Tenofovir Disoproxil Maleate With EmtricitabineAdrenaline Viatris
Pre-exposure prophylaxis (PrEP) against HIV infection in adults at medium to high risk of infection.
Access path
- TGA registered · Adrenaline Viatris
TGA label narrower than the PBS population
- Jul 2017Deferred
From the public summary
5.1 The PBAC deferred making a recommendation on tenofovir with emtricitabine for HIV Pre-exposure Prophylaxis (PrEP) to seek additional results for the cost- effectiveness model developed by the Kirby Institute.PSD · Jul 2017
5.2 In making this recommendation, the PBAC noted the significant price reduction offered by Alphapharm compared to the current PBS price for tenofovir with emtricitabine for treatment of HIV. However, based on the proposed annual PrEP cost of $''''''''''' in the submission, the cost per QALY gained would not be less than $30,000 unless uptake was restricted to high risk MSM and the uptake does not exceed approximately '''''%.PSD · Jul 2017
3.9 A description of the economic model developed by the Kirby Institute is provided in the AFAO report submitted with the minor application. In summary: The Kirby model assessed the cost-effectiveness of PrEP in MSM using a HIV transmission model. The model partitions the overall Australian population by population group and by HIV health state.PSD · Jul 2017
3.10 The key model assumptions were: An annual cost for tenofovir with emtricitabine of $9,605 (based on the PBS cost for treatment of HIV). The annual cost proposed in this minor submission for tenofovir with emtricitabine for PrEP is $''''''''' (general schedule). The assumed coverage of PrEP would be reached by year 3. The time required to reach the assumed coverage levels was based on experience from the Australian demonstration programs.PSD · Jul 2017
4.2 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 changes in community perceptions of HIV, and a reduction in stigma for those living with HIV.PSD · Jul 2017
4.3 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 values are redacted (marked as '''''') throughout the document. Table 3 presents cost thresholds at willingness-to-pay levels of $30,000, $60,000, and $90,000 per QALY, but the actual ICER for the proposed price is not disclosed.
Decision context
PopulationAdults aged 18 years or older at medium to high risk of HIV infection, as defined by the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) Guidelines, who return a negative HIV test prior to initiating treatment and continue to return negative HIV tests at 3-monthly intervals throughout treatment.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Deferred | — | — | Cost-minimisation · Cost-minimisation |
Consumer voice
Consumer input from 3 individuals and 10 organisations, including support groups and AIDS organisations, described benefits of TDF/FTC as PrEP including greater HIV protection, positive community perception changes, and stigma reduction. Organisations cited real-world efficacy data and highlighted legal and financial access challenges.
The comments described a range of benefits of TDF/FTC as PrEP, including greater protection from HIV, positive changes in community perceptions of HIV, and a reduction in stigma for those living with HIV. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to medium-high risk per ASHM guidelines with mandatory negative HIV testing at baseline and 3-monthly intervals.