Influenza Vaccine, Adjuvanted Quadrivalent And Adjuvanted Trivalent
Not recommended VaccinesRestrictedNot applicable line
Active immunisation against influenza in adults aged 65 years and above. The submission sought an increased price premium for Fluad (aTIV) and NIP listing of Fluad Quad (aQIV).
1
Submissions
1 resub
2019–19
On the record
—
ICER range
Cost-min
Cost basis
From the public summary
PBAC outcome
7.1 The PBAC did not recommend the requested price increase for adjuvanted trivalent influenza vaccine (aTIV, Fluad) on the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the Determination), for vaccination against influenza in adults aged 65 years and above on the basis that the extent of benefit of the adjuvanted trivalent formulation over the non-adjuvanted quadrivalent 27PSD · Jul 2019
7.2 The PBAC considered that this uncertainty made it difficult to assess the cost- effectiveness of aTIV, and that although a small price premium for aTIV over QIV may be reasonable, the proposed price premium was not justified.PSD · Jul 2019
Economic analysis
6.51 The submission presented a cost-utility analysis, comparing aTIV (Fluad) to QIVs.PSD · Jul 2019
6.52 The economic evaluation was presented to support a price premium. A static Markov model was developed to estimate the health benefits for an Australian population cohort aged 65 years, over a 35-year time horizon. Herd immunity was not included.PSD · Jul 2019
Clinical claim
Figure 3: Network diagram of the studies included to support the clinical claims aQIV: adjuvanted quadrivalent influenza vaccine; aTIV: adjuvanted trivalent influenza vaccine; QIV: quadrivalent influenza vaccine (non- adjuvanted); TIV: trivalent influenza vaccine (non-adjuvanted) Source: Compiled during the evaluationPSD · Jul 2019
6.4 The sources of evidence that the submission presented as the basis of each clinical claim, is outlined in Table 2. 6PSD · Jul 2019
Cost-effectiveness
Economic model was cost-minimisation analysis; no ICER with monetary threshold reported. Prices redacted in the PSD.
Decision context
PopulationAdults aged 65 years and above, healthy or with chronic underlying diseases (diabetes, cardiovascular, respiratory), for annual influenza vaccination.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2019 | Not recommended | For aTIV (Fluad): non-adjuvanted quadrivalent influenza vaccines (QIVs: Afluria Quad, FluQuadri, Fluarix Tetra). For aQI | — | RCT, Observational · Immunogenicity (GMTR, seroconversion rate); hospitalizations for influenza or pneumonia (observational studies) |
Similar precedents
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Regulatory · TGA
Label equal than PBS population — Both specify influenza immunisation in adults aged 65+ years, with or without chronic diseases; PBAC restates TGA label without population restriction.