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考虑到未来低成本丙型肝炎仿制药进入市场时治疗时机的成本效益分析。

Cost-effectiveness analysis of treatment timing considering the future entry of lower-cost generics for hepatitis C.

作者信息

Heath Katherine

机构信息

Mathematical Ecology Research Group, Department of Zoology, University of Oxford, Oxford OX1 3PS, UK,

New College, Oxford OX1 3BN, UK,

出版信息

Clinicoecon Outcomes Res. 2018 Sep 20;10:539-550. doi: 10.2147/CEOR.S171248. eCollection 2018.

DOI:10.2147/CEOR.S171248
PMID:30288069
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6159796/
Abstract

BACKGROUND

Cost-benefit analyses are crucial to inform treatment policies, particularly when the cost of patented drugs is very high. The cost of patented drugs is the limiting factor in hepatitis C treatment. However, hepatitis C drug costs are expected to fall following patent expiration, due to generic drug introduction.

METHODS

An existing mathematical model by Shih et al was extended to consider lower-cost future generics in health economic models of hepatitis C. The model compared the cost-effectiveness of treating patients now with patented drugs vs postponing treatment until after patent expiration.

RESULTS

For ledipasvir-sofosbuvir, this study finds that it is almost always more cost effective to treat hepatitis C with high-cost patented drugs immediately rather than waiting for patent expiry. For ledipasvir-sofosbuvir, a generic would need to enter the market at <16.40% of the patented price for delayed treatment to be cost effective. The further that patent expiry is in the future, the more cost effective delayed treatment becomes; however, uncertainty about generic pricing and market entry times are also higher if patent expiry is in the distant future.

CONCLUSION

It is more cost effective to treat hepatitis C sooner rather than later, regardless of the stage of the disease, and despite the high cost of patented drugs. However, patented drugs are being produced globally for prices much lower than those seen in the UK. Therefore, negotiation of patented drug prices with pharmaceutical companies may be a crucial step in cost effective treatment of hepatitis C.

摘要

背景

成本效益分析对于制定治疗政策至关重要,尤其是在专利药物成本非常高的时候。专利药物的成本是丙型肝炎治疗的限制因素。然而,由于仿制药的引入,预计专利到期后丙型肝炎药物成本将会下降。

方法

扩展了Shih等人现有的数学模型,以便在丙型肝炎的健康经济模型中考虑未来成本更低的仿制药。该模型比较了现在用专利药物治疗患者与推迟治疗直到专利到期后的成本效益。

结果

对于来迪派韦-索磷布韦,本研究发现,立即用高成本的专利药物治疗丙型肝炎几乎总是比等待专利到期更具成本效益。对于来迪派韦-索磷布韦,一种仿制药需要以低于专利价格16.40%的价格进入市场,延迟治疗才具有成本效益。专利到期时间越远,延迟治疗的成本效益就越高;然而,如果专利到期时间遥远,仿制药定价和进入市场时间的不确定性也会更高。

结论

无论疾病处于何种阶段,也不管专利药物成本有多高,尽早治疗丙型肝炎更具成本效益。然而,全球生产的专利药物价格远低于英国的价格。因此,与制药公司协商专利药物价格可能是丙型肝炎成本效益治疗的关键一步。

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本文引用的文献

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Efficacy of ledipasvir/sofosbuvir plus ribavirin for 12 weeks in patients with chronic hepatitis C genotype 3 and compensated liver disease.来迪派韦/索磷布韦联合利巴韦林治疗12周对慢性丙型肝炎基因3型和代偿性肝病患者的疗效。
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Negotiating better discounts for DAA therapy is critical to achieve HCV elimination by 2030.就直接抗病毒药物(DAA)疗法协商更优惠的折扣对于在2030年前实现丙型肝炎病毒消除至关重要。
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Age and gender distribution of Hepatitis C virus prevalence and genotypes of individuals of physical examination in WuHan, Central China.中国中部武汉地区体检人群丙型肝炎病毒流行率及基因型的年龄和性别分布
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Bias within economic evaluations - the impact of considering the future entry of lower-cost generics on currently estimated incremental cost-effectiveness ratios of a new drug.经济评估中的偏差——考虑低成本仿制药未来进入市场对新药当前估计的增量成本效益比的影响。
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