All-oral, interferon-free treatment for chronic hepatitis C: cost-effectiveness analyses

All-oral, interferon-free treatment for chronic hepatitis C: cost-effectiveness analyses
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DOI:
10.1111/jvh.12111
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发表时间:
2013-12-01
影响因子:
2.5
通讯作者:
Schinazi, R. F.
Schinazi, R. F.
中科院分区:
医学3区
文献类型:
--
作者:
Hagan, L. M.;Yang, Z.;Schinazi, R. F.

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基于干扰素的慢性丙型肝炎护理标准治疗 (SOC) 无法在感染人群的某些亚组中提供高治愈率,并且可能导致令人衰弱的副作用。评估全口服、无干扰素治疗的临床试验表明,在大多数人群中,持续病毒学应答率很高,且没有出现耐药性或重大不良事件。随着这些药物治疗方案逐渐获得 FDA 批准,除了临床疗效之外,评估其成本效益也很重要。采用具有终身、社会视角的决策分析马尔可夫模型,通过对 50 岁 HCV 阳性队列的疾病自然史和治疗进展进行建模,评估广义全口服药物治疗方案与 SOC 相比的成本效益。在基本案例分析中,全口服治疗在一系列支付意愿 (WTP) 阈值中主导 SOC,增量成本效益比 (ICER) 为 44514 美元/质量调整生命年 (QALY)。在敏感性分析中,该模型对全口服药物成本以及非肝硬化受试者的 SVR 率和治疗吸收率敏感,但对所有其他参数的变化都很稳健。全口服治疗在基因型 1 受试者中最具成本效益,但对于基因型 2 和 3 受试者在 WTP 阈值 80000 美元/QALY 下仍然具有成本效益。在年轻的治疗队列中,每花费一美元所获得的质量调整生命年最大化。使用该模型,成本效益程度取决于 WTP 阈值和批准药物组合的最终成本设定。
Interferon-based standard of care treatments (SOC) for chronic hepatitis C are unable to provide high cure rates in certain subgroups of the infected population and can cause debilitating side effects. Clinical trials evaluating all-oral, interferon-free treatments have demonstrated high rates of sustained virologic response with no resistance or major adverse events in most populations. As these drug regimens move towards FDA approval, it will be important to assess their cost-effectiveness in addition to their clinical efficacy. A decision-analytic Markov model with a lifetime, societal perspective was used to evaluate the cost-effectiveness of a generalized all-oral drug regimen compared to SOC by modelling the progression of a 50-year-old, HCV-positive cohort through disease natural history and treatment. In base case analysis, all-oral treatment dominated SOC across a range of willingness-to-pay (WTP) thresholds with an incremental cost-effectiveness ratio (ICER) of US$44514/quality-adjusted life year (QALY). In sensitivity analyses, the model was sensitive to all-oral drug costs as well as rates of SVR and treatment uptake among noncirrhotic subjects, but robust to variations in all other parameters. All-oral treatment was most cost-effective among genotype 1 subjects but remained cost-effective for genotypes 2 and 3 at WTP thresholds $80000/QALY. Quality-adjusted life years gained per dollar spent were maximized in younger treatment cohorts. Using this model, the degree of cost-effectiveness depended on the WTP threshold and the final cost set for approved drug combinations.