Influenza Vaccine, Adjuvanted
Recommended VaccinesRestrictedNot applicable line
Active immunisation against influenza in adults aged 65 years and above. The submission sought listing of both an adjuvanted trivalent influenza vaccine (aTIV/Fluad) at an increased price and an adjuvanted quadrivalent influenza vaccine (aQIV/Fluad Quad) on the National Immunisation Program.
1
Submissions
1 resub
2019–19
On the record
—
ICER range
Cost-min
Cost basis
Access path
- Jul 2019Recommended
vs aTIV (Fluad) compared to non-adjuvanted QIVs (Afluria Quad…
- PBS listing · Restricted
RecommendedDeferredNot recommended
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
Cost-minimisation basis for aTIV (March 2018); economic model details for current submission not fully detailed in available text.
Decision context
PopulationAdults aged ≥65 years for vaccination against influenza
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2019 | Recommended | aTIV (Fluad) compared to non-adjuvanted QIVs (Afluria Quad, FluQuadri, Fluarix Tetra); aQIV (Fluad Quad) compared to aTI | — | RCT · Immunogenicity |
Similar precedents
Influenza Vaccine, Adjuvanted Quadrivalent And Adjuvanted Trivalent92%Inactivated Trivalent Influenza Vaccine (Surface Antigen), Adjuvanted88%Inactivated Trivalent Influenza Vaccine (Split Virion)84%Inactivated Trivalent Influenza Vaccine (Split Virion), High Dose81%Quadrivalent Recombinant Influenza Vaccine81%Influenza Vaccine, Injection80%Inactivated Quadrivalent Influenza Vaccine80%Quadrivalent Influenza Vaccine79%
Regulatory · TGA
Label equal than PBS population — Both specify active immunisation against influenza in adults aged ≥65 years; TGA's mention of chronic diseases is descriptive, not restrictive.