PBAC's latest decision on Emtricitabine/tenofovir disoproxil fumarate: Not recommended (2016). Considered for Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at substantial risk of HIV infection.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2016
Submissions
1
2016 → 2016
Eligible population
Adults 18 years or older at substantial risk of sexually acquired HIV-1 infection, defined as annual incidence of HIV infection in the absence of PrEP of 3%, who return negative HIV-1 tests and are treated by an antiretroviral therapy approved prescriber within an approved PrEP service.
Cost-utility analysis was provided but PBAC considered cost-effectiveness estimates to be unreliable; ICER values not stated in public document.
Why PBAC said no
Reasons cited in the latest PSD: unreliable cost-effectiveness estimates, impractical and inappropriate population restriction criteria based on arbitrary 3% annual incidence threshold, inability to accurately estimate individual risk from self-reported behaviour, unresolved issues regarding financing and organisation of approved PrEP services