PBAC's latest decision on Icatibant: Recommended with restriction (2017). Considered for Symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults with C1-esterase inhibitor deficiency.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
4
first 2010
Submissions
4
2010 → 2017
Eligible population
Adults with hereditary angioedema due to C1-esterase inhibitor deficiency, assessed to be at significant risk of acute attacks.
Therapy area
Rare disease
Line of therapy
Any
Evidence base
Other
Economic model
not-modelled
ICER note
Minor submission — no economic evaluation required. This is an amendment to an existing listing to limit maximum quantity to 12 injections per script.
ICER (historical)
$45k/QALY–$105k/QALY across 2 submissions (2011–2016) — 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 (Deed of Agreement) with financial caps. Previous recommendation was for caps consistent with original listing estimates; November 2016 submission requested increase from $10–$20 million to $30–$60 million over 5 years, which PBAC did not support.
Submission history
Jul 2010: Not recommended
Jul 2011: Not recommended · Authority Required — ICER $75k/QALY
Nov 2016: Noted · Authority Required — ICER $105k/QALY
Jul 2017: Recommended with restriction · Authority Required