We evaluated the cost-effectiveness of two alternative direct-acting antiviral (DAA) treatment policies in a real-life cohort of hepatitis C virus–infected patients: policy 1, “universal,” treat all patients, regardless of fibrosis stage; policy 2, treat only “prioritized” patients, delay treatment of the remaining patients until reaching stage F3. A liver disease progression Markov model, which used a lifetime horizon and health care system perspective, was applied to the PITER cohort (representative of Italian hepatitis C virus–infected patients in care). Specifically, 8,125 patients naive to DAA treatment, without clinical, sociodemographic, or insurance restrictions, were used to evaluate the policies’ cost-effectiveness. The patients’ age and fibrosis stage, assumed DAA treatment cost of €15,000/patient, and the Italian liver disease costs were used to evaluate quality-adjusted life-years (QALY) and incremental cost-effectiveness ratios (ICER) of policy 1 versus policy 2. To generalize the results, a European scenario analysis was performed, resampling the study population, using the mean European country-specific health states costs and mean treatment cost of €30,000. For the Italian base-case analysis, the cost-effective ICER obtained using policy 1 was €8,775/QALY. ICERs remained cost-effective in 94%-97% of the 10,000 probabilistic simulations. For the European treatment scenario the ICER obtained using policy 1 was €19,541.75/QALY. ICER was sensitive to variations in DAA costs, in the utility value of patients in fibrosis stages F0-F3 post–sustained virological response, and in the transition probabilities from F0 to F3. The ICERs decrease with decreasing DAA prices, becoming cost-saving for the base price (€15,000) discounts of at least 75% applied in patients with F0-F2 fibrosis.

中文翻译：

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在实际队列中模拟“通用”与“优先”丙型肝炎病毒治疗政策的成本效益和健康收益

我们评估了现实生活中丙型肝炎病毒感染患者的两种替代性直接作用抗病毒（DAA）治疗策略的成本效益：策略1，“通用”治疗所有患者，无论其纤维化阶段如何；策略2，仅治疗“优先”患者，将其余患者的治疗推迟到F3期。PITER队列（代表接受意大利丙型肝炎病毒感染的患者）采用了以生命周期和医疗保健系统为视角的肝脏疾病进展马尔可夫模型。具体而言，使用了8125名未接受DAA治疗的患者，没有临床，社会人口统计学或保险方面的限制，来评估该政策的成本效益。患者的年龄和纤维化阶段，假设DAA治疗费用为每位患者15,000欧元，并使用意大利肝病费用评估了政策1与政策2的质量调整生命年（QALY）和增量成本效益比（ICER）。为概括结果，我们进行了欧洲情景分析，并对研究进行了重新抽样使用欧洲特定国家/地区的健康状况平均费用和30,000欧元的平均治疗费用。对于意大利基础案例分析，使用策略1获得的具有成本效益的ICER为€8,775 / QALY。在10,000个概率模拟中，ICER在94％-7％的成本效益中仍然有效。对于欧洲治疗方案，使用政策1获得的ICER为€19,541.75 / QALY。ICER对DAA成本，持续病毒学应答后纤维化阶段F0-F3患者的效用价值以及从F0到F3的转变概率均敏感。