Facoltà di economia, Università Cattolica del Sacro Cuore, L.go F.Vito 1, 00168 Roma, Italy.
Health Policy. 2011 Sep;102(1):72-80. doi: 10.1016/j.healthpol.2010.09.012. Epub 2010 Oct 28.
Nowadays, guidelines for the management of HBV infection in Italy, recommend using vaccines but the screening test among non-vaccinated people is useful to detect people that have a clear presence of the virus without symptoms of the disease. Thanks to the screening test, people infected with HBV are administered traditional therapy in order to stop the progression to cirrhosis, liver failure and hepatocellular carcinoma (HCC). These diseases cause the decrease of Qol and cause a high consumption of resources for the health system. The aim of this study is to evaluate the cost-effectiveness of a strategy (test strategy) involving the administration of the screening test to patients at risk and the treatment of the infected according to the protocol therapy. This programme is compared with a strategy (no test strategy) which does not include a screening and treats patients affected by cirrhosis or HCC.
We created a Markov model following the natural history of the disease and considering the antigen HBeAg to evaluate the cost effectiveness of the test strategy. The analysis was carried out considering a third-party payer perspective. The time horizon considered was 40 cycles of one year. Patients who resulted positive to the test were administered either interferon treatment; or lamivudine or adefovir or entecavir or tenofovir, consistently with the Italian guidelines. Treatments were administered to patients included in the no-test arm after cirrhosis symptoms or HCC.
The results of the base case analysis show that patients following the test strategy compared with patients of the no-test approach cost €17,179/QALY. The Monte Carlo simulation based on a probabilistic sensitivity analysis points out that in 95% of the scenarios assumed, the cost per QALY would be under a hypothetical threshold of €40,000 which is the amount that international guidelines for decision makers are likely to consider sustainable for a health system. In conclusion, anti-hbv test to all high-risk categories should be highly recommended.
如今,意大利管理 HBV 感染的指南建议使用疫苗,但对未接种疫苗人群进行筛查试验有助于发现无症状但明确存在病毒的人群。通过筛查试验,对 HBV 感染者进行传统治疗,以阻止其进展为肝硬化、肝功能衰竭和肝细胞癌(HCC)。这些疾病会降低生活质量(QoL),并导致卫生系统资源的大量消耗。本研究旨在评估一种策略(检测策略)的成本效益,该策略包括对高危人群进行筛查试验,并根据协议疗法对感染者进行治疗。该方案与不包括筛查且仅治疗肝硬化或 HCC 患者的策略(不检测策略)进行比较。
我们根据疾病的自然史并考虑 HBeAg 抗原创建了一个 Markov 模型,以评估检测策略的成本效益。分析从第三方支付者的角度进行。考虑的时间范围为 40 个一年周期。检测结果为阳性的患者接受干扰素治疗;或拉米夫定、阿德福韦酯、恩替卡韦或替诺福韦治疗,符合意大利指南。未检测组中的患者在出现肝硬化症状或 HCC 后接受治疗。
基于基本情况的分析结果表明,与未检测组相比,接受检测策略的患者每增加一个质量调整生命年(QALY)的成本为 17179 欧元。基于概率敏感性分析的蒙特卡罗模拟表明,在假设的 95%的情况下,每 QALY 的成本将低于 40000 欧元的假设阈值,这是决策者可能认为可持续的卫生系统的金额。总之,应对所有高危人群进行抗乙型肝炎病毒检测。