Colistimethate SodiumColistin Link
Treatment of colonisation and infections of the lung due to susceptible Pseudomonas aeruginosa in patients with cystic fibrosis.
Decisions on record
- Meeting Jul 2011 Not recommended For the treatment of colonisation and infections of the lung due to susceptible Pseudomonas aeruginosa in patients with cystic fibrosis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. no PSD
- Meeting Mar 2011 Not recommended Inhaled antibiotic for the treatment of lung infections in patients with cystic fibrosis
Access path
- TGA registered · Colistin Link
TGA label equal than the PBS population
- Mar 2011Not recommended
Insufficient evidence for chronic P. aeruginosa infection (no studies of the recommended 1-month on/off alternating…
- ↻ resubmittedMar 2011Noted
Comparator changed: no treatment (or placebo) in addition to standard care → no treatment…
- PBS listing · Authority Required
Cost-effectiveness
Economic evaluation incomplete; no definitive ICER calculated. Cost per patient free of P. aeruginosa infection estimated at <$15,000 (not an ICER in cost per QALY terms).
The submission estimated the incremental cost per additional patient free of P.aeruginosa infection at 27 months was less than $15,000. PSD · 2011
Decision context
PopulationPatients with cystic fibrosis with early/intermittent or chronic Pseudomonas aeruginosa lung colonisation and infections.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2011 | Not recommended | no treatment (or placebo) in addition to standard care | — | RCT, Single-arm, Registry · QoL, FEV1, FVC |
| Mar 2011 | Noted | no treatment (placebo) / inhaled tobramycin | — | RCT |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both texts describe identical populations: CF patients with lung colonisation or infections due to susceptible P. aeruginosa.