR tacrolimus and IR tacrolimus showed significant differences in long-term graft survival in favor of PR tacrolimus. Modeling these data in the UK showed that, over a 3-year time horizon, one graft would be saved for every 14 patients treated with PR tacrolimus with minimal impact on costs when compared with branded IR tacrolimus (Prograf).
截至2014年，英国移植登记处登记的约有8300例接受肝脏移植且肝脏功能正常的患者，仅在2013 - 2014年就进行了880例肝脏移植手术。他克莫司通常与类固醇和霉酚酸酯联合使用，目前是肝移植受者移植后免疫抑制的基石。
本研究的目的是评估在英国肝移植受者中，缓释他克莫司（Advagraf，日本东京安斯泰来制药公司）与品牌速释他克莫司（Prograf，日本东京安斯泰来制药公司）相比的成本效益。
在Microsoft Excel中建立一个模型，以估计与免疫抑制药物和再次移植相关的成本。三年的患者和移植物存活数据取自最近的一项回顾性登记分析，剂量数据取自处方信息。2014年英镑的成本取自《英国国家处方集》和英国国家医疗服务体系国家收费标准。
在3年的时间范围内，相对于速释他克莫司，使用缓释他克莫司治疗以避免一次移植物丢失需要治疗14例患者，避免一例死亡需要治疗18例患者。该模型对剂量假设敏感，增量成本估计在以下两种情况之间变化：假设缓释他克莫司（Advagraf）和速释他克莫司（Prograf）每千克给药剂量相同，每位患者节省1642英镑（标准差885英镑）；使用随机对照试验剂量数据时增加1350英镑（964英镑）。
最近对肝移植受者使用缓释他克莫司和速释他克莫司的常规临床实践数据进行的分析表明，长期移植物存活存在显著差异，缓释他克莫司更具优势。在英国对这些数据进行建模显示，在3年的时间范围内，每14例接受缓释他克莫司治疗的患者可挽救一个移植物，与品牌速释他克莫司（Prograf）相比，对成本的影响最小。
