PBAC's latest decision on Colistimethate sodium: Not recommended (2011). Considered for treatment of colonisation and infections of the lung due to susceptible Pseudomonas aeruginosa in patients with cystic fibrosis.
PBAC outcome
Not recommended
2011
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
1
first 2011
Submissions
1
2011 → 2011
Eligible population
patients with cystic fibrosis who have colonisation or infections of the lung due to susceptible Pseudomonas aeruginosa
Therapy area
Respiratory
Evidence base
RCT, Single-arm, Registry
Primary endpoint
QoL, FEV1, FVC
Key trials
Valerius 1991, Proesmans 2009, Jensen 1987, Day 1988, Hodson 2002, Nikonova 2010
Comparator
no treatment (or placebo) in addition to standard care
Economic model
CUA, Cost-minimisation
ICER note
No ICER in AUD per QALY reported. Economic analysis presented only cost per patient free of infection (<$15,000) and cost-minimisation analysis, neither of which is a standard ICER.
Why PBAC said no
Reasons cited in the latest PSD: Insufficient evidence for chronic P. aeruginosa infection (no studies of the recommended 1-month on/off alternating regimen with tobramycin; short treatment durations in trials vs. long-term therapy required clinically); uncertain clinical benefit in chronic infection (tobramycin showed greater FEV1 improvement in Hodson 2002); limited and immature trial data (interim analysis, small sample sizes, open-label design); economic analysis highly uncertain (cost-minimisation analysis lacked comparative effectiveness evidence for concomitant ciprofloxacin dosing); concern about generalisability of early/intermittent infection evidence to chronic infection management