title: Economic evaluation of 5-grass pollen tablets versus placebo in the treatment of allergic rhinitis in adults.
abstract: BACKGROUND
  Allergen immunotherapy (AIT) is aimed at modifying the immune response to a causative allergen, thereby reducing clinical symptoms and symptomatic medication intake and improving quality of life. Long-term AIT research has led to the development of 5-grass pollen tablets, currently indicated for the treatment of grass pollen-induced allergic rhinitis (AR).
  
  
  METHODS
  A post-hoc analysis was conducted using the Average Adjusted Symptom Score (AAdSS) to compare the effect of treatment of AR with 5-grass pollen tablets versus placebo treatment. Using the results of the VO34.04 and VO53.06 trials and economic data, cost-effectiveness analysis of 5-grass pollen tablet treatment was performed from the Italian third-party payer perspective with cost data derived from a study of 2008 updated to 2011. Also a societal perspective was considered by using the costs related to the losses of productivity by following the human capital approach. Using the results of the analysis, the estimated receiver-operating characteristic curve was plotted to evaluate medication effectiveness in terms of quality-adjusted life years (QALYs) and a decision tree constructed to model the possible outcomes and costs for adults and paediatric patients with a low, medium, and high AAdSS. Finally, probabilistic sensitivity analysis was conducted to test the robustness of the results as well as their consistency at an assumed cost-effectiveness threshold of € 30,000/QALY.
  
  
  RESULTS
  The results indicate that compared to the placebo, the 5-grass pollen tablet treatment provides a benefit of 0.127 QALYs in medium AAdSS patients and of 0.143 QALYs in high AAdSS patients. The 5-grass pollen tablet treatment was found to cost € 1,024/QALY for patients with a medium AAdSS and € 1,035/QALY for patients with a high AAdSS. Of all the simulations performed in the probabilistic sensitivity analysis, 99 % indicated that the incremental cost-effectiveness ratio of the 5-grass pollen tablet treatment was below the threshold of € 30,000/QALY in patients with medium and high AAdSS, whereas it was found to be dominated in 67 % of simulations related to patients with low AAdSS.
  
  
  CONCLUSIONS
  The 5-grass pollen tablet is a cost-effective treatment for adult AR patients with a medium or high AAdSS. This finding should be carefully considered when deciding the management strategy for these patients.
authors.affiliation: Faculty of Economics, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Ruggeri
authors.forename: Marco
authors.initials: M
authors.lastname: Oradei
authors.forename: Franco
authors.initials: F
authors.lastname: Frati
authors.forename: Paola
authors.initials: P
authors.lastname: Puccinelli
authors.forename: Cristina
authors.initials: C
authors.lastname: Romao
authors.forename: Ilaria
authors.initials: I
authors.lastname: Dell'Albani
authors.forename: Cristoforo
authors.initials: C
authors.lastname: Incorvaia
authors.forename: Americo
authors.initials: A
authors.lastname: Cicchetti
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D000485:Allergens / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003198:Computer Simulation; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D003663:Decision Trees; D003888:Desensitization, Immunologic / Q000191:economics* / Q000379:methods; D016527:Drug Costs; D006801:Humans; D007558:Italy; D018803:Models, Economic; D019057:Quality-Adjusted Life Years; D006255:Rhinitis, Allergic, Seasonal / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics; D013607:Tablets; D016896:Treatment Outcome
chemical_list: C578543:300IR 5-grass pollen allergen; D000485:Allergens; D013607:Tablets