Find in Library

Giorgio Walter Canonica, 1 Giorgio Lorenzo Colombo, 2, 3 Paola Rogliani, 4 Pierachille Santus, 5 Claudia Pitotti, 6 Sergio Di Matteo, 3 Chiara Martinotti, 3 Giacomo Matteo Bruno 3 1Asthma & Allergy Clinic, Humanitas University, Milan, Italy; 2S.A.V.E. S.r.l. Studi Analisi Valutazioni Economiche Health Economics & Outcomes Research - Research Center, Milan, Italy; 3Drug Science Department, Pavia University, Pavia, Italy; 4Respiratory Unit, Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Rome, Italy; 5Department of Biomedical and Clinical Sciences (DIBIC), University of Milan, Division of Pulmonary Diseases, Ospedale L. Sacco, ASST Fatebenefratelli-Sacco, Milan, Italy; 6Novartis Farma S.p.A, Milan, ItalyCorrespondence: Giorgio Walter Canonica Tel +39 0282247752Email giorgio_walter.canonica@hunimed.euIntroduction: 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.Methods: 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).Results: 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.Conclusion: 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.Keywords: severe allergic asthma, healthcare costs, effectiveness, cost-utility, omalizumab, PROXIMA study