title: Health and economic outcomes of introducing the new MenB vaccine (Bexsero) into the Italian routine infant immunisation programme.
abstract: BACKGROUND
  In 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.
  
  
  METHODS
  The 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.
  
  
  RESULTS
  MenB 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.
  
  
  CONCLUSIONS
  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.
authors: Postgraduate School of Public Health, Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.
authors: Marcello
authors: M
authors: Tirani
authors: CeRGAS-Centre for Research on Health and Social Care Management, Bocconi University, Milan, Italy.
authors: Michela
authors: M
authors: Meregaglia
authors: Department of Policy Analysis and Public Management & Dondena Centre for Research on Social Dynamics and Public Policy, Bocconi University, Milan, Italy.
authors: Alessia
authors: A
authors: Melegaro
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D017589:Immunization Programs; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D007558:Italy; D008297:Male; D016920:Meningitis, Bacterial / Q000191:economics / Q000453:epidemiology / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000191:economics / Q000627:therapeutic use*; D008875:Middle Aged; D011788:Quality of Life; D065288:Serogroup; D055815:Young Adult
chemical_list: C570015:4CMenB vaccine; D022401:Meningococcal Vaccines