19 August 2016
The Pharmaceutical Benefits Advisory Committee (PBAC), the key committee of experts which advises government on which drugs to subsidise through the Pharmaceutical Benefits Scheme (PBS) today announced that it has rejected the application from Gilead Sciences to list Truvada® for HIV Pre Exposure Prophylaxis (PREP).
While this is very disappointing for many people at risk of HIV and their clinicians and public health officials, the PBAC has indicated that they want to keep looking at this issue with a view to answering the questions PBAC has about Gilead's unsuccessful submission.
"PBAC is concerned with the cost effectiveness of subsidising medications. It is not the group which advises on safety. Truvada® a single pill taken daily to prevent the acquisition of HIV was determined safe and effective by the Therapeutic Drugs Administration in May this year. This drug has been being used in Australia for some time by individuals who are at risk of HIV and who are taking this proactive step to prevent acquiring HIV." said Adj A/Prof Crooks CEO of ASHM. "Without PBS subsidy, people at risk of HIV have to pay the high, unsubsidised price, or import low-cost generic drugs from overseas using the TGA's Personal Importation Scheme, or enrol in a PrEP demonstration project."
PrEP acts like malaria prophylaxis, or the oral contraceptive. It is taken before exposure to block a new infection occurring when a person is exposed to infection, through a mosquito bite in the case of malaria or through sex as in the case with HIV and pregnancy.
A/Prof Edwina Wright, leader of the PrEP X Demonstration Project in Victoria said, "People must understand that the PBAC decision to reject the application is not an indication that PrEP is not safe or that PrEP is not effective. PrEP is the most efficacious prevention strategy that is available preventing a person from acquiring HIV".
"The recommendation is that PrEP is taken daily. This ensures that the drug is present in effective concentrations and thereby provides an effective barrier to HIV becoming established in the person on PrEP. Because the drug is in the person's system it provides a continuous barrier, unlike condoms which may not be available at the time when a couple actually has sex. Condoms are a very good prevention strategy for HIV, but their use is prone to occasional mishaps, breakage or simply not being around when needed" said Wright.
A representative from Gilead Sciences has told us that they will continue to be committed to pursuing the listing of Truvada® for PrEP and that they will work with all stakeholders and the PBAC to progress this. "But we need to make sure today that people at risk of HIV are aware how they can access PrEP while the application process continues" said Crooks.
ASHM believes that it is an urgent priority to make PrEP available across all jurisdictions in Australia until Truvada becomes listed on the PBS for HIV prevention and will work with key stakeholders and across all jurisdictions to achieve this.
Clinicians can access information about PrEP from the ASHM website:
Information about Personal Importation Scheme:
Jurisdictional Information on how clinicians can support patients accessing PrEP can be found at
People at high risk of acquisition of HIV from Victoria can join the PrEPX Study:
People at high risk of acquisition of HIV from NSW and ACT can join the EPIC Study:
People at high risk of acquisition of HIV from Queensland can join QPrEPd:
Contacts available for further comment
Prof Edwina Wright (ASHM Clinical Advisor on PrEP) — 0414 242 600 (VIC)
Prof Mark Boyd (ASHM President) — 0424 144 186 (SA)
A/Prof Levinia Crooks (ASHM CEO) — 0411 249 891 (NSW, National)
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Media Release: PBAC Announcement on 19 Aug 2016