Park Hae-Young, Ku Hye-min, Sohn Hyun-Soon, Seo Hae-Sook, Yung Lee Hyun, Hwa Lim Kyung, Kwon Jin-Won
College of Pharmacy and Research Institute of Pharmaceutical Sciences, Kyungpook National University, Buk-gu Daegu, Republic of Korea.
School of Pharmacy, Sungkyunkwan University, Kyunggi, Republic of Korea.
Clin Ther. 2016 Mar;38(3):655-67.e1-2. doi: 10.1016/j.clinthera.2016.01.023. Epub 2016 Feb 20.
Bedaquiline is a new drug used for the treatment of multidrug-resistant tuberculosis (MDR-TB). This study aimed to evaluate the cost-effectiveness of adding bedaquiline to a standard regimen (SR) for treating patients with MDR-TB, including extensively drug-resistant (XDR)-TB, in the Republic of Korea.
A cohort-based decision-analytic model developed in a previously published study from the United Kingdom was used, with a 20-year time horizon and a 5% discount rate for cost and effectiveness, to evaluate the incremental cost-effectiveness ratios of bedaquiline + SR and SR only. The key parameters regarding the clinical data were available via the published Phase II trial of bedaquiline. Additional parameters for recurrence, cure status, loss to follow-up, surgery, death, cost, and health utility were based on Korean data if available; otherwise the international literature data were applied. Univariate and probabilistic sensitivity analyses were conducted.
Based on the analysis, a patient on bedaquiline + SR would gain 1.20 quality-adjusted life-years (QALYs) at 13,961,659 Korean won (KRW) (1100 KRW = US $1) of additional cost compared with a patient administered SR only, with an incremental cost/utility ratio of 11,638,656 KRW/QALY. Bedaquiline + SR had an 80% probability of being cost-effective, at a willingness-to-pay threshold of 26 million KRW, compared with SR only.
The results of this study suggest that, in the Republic of Korea, bedaquiline, as a part of combination therapy with SR, is a cost-effective option for the treatment of MDR-TB (including XDR-TB) compared with SR only.
贝达喹啉是一种用于治疗耐多药结核病(MDR-TB)的新药。本研究旨在评估在韩国,将贝达喹啉添加到标准治疗方案(SR)中用于治疗MDR-TB患者(包括广泛耐药结核病,即XDR-TB)的成本效益。
采用英国此前发表的一项研究中开发的基于队列的决策分析模型,时间跨度为20年,成本和效果的贴现率为5%,以评估贝达喹啉+SR与仅使用SR的增量成本效益比。关于临床数据的关键参数可通过已发表的贝达喹啉II期试验获得。如果有韩国数据,复发、治愈状态、失访、手术、死亡、成本和健康效用的其他参数则基于韩国数据;否则应用国际文献数据。进行了单因素和概率敏感性分析。
基于分析,与仅接受SR治疗的患者相比,接受贝达喹啉+SR治疗的患者将获得1.20个质量调整生命年(QALY),但需额外花费13,961,659韩元(1100韩元 = 1美元),增量成本/效用比为11,638,656韩元/QALY。与仅使用SR相比,在支付意愿阈值为2600万韩元时,贝达喹啉+SR具有80%的成本效益概率。
本研究结果表明,在韩国,与仅使用SR相比,贝达喹啉作为与SR联合治疗的一部分,是治疗MDR-TB(包括XDR-TB)的一种具有成本效益的选择。