PBAC's latest decision on Tobramycin, solution for inhalation: Recommended with restriction (2011). Considered for Management of proven Pseudomonas aeruginosa infection in a patient with cystic fibrosis.
PBAC outcome
Recommended with restriction
Authority Required (STREAMLINED)
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2011
Submissions
1
2011 → 2011
Eligible population
patients with cystic fibrosis who have a proven Pseudomonas aeruginosa infection
Therapy area
Respiratory
Line of therapy
Later-line
Evidence base
RCT | Single-arm
Primary endpoint
OS | other
Key trials
Trial 002, Trial 003, Chuchalin 2007, Gibson 2003
Comparator
placebo or standard care without the use of inhaled tobramycin
Economic model
Cost-minimisation
ICER note
Economic evaluation presented as incremental cost per hospitalisation avoided (chronic infection: <$15,000) and incremental cost per patient free of P. aeruginosa (eradication: <$15,000). These are not QALYs or LYs but clinical outcomes. No ICER in standard health economic terms stated.
Risk sharing
Risk-sharing arrangement in place — A risk share arrangement with expenditure thresholds based upon 6.5 prescriptions per patient per year may be necessary to ensure PBS use reflects the treatment paradigm considered for establishing cost effectiveness.