LinezolidAKM LINEZOLID
Treatment of microbiologically proven, multi-resistant methicillin-resistant Staphylococcus species (MRSS) infection in patients where no other antimicrobial agents can be used, and treatment of microbiologically proven Vancomycin-Resistant Enterococcus species (VRE) infection.
Decision on record
- Meeting Jul 2013 Not recommended Antibiotic
Access path
- TGA registered · AKM LINEZOLID
TGA label narrower than the PBS population
- Jul 2013Recommended · restricted
vs standard therapy (continuation of inadequate, unapproved or…
- PBS listing · Authority Required
Cost-effectiveness
The PBAC considered that the economic analysis was consistent with the clinical claim, but not consistent with the clinical evidence as no comparative data were provided. PBAC · 2013
Decision context
PopulationAdults and children with microbiologically proven, multi-resistant MRSS or VRE infections where standard antimicrobial therapy has failed, patients are intolerant, or there is laboratory-confirmed resistance, potential drug interaction, toxicity, or contraindication to other agents
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2013 | Recommended · restricted | standard therapy (continuation of inadequate, unapproved or no further therapy); for MRSS a mixed comparator of antimicr | $15k–45k | Single-arm · Clinical cure |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to microbiologically proven infections where standard therapy failed, intolerance, or resistance confirmed; TGA label broader on diagnostic certainty and prior therapy requirements.