Cost-effectiveness and budget impact of hepatitis C virus treatment with sofosbuvir and ledipasvir in the United States.
Cost-effectiveness and budget impact of hepatitis C virus treatment with sofosbuvir and ledipasvir in the United States.
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DOI：
10.7326/m14-1336
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发表时间：
2015-03-17
影响因子：
39.2
通讯作者：
Dunn MA
中科院分区：
文献类型：
--
作者：
Chhatwal J;Kanwal F;Roberts MS;Dunn MA
最近批准的药物sofosbuvir和ledipasvir用于慢性丙型肝炎病毒（HCV）治疗更有效，更安全，但比旧的标准治疗（oSOC）昂贵得多。目前尚不清楚是否以及在哪些患者中，其改善的疗效证明了其增加的成本。评价索非布韦和雷迪帕韦为基础的治疗的成本效益和预算影响。HCV自然病程的模拟模型。出版的文献。根据美国HCV基因型、年龄和纤维化分布定义的未经治疗和经治HCV人群。辈子第三方付款人。模拟基于索非布韦/雷迪帕韦的治疗与基于干扰素的治疗组成的oSOC的比较。质量调整生命年（QER）、增量成本效益比（ICER）和5年抗病毒药物支出。基于索非布韦的治疗相对于oSOC增加了0.56 QALY，每增加一个QALY的增量成本为55400美元。ICER的范围从9700美元到284300美元/QALY，取决于患者的既往治疗、HCV基因型和肝硬化的存在。在每个QALY的支付意愿为10万美元时，基于索非布韦的治疗在83%的初治患者和81%的有治疗经验的患者中具有成本效益。与osoc相比，在未来5年内，新药将额外花费650亿美元来治疗美国合格的HCV感染者，而由此产生的成本抵消将是160亿美元。结果对药物价格、药物疗效和治疗成功后的生活质量敏感。关于新的抗病毒药物在真实的世界中的有效性的数据是缺乏的。HCV治疗在大多数患者中具有成本效益，但需要额外的资源和基于价值的患者优先级来管理HCV患者。
The recently approved drugs, sofosbuvir and ledipasvir, for chronic hepatitis C virus (HCV) treatment are more efficacious and safer but are substantially more expensive than the old standard-of-care (oSOC). It remains unclear whether and in which patients their improved efficacy justifies their increased cost. To evaluate the cost-effectiveness and budget impact of sofosbuvir- and ledipasvir-based therapies. Simulation model of the natural history of HCV. Published literature. Treatment-naive and treatment-experienced HCV population defined on the basis of HCV genotype, age and fibrosis distribution in the United States. Lifetime. Third-party payer. Simulation of sofosbuvir/ledipasvir-based therapies compared with the oSOC that consisted of interferon-based therapies. Quality-adjusted life years (QALYs), incremental cost-effectiveness ratios (ICERs), and 5-year spending on antiviral drugs. Sofosbuvir-based therapies added 0.56 QALY relative to the oSOC, at an incremental cost of $55 400 per additional QALY. The ICERs ranged from $9700 to $284 300 per QALY depending on the patient’s status with respect to prior treatment, HCV genotype, and the presence of cirrhosis. At $100 000 willingness-to-pay per QALY, sofosbuivr-based therapies were cost-effective in 83% of treatment-naive and 81% of treatment-experienced patients. Compared with the oSOC, new drugs would cost an additional $65 billion in the next 5 years to treat eligible HCV-infected people in the United States, whereas the resulting cost offsets would be $16 billion. Results were sensitive to the drug price, drug efficacy and quality-of-life after a successful treatment. Data on real world effectiveness of new antivirals is lacking. HCV treatment is cost-effective in the majority of patients, but additional resource and value-based patient prioritization are needed to manage HCV patients.