PBAC's latest decision on Tobramycin: Recommended with restriction (2013). Considered for Treatment of Pseudomonas aeruginosa infection in patients aged 6 years or older with cystic fibrosis.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2013
Submissions
2
2013 → 2013
Eligible population
Patients aged 6 years or older with cystic fibrosis who have proven Pseudomonas aeruginosa infection, have been assessed for bronchial hyperresponsiveness with a negative test result, and tolerate the dry powder formulation following a 4 week trial.
Therapy area
Infectious disease
Line of therapy
Any
Evidence base
RCT
Primary endpoint
FEV1 % predicted
Key trials
Trial 2302, Trial 2303
Comparator
tobramycin solution for inhalation (TSI)
Economic model
Cost-minimisation
ICER note
No numeric ICER calculated. The submission used a discrete choice experiment to estimate consumer surplus rather than a traditional cost-utility analysis with ICER.
ICER (historical)
$15k/QALY–$45k/QALY in an earlier submission (2013) — 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: the sponsor bears the cost of providing TIP to the patient for the 4 week trial period before the patient can access continuing PBS-subsidised TIP.
Submission history
Mar 2013: Not recommended · Authority Required — ICER $45k/QALY
Nov 2013: Recommended with restriction · Authority Required