Health and Economic Outcomes of Introducing the New MenB Vaccine (Bexsero) into the Italian Routine Infant Immunisation Programme

Abstract

IntroductionIn January 2013 a novel type of multicomponent protein-based vaccine against group B meningococcal disease 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 bacterial meningitis and septicaemia in young children 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.MethodsThe present work is structured in two main parts. Firstly, we assess the epidemiological burden of group B meningococcal disease 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.ResultsMenB serotype is responsible for 59% of the 341 cases of Invasive Meningococcal Disease in Lombardia and Piemonte. Incidence rate for MenB infection is estimated to be 0.21/100,000/y resulting at the highest level in children ≤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 (ICER 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.DiscussionThe 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.

Vaccinating Italian infants with a new multicomponent vaccine (Bexsero®) against meningococcal B disease: A cost-effectiveness analysis

“…We believe that this approach is one of the strengths of our study. Indeed, cost-effectiveness studies often neglect the issue of underestimation and tend to be very conservative 25-29 . Our study indicated that the parameter “probability of sequelae” was one of the parameters impacting ICER.…”

“…Furthermore, a recent Italian cost-effectiveness analysis found that routine infant immunization with Bexsero® would not be cost-effective with an ICER of > 350,000 €/QALY 25 . In this latter study, Tirani et al 25 .…”

The Multicomponent Meningococcal Serogroup B Vaccine (4CMenB): Origin, Composition, Health Impact and Unknown Aspects

“…More substantial reductions in disease (71%) can be achieved after 10 years by routinely vaccinating infants in combination with a large-scale catch-up campaign targeting carriage, achieving cost-effectiveness at £17 per vaccine dose. Moreover, data from the Italian Health Service perspective came to the same conclusion evaluating the current incidence levels in Italy and the vaccine price [65]. However as MID incidence varies across the world, further pharmacoeconomic studies in different geographic and sociodemographic settings, including other aspects as parents demand, prevention of outbreak, new marketing strategy are needed to carefully evaluate the introduction of the 4CMenB into the routine immunization schedule.…”

Spontanuous Demand For Meningococcal B Vaccination: Effects On Appropriateness And Timing

“…Between 2007 and 2012 a study carried out in two Italian regions found that 341 cases of IBDs of which 202 were of serogroup B . 5 In the same period in Italy the Istituto Superiore di Sanità (ISS, Italian National Health Institute) reported 991 cases IBDs, of which 455 were caused by serogroup B . 6 Overall, 81% of all cases of meningitis occurring during the first year of life are caused by serotype B , 6 and more than half occur in 4–8 months old infants.…”