Mance Diana, Mance Davor, Vitezić Dinko
Diana Mance, Department of Physics, University of Rijeka, Radmile Matejčić 2, 51000 Rijeka, Croatia,
Croat Med J. 2016 Dec 31;57(6):582-590. doi: 10.3325/cmj.2016.57.582.
To develop a new method of health-economic analysis based on a marginal approach.
We tested the research hypothesis that a detailed comparative a priori incremental cost-effectiveness analysis provides the necessary input for budget impact analysis about the proper order of introduction of new therapies, and thus maximizes the cost-effectiveness bounded by the total budget constraint. For the analysis we chose a combination therapy for the treatment of hepatitis C virus (HCV) genotype 1 (GT1) infection, which was approved by the European Medicine Agency in 2015. We used the incremental cost-effective approach to assess the increase in the percentage of patients achieving sustained virological response (SVR) and the expenditure per additional SVR modulated by the new therapy's market entrance dynamics. Patient subpopulations were differentiated by their response to previous treatment, presence of cirrhosis, and HCV GT1 subtype. Final parameters were estimated by Monte Carlo simulations.
The new combination therapy had high efficacy, shorter duration, and was better tolerated than alternative interventions. The research hypothesis was confirmed: gradual introduction of the new therapy on the market, based on a priori incremental cost-effectiveness analysis, would result in average increase in successfully treated patients by 20%-40%, while additional costs would approximately be between 8%-40%, ie, ?21000-52000 per additional patient achieving SVR.
We showed the new combination therapy to be cost-effective for certain patient subpopulations, especially for experienced cirrhotic HCV GT1 patients. Results of the analysis are in agreement with the latest recommendations for HCV patients' treatment in Croatia. This economic evaluation could serve as a starting point for negotiations between pharmaceutical industry and insurance companies.
开发一种基于边际方法的卫生经济分析新方法。
我们检验了以下研究假设,即详细的比较性先验增量成本效益分析为关于新疗法引入的适当顺序的预算影响分析提供必要的输入,从而在总预算约束范围内使成本效益最大化。对于该分析,我们选择了一种用于治疗丙型肝炎病毒(HCV)基因1型(GT1)感染的联合疗法,该疗法于2015年获得欧洲药品管理局批准。我们使用增量成本效益方法来评估实现持续病毒学应答(SVR)的患者百分比的增加以及由新疗法的市场进入动态调节的每增加一例SVR的支出。患者亚组根据其对先前治疗的反应、肝硬化的存在以及HCV GT1亚型进行区分。最终参数通过蒙特卡罗模拟进行估计。
新的联合疗法具有高效、疗程短且耐受性优于替代干预措施的特点。研究假设得到证实:基于先验增量成本效益分析在市场上逐步引入新疗法,将使成功治疗的患者平均增加20% - 40%,而额外成本大约在8% - 40%之间,即每增加一例实现SVR的患者额外成本约为21000 - 52000欧元。
我们证明了新的联合疗法对某些患者亚组具有成本效益,特别是对于有经验的肝硬化HCV GT1患者。分析结果与克罗地亚针对HCV患者治疗的最新建议一致。这种经济评估可作为制药行业与保险公司之间谈判的起点。