title: A 36-month study on the cost/utility of add-on omalizumab in persistent difficult-to-treat atopic asthma in Italy.
abstract: 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 €450 increase in overall monthly costs was observed; however, when health benefits were considered, this cost increase translated into an incremental cost/utility ratio of €23,880 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.
authors.affiliation: Lung Unit, Orlandi General Hospital, Bussolengo, Verona, Italy.
authors.forename: Roberto Walter
authors.initials: RW
authors.lastname: Dal Negro
authors.forename: Silvia
authors.initials: S
authors.lastname: Tognella
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Pradelli
mesh_terms: D000328:Adult; D018927:Anti-Asthmatic Agents / Q000191:economics / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic / Q000191:economics / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000191:economics / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000191:economics / Q000276:immunology / Q000503:physiopathology; D015331:Cohort Studies; D003362:Cost-Benefit Analysis; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007558:Italy; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011788:Quality of Life
chemical_list: D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab; D007073:Immunoglobulin E