Respiratory Syncytial Virus Vaccine, Recombinant Pre-Fusion F Protein 3 Older Adult (Rsvpref3 Oa)
Prevention of RSV-confirmed lower respiratory tract disease (LRTD) in older adults. The submission requested NIP listing for adults aged ≥60 years (TGA indication) or ≥75 years (ATAGI base case).
From the public summary
The PBAC did not recommend that respiratory syncytial virus vaccine (Arexvy®, RSVpreF3 OA) 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). The PBAC noted that the submission had proposed two alternative NIP schedules (i) among adults aged ≥60 years of age (YOA); and (ii) among adults ≥75 YOA.PSD · Jul 2024
The primary reason for this outcome was due to the economic evaluation presented.PSD · Jul 2024
The submission presented an economic evaluation comparing a single dose of the RSVPreF3 OA vaccine with no vaccine based on AreSVi-006 and implementing a modelled evaluation for the following populations: • ≥60 YOA (approved TGA indication).PSD · Jul 2024
• ≥75 YOA (base case proposed in the ATAGI Advice to the PBAC).PSD · Jul 2024
The submission described RSVPreF3 OA vaccine as superior in terms of effectiveness in the prevention of RT-PCR confirmed RSV-LRTD compared with placebo (no vaccine) in adults ≥60 YOA, inclusive of those ≥75 YOA and having an acceptable safety profile despite being slightly more reactogenic compared to placebo (no vaccine).PSD · Jul 2024
The evaluation considered that the therapeutic conclusion presented in the submission was adequately supported by the evidence presented for the efficacy of RSVPreF3 OA vaccine in preventing RT-PCR confirmed RSV-LRTD compared with placebo in adults ≥60 YOA and adults ≥75 YOA.PSD · Jul 2024
The comments from individuals described concerns associated with contracting RSV, especially in those people living with pre-existing medical conditions, and noted the need for access to an effective RSV vaccine for themselves and other family members.PSD · Jul 2024
In addition to the comments from individuals, health care professionals described the RSV vaccine as effective in preventing RSV infection, reducing rates of morbidity and mortality, as well as reducing exacerbations of underlying medical conditions.PSD · Jul 2024
Cost-effectiveness
The document text provided is incomplete (ends mid-sentence in consumer comments section). No ICER values are stated in the available text. The submission was a cost-utility analysis versus no vaccine, but the specific ICER figures are not presented in the extracted portion of the PSD.
Decision context
PopulationAdults aged ≥60 years (TGA indication) or ≥75 years (ATAGI base case) for prevention of RSV-confirmed lower respiratory tract disease. Alternative populations considered: First Nations people aged 60-74 years and adults aged 60-74 years at high risk for severe RSV infection.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2024 | Not recommended | no vaccine | — | RCT · Prevention of RSV-confirmed LRTD |
Consumer voice
Individuals, healthcare professionals, and organisations highlighted concerns about RSV infection risk, emphasised the need for vaccine access, noted the high cost of the vaccine without NIP listing, and stressed the vaccine's effectiveness in preventing infection and reducing morbidity, mortality, and hospitalisation in older Australians.
The comments from individuals described concerns associated with contracting RSV, especially in those people living with pre-existing medical conditions, and noted the need for access to an effective RSV vaccine for themselves and other family members. Consumer comments · PSD