PBAC's latest decision on Quadrivalent influenza vaccine: Recommended with restriction (2019). Considered for Prevention of seasonal influenza in children aged 6 months to <5 years not currently eligible through the NIP, and in at-risk individuals currently eligible for NIP-funded influenza vaccination (adults ≥65 years, Aboriginal and Torres Strait Islanders ≥6 months, persons ≥6 months at increased risk of complications, and pregnant women).
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
4
first 2015
Submissions
4
2015 → 2019
Eligible population
Children aged 6 months to <5 years not currently eligible through the NIP, and at-risk individuals aged ≥6 months currently eligible for NIP-funded influenza vaccination (including adults ≥65 years, ATSI people, persons with chronic diseases/conditions, and pregnant women).
Therapy area
Vaccines
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Laboratory-confirmed influenza (children aged 6-35 months); Immunogenicity measured by seroconversion rates and GMT (at-risk populations)
Pivotal trial size
5,806 patients
Key trials
GQM05, GQM01, GQM02, GQM11, QIV03, QIV04, GRC43
Comparator
Placebo (no vaccination) for children aged 6 months to <5 years; QIVs (FluQuadri and FluQuadri Junior) for at-risk individuals currently eligible for NIP vaccination
Economic model
CUA
ICER note
Economic evaluation section not provided in the PSD excerpt. Cost-utility analysis mentioned for children aged 6-35 months; cost-minimisation analysis mentioned for at-risk populations, but no numeric ICER values are stated in the available text.
Submission history
Mar 2015: Recommended · Restricted
Jul 2015: Recommended with restriction · Restricted
Nov 2018: Recommended with restriction · Restricted
Jul 2019: Recommended with restriction · Restricted