Inactivated Quadrivalent Influenza Vaccine (Split Virion)

6.1 The PBAC recommended an extension to the listing of inactivated quadrivalent influenza vaccine (QIV), Fluarix Tetra, on Schedule 1 (Designated vaccines and circumstances in which vaccines may be provided) of the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the Determination), for the prevention of seasonal influenza, to include healthy children aged 6 months to <5 years who are currently eligible for …PSD · Jul 2020

6.2 The PBAC considered that Vaxigrip Tetra and FluQuadri were appropriate comparators given that these two QIVs are currently listed on the NIP for all children aged 6 months to <5 years and the PBAC has previously accepted that FluQuadri is non-inferior to Vaxigrip Tetra in terms of comparative effectiveness and safety at its November 2019 meeting.PSD · Jul 2020

5.24 The minor submission presented a cost-minimisation analysis of Fluarix Tetra compared with Vaxigrip Tetra. The equi-effective doses were estimated as a single 0.5 mL dose of Fluarix Tetra and a single 0.5 mL dose of Vaxigrip Tetra for children aged 6 months to < 5 years. 10PSD · Jul 2020

5.25 Given that the submission assumed no difference in costs of administration, monitoring or management of adverse events, the cost-minimisation analysis was based on equi-effective doses at parity to the nationally negotiated price ($'''''''').PSD · Jul 2020

5.22 The submission claimed that Fluarix Tetra is non-inferior to Vaxigrip Tetra in terms of effectiveness and safety in the prevention of seasonal influenza disease caused by the influenza virus type A and B contained in the vaccine.PSD · Jul 2020

5.23 Although based on an indirect comparison, the non-inferiority claim between Fluarix Tetra and other QIVs (Vaxigrip Tetra, FluQuadri) listed on the NIP in the target population was supported by ATAGI (ATAGI March 2020 pre-submission advice).PSD · Jul 2020

5.2 The PBAC noted and welcomed the input from one organisation via the Consumer Comments facility on the PBS website. Lung Foundation Australia was supportive of the requested extension to the existing listing of Fluarix Tetra, and noted that an additional QIV available for NIP-funded vaccination in healthy children aged 6 months to <5 years would provide a range of benefits by ensuring continued access to required vaccines at the right times.PSD · Jul 2020