Faculty of Economics, Università Cattolica del Sacro Cuore, Rome, Italy.
Clin Drug Investig. 2013 May;33(5):343-9. doi: 10.1007/s40261-013-0067-z.
Allergen immunotherapy (AIT) is aimed at modifying the immune response to a causative allergen, thereby reducing clinical symptoms and symptomatic medication intake and improving quality of life. Long-term AIT research has led to the development of 5-grass pollen tablets, currently indicated for the treatment of grass pollen-induced allergic rhinitis (AR).
A post-hoc analysis was conducted using the Average Adjusted Symptom Score (AAdSS) to compare the effect of treatment of AR with 5-grass pollen tablets versus placebo treatment. Using the results of the VO34.04 and VO53.06 trials and economic data, cost-effectiveness analysis of 5-grass pollen tablet treatment was performed from the Italian third-party payer perspective with cost data derived from a study of 2008 updated to 2011. Also a societal perspective was considered by using the costs related to the losses of productivity by following the human capital approach. Using the results of the analysis, the estimated receiver-operating characteristic curve was plotted to evaluate medication effectiveness in terms of quality-adjusted life years (QALYs) and a decision tree constructed to model the possible outcomes and costs for adults and paediatric patients with a low, medium, and high AAdSS. Finally, probabilistic sensitivity analysis was conducted to test the robustness of the results as well as their consistency at an assumed cost-effectiveness threshold of € 30,000/QALY.
The results indicate that compared to the placebo, the 5-grass pollen tablet treatment provides a benefit of 0.127 QALYs in medium AAdSS patients and of 0.143 QALYs in high AAdSS patients. The 5-grass pollen tablet treatment was found to cost € 1,024/QALY for patients with a medium AAdSS and € 1,035/QALY for patients with a high AAdSS. Of all the simulations performed in the probabilistic sensitivity analysis, 99 % indicated that the incremental cost-effectiveness ratio of the 5-grass pollen tablet treatment was below the threshold of € 30,000/QALY in patients with medium and high AAdSS, whereas it was found to be dominated in 67 % of simulations related to patients with low AAdSS.
The 5-grass pollen tablet is a cost-effective treatment for adult AR patients with a medium or high AAdSS. This finding should be carefully considered when deciding the management strategy for these patients.
变应原免疫疗法（AIT）旨在改变对致病变应原的免疫反应，从而减轻临床症状和对症药物的摄入，并改善生活质量。长期的 AIT 研究导致了 5 种花粉片剂的发展，目前用于治疗花粉引起的过敏性鼻炎（AR）。
使用平均调整症状评分（AAdSS）进行事后分析，比较 5 种花粉片剂治疗 AR 与安慰剂治疗的效果。利用 VO34.04 和 VO53.06 试验的结果和经济数据，从意大利第三方付款人的角度对 5 种花粉片剂治疗进行成本效益分析，成本数据源自 2008 年的一项研究，该研究于 2011 年进行了更新。还考虑了从人力资本方法来看与生产力损失相关的社会视角。利用分析结果，绘制了估计的接受者操作特征曲线，以评估药物在质量调整生命年（QALY）方面的有效性，并构建决策树，为 AAdSS 较低、中、高的成年和儿科患者建模可能的结果和成本。最后，进行概率敏感性分析以测试结果的稳健性及其在假设的成本效益阈值为 30,000 欧元/QALY 时的一致性。
结果表明，与安慰剂相比，中 AAdSS 患者的 5 种花粉片剂治疗提供了 0.127 QALY 的益处，高 AAdSS 患者的 5 种花粉片剂治疗提供了 0.143 QALY 的益处。对于 AAdSS 中度患者，5 种花粉片剂治疗的费用为每 QALY1024 欧元，对于 AAdSS 高度患者，5 种花粉片剂治疗的费用为每 QALY1035 欧元。在概率敏感性分析中进行的所有模拟中，99%的模拟表明，在 AAdSS 中度和高度患者中，5 种花粉片剂治疗的增量成本效益比低于 30,000 欧元/QALY 的阈值，而在与 AAdSS 低度患者相关的 67%的模拟中，5 种花粉片剂治疗被认为是次要的。
5 种花粉片剂是治疗 AAdSS 中度或高度的成年 AR 患者的一种具有成本效益的治疗方法。在决定这些患者的管理策略时，应仔细考虑这一发现。
