NirsevimabBeyfortus
Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Decisions on record
- Meeting May 2025 Deferred Prevention of RSV lower respiratory tract disease in infants and children
- Meeting Mar 2025 Not stated Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates, infants and young children no PSD
- Meeting Jul 2024 Not recommended Prevention of respiratory syncytial virus lower respiratory tract disease
Access path
- TGA registered · Beyfortus
TGA label equal than the PBS population
- Jul 2024Not recommended
vs placebo (no immunisation)
- May 2025Deferred
Comparator changed: placebo (no immunisation) → no immunisation (placebo); near-market…
From the public summary
7.1 The PBAC deferred making a recommendation for nirsevimab, for the prevention of lower respiratory tract illness (LTRI) caused by respiratory syncytial virus (RSV) in neonates and infants born during or entering their first RSV season, and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.PSD · May 2025
The PBAC also acknowledged that nirsevimab would have additional value for infants at increased risk of severe disease from RSV during their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. The PBAC considered that no immunisation was the appropriate comparator for the second season. The PBAC advised that the 63 OFFICIALPSD · May 2025
The ICER for nirsevimab for the first RSV season was Not adequately addressed substantially underestimated and also highly uncertain The ICER generated by the revised economic analysis did not given the results were highly sensitive to small variations incorporate several of the modifications that had been advised in several inputs (Para 7.1 & 7.17, July 2024 PSD).PSD · May 2025
OFFICIAL Public Summary Document - May 2025 PBAC Meeting Matter of concern How the resubmission addresses the issues The PBAC noted that the timing of RSV outbreaks varies Not adequately addressed with the climate across different regions of Australia and The resubmission model did not address the issue of that the timing of administration of nirsevimab, in relation inappropriately assuming optimal timing of administration of to the RSV season, was a key …PSD · May 2025
• For infants born during or entering their first RSV season: o Nirsevimab is superior in terms of effectiveness and non-inferior in terms of safety compared with no immunisation; o Nirsevimab is superior in terms of effectiveness and non-inferior in terms of safety compared with RSVpreF.PSD · May 2025
• For children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season: o Nirsevimab is superior in terms of effectiveness and non-inferior in terms of safety compared with no immunisation.PSD · May 2025
6.2 The PBAC noted and welcomed the input from 6 organisations via the Consumer Comments facility on the PBS website in relation to the resubmission. The PBAC recalled that it had previously received consumer input when it considered nirsevimab in July 2024, including individuals (15), health care professionals (2) and organisations (8). Consumer comments from the July 2024 meeting are summarised in the previous PSD (paragraphs 6.2 to 6.6, July 2024 PSD).PSD · May 2025
6.3 The organisations that provided comments in relation to the resubmission are listed below, with key input summarised.PSD · May 2025
Cost-effectiveness
ICER values are redacted in the public document. The PSD indicates that the ICER for nirsevimab for the first RSV season was substantially underestimated and highly uncertain, with values shown as blanks or censored (e.g., '$ 1/QALY and $ 2/QALY' with dollar amounts removed).
Decision context
PopulationTwo populations: (i) neonates and infants born during or entering their first RSV season; and (ii) children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Why it was knocked back
- inappropriate funding mechanism (NIP pathway for passive immunisation not established), substantially underestimated and highly uncertain ICER, limited and inadequately presented clinical evidence for high-risk subgroups and second RSV season population, unresolved transitivity issues between nirsevimab and RSVpreF trial evidence, clinical evidence does not support superiority versus RSVpreF, economic model did not incorporate PBAC-advised modifications, inappropriate assumptions regarding optimal timing of nirsevimab administration in clinical practice, continued assumption of benefits from reduced wheezing and asthma despite PBAC advice to remove these
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| May 2025 | Deferred | no immunisation (placebo); near-market comparator: recombinant RSV prefusion F protein maternal vaccine (RSVpreF) | — | RCT · Incidence of medically attended RSV-associated lower respiratory tract infection; incidence of medically attended RSV-associated LRTI resulting in hospitalisation |
| Jul 2024 | Not recommended | placebo (no immunisation) | — | RCT · Incidence of medically attended lower respiratory tract infection (MA-LRTI) |
Consumer voice
Six organisations provided consumer input supporting national access to nirsevimab for RSV protection in infants and young children. Key concerns included RSV's association with childhood asthma, severe hospitalisation impacts, disease burden in Aboriginal and Torres Strait Islander populations, inequities in current jurisdictional access, and financial/care impacts on families.
babies with severe RSV may require hospitalisation and in some cases intensive care and intubation, which impacts on breastfeeding and physical/mental health of all involved Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA label and PBAC indication describe identical populations: neonates/infants in first RSV season and children ≤24 months vulnerable through second season.