PBAC's latest decision on Omalizumab: Recommended with restriction (2025). Considered for Initial treatment and continuing treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) with inadequate response to intranasal corticosteroids and serum IgE ≥30 IU/mL.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
11
first 2010
Submissions
11
2010 → 2025
Eligible population
Adult patients (≥18 years) with severe CRSwNP, inadequate response to intranasal corticosteroids, serum IgE ≥30 IU/mL, who have undergone nasal polyp surgery or are documented as unsuitable for surgery, with persistent symptoms despite optimised therapy.
Therapy area
Immunology
Line of therapy
First-line
Evidence base
Single-arm
Primary endpoint
Surrogate
Comparator
mepolizumab
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.
ICER (historical)
$15k/QALY–$45k/QALY across 2 submissions (2010–2015) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Risk sharing
Risk-sharing arrangement in place — Risk sharing arrangement mentioned in context of mepolizumab (the comparator) with financial caps and % rebate; specific RSA terms for omalizumab not detailed in this PSD excerpt.
Submission history
Nov 2010: Not recommended · Authority Required — ICER $75k/QALY
Nov 2014: Recommended with restriction · Restricted
Nov 2015: Recommended with restriction · Authority Required
Nov 2015: Recommended with restriction · Restricted — ICER $45k/QALY
Jul 2016: Recommended with restriction · Authority Required
Nov 2016: Recommended · Restricted
Mar 2018: Recommended with restriction · Authority Required
Nov 2021: Not recommended · Authority Required
Mar 2025: Noted · Authority Required
Mar 2025: Recommended with restriction · Authority Required
May 2025: Recommended with restriction · Authority Required