意大利慢性乙型肝炎患者不同治疗方法的成本效益分析。
A cost-effectiveness analysis of different therapies in patients with chronic hepatitis B in Italy.
作者信息
Colombo Giorgio L, Gaeta Giovanni B, Viganò Mauro, Di Matteo Sergio
机构信息
University of Pavia, School of Pharmacy, Italy;
出版信息
Clinicoecon Outcomes Res. 2011;3:37-46. doi: 10.2147/CEOR.S16655. Epub 2011 Feb 15.
INTRODUCTION
Chronic hepatitis B (CHB) is a prevalent disease associated with high morbidity, mortality, and impact on health care costs. Antiviral therapy is aimed at reducing hepatitis B virus replication in order to limit progressive liver disease and improve the natural history of the disease. This study estimates the cost-effectiveness of lamivudine, adefovir, telbivudine, entecavir, tenofovir, and pegylated interferon in patients with CHB.
METHODS
A Markov model was developed to evaluate the costs and benefits of antivirals in a cohort of patients with CHB (hepatitis B e antigen [HBeAg]-positive and HBeAg-negative) and cirrhosis over a period of 10 years. Different rescue therapies were considered, according to current guidelines. Data on efficacy and changes in quality of life were derived from clinical trials and epidemiological Italian data. Direct costs were assessed from the perspective of the Italian National Health Service.
RESULTS
Tenofovir was associated with lower costs and higher efficacy compared with entecavir, telbivudine, and adefovir, as shown by their incremental cost-effectiveness ratios (ICER) per quality-adjusted life-year (QALY) gained: tenofovir €30,959, entecavir €45,971, telbivudine €62,051, and adefovir €82,824. Even following 1 year of pegylated interferon therapy, tenofovir had a more favourable ICER per QALY gained compared with the other rescue options. The analysis of patients with cirrhosis confirms the results obtained with the CHB cohort though with higher ICERs. Sensitivity analyses on the main variables confirm the results of the base case scenario.
CONCLUSION
Within the Italian health care system, in patients with CHB, tenofovir is a cost-effective strategy compared with other available therapies. Public health care authorities would benefit from mathematical models designed to estimate the future burden of CHB infection together with the impact of treatment and drug resistance.
引言
慢性乙型肝炎（CHB）是一种常见疾病，具有高发病率、高死亡率，并对医疗成本产生影响。抗病毒治疗旨在减少乙型肝炎病毒复制，以限制肝病进展并改善疾病的自然病程。本研究评估了拉米夫定、阿德福韦、替比夫定、恩替卡韦、替诺福韦和聚乙二醇化干扰素在慢性乙型肝炎患者中的成本效益。
方法
建立了一个马尔可夫模型，以评估抗病毒药物在一组慢性乙型肝炎患者（乙型肝炎e抗原[HBeAg]阳性和HBeAg阴性）和肝硬化患者中10年内的成本和效益。根据当前指南考虑了不同的挽救治疗方法。疗效和生活质量变化的数据来自临床试验和意大利流行病学数据。直接成本从意大利国家卫生服务的角度进行评估。
结果
与恩替卡韦、替比夫定和阿德福韦相比，替诺福韦的成本更低且疗效更高，这体现在每获得一个质量调整生命年（QALY）的增量成本效益比（ICER）上：替诺福韦为30,959欧元，恩替卡韦为45,971欧元，替比夫定为62,051欧元，阿德福韦为82,824欧元。即使在聚乙二醇化干扰素治疗1年后，与其他挽救方案相比，替诺福韦每获得一个QALY的ICER也更有利。对肝硬化患者的分析证实了慢性乙型肝炎队列获得的结果，尽管ICER更高。对主要变量的敏感性分析证实了基础病例情景的结果。
结论
在意大利医疗保健系统中，对于慢性乙型肝炎患者，与其他可用疗法相比，替诺福韦是一种具有成本效益的策略。公共卫生保健当局将受益于旨在估计慢性乙型肝炎感染未来负担以及治疗和耐药性影响的数学模型。
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