Cost-utility of add-on Omalizumab in difficult-totreat allergic asthma in Italy

R.W. Dal Negro, L. Pradelli, S.Tognella, C. Micheletto, S. Iannazzo

Objective: Omalizumab (OM), an innovative biological treatment for difficult asthma with perennial sensitisations, is an humanized monoclonal anti-IgE antibody that binds free circulating IgE; inhibits mast cell and basophil activation by combining free IgE, leads to IgE receptor down-regulation, thus blocking the inflammatory cascade. AIM of the study was to assess real-world cost-utility of add-on OM in Italy. Methods: changes in clinical and economical outcomes, and in quality of life (QoL) associated with add-on OM in adults(n=23) with severe difficult asthma were compared with those recorded before OM in the same subjects. Variables were: lung function; IgE levels; health status; ACT score; QoL (SGRQ); n. GP and specialist visits; emergency visits; hospitalizations, and concomitant pharmacological treatments. Further indices were: changes in Health-related QoL; total health-care costs, and incremental cost/utility. Data were statistically compared (Student's T test), and p < 0.01 was accepted for statistical significance. Results: asthma clinical outcomes and patients' health-related quality of life improved significantly by adding OM, and both costs for drugs and hospital care dropped significantly (p<0.01). The net economic effect was a 350 € increase in overall monthly costs; when related to health benefits, it corresponded to an incremental cost/utility ratio of about 26,000 €/QALY, which represents a quite favourable figure in terms of willingness to pay for health benefits in industrialised countries. Conclusions: Omalizumab added to an optimised therapy significantly improves clinical outcomes in difficult-to-treat, persistent allergic asthma. Costs also increased, but proved justified by health benefits achieved.
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