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Inactivated Quadrivalent Influenza Vaccine

Recommended VaccinesUnrestrictedNot applicable line

Prevention of seasonal influenza caused by influenza virus Types A and B in adults aged 18 years and over.

1
Submissions
2016–16
On the record
ICER range
Cost-min
Cost basis

Access path

1 submission · public record
  1. Aug 2016
    Recommended

    vs Fluarix® Tetra influenza vaccine

  2. PBS listing · Unrestricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
7.1 The PBAC deferred making a recommendation on whether Afluria® Quad should be included on the Designated Vaccines list for the NIP for the prevention of seasonal influenza until such time as the TGA is in a position to advise its '''''''''''''''''''''''''''''' '''''''''''''''' concerns ''''''''''''''''''''' '''''''''''''''''''''''' ''''''''''''''''''' ''''''''''''' have been addressed.PSD · Aug 2016
7.2 The PBAC recalled that it previously recommended that Fluarix® Tetra (in March 2015) and FluQuadri® (in July 2015) be included on the Designated Vaccines list for the NIP for the prevention of seasonal influenza for eligible persons aged 3 years and older. The PBAC noted that listing was requested for adults aged 18 years and older who are eligible for NIP-funded vaccine, and that Seqirus intends to 6PSD · Aug 2016
Economic analysis
6.8 The submission provided a cost-minimisation analysis and considered Afluria® Quad to be equivalent to Fluarix® Tetra.PSD · Aug 2016
6.9 The equi-effective doses are estimated as Afluria® Quad 0.5 mL 15 μg HA/4 strains for once off vaccination annually and Fluarix® Tetra 0.5 mL 15 μg HA/4 strains for one off vaccination annually.PSD · Aug 2016
Clinical claim
6.7 The submission described Afluria® Quad as non-inferior in terms of comparative effectiveness and non-inferior in terms of comparative safety over Fluarix® Tetra in adults. The PBAC considered that these claims were reasonable. 4PSD · Aug 2016

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated by design.

The PBAC noted that listing of Afluria® Quad was requested on a cost-minimisation basis compared with Fluarix® Tetra and accepted that one dose of 0.5 mL Afluria® Quad is likely to be equi-effective to one dose of 0.5 mL Fluarix® Tetra. PBAC · 2016
Cost-effectiveness accepted

Decision context

PopulationAdults aged 18 years and older who are eligible to receive NIP-funded influenza vaccine.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Aug 2016 Recommended Fluarix® Tetra influenza vaccine RCT · Surrogate

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to adults eligible for NIP-funded vaccine; TGA label covers all persons aged 18+ years.