156 Economic Evaluation of Grass Tablets for Immunotherapy (oralair) Compared to Placebo in Adults and Children in Italy

BACKGROUND: Specific immunotherapy is based on the regular administration over time of a maintenance dose of allergen extracts to allergic patients in order to modify the immune response, thus achieving a decrease in symptoms/drug intake and an improvement in quality of life, possibly on the long-term. Grass pollen tablet, Oralair (Stallergenes, Antony Cedex, France), were developed and registered for rhinoconjunctivitis allergy induced by grass pollen. There is sufficient evidence for the clinical efficacy of the product, but pharmaco-economy data are lacking. METHODS: An economic analysis, using a rescue medication adjusted score (AASS) was performed, based on the available registration trials—to assess the magnitude of Oralair effect if patients had not taken any rescue medication. In the present study the results of an adult and a pediatric study are pooled together with economic data in order to perform a cost–effectiveness analysis from the third party payer perspective. Medical visits, diagnostic exams, skin prick test, and drugs were valorized in euros according to the National tariffs and the standard drug prices in the Italian setting. The estimated ROC also enabled us to quantify the effectiveness in terms of Quality Adjusted Life Years (QALY). A decision tree was structured in order to model the possible outcomes and costs, according to a low, moderate and high AASS in adults and pediatric patients. A probabilistic sensitivity analysis was finally conducted to test the robustness of the results as well as the consistency with an assumed cost effectiveness threshold of euros 30.000/QALY. RESULTS: The results showed a relative difference of 1.84 in favor of the active treatment versus placebo in absolute value in adult study and of 1.64 in pediatric study. The results also show how the Oralair administration costs 1024 euro/QALY with high and moderate AASS. Including also the loss of productivity the incremental cost-effectiveness ratio (ICER) in adults is 700 euro/QALY. The 95% of the simulation performed by sensitivity analysis shows an ICER below the threshold of 30.000 euro/QALY. CONCLUSIONS: In conclusion our results show that Oralair grass tablet is a cost effective strategy in adults and pediatric patients with moderate and severe AASS.