PBAC's latest decision on Nirsevimab: Not recommended (2025). Considered for 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.
PBAC outcome
Not recommended
Not applicable
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2024
Submissions
2
2024 → 2025
Eligible population
Two 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.
Therapy area
Vaccines
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Incidence of medically attended RSV-associated lower respiratory tract infection; incidence of medically attended RSV-associated LRTI resulting in hospitalisation
no immunisation (placebo); near-market comparator: recombinant RSV prefusion F protein maternal vaccine (RSVpreF)
Economic model
CUA
ICER note
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).
Why PBAC said no
Reasons cited in the latest PSD: 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