Marcellusi Andrea, Viti Raffaella, Russo Simone, Andreoni Massimo, Antinori Andrea, Mennini Francesco Saverio
Economic Evaluation and HTA (CEIS-EEHTA)-IGF Department, Faculty of Economics, University of Rome "Tor Vergata", Via Columbia 2, 00133, Rome, Italy.
Department of Demography, University of Rome "La Sapienza", Rome, Italy.
Clin Drug Investig. 2016 May;36(5):377-87. doi: 10.1007/s40261-016-0382-2.
Highly active antiretroviral therapy (HAART) has modified the clinical course of human immunodeficiency virus (HIV) infection, reducing the rate of disease progression, the incidence of opportunistic infections and mortality. Several recent studies show early antiretroviral therapy reduces the risk of AIDS and HIV-related disease. The aim of this study was to perform an economic analysis to estimate the cost-utility of early antiretroviral therapy in Italy for managing HIV-infected patients.
The incremental cost-utility analysis was carried out to quantify the benefits of the early-treatment approach in HIV subjects. A Markov simulation model including direct costs and health outcomes was developed from a third-party (Italian National Healthcare Service) payer's perspective for four CD4 strata. 5000 Monte Carlo simulations were performed on two distinct scenarios: Standard of care (SoC) in which 30% of patients started HAART with a CD4 count ≥500 cells/mm(3) versus the early-treatment scenario (ETS), where the number of patients starting HAART with a CD4 count ≥500 cells/mm(3) increased to 70%. A systematic literature review was carried out to identify epidemiological and economic data, which were subsequently used to inform the model. In addition, a one-way probabilistic sensitivity analysis was performed in order to measure the relationship between the effectiveness of the treatments and the number of patients to undergo early treatment.
The model shows, in terms of the incremental cost-effectiveness ratio (ICER) per quality-adjusted life years (QALY) gained, that early treatment appeared to be the most cost-effective option compared to SoC (ICER = €13,625) over a time horizon of 10 years. The cost effectiveness of ETS is more sustainable as it extends the time horizon analysis (ICER = €7526 per QALY to 20 years and €8382 per QALY to 30 years). The one-way sensitivity analysis on the main variables confirmed the robustness of the model for the early-treatment approach.
Our model represents a tool for policy makers and health-care professionals to provide information on the cost effectiveness of the early-treatment approach in HIV-infected patients in Italy. Starting HAART earlier keeps HIV-infected patients in better health and reduces the incidence of AIDS- and non-AIDS-related events, generating a gain in terms of both patients' health and correct resource allocation.
高效抗逆转录病毒疗法（HAART）改变了人类免疫缺陷病毒（HIV）感染的临床进程，降低了疾病进展速度、机会性感染发生率和死亡率。近期多项研究表明，早期抗逆转录病毒疗法可降低患艾滋病和HIV相关疾病的风险。本研究旨在进行一项经济学分析，以评估在意大利对HIV感染患者进行早期抗逆转录病毒治疗的成本效益。
采用增量成本效益分析来量化HIV感染者早期治疗方法的益处。从第三方（意大利国家医疗服务体系）支付方的角度，针对四个CD4分层，开发了一个包含直接成本和健康结果的马尔可夫模拟模型。在两种不同情景下进行了5000次蒙特卡洛模拟：标准治疗（SoC）情景，即30%的患者在CD4细胞计数≥500个/mm³时开始HAART治疗；早期治疗情景（ETS），即CD4细胞计数≥500个/mm³时开始HAART治疗的患者数量增加到70%。进行了系统的文献综述以确定流行病学和经济数据，随后将这些数据用于模型构建。此外，还进行了单向概率敏感性分析，以衡量治疗效果与接受早期治疗患者数量之间的关系。
该模型显示，就每获得一个质量调整生命年（QALY）的增量成本效益比（ICER）而言，在10年的时间范围内，与标准治疗相比，早期治疗似乎是最具成本效益的选择（ICER = 13625欧元）。早期治疗情景的成本效益更具可持续性，因为随着时间范围分析的延长（到20年时ICER为每QALY 7526欧元，到30年时为每QALY 8382欧元）。对主要变量的单向敏感性分析证实了该模型对早期治疗方法的稳健性。
我们的模型为政策制定者和医疗保健专业人员提供了一种工具，用于提供有关意大利HIV感染患者早期治疗方法成本效益的信息。更早开始HAART治疗可使HIV感染患者保持更好的健康状态，并降低与艾滋病和非艾滋病相关事件的发生率，在患者健康和合理资源分配方面均有所获益。
