Australia's PBAC rejects application for Gilead's HIV PrEP

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC), the key committee of experts which advises government on which drugs to subsidize through the Pharmaceutical Benefits Scheme (PBS), has rejected the application from Gilead Sciences (Nasdaq: GILD) to list Truvada (emtricitabine/tenofovir disoproxil) 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 it wants 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 subsidizing 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 chief executive of Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM), adding "Without PBS subsidy, people at risk of HIV have to pay the high, unsubsidized price, or import low-cost generic drugs from overseas using the TGA's Personal Importation Scheme, or enrol in a PrEP demonstration project."