Adis, a Wolters Kluwer Business, Auckland, New Zealand.
Pharmacoeconomics. 2011 Nov;29(11):989-1009. doi: 10.2165/11207210-000000000-00000.
This article provides an overview of the clinical profile of rotavirus vaccine RIX4414 (Rotarix™) in the prevention of rotavirus gastroenteritis (RVGE) in developing countries, followed by a comprehensive review of pharmacoeconomic analyses with the vaccine in low- and middle-income countries. RVGE is associated with significant morbidity and mortality among children <5 years of age in developing countries. The protective efficacy of a two-dose oral series of rotavirus vaccine RIX4414 has been demonstrated in several well designed clinical trials conducted in developing countries, and the 'real-world' effectiveness of the vaccine has also been shown in naturalistic and case-control trials after the introduction of universal vaccination programmes with RIX4414 in Latin American countries. The WHO recommends universal rotavirus vaccination programmes for all countries. Numerous modelled cost-effectiveness analyses have been conducted with rotavirus vaccine RIX4414 across a wide range of low- and middle-income countries. Although data sources and assumptions varied across studies, results of the analyses consistently showed that the introduction of the vaccine as part of a national vaccination programme would be very (or highly) cost effective compared with no rotavirus vaccination programme, according to widely used cost-effectiveness thresholds for developing countries. Vaccine price was not known at the time the analyses were conducted and had to be estimated. In sensitivity analyses, rotavirus vaccine RIX4414 generally remained cost effective at the highest of a range of possible vaccine prices considered. Despite these favourable results, decisions regarding the implementation of universal vaccination programmes with RIX4414 may also be contingent on budgetary and other factors, underscoring the importance of subsidized vaccination programmes for poor countries through the GAVI Alliance (formerly the Global Alliance for Vaccines and Immunization).
本文概述了在发展中国家，轮状病毒疫苗 RIX4414（RotarixTM）用于预防轮状病毒胃肠炎（RVGE）的临床概况，随后全面回顾了在低收入和中等收入国家使用该疫苗的药物经济学分析。在发展中国家，轮状病毒胃肠炎与 5 岁以下儿童的高发病率和高死亡率有关。在发展中国家进行的几项精心设计的临床试验已经证明了两剂口服轮状病毒疫苗 RIX4414 的保护效力，并且在拉丁美洲国家引入 RIX4414 进行普遍疫苗接种计划后，疫苗的“真实世界”效果也在自然和病例对照试验中得到了证明。世界卫生组织建议所有国家普遍开展轮状病毒疫苗接种计划。在许多低收入和中等收入国家，已经使用轮状病毒疫苗 RIX4414 进行了大量的成本效益模型分析。尽管研究之间的数据来源和假设有所不同，但分析结果一致表明，与没有轮状病毒疫苗接种计划相比，将疫苗作为国家免疫接种计划的一部分引入，根据发展中国家广泛使用的成本效益阈值，将是非常（或高度）具有成本效益的。在进行分析时，疫苗价格尚不清楚，因此必须进行估计。在敏感性分析中，轮状病毒疫苗 RIX4414 通常在考虑的一系列可能疫苗价格中的最高价格下仍然具有成本效益。尽管取得了这些有利的结果，但关于实施 RIX4414 普遍疫苗接种计划的决定也可能取决于预算和其他因素，这突显了通过 GAVI 联盟（前身为全球疫苗和免疫联盟）为贫困国家提供补贴疫苗接种计划的重要性。
