Emtricitabine/Tenofovir Disoproxil FumarateAdrenaline Viatris
Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at substantial risk of HIV infection.
Access path
- TGA registered · Adrenaline Viatris
TGA label narrower than the PBS population
- Jul 2016Not recommended
unreliable cost-effectiveness estimates, impractical and inappropriate population restriction criteria based on…
From the public summary
9.1 The PBAC rejected the request for PBS listing on the basis of unacceptable and uncertain cost effectiveness in the proposed population and at the proposed price.PSD · Jul 2016
The PBAC noted that the submission had tried to limit the population that would be eligible for treatment to those at highest risk, which represented a relatively small proportion of the potential population. The PBAC noted this restriction was proposed in order to improve the cost-effectiveness rather than to limit use in those who would not benefit.PSD · Jul 2016
8.4 The submission presented an economic evaluation using two structurally similar but independent models:PSD · Jul 2016
The first was a Markov state transition model which considered the costs and consequences of prevention, detection and treatment of HIV infection in a homogeneous cohort of individuals at high risk of infection. This model considered the costs and consequences of treating an average individual at high risk of HIV infection without taking into account costs and consequences within the broader population.PSD · Jul 2016
8.1 The submission described Truvada + SOC as superior in terms of comparative effectiveness and non-inferior in terms of comparative safety over SOC. This claim was not strongly supported in terms of the requested PBS listing. Truvada + SOC was observed to be significantly more effective than SOC in some of the studies presented by the submission, but this effectiveness was conditional on adherence.PSD · Jul 2016
6.2 The PBAC noted and welcomed the input from individuals (92), health care professionals (2) and organisations (19) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of use of Truvada for PrEP, including reduction of risk of transmission of HIV, increased screening for HIV and other STIs, and reduced anxiety of contraction of HIV for people at risk.PSD · Jul 2016
Cost-effectiveness
Cost-utility analysis was provided but PBAC considered cost-effectiveness estimates to be unreliable; ICER values not stated in public document.
The PBAC noted that the submission had tried to limit the population that would be eligible for treatment to those at highest risk in order to improve the cost effectiveness. However, the PBAC considered that the cost-effectiveness estimates were unreliable and that attempts to limit the eligible population in the ways proposed by the submission would not be practical or appropriate. PBAC · 2016
Decision context
PopulationAdults 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.
Why it was knocked back
- 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
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2016 | Not recommended | standard of care | — | RCT · Other |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| iPrEx | Ph 3 | 2,499 | HIV Seroconversion | completed |
| TDF2 | Ph 2, PHASE3 | 1,219 | Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and … | completed |
| PROUD | Ph 4 | 544 | Time to accrual of 500 participants and Retention at 12 and 24 months from randomisation | completed |
| VOICE | Ph 2 | 5,029 | Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms | completed |
Consumer voice
Consumer input described benefits of Truvada for PrEP including reduction of HIV transmission risk, increased screening for HIV and other STIs, and reduced anxiety about HIV contraction. Comments also provided insights into clinical use patterns including reasons for initiation and usage patterns.
reduction of risk of transmission of HIV, increased screening for HIV and other STIs, and reduced anxiety of contraction of HIV for people at risk Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to adults at substantial risk (≥3% annual incidence) with negative HIV tests treated by approved prescribers in approved services.