Cost-effectiveness of Early Treatment of Hepatitis C Virus Genotype 1 by Stage of Liver Fibrosis in a US Treatment-Naive Population.
Cost-effectiveness of Early Treatment of Hepatitis C Virus Genotype 1 by Stage of Liver Fibrosis in a US Treatment-Naive Population.
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DOI：
10.1001/jamainternmed.2015.6011
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发表时间：
2016-01
影响因子：
39
通讯作者：
Kahn, James G.
中科院分区：
文献类型：
--
作者：
Chahal, Harinder S.;Marseille, Elliot A.;Tice, Jeffrey A.;Pearson, Steve D.;Ollendorf, Daniel A.;Fox, Rena K.;Kahn, James G.
丙型肝炎病毒（HCV）感染的新型治疗方法非常有效，但价格昂贵。因此，许多保险公司只承保晚期纤维化阶段的治疗。早期治疗的额外健康益处和成本尚不清楚。评估（1）治疗所有HCV患者与仅治疗晚期纤维化患者和（2）治疗每个阶段纤维化的成本效益。本研究采用了一种决策分析模型治疗HCV基因型1。该模型采用了终身视野和社会视角，代表了所有既往未接受过治疗的HCV基因型1型美国患者。模型中的比较包括所有纤维化分期的抗病毒治疗（METAVIR [病毒性肝炎组织学数据的荟萃分析] F0期[无纤维化]至F4期[肝硬化]）与仅F3期（大量间隔，无肝硬化）和F4期以及特定纤维化分期的治疗。数据收集时间为2014年3月1日至9月1日，分析时间为2014年9月1日至2015年6月30日。6种HCV治疗选择（特别是联合sofosbuvir和ledipasvir治疗）或不治疗。使用总医疗成本、质量调整生命年（QRR）和增量成本效益比（ICER）来衡量成本和健康结局，ICER计算为策略之间的成本差异除以QRR差异。我们模拟了1000个个体，但将结果标准化为单个HCV感染者。在基础病例分析中，在接受8或12周sofosbuvir-ledipasvir治疗的患者中，与治疗F3和F4期相比，治疗所有纤维化期增加了0.73 QALY和28899美元，ICER为39475美元/QALY。在F2期（门静脉纤维化伴罕见间隔）治疗与等到F3期相比，每增加一个QALY的成本为19 833美元;在F1期（门静脉纤维化无间隔）治疗与等到F2期相比，每增加一个QALY的成本为81 165美元;在F0期治疗与等到F1期相比，每增加一个QALY的成本为187 065美元。其他方案的结果显示出类似的模式。在基础病例药物价格下，治疗50%符合条件的HCV基因1型美国患者将花费530亿美元。在敏感性分析中，治疗所有阶段与治疗F3和F4阶段的ICER对队列年龄、药物成本、F1和F2阶段的效用值以及符合8周治疗条件的患者百分比最敏感。除70岁的患者外，ICER仍低于10万美元/QALY。索非布韦-ledipasvir治疗成本降低46%，所有纤维化阶段的ICER降低48%。在这个模拟模型中，在纤维化的早期阶段治疗HCV感染似乎可以改善健康结果，并且具有成本效益，但产生了大量的总成本。这些发现可能对医疗保险政策和临床决策产生影响。
Novel treatments for hepatitis C virus (HCV) infection are highly efficacious but costly. Thus, many insurers cover therapy only in advanced fibrosis stages. The added health benefits and costs of early treatment are unknown. To assess the cost-effectiveness of (1) treating all patients with HCV vs only those with advanced fibrosis and (2) treating each stage of fibrosis. This study used a decision-analytic model for the treatment of HCV genotype 1. The model used a lifetime horizon and societal perspective and was representative of all US patients with HCV genotype 1 who had not received previous treatment. Comparisons in the model included antiviral treatment of all fibrosis stages (METAVIR [Meta-analysis of Histological Data in Virial Hepatitis] stages F0 [no fibrosis] to F4 [cirrhosis]) vs treatment of stages F3 (numerous septa without cirrhosis) and F4 only and by specific fibrosis stage. Data were collected from March 1 to September 1, 2014, and analyzed from September 1, 2014, to June 30, 2015. Six HCV therapy options (particularly combined sofosbuvir and ledipasvir therapy) or no treatment. Cost and health outcomes were measured using total medical costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs), calculated as the difference in costs between strategies divided by the difference in QALYs. We simulated 1000 individuals, but present the results normalized to a single HCV-infected person. In the base-case analysis, among patients receiving 8 or 12 weeks of sofosbuvir-ledipasvir treatment, treating all fibrosis stages compared with treating stages F3 and F4 adds 0.73 QALYs and $28 899, for an ICER of $39 475 per QALY gained. Treating at stage F2 (portal fibrosis with rare septa) costs $19 833 per QALY gained vs waiting until stage F3; treating at stage F1 (portal fibrosis without septa), $81 165 per QALY gained compared with waiting until stage F2; and treating at stage F0, $187 065 per QALY gained compared with waiting until stage F1. Results for other regimens show a similar pattern. At base-case drug prices, treating 50% of all eligible US patients with HCV genotype 1 would cost $53 billion. In sensitivity analyses, the ICER for treating all stages vs treating stages F3 and F4 was most sensitive to cohort age, drug costs, utility values in stages F1 and F2, and percentage of patients eligible for 8-week therapy. Except for patients aged 70 years, the ICER remains less than $100 000 per QALY gained. A 46% reduction in cost of sofosbuvir-ledipasvir therapy decreases the ICER for treating at all fibrosis stages by 48%. In this simulated model, treating HCV infection at early stages of fibrosis appeared to improve health outcomes and to be cost-effective but incurred substantial aggregate costs. The findings may have implications for health care coverage policies and clinical decision making.
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