Quadrivalent Recombinant Influenza Vaccine
Recommended VaccinesUnrestrictedNot applicable line 💬 consumer voice
Prevention of influenza in people aged 65 years and over.
1
Submissions
2024–24
On the record
—
ICER range
Cost-min
Cost basis
Access path
- Mar 2024Recommended
vs adjuvanted egg-based quadrivalent influenza vaccine (aQIV…
- PBS listing · Unrestricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
The PBAC recommended that influenza vaccine (Flublok® Quadrivalent, RIV4) be a designated vaccine for the purposes of the National Health Act 1953 for vaccination against influenza in people aged at least 65 years of age. The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost- effectiveness of RIV4 would be acceptable if it were cost-minimised against adjuvanted quadrivalent influenza vaccine (aQIV).PSD · Mar 2024
The PBAC noted that the consumer comments outlined that RIV4 would provide an additional option for influenza vaccination in people aged ≥ 65 years.PSD · Mar 2024
Economic analysis
The submission requested a price for RIV4 of $ per dose based on the assumed confidential price of aQIV ($) plus a $ technology premium (refer to Paragraphs 6.29 to 6.40). The Pre-Sub-Committee Response stated that the value of $ was an estimate only and clarified that the request was for a premium of the “same quantum” as that recommended by the PBAC for QIVc over QIVe (in the <65 years cohort).PSD · Mar 2024
The submission described this as a cost-consequence analysis. The submission estimated the equi-effective doses as: RIV4 (1 x 0.5 mL) = aQIV (1 x 0.5 mL).PSD · Mar 2024
Clinical claim
The submission described RIV4 as “at least non-inferior” in terms of comparative effectiveness, immunogenicity and safety to the currently listed and supplied vaccine, aQIV. This claim was adequately supported based on the ATAGI pre-submission advice which stated: “based on the available data, ATAGI has reasonable confidence that RIV4 is ‘at least’ equivalent to adjuvanted vaccines in this population”.PSD · Mar 2024
The submission further stated RIV4 is expected to provide “important technological advantages” over aQIV. The ATAGI post-submission advice stated “Overall, given that recombinant and cell-based vaccines are currently proposed for different populations but share several potential advantages, ATAGI considered it may be reasonable to assume that both technologies provide similar manufacturing/technology advantages in their respective populations.” The ESC …PSD · Mar 2024
Consumer comments
The PBAC noted and welcomed the input from three organisations via the Consumer Comments facility on the PBS website. The comments described a range of benefits of vaccination with RIV4 including that it would provide an additional option for people aged ≥ 65 years and the recombinant technology may be associated with potential manufacturing advantages including a reduced requirement for egg-based manufacturing.PSD · Mar 2024
Cost-effectiveness
Cost-consequence analysis conducted; no ICER calculated as this is a vaccine submission with cost-minimisation/cost-consequence framework.
Decision context
PopulationAdults aged 65 years and over for the prevention of influenza.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended | adjuvanted egg-based quadrivalent influenza vaccine (aQIV, Fluad® Quad) | — | RCT · Relative vaccine effectiveness (rVE), influenza hospital encounters, influenza inpatient stays |
Consumer voice
Three organisations provided consumer input via the PBS website, describing benefits of RIV4 vaccination for people aged ≥65 years, including providing an additional vaccine option and potential manufacturing advantages. Lung Foundation Australia specifically noted that RIV4 would enable an alternative supply line and emphasised the importance of access to effective influenza vaccines for this age
enable an alternative line of supply Consumer comments · PSD
access barriersunmet needtreatment optionssupply security
Similar precedents
Influenza Vaccine, Adjuvanted Quadrivalent And Adjuvanted Trivalent84%Inactivated Quadrivalent Influenza Vaccine82%Quadrivalent Influenza Vaccine82%Inactivated Trivalent Influenza Vaccine (Split Virion)81%Influenza Vaccine, Adjuvanted81%Inactivated Trivalent Influenza Vaccine (Split Virion), High Dose80%Inactivated Trivalent Influenza Vaccine (Surface Antigen), Adjuvanted80%Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated, Cell-Based)78%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to age ≥65 years while TGA label permits all adults ≥18 years.