Meningococcal Group B Vaccine (Recombinant, Adsorbed)
Not recommended VaccinesNot applicableNot applicable line 💬 consumer voice
Active immunisation against disease caused by Neisseria meningitidis group B strains in infants and adolescents aged 2 months and older.
1
Submissions
1 resub
2015–15
On the record
$105k–200k
ICER range
1 sourced ICER · 2015
ICER stated
Cost basis
risk sharing
From the public summary
PBAC outcome
7.1 The PBAC rejected the re-submission requesting listing of the 4CMenB vaccine on the National Immunisation Program Schedule for the prevention of meningococcal B disease in infants and adolescents. The basis of the rejection was that the re-submission did not address multiple uncertainties in relation to the clinical effectiveness of the vaccine against the disease when delivered in a vaccination program, that the optimistic assumptions about the …PSD · Jul 2015
7.2 The PBAC noted that the proposed vaccination program of routine infant and adolescent with catch-up for older infants and toddlers and adolescents (program 5) was consistent with the November 2013 and July 2014 submissions. This minor re-submission proposed four other potential programs, including routine adolescent with catch-up for adolescents. The PBAC noted the advice from ATAGI on this item.PSD · Jul 2015
Economic analysis
6.13 The previous major submission considered by PBAC in July 2014 presented a cost- utility analysis of Program #5 against no vaccination. The PBAC considered the base case ICER of more than $200,000/QALY to be unacceptably high and was based on uncertain and optimistic assumptions about the extent and duration of effect and herd immunity, noting particularly the ESC and ATAGI doubts about the vaccine’s effectiveness against NHBA.PSD · Jul 2015
6.14 The minor re-submission claimed that it re-specified the best estimate of the base case ICER (to which the five vaccination programs were applied) by:PSD · Jul 2015
Clinical claim
6.11 The re-submission described 4CMenB as superior in terms of comparative effectiveness, with an acceptable tolerability profile in infants and adolescents. This was unchanged from the previous submission.PSD · Jul 2015
6.12 The PBAC reaffirmed its November 2013 and July 2014 conclusion that the vaccine is effective in inducing antibodies against the component antigens of 4CMenB.PSD · Jul 2015
Consumer comments
6.2 The PBAC noted and welcomed the input from individuals (14) via the Consumer Comments facility on the PBS website. The majority of comments supported listing of the vaccine due to perceived benefits of community protection, and potential to save lives and eradicate disease, although there was one comment that claimed that the significant financial costs, rarity of disease and absence of evidence demonstrating safety did not support listing of the …PSD · Jul 2015
Cost-effectiveness
ICER uncertainICER / price too highEconomic model disputedImmature survival data
Decision context
PopulationInfants 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.
Risk sharingPrice 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 it was knocked back
- 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
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2015 | Not recommended | no vaccination | $105k–200k | RCT · Surrogate |
Consumer voice
The majority of 14 consumer comments supported listing of the vaccine due to perceived benefits of community protection and potential to save lives and eradicate disease, although one comment opposed listing citing significant financial costs, disease rarity, and absence of safety evidence.
The majority of comments supported listing of the vaccine due to perceived benefits of community protection, and potential to save lives and eradicate disease Consumer comments · PSD
community protectiondisease eradicationcost concernssafety evidenceunmet need
Similar precedents
Meningococcal Group B Vaccine (4cmenb)87%Meningococcal Group B Vaccine, Multicomponent (4cmenb)85%Meningococcal (Groups A, C, W-135 And Y) Oligosaccharide Crm197 Conjugate Vaccine73%Meningococcal Polysaccharide Serogroups A, C, W-135 And Y Conjugate Vaccine72%Meningococcal Polysaccharide Conjugate Vaccine Serogroups A, C, W-135 And Y70%Hepatitis B Surface Antigen Recombinant Vaccine67%Adacel66%Rotavirus Vaccine65%