Cell-Cultured Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated)
Prevention of influenza in children aged 6 months to <5 years, Aboriginal and Torres Strait Islander people aged ≥6 months to <65 years, persons aged ≥6 months to <65 years with medical conditions increasing risk of influenza complications, and pregnant women.
Access path
- Mar 2024Recommended · restricted
vs QIVe (quadrivalent egg-based influenza vaccine)
- PBS listing · Restricted
From the public summary
The PBAC recommended that influenza vaccine (Flucelvax® Quad, QIVc) be a designated vaccine for the purposes of the National Health Act 1953, for the vaccination against influenza in children aged ≥6 months to <5 years. The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of QIVc would be acceptable at the same price as was previously recommended for QIVc for the current NIP-funded population.PSD · Mar 2024
The PBAC considered that the nomination of existing NIP-funded quadrivalent egg- based vaccines (QIVe) as the main comparator was appropriate for the proposed population.PSD · Mar 2024
The submission presented a cost-utility analysis for a comparison of QIVc vs QIVe based on the V130_67 study. As the request for the PBAC to consider the claim that QIVc is superior in effectiveness to QIVe in the currently funded cohorts on the NIP was withdrawn by the sponsor, the economic model was not considered by the PBAC and is not presented.PSD · Mar 2024
Vaccine cost/person/year Table 7: Drug cost per child (aged 6 months to 5 years) for proposed and comparator drugs QIVc QIVe QIVc / QIVe recommended dose and frequency Financial estimates Financial estimates Dose One or two dosesa 1.25 doses 1.25 doses Frequency Once or twice a year a Once a year Once a year QIVc: $ per dose Cost/child/year $ $ QIVe: $ per dose Source: Table 3.6.1, p116 of the submission and the “Flucelvax Quad Section 4 spreadsheet”.PSD · Mar 2024
For the population aged ≥6 months to <65 years, the submission claimed QIVc was superior to QIVe in effectiveness in terms of clinically relevant influenza-related outcomes, and comparable to QIVe in terms of safety. The pre-PBAC response withdrew this claim.PSD · Mar 2024
For the newly requested 6 months to <5 years age group, the evaluation considered that superior effectiveness was not adequately supported by the evidence presented in the submission because there were no comparative effectiveness data in the included evidence, and:PSD · Mar 2024
Lung Foundation Australia expressed its support for the NIP listing of QIVc for people aged 6 months and older. The organisation emphasised the potential benefits of reducing the burden of illness associated with influenza, particularly among children.PSD · Mar 2024
Lung Foundation Australia noted that availability of QIVc for people aged 6 months and older through the NIP would provide Australians with an alternate supply of influenza vaccine, ensuring continued access when needed. Lung Foundation Australia also noted the benefits of reducing the risk of disease associated with influenza outbreaks and minimising the economic and social burden associated with illness. 6PSD · Mar 2024
Cost-effectiveness
No ICER calculated; this is a vaccine listing submission for which cost-effectiveness was previously assessed at September 2022 meeting. Current submission is for population extension without new economic evaluation.
Decision context
PopulationChildren aged 6 months to <5 years; Aboriginal and Torres Strait Islander people aged ≥6 months to <65 years; persons aged ≥6 months to <65 years with medical conditions increasing risk of influenza complications; pregnant women.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended · restricted | QIVe (quadrivalent egg-based influenza vaccine) | — | RCT · Immunogenicity (HAI and microneutralisation assays) |
Consumer voice
Lung Foundation Australia supported NIP listing of QIVc for people aged 6 months and older, emphasising potential benefits in reducing influenza disease burden in children and ensuring continued vaccine access while minimising economic and social burden.
Lung Foundation Australia expressed its support for the NIP listing of QIVc for people aged 6 months and older. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to children <5 years, specific Aboriginal/TSI and at-risk age groups, and pregnant women; excludes healthy adults ≥65 years covered by TGA label.