Liu Lin, Hong Dongsheng, Ma Kuifen, Wu Bin, Lu Xiaoyang
Department of Pharmacy, The First affiliated hospital, College of Medicine, Zhejiang University, Hangzhou, China.
Medical Decision and Economic Group, Department of Pharmacy, Ren Ji Hospital, South Campus, School of Medicine, Shanghai Jiaotong University, Shanghai, China
BMJ Open. 2020 Aug 4;10(8):e034123. doi: 10.1136/bmjopen-2019-034123.
As the cost-effectiveness evaluation of cinacalcet and conventional therapy in China has not been reported, the objective of this study was to make a pharmacoeconomic evaluation of cinacalcet specific to the Chinese healthcare setting in patients with moderate-to-severe secondary hyperparathyroidism (SHPT) undergoing dialysis.
Data from Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events trial were used for this analysis. A semi-Markov model was constructed to estimate quality-adjusted life years (QALYs) and lifetime costs in cinacalcet plus conventional therapy (cinacalcet strategy) compared with conventional therapy (standard strategy), in patients with moderate-to-severe SHPT undergoing dialysis. Treatment effect estimates from the unadjusted intent-to-treat (ITT) analysis and covariate-adjusted ITT analysis were used as the main analyses. Model sensitivity to variations in individual inputs and overall decision uncertainty were assessed through probabilistic sensitivity analyses.
Incremental cost-effectiveness ratio (ICER) as measured by cost per QALY gained.
The ICER for cinacalcet strategy was US$44 400 per QALY gained using the covariate-adjusted ITT analysis. Probabilistic sensitivity analysis suggested a 46.2% chance of the ICER being below a willingness-to-pay threshold of US$26 508. Treatment effects from unadjusted ITT analysis yielded an ICER of US$87 210 per QALY. The model was most sensitive to the treatment effect on mortality.
Existing evidence does not support the cost-effectiveness of cinacalcet strategy in patients with moderate-to-severe SHPT undergoing dialysis when applying a willingness-to-pay threshold of US$26 508 per QALY, whether it is using the treatment effect from covariate-adjusted ITT analysis or unadjusted ITT analysis.
由于在中国尚未有西那卡塞与传统疗法的成本效益评估报告,本研究旨在对接受透析的中重度继发性甲状旁腺功能亢进症(SHPT)患者,在中国医疗环境下使用西那卡塞进行药物经济学评估。
本分析采用西那卡塞治疗降低心血管事件评估试验的数据。构建了一个半马尔可夫模型,以估计接受透析的中重度SHPT患者中,与传统疗法(标准策略)相比,西那卡塞联合传统疗法(西那卡塞策略)的质量调整生命年(QALY)和终身成本。未调整的意向性治疗(ITT)分析和协变量调整的ITT分析得出的治疗效果估计值用作主要分析。通过概率敏感性分析评估模型对个体输入变化的敏感性和总体决策不确定性。
以每获得一个QALY的成本衡量的增量成本效益比(ICER)。
使用协变量调整的ITT分析,西那卡塞策略的ICER为每获得一个QALY 44,400美元。概率敏感性分析表明,ICER低于26,508美元支付意愿阈值的概率为46.2%。未调整的ITT分析得出的治疗效果产生的ICER为每QALY 87,210美元。该模型对死亡率的治疗效果最为敏感。
当每QALY的支付意愿阈值为26,508美元时,无论是使用协变量调整的ITT分析还是未调整的ITT分析得出的治疗效果,现有证据均不支持西那卡塞策略在接受透析的中重度SHPT患者中的成本效益。