Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan.
Am J Kidney Dis. 2012 Aug;60(2):262-71. doi: 10.1053/j.ajkd.2011.12.034. Epub 2012 Mar 24.
Cinacalcet effectively reduces elevated levels of parathyroid hormone (PTH) in patients with secondary hyperparathyroidism (SHPT), even those with severe disease for whom parathyroidectomy can be the treatment of choice. The objective of this study was to estimate the cost-effectiveness of cinacalcet treatment in hemodialysis patients with severe SHPT in Japan.
Cost-effectiveness analysis.
SETTING & POPULATION: Patients with severe SHPT (intact PTH >500 pg/mL) who were receiving hemodialysis in Japan.
MODEL, PERSPECTIVE, & TIMEFRAME: A Markov model was constructed from the health care system perspective in Japan. Patients were followed up over their lifetime. Dialysis costs were not included in the base case.
Cinacalcet as an addition to conventional treatment compared to conventional treatment alone. In both arms, patients underwent parathyroidectomy if intact PTH level was >500 pg/mL for 6 months and they were eligible for surgery.
Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).
ICERs for cinacalcet for those who were eligible for surgery and those who were not were $352,631/QALY gained and $21,613/QALY gained, respectively. Sensitivity and scenario analyses showed that results were fairly robust to variations in model parameters and assumptions. In the probabilistic sensitivity analysis, cinacalcet was cost-effective in only 0.9% of simulations for those eligible for surgery, but in more than 99.9% of simulations for those ineligible for surgery, if society would be willing to pay $50,000 per additional QALY.
Data for the long-term effect of cinacalcet on patient-level outcomes are limited. The model predicted rates for clinical events using data for the surrogate biochemical end points.
The use of cinacalcet to treat severe SHPT is likely to be cost-effective for only those who cannot undergo parathyroid surgery for medical or personal reasons.
西那卡塞可有效降低继发性甲状旁腺功能亢进（SHPT）患者甲状旁腺激素（PTH）水平升高，甚至对甲状旁腺切除术可能是治疗选择的严重疾病患者也有效。本研究旨在评估西那卡塞治疗日本血液透析患者严重 SHPT 的成本效益。
成本效益分析。
正在日本接受血液透析的严重 SHPT 患者（全段甲状旁腺素>500pg/mL）。
模型、视角和时间范围：从日本卫生保健系统的角度构建了一个 Markov 模型。患者在其一生中接受随访。透析费用未包含在基础病例中。
西那卡塞联合常规治疗与单独常规治疗相比。在这两个治疗组中，如果全段甲状旁腺素水平>500pg/mL 且符合手术条件，患者将接受甲状旁腺切除术。
成本、质量调整生命年（QALY）和增量成本效益比（ICER）。
对于符合手术条件和不符合手术条件的患者，西那卡塞的 ICER 分别为每获得一个 QALY 增加 352631 美元和 21613 美元。敏感性和情景分析表明，结果对模型参数和假设的变化相当稳健。在概率敏感性分析中，对于符合手术条件的患者，西那卡塞仅在 99.9%的模拟中具有成本效益，如果社会愿意为每增加一个 QALY 支付 50000 美元，则在 99.9%以上的模拟中具有成本效益。
关于西那卡塞对患者水平结局的长期影响的数据有限。该模型使用替代生化终点数据预测临床事件的发生率。
对于因医疗或个人原因无法进行甲状旁腺手术的患者，使用西那卡塞治疗严重 SHPT 可能具有成本效益。
