Tenofovir Disoproxil Fumarate / EmtricitabineTenofovir Disoproxil Emtricitabine Viatris 300/200
Pre-exposure prophylaxis (PrEP) against HIV-1 in adults at medium to high risk of infection.
Access path
- TGA registered · Tenofovir Disoproxil Emtricitabine Viatris 300/200
TGA label narrower than the PBS population
- Jul 2017Deferred
vs standard of care alone (HIV testing and safer sex practices)
From the public summary
7.1 The PBAC deferred making a recommendation on tenofovir with emtricitabine (TDF/FTC) for HIV Pre-exposure Prophylaxis (PrEP) to seek additional results for the cost-effectiveness model developed by the Kirby Institute. Specifically the Committee requested additional analyses considering alternative uptake scenarios 34PSD · Jul 2017
7.2 The PBAC recalled the July 2016 PrEP submission was rejected on the basis of unacceptable and uncertain cost-effectiveness at the proposed price. At that time, the PBAC considered attempts to severely restrict the eligible population based on individual risk calculation in the submission may not have been feasible, appropriate or acceptable to clinicians and consumers, and considered it may be more appropriate for a broader group of individuals to …PSD · Jul 2017
The issues with the Model 2: The individual risk distribution reflects some non- “Sexual contact between individuals was assumed to be randomness in sexual contacts as it assumed that there random rather than assortative by risk level. This was was a small group of extremely risky individuals interacting considered unrealistic as individuals at high risk may be more with each other.PSD · Jul 2017
The resubmission included the exogenous introduction of HIV-infected individuals into the model and transmission was no longer rapidly exhausted.PSD · Jul 2017
6.27 The resubmission described TDF/FTC plus SOC as superior in terms of comparative effectiveness and non-inferior in terms of comparative safety over SOC. This was unchanged from the July 2016 submission.PSD · Jul 2017
6.28 The PBAC considered that the claim of superior comparative effectiveness was reasonable.PSD · Jul 2017
6.2 The PBAC noted and welcomed the input from individuals (3), and organisations (10) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of TDF/FTC as PrEP, including greater protection from HIV, positive 8PSD · Jul 2017
6.3 The PBAC noted advice received from the Australian Federation of AIDS Organisations (AFAO) and National Association of People with HIV Australia (NAPWHA), which described the benefits of PrEP, including data from the IPERGAY trial which reported an 86% reduction in the risk of HIV infection among participants, and further described the efficacy of PrEP in a ‘real-world’ setting, and associated health benefits such as more frequent sexual health checks …PSD · Jul 2017
Cost-effectiveness
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.
Decision context
PopulationAdults 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Deferred | standard of care alone (HIV testing and safer sex practices) | — | RCT · HIV seroconversion incidence |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| IPERGAY | Ph 3 | 400 | Contamination with HIV-1 or -2 | completed |
Consumer voice
Consumer input from 3 individuals and 10 organisations described benefits of TDF/FTC as PrEP, including greater protection from HIV and positive outcomes.
greater protection from HIV, positive Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to medium-to-high risk adults with documented negative HIV status and 3-monthly testing; TGA label requires only high risk and safer sex practices.