Luhnen Miriam, Waffenschmidt Siw, Gerber-Grote Andreas, Hanke Gloria
Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670, Cologne, Germany.
Appl Health Econ Health Policy. 2016 Oct;14(5):527-43. doi: 10.1007/s40258-016-0253-2.
The approval of sofosbuvir offers new therapeutic options for patients suffering from chronic hepatitis C. In phase III trials, it has demonstrated significantly greater efficacy and safety in comparison with the old standard of care. In addition, it provides the first interferon-free regimen allowing treatment of patients without previous therapeutic options. A current debate regarding pricing and affordability can be attributed to high treatment costs. The objective of this review was to compare health economic evaluations of sofosbuvir for the treatment of chronic hepatitis C in terms of models, patient populations, interventions and results.
A systematic review was conducted using the data sources Medline (1946-09/2015), Embase (1974-09/2015), the Health Technology Assessment Database (September 2015) and the UK National Health Service Economic Evaluation Database (September 2015). We included health economic evaluations that measured the cost-effectiveness of sofosbuvir-based regimens compared with regimens without sofosbuvir for the treatment of adult patients infected with chronic hepatitis C. The articles were then critically appraised regarding the effectiveness data, cost data and models utilised.
Fourteen studies were included, which analysed the cost-effectiveness of sofosbuvir in seven different countries. Differences in study characteristics were found regarding study populations, modelling and willingness-to-pay thresholds. The study results demonstrated the cost-effectiveness of the treatment combination of sofosbuvir with pegylated interferon and ribavirin in comparison with the old standard of care. Dual therapy with sofosbuvir and ribavirin was considered cost effective only in comparison with no therapy.
Despite high costs, the included studies indicate that sofosbuvir-based regimens are cost effective in most patients. While the results are unequivocal with regard to sofosbuvir-based triple therapy, the cost-effectiveness of sofosbuvir-based dual therapy heavily depends on country-specific willingness to pay. Although interferon-containing triple therapy has now been replaced by newly approved direct-acting antivirals in most middle- and high-income countries, the availability of these oral treatment combinations is poor in low-income countries. Therefore, the findings of our review are still of relevance.
索磷布韦的获批为慢性丙型肝炎患者提供了新的治疗选择。在III期试验中,与旧的标准治疗方案相比,它已显示出显著更高的疗效和安全性。此外,它提供了首个无需使用干扰素的治疗方案,使以前没有治疗选择的患者也能接受治疗。目前关于定价和可承受性的争论可归因于高昂的治疗成本。本综述的目的是从模型、患者群体、干预措施和结果等方面比较索磷布韦治疗慢性丙型肝炎的卫生经济学评估。
使用Medline(1946年 - 2015年9月)、Embase(1974年 - 2015年9月)、卫生技术评估数据库(2015年9月)和英国国家医疗服务体系经济评估数据库(2015年9月)等数据源进行系统综述。我们纳入了衡量基于索磷布韦的治疗方案与不含索磷布韦的治疗方案相比治疗成人慢性丙型肝炎感染患者的成本效益的卫生经济学评估。然后对这些文章在有效性数据、成本数据和所使用的模型方面进行严格评估。
纳入了14项研究,这些研究分析了索磷布韦在7个不同国家的成本效益。在研究人群、建模和支付意愿阈值方面发现了研究特征的差异。研究结果表明,与旧的标准治疗方案相比,索磷布韦与聚乙二醇干扰素和利巴韦林联合治疗具有成本效益。索磷布韦和利巴韦林的双联疗法仅在与不治疗相比时才被认为具有成本效益。
尽管成本高昂,但纳入的研究表明基于索磷布韦的治疗方案对大多数患者具有成本效益。虽然基于索磷布韦的三联疗法的结果是明确的,但基于索磷布韦的双联疗法的成本效益在很大程度上取决于各国的支付意愿。尽管在大多数中高收入国家,含干扰素的三联疗法现已被新批准的直接作用抗病毒药物所取代,但在低收入国家,这些口服治疗组合的可及性很差。因此,我们综述的结果仍然具有相关性。