PBAC's latest decision on Linezolid: Recommended with restriction (2013). Considered for 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.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$45k/QALY
Range: $15k/QALY–$45k/QALY
Submissions
1
first 2013
Submissions
1
2013 → 2013
Eligible population
Adults 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
Therapy area
Infectious disease
Line of therapy
Later-line
Evidence base
Single-arm
Primary endpoint
Clinical cure
Pivotal trial size
828 patients
Key trials
Birmingham 2003, Study 025, Moise 2002, Rayner 2004, Antony 2001, Chien 2000, Study 067, Watanabe 2012, Study 082-VRE, Moschovi 2010, Study 054A
Comparator
standard therapy (continuation of inadequate, unapproved or no further therapy); for MRSS a mixed comparator of antimicrobials with activity against multi-resistant MRSS; for severe VRE infections daptomycin or teicoplanin