Canonica Giorgio Walter, Colombo Giorgio Lorenzo, Rogliani Paola, Santus Pierachille, Pitotti Claudia, Di Matteo Sergio, Martinotti Chiara, Bruno Giacomo Matteo
Asthma & Allergy Clinic, Humanitas University, Milan, Italy.
S.A.V.E. S.r.l. Studi Analisi Valutazioni Economiche Health Economics & Outcomes Research - Research Center, Milan, Italy.
Risk Manag Healthc Policy. 2020 Jan 22;13:43-53. doi: 10.2147/RMHP.S211321. eCollection 2020.
Inadequately controlled severe asthma patients require additional therapy accounting for significant clinical and economic burden. Our analysis aims to determine the cost-effectiveness of omalizumab in the management of severe allergic asthma in Italy based on observational data from the PROXIMA study.
Observational data on efficacy, healthcare resource utilization and changes in quality of life at 12 months after the initiation of omalizumab were examined to estimate the cost-effectiveness compared to pre-omalizumab period and results were expressed with Incremental Cost-Effectiveness Ratio (ICER). The cost-utility analysis estimated the cost per quality-adjusted life-year (QALY) gained. Direct health costs were assessed from the perspective of the Italian National Health Service (NHS).
Omalizumab reduced the incidence of exacerbations, number of hospitalizations, physician visits, and improved quality of life after 12 months of treatment. Omalizumab had a greater effectiveness than pre-omalizumab treatment involving 0.132 QALYs gained and led to a €3729 per patient reduction in direct healthcare costs, excluding the add-on treatment cost. Nevertheless, the addition of omalizumab cost led to €7478 increase in total direct costs with respect to pre-omalizumab period. Based on difference in total direct cost and difference in QALY between post and pre-omalizumab period, the ICER was €56,847. According to sensitivity analysis, omalizumab provided a cost-effective use of NHS resources, already at 20% discounted price.
This study offers a real-world evidence of omalizumab effectiveness in Italy. Despite the high acquisition cost of the innovative drug, omalizumab is a sustainable treatment option for patients with uncontrolled severe allergic asthma.
重症哮喘患者若病情控制不佳，则需要额外治疗，这会带来巨大的临床和经济负担。我们的分析旨在基于PROXIMA研究的观察数据，确定在意大利使用奥马珠单抗治疗重症过敏性哮喘的成本效益。
研究奥马珠单抗治疗12个月后的疗效、医疗资源利用情况和生活质量变化的观察数据，以评估与使用奥马珠单抗前相比的成本效益，并采用增量成本效益比（ICER）来表示结果。成本效用分析评估了每获得一个质量调整生命年（QALY）的成本。直接医疗成本从意大利国家医疗服务体系（NHS）的角度进行评估。
奥马珠单抗治疗12个月后，可降低哮喘发作的发生率、住院次数、门诊次数，并改善生活质量。与使用奥马珠单抗前相比，奥马珠单抗疗效更佳，可使每位患者获得0.132个QALY，并使直接医疗成本减少3729欧元（不包括附加治疗成本）。然而，添加奥马珠单抗导致总直接成本相对于使用奥马珠单抗前增加了7478欧元。根据使用奥马珠单抗后与使用前总直接成本的差异以及QALY的差异，ICER为56,847欧元。敏感性分析表明，即使以20%的折扣价计算，奥马珠单抗对NHS资源的使用仍具有成本效益。
本研究提供了奥马珠单抗在意大利有效性的真实世界证据。尽管这种创新药物的购置成本高昂，但对于病情控制不佳的重症过敏性哮喘患者而言，奥马珠单抗是一种可持续的治疗选择。
