Tenofovir With Emtricitabine
Recommended · restricted Infectious diseaseAuthority RequiredNot applicable line 💬 consumer voice
Pre-exposure prophylaxis (PrEP) against HIV in adults at medium to high risk of infection.
1
Submissions
1 resub
2017–17
On the record
$104k–153k
ICER range
1 sourced ICER · 2017
ICER stated
Cost basis
Access path
- Dec 2017Recommended · restricted
vs standard of care (combination of safe sex practices)
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended the listing of tenofovir with emtricitabine for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP). The PBAC was satisfied that tenofovir with emtricitabine provides, for some patients, a significant reduction in the risk of sexually-acquired HIV when used in combination with the promotion of other safe sex practices, compared with the promotion of other safe sex practices alone.PSD · Dec 2017
5.2 In response to the request from the Minister (delegate) under section 101(3) of the National Health Act 1953 (‘the Act’), the PBAC considered the price or range of prices at which it considered treatment with tenofovir with emtricitabine as PrEP would be acceptably cost-effective for the purposes of the Act.PSD · Dec 2017
Economic analysis
4.3 The results for the following additional analyses were provided by the Kirby Institute: Uptake in 40%, 50%, 60%, 70% and 80% of the eligible high and medium risk populations. The annual cost of PrEP required for ICER thresholds of $10,000, $15,000, $20,000 and $25,000 per QALY gained.PSD · Dec 2017
4.4 The Kirby Institute advised that in the process of preparing the additional analyses, an error was identified in the costing calculations for providing PrEP for the specified coverage in each scenario. The error resulted in PrEP costs and the resulting ICER being over-estimated by 10-20% in the original analysis, and the PrEP unit cost being required to meet the cost-effectiveness thresholds being underestimated by a similar margin.PSD · Dec 2017
Cost-effectiveness
Assuming 40% uptake in high and medium risk individuals, and an annual PrEP cost of $9,605, the cost per QALY gained is $104,330. If uptake is increased to 80%, the ICER increases to $152,650 per QALY gained. PSD · 2017
ICER uncertain
Decision context
PopulationAdults 18 years or older at medium to high risk of HIV infection, as defined by updated Australian Society for HIV Medicine Guidelines, who return a negative HIV test prior to initiating treatment and continue to return negative HIV tests at 3 monthly intervals.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Dec 2017 | Recommended · restricted | standard of care (combination of safe sex practices) | $104k–153k | Cost-minimisation · Cost-minimisation |
Consumer voice
No consumer comments were received for this item, though the PBAC noted a large volume of supportive consumer comments had been received at a previous July 2017 meeting.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Tenofovir Disoproxil Fumarate / Emtricitabine90%Tenofovir Disoproxil Maleate With Emtricitabine89%Emtricitabine/Tenofovir Disoproxil Fumarate86%Tenofovir Disoproxil Fumarate With Emtricitabine / Tenofovir Disoproxil Maleate With Emtricitabine / Tenofovir Disoproxil Phosphate With Emtricitabine85%Tenofovir Disoproxil Fumarate With Emtricitabine83%Tenofovir Alafenamide / Emtricitabine77%Emtricitabine + Tenofovir Alafenamide77%Tenofovir Disoproxil Fumarate With Emtricitabine And Rilpivirine Hydrochloride76%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to medium-to-high risk per ASHM guidelines and mandates negative HIV tests at baseline and 3-monthly intervals.