Clinical impact and cost-effectiveness of vaccinating infants and adolescents against invasive meningococcal B disease in the Netherlands

BACKGROUND: Invasive meningococcal B disease (IMD-B) causes morbidity and mortality among infants and adolescents in the Netherlands. While multiple vaccines against IMD-B are licensed by the European Medicines Agency, none of them is currently part of the Dutch National Immunization Program (NIP). We evaluated the clinical impact and cost-effectiveness of different IMD-B vaccination strategies for Dutch infants and adolescents. METHODS: We developed a static, single-cohort Markov model to estimate the lifetime number of IMD-B cases and deaths prevented, as well as the incremental cost-effectiveness ratio (ICER), of vaccinating infants with 4CMenB (age 0; 2 + 1 schedule) or adolescents with 4CMenB, MenB-fHBp, or MenABCWY + MenB-fHBp (age 15; 1 + 1 schedule), compared with no IMD-B vaccination. The analysis adopted a societal perspective, including costs and quality-adjusted life years (QALYs) related to vaccination, adverse events, acute IMD-B, long-term sequelae, productivity losses of patients and caregivers, special education needs, and out-of-pocket expenses for patients and their families. We also conducted a threshold analysis for the incidence of IMD-B and a systematic uncertainty assessment. RESULTS: For infants, the use of 4CMenB would prevent 11.14 IMD-B cases and 0.85 IMD-B-related deaths in one birth cohort of 166,073 infants over a lifetime. For adolescents, IMD-B vaccination would prevent 7.24-8.57 cases and 0.25-0.29 deaths in a single cohort of 197,782 adolescents, depending on which vaccine is used. The ICER was €594,056/QALY for 4CMenB in infants, while for adolescents the ICER ranged between €717,287/QALY and €890,023/QALY, depending on the vaccine type used. These ICERs exceed the commonly used cost-effectiveness thresholds (€20,000 to €80,000/QALY gained) in the Netherlands, rendering vaccination not cost-effective. This outcome proved robust in deterministic and probabilistic sensitivity analyses, as well as in scenario analyses. The threshold analysis demonstrated that IMD-B vaccination may only become cost-effective at a €80,000/QALY threshold with more than a sixfold increase in incidence. CONCLUSIONS: The modelled IMD-B vaccination programs resulted in the prevention of limited morbidity and mortality at a high financial burden. The inclusion of any of the evaluated vaccines in the Dutch NIP for infants or adolescents is not cost-effective in any target group at conventional Dutch cost-effectiveness thresholds given current IMD-B incidence levels.