Meningococcal (Groups A, C, W-135 And Y) Oligosaccharide Crm197 Conjugate Vaccine
Recommended VaccinesUnrestrictedNot applicable line 💬 consumer voice
Prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135 and Y in adolescents aged 14-19 years as part of school-based or catch-up immunisation programs.
3
Submissions
1 resub
2018–23
On the record
—
ICER range
Cost-min
Cost basis
Access path
- Jul 2018Recommended · restricted
vs no vaccine (placebo); near-market comparators: MenACWY-TT…
- Aug 2018Recommended · restricted
- Nov 2023Recommended
Comparator changed: no vaccine (placebo); near-market comparators: MenACWY-TT (Nimenrix)…
- PBS listing · Unrestricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended the listing of meningococcal serogroup A, C, W-135 and Y oligosaccharides conjugated individually to Corynebacterium diphtheriae CRM197 protein (MenACWY-CRM) vaccine (Menveo® solution for injection) as a designated vaccine on the National Health (Immunisation Program — Designated Vaccines) Determination 2014 (No.PSD · Nov 2023
6.2 The PBAC considered that nomination of Menveo solution and powder for reconstitution and secondary comparator Nimenrix were appropriate.PSD · Nov 2023
Economic analysis
5.10 As a Committee Secretariat submission, the economic analysis has not been independently evaluated.PSD · Nov 2023
5.11 The submission applied the assumption of equivalence between Menveo solution for injection and Menveo solution and powder for reconstitution, with an equi-effective dose of 0.5 mL solution for injection = 0.5 mL solution and powder for reconstitution.PSD · Nov 2023
Clinical claim
5.7 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of Menveo solution for injection compared with Menveo solution and powder for reconstitution.PSD · Nov 2023
5.8 The submission also claimed non-inferior comparative effectiveness and non-inferior comparative safety of Menveo solution for injection compared with Nimenrix. This was on the basis that the PBAC had previously found that the claim that Menveo solution and powder for reconstitution had non-inferior comparative effectiveness and non-inferior comparative safety to Nimenrix was reasonable (Menveo PSD, July and August 2018 PBAC Meeting).PSD · Nov 2023
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission requested the existing nationally negotiated price for MenACWY vaccine with nil net cost to government.
The positive PBAC recommendation for the NIP listing of the MenACWY-TT vaccine for the adolescent population is yet to be implemented and is contingent upon the sponsor of MenACWY-TT accepting a price reduction such that the incremental cost- PSD · 2018
Price cut / RSA needed ×2Surrogate endpointCost-effectiveness accepted
Decision context
PopulationAdolescents aged at least 14 years old but less than 17 years old as part of a school-based program, or aged at least 14 years old but less than 19 years old who did not receive vaccination as part of a school-based program, for prevention of invasive meningococcal disease.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended | Menveo solution and powder for reconstitution; Nimenrix | — | RCT · Immunogenicity and safety |
| Aug 2018 | Recommended · restricted | no vaccine (placebo); near-market comparators: MenACWY-TT (Nimenrix) and MenACWY-DT (Menactra) | — | RCT · Surrogate |
| Jul 2018 | Recommended · restricted | no vaccine (placebo); near-market comparators: MenACWY-TT (Nimenrix) and MenACWY-DT (Menactra) | — | RCT · Immunogenicity (seroresponse, hSBA titres, GMTs); safety and adverse events |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
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