中国替诺福韦治疗慢性乙型肝炎的成本效益分析

StephenW

Hepatol Int. 2016 Nov;10(6):924-936. Epub  2016 Jun 7.
Cost-effectiveness analysis of tenofovir disoproxil fumarate for treatment of chronic hepatitis B in China.Ke W1, Zhang C1, Liu L1, Gao Y1, Yao Z1, Ye X1, Zhou S1, Yang Y2.
Author information

• 1Department of Epidemiology and Health Statistics, School of Public Health, Guangdong Pharmaceutical University, Guangzhou, 510310, Guangdong, China.
• 2Department of Epidemiology and Health Statistics, School of Public Health, Guangdong Pharmaceutical University, Guangzhou, 510310, Guangdong, China. [email protected].
  

AbstractBACKGROUND: Tenofovir disoproxil fumarate (TDF) is newly available for treatment of chronic hepatitis B patients in China. To date, no study has been conducted to examine the cost-effectiveness of this treatment. The aim of this study was to estimate the cost-effectiveness of TDF versus four oral nucleos(t)ide analogs [lamivudine (LAM), adefovir (ADV), telbivudine (LdT), and entecavir (ETV)] and from a pharmacoeconomic perspective to assess current drug pricing for TDF.
METHODS: Based on Chinese healthcare perspectives, a Markov model was applied to simulate the lifetime (40-year time span) costs and quality-adjusted life-years (QALYs) for five different monotherapy strategies. Two kinds of rescue combination strategies (base-case: LAM + ADV then ETV + ADV; alternative: directly using ETV + ADV) were separately considered for treatment of patients refractory to monotherapy. Model parameters (including disease transition, cost, and utility) were obtained from previous Chinese population studies. Both branded and generic drugs were separately analyzed. Study model uncertainties were assessed by one-way and probabilistic sensitivity analyses. Two-way sensitivity analysis was used to explore uncertainties between efficacy and price of TDF.
RESULTS: In the base-case analysis, the lowest lifetime cost and the best cost-effectiveness ratio were obtained by ETV, which was considered the reference treatment. LAM, ADV, and LdT treatments had significantly greater costs and lower efficacies. Compared to ETV, TDF was more effective but also more expensive. The incremental cost-effectiveness ratios of TDF versus ETV were much higher than the willing-to-pay threshold of $20,466 US dollars (USD) per QALY gained (3 × gross domestic product per capita of China, 2014). TDF would be the most cost-effective strategy if the annual cost did not exceed $2260 USD and $1600 USD for branded and generic drugs, respectively.
CONCLUSIONS: For Chinese chronic hepatitis B patients, ETV is still the most cost-effective strategy over TDF and other nucleos(t)ide analogs, with a threshold of $20,466 USD/QALY gained.


KEYWORDS: Chronic hepatitis B; Cost-effectiveness; Tenofovir disoproxil fumarate

PMID:27271357DOI:10.1007/s12072-016-9741-6

StephenW

Hepatol Int。 2016 Nov; 10（6）：924-936。 2016年6月7日。
中国替诺福韦地索普西延胡索酸盐治疗慢性乙型肝炎的成本效益分析。
Ke W1，Zhang C1，Liu L1，Gao Y1，Yao Z1，Ye X1，Zhou S1，Yang Y2。
作者信息
中国替诺福韦地索普西延胡索酸性治疗慢性乙型肝炎的成本效益分析
    广东广州药学院公共卫生学院流行病与卫生统计司，广东，510310。
    广东药学院公共卫生学院流行病与卫生统计学系，广东，510310，广东。 [email protected]。

抽象
背景：

替诺福韦disoproxil延胡索酸盐（TDF）是新近可用于治疗中国的慢性乙型肝炎患者。到目前为止，还没有进行研究来检查这种治疗的成本效益。本研究的目的是估计TDF与四种口服核苷类似物[拉米夫定（LAM），阿德福韦（ADV），替比夫定（LdT）和恩替卡韦（ETV）]的成本效益，并从药物经济学角度以评估TDF的当前药品定价。
方法：

基于中国医疗保健观点，应用马尔科夫模型模拟五种不同单一治疗策略的生命周期（40年时间跨度）成本和质量调整生命年（QALY）。分别考虑两种救援组合策略（基础病例：LAM + ADV然后ETV + ADV;替代方案：直接使用ETV + ADV）用于治疗难治性单一治疗的患者。模型参数（包括疾病转变，成本和效用）从以前的中国人口研究中获得。分别分析了品牌药和仿制药。研究模型不确定性通过单向和概率敏感性分析进行评估。使用双向灵敏度分析来研究TDF的功效和价格之间的不确定性。
结果：

在基本案例分析中，通过ETV获得最低寿命成本和最佳成本效益比，其被认为是参考治疗。 LAM，ADV和LdT治疗具有显着更高的成本和更低的功效。与ETV相比，TDF更有效，但也更昂贵。 TDF与ETV的增量成本效益比率远远高于每QALY增加的20,466美元（USD）的愿意支付阈值（3×中国人均国内生产总值，2014）。如果品牌和仿制药的年成本分别不超过2260美元和1600美元，TDF将是最具成本效益的战略。
结论：

对于中国慢性乙型肝炎患者，ETV仍然是TDF和其他核苷类似物最具成本效益的策略，阈值为20,466美元/ QALY。
关键词：

慢性乙型肝炎;成本效益;替诺福韦地索普西富马酸盐

PMID：
    27271357
DOI：
    10.1007 / s12072-016-9741-6

齐欢畅2

国产替诺福伟啥时候上市？如果上市，乙肝的药物价格将大大降低。

neilhbver

如果是国产仿制药的话。还是别国产了

MP4

齐欢畅2 发表于 2016-10-28 18:46
国产替诺福伟啥时候上市？如果上市，乙肝的药物价格将大大降低。

广生堂的之前撤回申请，现在公告说正在优先审评
http://www.sda.gov.cn/WS01/CL0050/137900.html

即使进入优先审评,该产品仍处于评审阶段,何时取得批文、能否取得批文

尚存在不确定性。
http://app.finance.ifeng.com/data/stock/ggzw/300436/15857859

weiwei1968

我昨天去看病，肝功能不正常，医生要给我开替诺福伟 490元，不知道是不是国产的，我没要

MP4

weiwei1968 发表于 2016-10-29 09:55
我昨天去看病，肝功能不正常，医生要给我开替诺福伟 490元，不知道是不是国产的，我没要 ...

490要么天津要么南非产，一般天津的，都是正版授权，可以放心吃

weiwei1968

回复 MP4 的帖子

我没吃过抗病毒药，直接上替诺福伟，有点不好吧！

MP4

weiwei1968 发表于 2016-10-29 10:15
回复 MP4 的帖子

我没吃过抗病毒药，直接上替诺福伟，有点不好吧！

若你恩替没报销，替诺是你最佳选择

weiwei1968

大将军帮我看看B超结果是不是不好啊