Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, South Korea.
Department of Statistics, Kyungpook National University, Daegu, South Korea.
Clin Ther. 2018 Jan;40(1):123-134. doi: 10.1016/j.clinthera.2017.02.005. Epub 2017 Mar 11.
Sevelamer, a noncalcium phosphate binder, has been shown to attenuate the progression of vascular calcification and improve survival in patients with chronic kidney disease undergoing dialysis compared with calcium-based binders. Using real-world data from a cohort study and the Health Insurance Review and Assessment Service database, we conducted a cost-effectiveness analysis comparing sevelamer with calcium acetate in dialysis patients from the perspective of the National Health Insurance Service in South Korea.
Data (demographic, diagnostic, laboratory, and survival) from 4674 patients undergoing dialysis enrolled in a multicenter prospective cohort study conducted in South Korea between September 2008 and December 2012 were linked to phosphate binder use, hospitalization, and cost data available from the Health Insurance Review and Assessment Service database. After propensity score matching, a dataset comprising comparable patients treated with either sevelamer (n = 501) or calcium acetate (n = 501) was used in the cost-effectiveness analysis. A Markov model was used to estimate costs, life years, quality-adjusted life years (QALYs), and cost-effectiveness over each patient's lifetime. Forty-month treatment-specific overall survival (OS) data available from the dataset were extrapolated to lifetime survival with the use of regression analysis.
Patients had a mean age of 56.3 years and were treated with dialysis for a mean duration of 67.6 months. Compared with calcium acetate, sevelamer was associated with an incremental cost of South Korean Won (₩) 12,246,911 ($10,819) and a gain of 1.758 life years and 1.108 QALYs per patient. This outcome yielded incremental cost-effectiveness ratios of ₩6,966,350 ($6154) and ₩11,057,699 ($9768) per life year and QALY gained, respectively. Conclusions regarding sevelamer's cost-effectiveness were insensitive to alternative assumptions in time horizon, discount rate, hospitalization rate, costs, and health utility estimates, and they remained consistent in 100% of the model iterations, considering a willingness-to-pay threshold of ₩31,894,720 ($28,176) per QALY gained.
This analysis of real-world data found that sevelamer's higher cost relative to calcium acetate was adequately offset by improved survival among patients undergoing dialysis in South Korea. As such, sevelamer offers good value for money, representing a cost-effective alternative to calcium-based binders.
与碳酸钙结合剂相比，非钙磷酸盐结合剂司维拉姆已被证明可减轻接受透析治疗的慢性肾脏病患者血管钙化的进展并改善其生存率。本研究使用来自队列研究的真实世界数据和健康保险审查与评估服务数据库，从韩国国家健康保险服务的角度，对接受透析治疗的患者中司维拉姆与醋酸钙的成本效益进行了比较。
对 2008 年 9 月至 2012 年 12 月在韩国进行的一项多中心前瞻性队列研究中的 4674 名透析患者的人口统计学、诊断、实验室和生存数据进行了链接，并与健康保险审查和评估服务数据库中可用的磷酸盐结合剂使用、住院和成本数据进行了链接。在进行倾向评分匹配后，使用一组接受司维拉姆（n = 501）或醋酸钙（n = 501）治疗的可比患者的数据，在成本效益分析中进行了数据集的匹配。采用马尔可夫模型估计每位患者终生的成本、寿命年、质量调整寿命年（QALY）和成本效益。使用回归分析将数据集内可用的 40 个月的特定治疗总生存率（OS）数据外推至终生生存率。
患者的平均年龄为 56.3 岁，接受透析治疗的平均时间为 67.6 个月。与醋酸钙相比，司维拉姆的增量成本为韩元 12246911 韩元（10819 美元），每位患者的寿命增加了 1.758 年，QALY 增加了 1.108。这一结果产生了增量成本效益比分别为韩元 6966350 韩元（6154 美元）和韩元 11057699 韩元（9768 美元）/寿命年和 QALY 增加。在时间范围、贴现率、住院率、成本和健康效用估计的替代假设下，司维拉姆的成本效益结论是稳健的，在考虑到每获得一个质量调整生命年愿意支付的韩元 31894720 韩元（28176 美元）的支付意愿阈值时，模型迭代的 100%中都保持一致。
本真实世界数据的分析发现，与醋酸钙相比，司维拉姆的成本增加被透析患者生存率的提高所抵消。因此，司维拉姆物有所值，是一种比碳酸钙结合剂更具成本效益的替代方案。
