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. CONCLUSION: 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.
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 AAdSSpatients and of 0.143 QALYs in high AAdSSpatients. 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. CONCLUSION: 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: J Bousquet; N Khaltaev; A A Cruz; J Denburg; W J Fokkens; A Togias; T Zuberbier; C E Baena-Cagnani; G W Canonica; C van Weel; I Agache; N Aït-Khaled; C Bachert; M S Blaiss; S Bonini; L-P Boulet; P-J Bousquet; P Camargos; K-H Carlsen; Y Chen; A Custovic; R Dahl; P Demoly; H Douagui; S R Durham; R Gerth van Wijk; O Kalayci; M A Kaliner; Y-Y Kim; M L Kowalski; P Kuna; L T T Le; C Lemiere; J Li; R F Lockey; S Mavale-Manuel; E O Meltzer; Y Mohammad; J Mullol; R Naclerio; R E O'Hehir; K Ohta; S Ouedraogo; S Palkonen; N Papadopoulos; G Passalacqua; R Pawankar; T A Popov; K F Rabe; J Rosado-Pinto; G K Scadding; F E R Simons; E Toskala; E Valovirta; P van Cauwenberge; D-Y Wang; M Wickman; B P Yawn; A Yorgancioglu; O M Yusuf; H Zar; I Annesi-Maesano; E D Bateman; A Ben Kheder; D A Boakye; J Bouchard; P Burney; W W Busse; M Chan-Yeung; N H Chavannes; A Chuchalin; W K Dolen; R Emuzyte; L Grouse; M Humbert; C Jackson; S L Johnston; P K Keith; J P Kemp; J-M Klossek; D Larenas-Linnemann; B Lipworth; J-L Malo; G D Marshall; C Naspitz; K Nekam; B Niggemann; E Nizankowska-Mogilnicka; Y Okamoto; M P Orru; P Potter; D Price; S W Stoloff; O Vandenplas; G Viegi; D Williams Journal: Allergy Date: 2008-04 Impact factor: 13.146
Authors: S R Durham; S M Walker; E M Varga; M R Jacobson; F O'Brien; W Noble; S J Till; Q A Hamid; K T Nouri-Aria Journal: N Engl J Med Date: 1999-08-12 Impact factor: 91.245
Authors: Giuseppe Frenguelli; Giovanni Passalacqua; Sergio Bonini; Alessandro Fiocchi; Cristoforo Incorvaia; Francesco Marcucci; Emma Tedeschini; Giorgio Walter Canonica; Franco Frati Journal: Ann Allergy Asthma Immunol Date: 2010-09 Impact factor: 6.347
Authors: N F Ray; J N Baraniuk; M Thamer; C S Rinehart; P J Gergen; M Kaliner; S Josephs; Y H Pung Journal: J Allergy Clin Immunol Date: 1999-03 Impact factor: 10.793