AztreonamAZACTAM
Management of proven Pseudomonas aeruginosa infection in patients with cystic fibrosis.
Decisions on record
- Meeting Jul 2012 Recommended Cystic fibrosis
- Meeting Nov 2010 Not recommended Anti-infective for use in cystic fibrosis no PSD
Access path
- TGA registered · AZACTAM
TGA label narrower than the PBS population
- 2010Not recommended
placebo was not the appropriate comparator; efficacy of aztreonam beyond 28 days in the appropriate treatment algorithm…
- ↻ resubmitted2012Recommended · restricted
Comparator changed: nebulised IV formulation of tobramycin → tobramycin solution for…
- Jul 2012Recommended · restricted
Listing: Authority Required (Streamlined) → Authority Required
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation basis; no ICER calculated. Economic evaluation was cost per respiratory hospitalisation avoided over 24 weeks (less than $15,000), but PBAC considered cost-effectiveness unacceptably high and uncertain at the reduced price offered.
The PBAC noted that the submission's calculated cost-effectiveness ratio compared favourably to the estimated costs of cystic fibrosis hospitalisations (AR-DRG E60A and E60B) in the current Australian setting of between $15,000 and $45,000, however the PBAC considered there to be various confounding factors. PBAC · 2012
Decision context
PopulationPatients aged 6 years or older with moderate to severe cystic fibrosis and chronic Pseudomonas aeruginosa infection.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2012 | Recommended · restricted | tobramycin solution for inhalation | — | RCT · FEV1 |
| 2012 | Recommended · restricted | tobramycin solution for inhalation | — | RCT · QoL (CFQ-R Respiratory Symptoms Scale) |
| 2010 | Not recommended | nebulised IV formulation of tobramycin | $200k | RCT · time to the need for inhaled or IV antibiotics (CP-AI-005), change in CFQ-R respiratory domain scores, FEV % predicted |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to chronic P. aeruginosa infection, age ≥6 years, and later-line therapy; TGA label includes all gram-negative bacteria control regardless of chronicity or line.