Department of Medicine and Surgery, Center for Digestive Health, University of Milano-Bicocca, Monza, Italy.
Research Centre on Public Health (CESP), University of Milan-Bicocca, Milan, Italy.
Liver Int. 2017 Jul;37(7):982-994. doi: 10.1111/liv.13339. Epub 2017 Mar 2.
Chronic hepatitis C (CHC) has been undertreated among elderly patients. Interferon-free treatment represents an opportunity for these patients. The aim of this study was to assess the cost-effectiveness of directly acting antivirals (DAAs) in CHC elderly patients.
A Markov model of CHC natural history was built. This study focuses on CHC patients older than 65 years, stratified according to genotype (1/4, 2 and 3), liver fibrosis (METAVIR F1 to F4), age and frailty phenotype (robust, pre-frail and frail). DAAs combination vs no treatment was simulated for each theoretical population, assessing life years, quality-adjusted life years (QALYs), costs, incremental cost-effectiveness ratios (ICERs) in a lifetime time horizon and by the Healthcare System perspective.
Incremental cost-effectiveness ratio increased with age and frailty status in all fibrosis stages. For robust F3 and F4 patients ICERs remained below the willingness-to-pay threshold (WTP) of 40 000€/QALY up to age 75 and 86 years, respectively, depending on drug price and sustained virological response probability (sensitivity analysis). Notably, in F4 and frail subjects older than 75 years, ICER was more sensitive to non-liver-related mortality rate. In elderly F1 and F2 patients, ICERs were below WTP only up to 77 years old, with wide variability among frailty phenotypes.
Cost-effectiveness of DAAs treatment of elderly CHC patients is solid in those with advanced fibrosis, but it depends strongly on frailty status and age, particularly in patients with milder fibrosis stages. Accurate assessment of clinical variables, including frailty, is necessary to allocate limited resources to this special population.
慢性丙型肝炎（CHC）在老年患者中治疗不足。无干扰素治疗为这些患者提供了机会。本研究旨在评估直接作用抗病毒药物（DAAs）在 CHC 老年患者中的成本效益。
建立了 CHC 自然史的 Markov 模型。本研究主要关注年龄大于 65 岁的 CHC 患者，根据基因型（1/4、2 和 3）、肝纤维化（METAVIR F1 至 F4）、年龄和虚弱表型（健壮、虚弱前期和虚弱）进行分层。为每个理论人群模拟了 DAA 联合治疗与无治疗，评估了每个理论人群的寿命、质量调整生命年（QALYs）、成本、终生时间范围内的增量成本效益比（ICER）以及从医疗保健系统角度的增量成本效益比。
在所有纤维化阶段，随着年龄和虚弱状态的增加，增量成本效益比也随之增加。对于健壮的 F3 和 F4 患者，在药物价格和持续病毒学应答率（sVR）的影响下，ICER 仍低于 40000 欧元/QALY 的意愿支付阈值（WTP），直到分别 75 岁和 86 岁。值得注意的是，在 F4 和 75 岁以上的虚弱患者中，ICER 对非肝脏相关死亡率更为敏感。在年龄较大的 F1 和 F2 患者中，ICER 仅在 77 岁以下低于 WTP，且不同虚弱表型之间存在较大差异。
在晚期纤维化的老年 CHC 患者中，DAA 治疗的成本效益是可靠的，但强烈依赖于虚弱状态和年龄，尤其是在纤维化程度较轻的患者中。准确评估包括虚弱在内的临床变量对于将有限资源分配给这一特殊人群至关重要。
