PMID- 22954018 OWN - NLM STAT- MEDLINE DCOM- 20130211 LR - 20151119 IS - 1532-4303 (Electronic) IS - 0277-0903 (Linking) VI - 49 IP - 8 DP - 2012 Oct TI - A 36-month study on the cost/utility of add-on omalizumab in persistent difficult-to-treat atopic asthma in Italy. PG - 843-8 LID - 10.3109/02770903.2012.717659 [doi] AB - OBJECTIVE: Omalizumab is a biological treatment for difficult-to-treat allergic asthma. Its mechanism of action relies on impeding the binding of immunoglobulin E (IgE) to specific cellular receptors, thus blocking the inflammatory cascade. At present, no long-term data are available on its cost/effectiveness. The aim of this study is to assess long-term clinical outcomes and to measure the cost/utility of long-term omalizumab use in difficult-to-treat allergic asthmatics. METHODS: The clinical, economic, and quality-of-life (QoL) outcomes of 36-month add-on omalizumab therapy were compared to equivalent outcomes for the year before the therapy's introduction in a cohort (n = 16) of adults with severe uncontrolled atopic asthma on chronic high-dose antiasthma treatments. The variables considered were lung function, IgE levels, health status, Asthma Control Test (ACT) score, QoL (St. George Questionnaire), general practitioner (GP) and specialist visits, number and duration of hospitalizations, emergency room admission, and pharmacological treatment (both dose and duration). Derived calculated indicators were changes in health-related QoL, total healthcare costs, and incremental cost/utility. Data from the two periods were tested for statistically significant differences according to Student's t test and p < .05 was accepted. RESULTS: Add-on omalizumab significantly and progressively improved asthma control and patient health-related QoL. Symptomatic drug and hospital care costs for these patients dropped significantly. A euro450 increase in overall monthly costs was observed; however, when health benefits were considered, this cost increase translated into an incremental cost/utility ratio of euro23,880 per quality-adjusted life year gained, which is quite a favorable and convenient figure in terms of the willingness to pay for health benefits in industrialized countries. CONCLUSIONS: The 36-month add-on omalizumab therapy persistently improved all clinical outcomes in difficult-to-treat asthmatic patients. Costs were also optimized and related to the extent of long-term health benefits achieved. FAU - Dal Negro, Roberto Walter AU - Dal Negro RW AD - Lung Unit, Orlandi General Hospital, Bussolengo, Verona, Italy. FAU - Tognella, Silvia AU - Tognella S FAU - Pradelli, Lorenzo AU - Pradelli L LA - eng PT - Comparative Study PT - Journal Article DEP - 20120907 PL - England TA - J Asthma JT - The Journal of asthma : official journal of the Association for the Care of Asthma JID - 8106454 RN - 0 (Anti-Asthmatic Agents) RN - 0 (Antibodies, Anti-Idiotypic) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 2P471X1Z11 (Omalizumab) RN - 37341-29-0 (Immunoglobulin E) SB - IM MH - Adult MH - Anti-Asthmatic Agents/economics/*therapeutic use MH - Antibodies, Anti-Idiotypic/economics/*therapeutic use MH - Antibodies, Monoclonal, Humanized/economics/*therapeutic use MH - Asthma/*drug therapy/economics/immunology/physiopathology MH - Cohort Studies MH - Cost-Benefit Analysis MH - Female MH - Forced Expiratory Volume/drug effects MH - Humans MH - Immunoglobulin E/blood MH - Italy MH - Male MH - Middle Aged MH - Omalizumab MH - Quality of Life EDAT- 2012/09/08 06:00 MHDA- 2013/02/12 06:00 CRDT- 2012/09/08 06:00 PHST- 2012/09/08 06:00 [entrez] PHST- 2012/09/08 06:00 [pubmed] PHST- 2013/02/12 06:00 [medline] AID - 10.3109/02770903.2012.717659 [doi] PST - ppublish SO - J Asthma. 2012 Oct;49(8):843-8. doi: 10.3109/02770903.2012.717659. Epub 2012 Sep 7.