PBAC's latest decision on Tenofovir alafenamide/emtricitabine: Recommended with restriction (2016). Considered for Treatment of HIV-1 infection in treatment-naïve and treatment-experienced patients as part of combination antiretroviral therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2016
Submissions
1
2016 → 2016
Eligible population
HIV-1 positive patients; treatment-naïve patients and treatment-experienced virologically suppressed patients on Truvada®-based regimens, in combination with other antiretroviral agents.
Therapy area
Infectious disease
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
ORR
Pivotal trial size
668 patients
Key trials
Study 1089, Study 104, Study 111, Study 112
Comparator
Truvada®
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis based on drug cost only; no ICER calculated.