Tobramycin, Solution For Inhalation

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.

The PBAC noted that the two key randomised trials presented in the submission (Trials 002 and 003) were more than 10 years old and had previously been considered by PBAC in 2000 and 2002. Another randomised trial (Chuchalin 2007) was identified during the evaluation but not included by the sponsor due to differences in the formulations of tobramycin (300 mg/4 mL in Chuchalin 2007 vs 300 mg/5 mL in the submission). While PBAC accepted this, it was nonetheless informative and relevant to consideration as it was of similar design to Trials 002 and 003 and featured more recent data. PBAC · 2011

Populationpatients with cystic fibrosis who have a proven Pseudomonas aeruginosa infection

Risk sharingA 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.

Label narrower than PBS population — PBAC restricts to proven infection and later-line treatment; TGA label permits management of patients with infections without proven status or line restrictions.