PBAC's latest decision on Aztreonam: Recommended with restriction (2012). Considered for Management of proven Pseudomonas aeruginosa infection in patients with cystic fibrosis.
PBAC outcome
Recommended with restriction
Authority Required (Streamlined)
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2010
Submissions
2
2010 → 2012
Eligible population
patients with cystic fibrosis and chronic P. aeruginosa infection aged 6 years or older
Therapy area
Respiratory
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
QoL (CFQ-R Respiratory Symptoms Scale)
Pivotal trial size
273 patients
Key trials
GS-US-205-0110
Comparator
tobramycin solution for inhalation
Economic model
Cost-minimisation
ICER note
Cost-minimisation basis recommended; no ICER calculated. Submission presented cost per respiratory hospitalisation avoided of less than $15,000 over 24 weeks, but PBAC considered cost-effectiveness unacceptably high and uncertain.
ICER (historical)
$200k/QALY in an earlier submission (2010) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
2010: Not recommended — ICER $200k/QALY
2012: Recommended with restriction · Authority Required (Streamlined)