The PBAC did not recommend the inclusion of the 4CMenB vaccine on the National Immunisation Program Schedule for the prevention of meningococcal B disease in infants and adolescents. The PBAC considered that there was a limited demonstration of, and multiple uncertainties in relation to the clinical effectiveness of the vaccine against the disease when delivered in a vaccination program. In addition, the PBAC concluded that the ICER was unacceptably high and was based on uncertain assumptions about extent and duration of effect and herd immunity. The PBAC noted that the submission estimated that over 4 million children and adolescents would be vaccinated over the first 5 years of a full vaccination program. The PBAC noted that based on estimates provided by the Australian Technical Advisory Group on Immunisation (ATAGI), this vaccination program would prevent 224 cases of invasive meningococcal disease, 9 deaths due to meningococcal B disease, and 93 patients with sequelae after 5 years. The PBAC concluded that the rarity of invasive meningococcal B disease, compared to the large number of vaccinations that are required was the primary driver of the unfavourable ICER. Sponsor’s comments: Novartis Vaccines has initiated discussions with the PBAC to clarify and address the issues raised. 4
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- Spring '14
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