Health and economic outcomes of introducing the new MenB vaccine (Bexsero) into the Italian routine XXXX immunisation programme.

@entity1 @entity295 @entity4008 @entity281 @entity7135 @entity10679
INTRODUCTION: In January 2013 a novel type of multicomponent protein-based vaccine against @entity7135 was licensed by the European Medicines Agency. With the widespread use of the meningococcal serogroup C conjugate vaccines, serogroup B remains now the major cause of @entity4008 and @entity295 in young @entity1 in Europe. The aim of this study is to investigate the health and the economic outcomes of MenB vaccine introduction into the Italian routine mass vaccination programme. METHODS: The present work is structured in two main parts. Firstly, we assess the epidemiological burden of @entity7135 using official hospitalisation and notification data from two of the most populated Italian regions (Lombardia and Piemonte) during a 6-year study period (2007-2012). Secondly, we evaluate the cost-effectiveness of the immunisation programme in Italy from the public health payer perspective under base case parameters assumptions and performing a comprehensive sensitivity analysis to assess the robustness and the uncertainty of our model results. RESULTS: MenB serotype is responsible for 59% of the 341 cases of Invasive @entity7135 in Lombardia and Piemonte. Incidence rate for @entity281 is estimated to be 0.21/100,000/y resulting at the highest level in @entity1  <=4 years of age. Although the new MenB vaccine can potentially prevent about one third of the disease cases in the Italian population, model results show this strategy is unlikely to be cost-effective ( @entity10679 value over    350,000/QALY) with a vaccine that prevents disease only. These results are robust under most of the sensitivity scenarios except when allowing for lower discount rates. DISCUSSION: The introduction of the novel vaccine into the routine immunisation schedule needs to be carefully evaluated. The new MenB vaccine has the potential to reduce the disease burden at the population level. However, from the Italian Health Service perspective, the immunisation programme is unlikely to be cost-effective at the current incidence levels and vaccine price.
