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Meningococcal Group B Vaccine, Multicomponent (4cmenb)

Recommended · restricted VaccinesRestrictedNot applicable line 💬 consumer voice

Active immunisation against invasive meningococcal disease (IMD) caused by Neisseria meningitidis group B strains in individuals from 2 months of age and older.

1
Submissions
1 resub
2019–19
On the record
Redacted
ICER range
commercial-in-confidence
Redacted
Cost basis

Access path

1 submission · public record
  1. Nov 2019
    Recommended · restricted

    vs no vaccine

  2. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
7.1 The PBAC recommended the listing of multicomponent meningococcal group B vaccine (4CMenB, Bexsero®), on the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the Determination), for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis group B strain in Aboriginal and Torres Strait Islander children.PSD · Nov 2019
7.2 The PBAC noted the large number of consumer comments (paragraph 6.2) supporting inclusion of 4CMenB on the National Immunisation Program (NIP) to prevent IMD caused by the group B strain of Neisseria meningitidis.PSD · Nov 2019
Economic analysis
6.24 The economic evaluation presented was a cost-utility analysis and this is unchanged from the previous resubmission. Although the methodological modelling approach is consistent with the previous submission, the structure is substantially different.PSD · Nov 2019
Outcomes sequelae avoided, quality-adjusted life years Time horizon Life-time horizon (100 years) Unchanged.PSD · Nov 2019
Clinical claim
In adolescents, 4CMenB is more effective than no Men B vaccination in preventing gonorrhoea.PSD · Nov 2019
Abbreviations: 4CMenB= multicomponent meningococcal group B vaccine; ATAGI= Australian Technical Advisory Group on Immunisation; fHbp= factor H binding protein; IMD = invasive meningococcal disease; Men B= Meningococcal B; NadA= Neisseria Adhesin A; NHBA= Neisseria Heparin Binding Antigen; OMV= Outer Membrane Vesicles; Source: Table 1.1, p.35 of the resubmission. 1PSD · Nov 2019
Consumer comments
6.2 The PBAC noted and welcomed the input from individuals (201), health care professionals (28) and organisations (6) via the Consumer Comments facility on the PBS website. The comments described the devastating, often life-long consequences of IMD and the high impact on the quality of life of families that are affected.PSD · Nov 2019

Cost-effectiveness

Price information and specific ICER values are redacted throughout the document (indicated by quotation marks and asterisks).

Decision context

PopulationInfants and adolescents for active immunisation against invasive meningococcal disease caused by Neisseria meningitidis group B; includes catch-up programs for children under 2 years, Aboriginal and Torres Strait Islander people under 20 years, and people with medical conditions increasing IMD risk.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Nov 2019 Recommended · restricted no vaccine RCT · Other

Consumer voice

Nov 2019

Consumers described the devastating, lifelong consequences of invasive meningococcal disease (IMD) and its high impact on family quality of life. Many raised affordability and equity concerns regarding vaccine access, diagnostic difficulties, rapid disease progression, and the need for protection against Men B strain.

The comments described the devastating, often life-long consequences of IMD and the high impact on the quality of life of families that are affected. Consumer comments · PSD
quality of lifeunmet needout-of-pocket costaccess barrierstreatment burden on family

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