Meningococcal group b vaccine (recombinant, adsorbed)
Brand: Bexsero
PBAC's latest decision on Meningococcal group b vaccine (recombinant, adsorbed): Not recommended (2015). Considered for Active immunisation against disease caused by Neisseria meningitidis group B strains in infants and adolescents aged 2 months and older.
PBAC outcome
Not recommended
Not applicable
ICER (AUD/QALY)
$200k/QALY
Range: $105k/QALY–$200k/QALY
Submissions
1
first 2015
Submissions
1
2015 → 2015
Eligible population
Infants aged 2 months and older, and adolescents aged 15 years, with catch-up vaccination for infants up to 24 months of age and adolescents aged 16-19 years.
Therapy area
Vaccines
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Surrogate
Key trials
V72P12, V72P13, V72P10, V72_29
Comparator
no vaccination
Economic model
CUA
Eligible patients/year
200,000
Risk sharing
Risk-sharing arrangement in place — Price reduction for 4CMenB under catch-up programs for children and adolescents, plus proposed managed entry scheme (MES) including observational studies of IMD incidence, vaccine effectiveness, nasopharyngeal carriage, and safety surveillance.
Why PBAC said no
Reasons cited in the latest PSD: unacceptably high ICER based on uncertain and optimistic assumptions about extent and duration of effect and herd immunity, ESC and ATAGI doubts about effectiveness of NHBA antigen, concerns about high frequency of adverse events (fever and febrile seizures) in infants relative to modelled benefits, insufficient reduction in ICER even with proposed managed entry scheme at current requested price