CEIS-Economic Evaluation and HTA (EEHTA), Faculty of Economics, University of Rome "Tor Vergata", Via Columbia 2, 00133, Rome, Italy.
Institute for Leadership and Management in Health, Kingston University London, London, UK.
Pharmacoeconomics. 2019 Feb;37(2):255-266. doi: 10.1007/s40273-018-0733-3.
We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy.
A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered.
The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively.
This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV.
根据意大利丙型肝炎病毒 (HCV) 治疗准入政策,评估意大利国家卫生系统 (NHS) 对直接作用抗病毒 (DAA) 治疗的投资的成本后果。
开发了一个多状态、20 年时间 horizon 的 HCV 肝病进展马尔可夫模型。纤维化阶段、年龄和基因型分布来自意大利病毒肝炎治疗研究平台 (PITER) 队列。在每个健康状态下,疗效、疾病进展概率和直接成本都从文献中获得。收支平衡点 (BPT) 定义为累计节省的成本收回意大利 NHS 对 DAA 治疗投资所需的时间。考虑了三个不同的 PITER 登记期,涵盖了意大利 DAA 准入的全部演变。
对 2015 年 1 月至 2017 年 12 月在 30 个 PITER 临床中心接受 DAA 治疗的 2657 例连续患者的疾病阶段进行了标准化,标准化后的患者数为 1000 例。2015 年、2016 年和 2017 年,DAA 的投资分别为 2500 万欧元、1500 万欧元和 900 万欧元。对于 2015 年接受治疗的患者,由于治疗患者的疾病严重程度和 DAA 价格高,BPT 未达到。对于 2016 年和 2017 年,估计的 BPT 分别为 6.6 年和 6.2 年。对于 2016 年和 2017 年分别接受治疗的 1000 名患者,20 年后的总成本节省分别为 5013 万欧元和 5550 万欧元。
本研究可为公共决策者提供有用的工具,了解 HCV 临床和流行病学特征如何影响 HCV 的经济负担。