PBAC's latest decision on Tenofovir disoproxil fumarate / emtricitabine: Recommended with restriction (2017). Considered for Pre-exposure prophylaxis (PrEP) against HIV-1 in adults at medium to high risk of infection.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2017
Submissions
1
2017 → 2017
Eligible population
Adults 18 years or older at medium to high risk of HIV-1 infection (as defined by ASHM Guidelines), who are negative for HIV at baseline and remain negative at 3-monthly intervals.
Therapy area
Infectious disease
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
HIV seroconversion incidence
Pivotal trial size
757 patients
Key trials
IPERGAY, ADAPT
Comparator
standard of care alone (HIV testing and safer sex practices)
Economic model
CUA
Eligible patients/year
8,763
ICER note
ICER was modelled but the July 2017 resubmission showed 'More than $200,000 per QALY gained' (stated as exceeding the threshold), compared to the July 2016 submission which estimated $105,000–$200,000 per QALY for Model 1. The exact figure is not precisely stated as a single numeric value in the public document.