Wikman-Jorgensen Philip Erick, Ruiz-Algueró Marta, Iniesta Carlos, Pulido Federico, Llenas-García Jara
Internal Medicine & Infectious Diseases Department, Elda General University Hospital-FISABIO, Elda, Spain; Clinical Medicine Department, Universidad Miguel Hernández, Elche, Spain.
Faculty of Medicine, University of British Columbia, Vancouver, Canada; Centre of Biomedical Research for Infectious Diseases (CIBERINFEC), Madrid, Spain.
Enferm Infecc Microbiol Clin (Engl Ed). 2025 Aug-Sep;43(7):416-425. doi: 10.1016/j.eimce.2024.12.014. Epub 2025 May 22.
This study aims to compare the cost-effectiveness of currently approved daily PrEP in Spain, with tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC), in gay, bisexual and other men who have sex with men (GBMSM) versus newer alternatives like daily tenofovir alafenamide plus emtricitabine (TAF/FTC) or injectable cabotegravir every 2 months (CAB).
We fitted a dynamic compartmentalized Markov model that represents the dynamics of HIV-1 transmission in GBMSM in Spain. The model was calibrated to replicate the epidemiological data of the HIV epidemic in GBMSM in Spain from 2013 to 2018. We used the perspective of the national health system and applied a 40-year time horizon. Quality-adjusted life years (QALYs) were the health outcome variable, and the cost was accounted for in 2018 Euros (€). Our outcome variable was the incremental cost-effectiveness ratio (ICER) for PrEP. We used the 2018 gross domestic product per capita of Spain (€25,854) as the willingness-to-pay (WTP) threshold.
The 2019 scenario with no PrEP in place would yield 17,424,891 QALYs and a cost of 2018 €17,345,310,254. The present scenario of daily TDF/FTC yields 18,615,325 QALYs, an increase of 1,190,434 QALYs at a cost of 2018 €15,354,878,534 (decrease of -2018 €1,990,431,719), generating an ICER of -2018 €1672 per QALY gained. The introduction of daily TAF/FTC in the present scenario would yield an increase in 449,392 QALYs at an additional cost of 2018 €13,634,260,217. The ICER would thus be 2018 €30,339 per QALY gained. Introducing CAB in the present scenario would yield an increase of 573,007 QALYs at an additional cost of 2018 €16,754,471,790 (average cost-effectiveness ratio=29,239). Compared to TAF, the increase in QALYs would be 123,614 at an additional cost of 2018 €5,707,367,590, yielding an ICER of 2018 €46,170/QALY gained. A one-way sensitivity analysis and a probabilistic sensitivity analysis was carried out.
The present Spanish policy of PrEP is a cost-saving strategy. TAF/FTC and CAB are not cost-effective at current market prices.
本研究旨在比较西班牙目前批准的每日暴露前预防用药（PrEP）方案，即替诺福韦酯富马酸盐加恩曲他滨（TDF/FTC），在男同性恋、双性恋和其他与男性发生性关系的男性（GBMSM）中的成本效益，与新的替代方案，如每日替诺福韦艾拉酚胺加恩曲他滨（TAF/FTC）或每两个月注射一次卡博特韦（CAB）。
我们构建了一个动态的分区马尔可夫模型，该模型代表了西班牙GBMSM中HIV-1传播的动态情况。该模型经过校准，以复制2013年至2018年西班牙GBMSM中HIV流行的流行病学数据。我们采用国家卫生系统的视角，并应用40年的时间范围。质量调整生命年（QALYs）是健康结果变量，成本以2018年欧元（€）计算。我们的结果变量是PrEP的增量成本效益比（ICER）。我们将2018年西班牙人均国内生产总值（€25,854）用作支付意愿（WTP）阈值。
2019年未实施PrEP的情景将产生17,424,891个QALYs，成本为2018年€17,345,310,254。目前每日使用TDF/FTC的情景产生18,615,325个QALYs，增加了1,190,434个QALYs，成本为2018年€15,354,878,534（减少了-2018年€1,990,431,719），每获得一个QALY的ICER为-2018年€1672。在当前情景中引入每日TAF/FTC将使QALYs增加449,392个，额外成本为2018年€13,634,260,217。因此，ICER将为每获得一个QALY 2018年€30,339。在当前情景中引入CAB将使QALYs增加573,007个，额外成本为2018年€16,754,471,790（平均成本效益比=29,239）。与TAF相比，QALYs增加123,614个，额外成本为2018年€5,707,367,590，每获得一个QALY的ICER为2018年€46,170。进行了单向敏感性分析和概率敏感性分析。
西班牙目前的PrEP政策是一种节省成本的策略。TAF/FTC和CAB在当前市场价格下不具有成本效益。
