Buti María, Gros Blanca, Oyagüez Itziar, Andrade Raúl J, Serra Miguel A, Turnes Juan, Casado Miguel A
Pharmacoeconomics & Outcomes Research Iberia, Madrid..
Hospital Vall d' Hebrón, Barcelona..
Farm Hosp. 2014 Sep 16;38(5):418-29. doi: 10.7399/fh.2014.38.5.7640.
The prevalence of Hepatitis C (HCV) in Spain is 2,5%, with a high morbimortality rate. Triple therapy based on telaprevir plus peginterferon/ribavirin ([T/PR]) has demonstrated to be an effective approach in treatment-naïve G1-HCV patients. This analysis evaluated, through a Markov model, the incremental cost-effectiveness ratio of triple therapy compared to peginterferon/ ribavirin ([PR]) alone in naïve patients depending on fibrosis stage, from the Spanish Healthcare Authorities perspective.
Efficacy results and adverse events incidence were based on the combined results of ADVANCE and OPTIMIZE studies. Adverse events and disease-related costs (€, 2014) were built up from panel expert opinion except from transplant and post-transplant costs, taken from published data. Drug costs were obtained from national databases and adjusted for the mandatory deduction. Outcomes and costs were both discounted at 3%/year.
The analysis shows higher costs and improved outcomes associated with [TR/PR] relative to [PR] alone, resulting in an incremental cost-effectiveness ratio (ICER) of €18,288/ QALY for all the cohort, €14,152QALY for moderate fibrosis, €11,364QALY for bridging fibrosis, €15,929/QALY for cirrhosis. Over a lifetime period, the use of [T/PR] could avoid 12 cirrhosis and 4 liver transplants per 1,000 patients compared to [PR] alone. The probabilistic analysis, following 10,000 Montecarlo simulations, demonstrated the probability of an ICER below a €30,000/QALY gained threshold of 69%. At a willingness- to-pay of €30,000/QALY, [T/PR] could be considered as an efficient option compared with [PR] alone for treatment-naïve genotype 1 HCV patients, over a lifetime horizon.
西班牙丙型肝炎（HCV）的患病率为2.5%，病亡率很高。基于特拉匹韦联合聚乙二醇干扰素/利巴韦林（[T/PR]）的三联疗法已被证明是初治G1-HCV患者的有效治疗方法。本分析通过马尔可夫模型，从西班牙医疗当局的角度评估了三联疗法与单纯聚乙二醇干扰素/利巴韦林（[PR]）相比，在初治患者中根据纤维化阶段的增量成本-效果比。
疗效结果和不良事件发生率基于ADVANCE和OPTIMIZE研究的综合结果。不良事件和疾病相关成本（欧元，2014年）除移植和移植后成本（取自已发表数据）外，均由专家小组意见得出。药物成本从国家数据库中获取并根据强制扣除进行调整。结果和成本均按每年3%进行贴现。
分析表明，与单纯[PR]相比，[TR/PR]的成本更高，但结果有所改善，所有队列的增量成本-效果比（ICER）为18,288欧元/质量调整生命年，中度纤维化患者为14,152欧元/质量调整生命年，桥接纤维化患者为11,364欧元/质量调整生命年，肝硬化患者为15,929欧元/质量调整生命年。在整个生命周期内，与单纯[PR]相比，使用[T/PR]每1000名患者可避免12例肝硬化和4例肝移植。经过10,000次蒙特卡洛模拟的概率分析表明，ICER低于每获得一个质量调整生命年30,000欧元阈值的概率为69%。在支付意愿为每质量调整生命年30,000欧元的情况下，与单纯[PR]相比，对于初治基因型1 HCV患者，在整个生命周期内，[T/PR]可被视为一种有效的选择。
