Inactivated Trivalent Influenza Vaccine (Split Virion), High Dose
Active immunisation against influenza disease caused by influenza virus types A and B in persons aged 65 years and older.
Access path
- Jul 2018Not recommended
vs quadrivalent influenza vaccine standard dose (QIV-SD)
- ↻ resubmittedNov 2019Recommended
Comparator changed: quadrivalent influenza vaccine standard dose (QIV-SD) → standard dose…
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended an increase in the price of inactivated trivalent influenza vaccine (Fluzone High-Dose, TIV-HD), on the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the Determination), for active immunisation against influenza in adults aged ≥65 years.PSD · Nov 2019
7.2 The PBAC reaffirmed its July 2018 advice6 that the proposed clinical place for TIV-HD was appropriate, noting the high incidence of influenza, high mortality and hospitalisation rates associated with influenza in the proposed population, as well as the typically lower vaccine effectiveness observed in this population.PSD · Nov 2019
6.61 The ESC considered, given the claim of superiority for TIV-HD over aQIV was not adequately supported, that a cost-minimisation analysis vs aQIV would have been more appropriate than a cost-utility analysis.PSD · Nov 2019
6.62 The resubmission presented two cost-utility models for Australians aged ≥ 65 years: The economic model that compared TIV-HD to QIV-SD used within the previous submission (the Main model), but with a revised TIV-HD price (previously $''''''''''', now $'''''''''''').PSD · Nov 2019
6.40 Consistent with the previous submission, this submission claimed that: TIV-HD is superior to TIV-SD in terms of a reduction in cases of clinically diagnosed and laboratory confirmed influenza; TIV-HD is superior to TIV-SD in terms of reduction in cardiorespiratory hospitalisations.PSD · Nov 2019
6.41 The PBAC reiterated that the claim of superior comparative effectiveness was reasonable and adequately supported by the data.PSD · Nov 2019
6.2 The PBAC noted and welcomed the input from organisations (3) via the Consumer Comments facility on the PBS website: Diabetes Australia, Diabetes NSW & ACT and Diabetes Queensland noted the higher risk of complications associated with influenza for those aged 65 years and over, including hospitalisation and death, and that the risk was further increased for those with diabetes.PSD · Nov 2019
Cost-effectiveness
Pricing and financial implications redacted in public summary. Document states net cost to government was projected to be $'''' million in Year 1 and $'''' million in Year 6 with claimed offset by hospitalisation savings, but no explicit ICER value is stated.
Decision context
PopulationAdults aged 65 years and older for active immunisation against influenza disease caused by influenza virus types A and B.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2019 | Recommended | standard dose quadrivalent influenza vaccine (QIV-SD) | — | RCT · Occurrences of culture- or PCR confirmed influenza |
| Jul 2018 | Not recommended | quadrivalent influenza vaccine standard dose (QIV-SD) | — | RCT · Clinically diagnosed and laboratory confirmed influenza; cardiorespiratory hospitalisation |
Consumer voice
Three diabetes organisations (Diabetes Australia, Diabetes NSW & ACT, and Diabetes Queensland) provided input emphasising the elevated risk of influenza complications for people aged 65+ years with diabetes, and supported the listing of TIV-HD as a more effective vaccine option.
Diabetes Australia, Diabetes NSW & ACT and Diabetes Queensland noted the higher risk of complications associated with influenza for those aged 65 years and over, including hospitalisation and death, and that the risk was further increased for those with diabetes. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify active immunisation against influenza A and B in persons aged ≥65 years; no population restriction applied.