Tenofovir Disoproxil Fumarate With Emtricitabine / Tenofovir Disoproxil Maleate With Emtricitabine / Tenofovir Disoproxil Phosphate With EmtricitabineAdrenaline Viatris
Recommended · restricted Infectious diseaseRestrictedFirst-line line
Pre-exposure prophylaxis (PrEP) against HIV infection in individuals at risk of acquiring HIV.
1
Submissions
1 resub
2020–20
On the record
—
ICER range
Cost-min
Cost basis
Access path
- TGA registered · Adrenaline Viatris
- Sep 2020Recommended · restricted
vs Not applicable
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended the continued PBS listing of tenofovir disoproxil with emtricitabine (TD/FTC) for pre-exposure prophylaxis (PrEP) against HIV infection and further recommended the restriction level be reduced to a Restricted Benefit to support broad access for patients who are at risk of HIV infection.PSD · Sep 2020
6.2 In making this recommendation, the PBAC considered the guidelines and additional training provided by the ASHM, as a peak clinical organisation in this field, provide an adequate framework for PrEP prescribing that is likely to result in the cost-effective use of PrEP in the context of: the level of price reduction since listing and current price of TD/FTC on the PBS (and possible future price reductions due to price disclosure); the PBS …PSD · Sep 2020
Cost-effectiveness
No ICER calculated in this submission. This is a consideration of changed PBS prescribing criteria for an already-listed drug. PBAC noted the Kirby Institute model from December 2017 showed cost-effectiveness below $30,000 per QALY in all scenarios at current price ($1,355 annual cost).
ICER uncertainEconomic model disputedCost-effectiveness accepted
Decision context
PopulationIndividuals at risk of HIV infection, including men who have sex with men (MSM), Indigenous populations, overseas-born MSM, and heterosexuals; no specific risk classification required under revised criteria.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Sep 2020 | Recommended · restricted | Not applicable | — | Cost-minimisation · Cost-minimisation |
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