Institute for Technology Assessment, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Liver Center and Gastrointestinal Division, Massachusetts General Hospital, Boston, Massachusetts.
Tsinghua University School of Medicine, Beijing, China.
Clin Gastroenterol Hepatol. 2017 Jun;15(6):827-837.e8. doi: 10.1016/j.cgh.2016.09.015. Epub 2016 Sep 17.
BACKGROUND & AIMS: Direct-acting antivirals (DAAs) are effective in treatment of hepatitis C virus (HCV) genotype 1 infection, but their cost and value have been debated. We performed a systematic review of published cost-effectiveness analyses of DAAs, synthesized their results with updated drug prices, and calculated the maximum price at which DAA therapy for HCV genotype 1 infection is cost-effective (increased quality-adjusted life-years [QALYs] and increased cost that the society is willing to pay) and cost-saving (increased QALYs and decreased costs).
We conducted a systematic review of the PubMed, Medline, EMBASE, Cochrane library, EconLit, Database of Abstracts of Reviews of Effects, National Health Service Economic Evaluation Database, Health Technology Assessment, and Tufts University databases for cost-effectiveness analyses published from 2011 through 2015. Our analysis included cost effectiveness of DAAs versus previous standard-of-care regimens (peginterferon and ribavirin, boceprevir and telaprevir), or no treatment, performed for patients with HCV genotype 1 infection. We excluded studies that were not written in English or those that did not report QALYs. Reported incremental cost-effectiveness ratios (ICERs) and treatment costs for each comparison were extracted; the threshold price was estimated for each analysis in which regimens were found to be cost-effective (ICER ≤$100,000/QALY) or cost-saving (ICER <$0), those that decreased costs and increased QALYs.
We identified 24 cost-effectiveness studies that reported 170 ICERs for combinations of 11 drugs, from 11 countries. Of those, 81 ICERs were determined for first-generation DAAs (boceprevir and telaprevir) and 89 ICERs were determined for second-generation DAAs (drugs approved after the first-generation DAAs) as a primary intervention. The median threshold prices at which first-generation and second-generation DAAs became cost-effective were estimated as $120,100 (interquartile range, $90,700-$176,800) and $227,200 (interquartile range, $142,800-$355,800), respectively. At the discounted price of $60,000, a total of 71% of the analyses found second-generation DAAs to be cost-saving and 22% to be cost-effective.
In a systematic review, we found treatment of HCV genotype 1 infection with second-generation DAAs to be cost-effective when they cost less than and $227,200; these drugs produced cost savings at current discounts.
直接作用抗病毒药物（DAAs）在治疗丙型肝炎病毒（HCV）基因型 1 感染方面非常有效，但它们的成本和价值一直存在争议。我们对已发表的 DAA 成本效益分析进行了系统评价，综合了最新的药物价格数据，并计算了 DAA 治疗 HCV 基因型 1 感染的最高价格（增加的质量调整生命年[QALYs]和社会愿意支付的增加成本）和成本节约（增加的 QALYs 和降低的成本）。
我们对 PubMed、Medline、EMBASE、Cochrane 图书馆、EconLit、Effect 摘要数据库、国家卫生服务经济评估数据库、卫生技术评估和塔夫茨大学数据库进行了系统评价，以获取 2011 年至 2015 年发表的成本效益分析。我们的分析包括 DAA 与先前的标准治疗方案（聚乙二醇干扰素和利巴韦林、博西普韦和特拉匹韦）或无治疗相比，针对 HCV 基因型 1 感染患者的成本效益。我们排除了非英文撰写或未报告 QALYs 的研究。提取了每个比较的报告增量成本效益比（ICER）和治疗成本；对于被发现具有成本效益（ICER≤100,000/QALY）或成本节约（ICER<0）的每个分析，我们估计了方案的门槛价格，即降低成本和增加 QALYs。
我们确定了 24 项成本效益研究，这些研究来自 11 个国家，共报告了 11 种药物组合的 170 个 ICER。其中，第一代 DAA（博西普韦和特拉匹韦）的 81 个 ICER 和第二代 DAA（第一代 DAA 后批准的药物）的 89 个 ICER 被确定为主要干预措施。第一代和第二代 DAA 具有成本效益的估计中位数门槛价格分别为 120,100 美元（四分位距，90,700-176,800 美元）和 227,200 美元（四分位距，142,800-355,800 美元）。在 60,000 美元的折扣价格下，共有 71%的分析发现第二代 DAA 具有成本节约效果，22%的分析发现第二代 DAA 具有成本效益。
在一项系统评价中，我们发现第二代 DAA 治疗 HCV 基因型 1 感染的成本低于 227,200 美元时具有成本效益；这些药物在目前的折扣下产生了成本节约。
