Brunelli Steven M, Sibbel Scott P, Van Wyck David, Sharma Amit, Hsieh Andrew, Chertow Glenn M
DaVita Clinical Research, 825 South 8th Street, Suite 300, Minneapolis, MN, 55404, USA.
DaVita Inc., Denver, CO, USA.
Drugs R D. 2017 Mar;17(1):159-166. doi: 10.1007/s40268-016-0163-7.
Ferric citrate (FC) has demonstrated efficacy as a phosphate binder and reduces the requirements for erythropoiesis-stimulating agents (ESAs) and intravenous (IV) iron in dialysis patients. We developed a net budgetary impact model to evaluate FC vs. other phosphate binders from the vantage of a large dialysis provider. We used a Markov microsimulation model to simulate mutually referential longitudinal effects between serum phosphate and phosphate binder dose; categories of these defined health states. Health states probabilistically determined treatment attendance and utilization of ESA and IV iron. We derived model inputs from a retrospective analysis of incident phosphate binder users from a large dialysis organization (January 2011-June 2013) and incorporated treatment effects of FC from a phase III trial. The model was run over a 1-year time horizon. We considered fixed costs of providing dialysis; costs of administering ESA and IV iron; and payment rates for dialysis, ESAs, and IV iron. In the base-case model, FC had a net budgetary impact (savings) of +US$213,223/year per 100 patients treated vs. standard of care. One-way sensitivity analyses showed a net budgetary impact of up to +US$316,296/year per 100 patients treated when higher hemoglobin levels observed with FC translated into a 30% additional ESA dose reduction, and up to +US$223,281/year per 100 patients treated when effects on missed treatment rates were varied. Two-way sensitivity analyses in which acquisition costs for ESA and IV iron were varied showed a net budgetary impact of +US$104,840 to +US$213,223/year per 100 patients treated. FC as a first-line phosphate binder would likely yield substantive savings vs. standard of care under current reimbursement.
柠檬酸铁（FC）已被证明可作为一种磷结合剂，降低透析患者对促红细胞生成素（ESA）和静脉注射铁剂的需求。我们开发了一个净预算影响模型，从大型透析服务提供商的角度评估FC与其他磷结合剂。我们使用马尔可夫微观模拟模型来模拟血清磷和磷结合剂剂量之间的相互参照纵向效应；这些效应定义了健康状态类别。健康状态概率性地决定了治疗出勤率以及ESA和静脉注射铁剂的使用情况。我们从对一个大型透析机构（2011年1月至2013年6月）新使用磷结合剂患者的回顾性分析中得出模型输入数据，并纳入了一项III期试验中FC的治疗效果。该模型在1年的时间范围内运行。我们考虑了提供透析的固定成本、管理ESA和静脉注射铁剂的成本，以及透析、ESA和静脉注射铁剂的支付费率。在基础案例模型中，与标准治疗相比，FC每治疗100名患者每年有+213,223美元的净预算影响（节省）。单向敏感性分析表明，当FC观察到的较高血红蛋白水平转化为额外30%的ESA剂量减少时，每治疗100名患者每年的净预算影响高达+316,296美元；当对错过治疗率的影响不同时，每治疗100名患者每年的净预算影响高达+223,281美元。对ESA和静脉注射铁剂采购成本进行变化的双向敏感性分析表明，每治疗100名患者每年的净预算影响为+104,840美元至+213,223美元。在当前报销情况下，FC作为一线磷结合剂可能比标准治疗产生大量节省。
