Rsv Pre-Fusion F Protein Vaccine (Rsvpref)
Prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) in adults aged 75 years and older, Aboriginal and Torres Strait Islander peoples aged 60 to 74 years, and adults aged 60 to 74 years with at least one risk factor for severe RSV disease.
Access path
- Jul 2025Recommended · restricted
vs no vaccine (standard of care)
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended that respiratory syncytial virus vaccine (Abrysvo®, RSVpreF) be a designated vaccine for the purposes of the National Health Act 1953 for the prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) for adults 75 years of age and above, and for Aboriginal and Torres Strait Islander peoples aged 60 to 74 years.PSD · Nov 2024
The PBAC advised that inputs for the economic evaluation relating to the duration of protection, and the incidence of hospitalisations due to RSV and associated mortality should be revised, and that RSVpreF would be cost-effective with an incremental cost- 48PSD · Nov 2024
6.40 The submission presented a modelled economic evaluation comparing a single dose of RSVpreF with no vaccine, with evidence drawn from RENOIR. The type of economic evaluation presented was a cost-utility analysis. The evaluation considered that this was reasonable given the clinical claim of RSVpreF being superior in efficacy to no vaccine.PSD · Nov 2024
The summary of the model structure, key inputs and rationale is presented in Table 11.PSD · Nov 2024
RSVpreF is more effective than placebo (no vaccine) at preventing LRTI and ARI caused by RSV.PSD · Nov 2024
RSVpreF has non-inferior safety compared to placebo (no vaccine). Source: Table 1.1.1, p4 of the submission.PSD · Nov 2024
• National Aboriginal Community Controlled Health Organisation (NACCHO) described the disproportionate burden of RSV disease in Aboriginal and Torres Strait Islander people. Increased prevalence of chronic diseases in Aboriginal and 7PSD · Nov 2024
• Lung Foundation Australia described strong consumer support for making the RSV vaccine available on the NIP for people aged 60 and over, and for those with a lung disease or other medical condition, based on a survey of 860 people living or caring for someone with a lung disease or lung cancer in December 2023 – January 2024.PSD · Nov 2024
Cost-effectiveness
ICER values not stated in the public document; commercial-in-confidence or not presented in detail in the sections provided.
Decision context
PopulationAdults aged 75 years and above; Aboriginal and Torres Strait Islander peoples aged 60 to 74 years; adults aged 60 to 74 years with at least one risk condition for severe RSV disease (cardiac disease, chronic respiratory condition, immunocompromising condition, chronic metabolic disorder, chronic kidney disease stage 4 or 5, or chronic neurological condition).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | no vaccine (standard of care) | — | RCT · RSV-LRTI |
Consumer voice
Two individuals and four organisations provided input supporting RSV vaccination listing. Individual comments highlighted benefits of effective RSV vaccination for older adults and high vaccine costs without NIP listing. Organisational comments were supportive of the proposed listing, with themes including disproportionate disease burden in Aboriginal and Torres Strait Islander populations.
The comments from individuals focussed on the benefits of effective RSV vaccination for older adults, and the high cost of the vaccine without a listing on the NIP. Consumer comments · PSD