PBAC's latest decision on Dolutegravir: Recommended (2013). Considered for Treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in patients with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease, and continuing treatment in patients who have previously received PBS-subsidised therapy for HIV infection.
PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2013
Submissions
1
2013 → 2013
Eligible population
ART-naïve and ART-experienced but INI-naïve patients with HIV-1 infection; also treatment-experienced patients with INI resistance (CD4 count <500 cells/mm³ or symptomatic HIV disease).
Therapy area
Infectious disease
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
ORR
Pivotal trial size
822 patients
Key trials
SPRING-2, SAILING, VIKING-3
Comparator
raltegravir
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis conducted; no ICER calculated as this was a cost-minimisation rather than cost-effectiveness submission.