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Inactivated Trivalent Influenza Vaccine (Split Virion)

Recommended VaccinesUnrestrictedNot applicable line

Active immunisation against influenza disease caused by influenza virus subtypes A and type B for use in persons 65 years and older.

1
Submissions
2018–18
On the record
—
ICER range
Cost-min
Cost basis

Decision on record

1 decision
  • Meeting Mar 2018 Recommended Prevention of seasonal influenza

Access path

1 submission · public record
  1. Mar 2018
    Recommended

    vs quadrivalent inactivated influenza vaccine (QIV)

  2. PBS listing · Unrestricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
7.1 The PBAC recommended that inactivated trivalent influenza vaccine (TIV-HD) be a designated vaccine for the purposes of the National Health Act 1953 for active immunisation against influenza in adults aged ≥65 years.PSD · Mar 2018
7.2 The PBAC considered that the TIV-HD vaccine would be acceptably cost-effective if subsidised on a cost-minimisation basis with the currently NIP listed quadrivalent inactivated vaccines (QIV) for those aged ≥65.PSD · Mar 2018
Economic analysis
Influenza vaccine July 2009 NIP listing for Recommended CMA to current NIP (Intanza) patients aged 65 funded vaccines for and older via this age group eg intradermal route Vaxigrip Trivalent influenza July 2014 Extend NIP Recommended Compared to vaccine schedule to Fluarix trivalent include vaccination for Indigenous children aged 6 months to 5 years of age Quadrivalent influenza March 2015 People 3 to 9 Recommended (did not CMA to Fluarix vaccine …PSD · Mar 2018
3.3 The submission was prepared in response to liaison with the company from the Chief Medical Officer following the outcomes of the 2017 influenza season in Australia.PSD · Mar 2018
Clinical claim
6.14 The submission claimed superior comparative effectiveness and non-inferior comparative safety of TIV-HD compared with TIV-SD. The submission noted that QIV, the current standard of care, was listed based on non-inferiority to TIV-SD (Submission, P6).PSD · Mar 2018
6.15 ATAGI considered that TIV-HD was suitable for listing on the NIP designated vaccines list for the prevention of seasonal influenza in adults aged 65 and above, subject to TGA approval for registration (Pre-Submission PBAC Advice).PSD · Mar 2018

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated. Proposed price equal to nationally negotiated price of QIV comparator.

The PBAC considered that the TIV-HD vaccine would be acceptably cost-effective if subsidised on a cost-minimisation basis with the currently NIP listed quadrivalent inactivated vaccines (QIV) for those aged ≥65. PBAC · 2018
Cost-effectiveness accepted

Decision context

PopulationAdults aged ≥65 years eligible for free influenza vaccines through the National Immunisation Program.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Mar 2018 Recommended quadrivalent inactivated influenza vaccine (QIV) — Registry · Surrogate

Similar precedents

By decision profile
Inactivated Trivalent Influenza Vaccine (Split Virion), High Dose94%Inactivated Trivalent Influenza Vaccine (Surface Antigen), Adjuvanted88%Influenza Vaccine, Injection85%Influenza Vaccine, Adjuvanted84%Influenza Vaccine, Adjuvanted Quadrivalent And Adjuvanted Trivalent84%Quadrivalent Recombinant Influenza Vaccine81%Inactivated Quadrivalent Influenza Vaccine80%Quadrivalent Influenza Vaccine79%

Regulatory · TGA

Label equal than PBS population — Both TGA and PBAC indications specify active immunisation against influenza A and B in persons aged ≥65 years with identical population scope.