Meningococcal Group B Vaccine (4cmenb)
Not recommended VaccinesNot applicable line 💬 consumer voice
Active immunisation against disease caused by Neisseria meningitidis group B strains in individuals from 2 months of age and older. The submission requested inclusion in the National Immunisation Program with a routine 3+1 schedule in infants, a 2-dose course in adolescents, and a catch-up program in older infants, toddlers and adolescents.
1
Submissions
2013–13
On the record
—
ICER range
Not modelled
Cost basis
From the public summary
PBAC outcome
7.1 The PBAC rejected the resubmission requesting listing of the 4CMenB vaccine on the National Immunisation Program Schedule for the prevention of meningococcal B disease in infants and adolescents.PSD · Nov 2013
7.2 The resubmission was rejected on the basis of 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, as well as an unacceptably high and uncertain ICER, including when based on optimistic assumptions about the extent and duration of effect and herd immunity.PSD · Nov 2013
Economic analysis
The PBAC noted that changing the assumptions from those originally submitted in the economic model to those in the pre-PBAC response resulted in minor changes to the ICER/QALY. However, when recalculated with annual discount rates of 5.0% costs/5.0% outcomes, the ICER for the base case Scenario 6 was greater than $200,000/QALYG.PSD · Nov 2013
The PBAC noted from sensitivity analyses of discounting and price, using the pre-PBAC response model, that a further price reduction would be necessary to give an ICER/QALY in the range that the PBAC has accepted for other vaccines it has recommended for inclusion in the NIP. 11.PSD · Nov 2013
Clinical claim
6.12 The resubmission 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 and remained uncertain.PSD · Nov 2013
6.13 The PBAC agreed in November 2013 that the vaccine is effective in inducing antibodies against the component antigens of 4CMenB. However, in the context of a population-based intervention against IMD, the Committee had also considered that the clinical claim was highly uncertain because of the likely short persistence of the antibody response, the unknown effect upon carriage of the bacteria, and the overall uncertain long-term protective efficacy …PSD · Nov 2013
Consumer comments
6.2 The PBAC noted and welcomed the input from individuals (40), health care professionals (3) and organisations (6) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with 4CMenB including preventing death and significant disability from the sudden onset of invasive meningococcal B disease.PSD · Nov 2013
Cost-effectiveness
No economic evaluation / ICER presented in this public summary document.
Decision context
PopulationInfants from 2 months of age (receiving 3 primary doses at 2, 4, 6 months and a booster at 12 months) and adolescents aged 11-17 years (receiving 1, 2, or 3 doses).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2013 | Not recommended | no vaccination | — | RCT · Surrogate |
Consumer voice
Consumer input described benefits of 4CMenB treatment in preventing death and significant disability from invasive meningococcal B disease. Comments were received from 40 individuals, 3 healthcare professionals, and 6 organisations.
The comments described a range of benefits of treatment with 4CMenB including preventing death and significant disability from the sudden onset of invasive meningococcal B disease. Consumer comments · PSD
preventing deathpreventing disabilityunmet needsudden onset disease
Similar precedents
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