VAC responds to PBAC decision not to recommend PrEP for PBS listing

The Victorian AIDS Council (VAC) has expressed disappointment at today’s Pharmaceutical Benefits Advisory Committee (PBAC) decision not to recommend PrEP for listing on the Pharmaceutical Benefits Scheme, and encouraged pharmaceutical company Gilead to resubmit a new application. Gilead made the application to have Truvada listed on the PBS for use as PrEP after the drug was approved by the Therapeutic Goods Administration earlier this year. Cost-effectiveness was cited as one reason for PBAC’s negative decision, which means Gilead would have to make a full resubmission later this year for PrEP to be reconsidered at a March 2017 PBAC meeting. “This is an incredibly disappointing outcome. PBAC’s decision means Australians will have to wait even longer to access a HIV-prevention tool that has been proven to work. Every year 1200 Australians contract HIV, and PrEP could substantially reduce this number. It is distressing to see access to PrEP for the people who need it most held back by a decision like this,” said VAC CEO Simon Ruth. “We encourage Gilead to resubmit in November for a decision in March, and to do everything they can to bring down the cost of the drug and get this over the line. We hope Gilead and the government will do everything they can do expedite the process.” “We can’t end HIV without PrEP—it is the most effective HIV-prevention tool we have. Other countries have already approved PrEP and now we need it to be accessible and affordable in Australia.” Ruth commented specifically on one section of the PBAC decision, which stated: “The efficacy of Truvada was highly dependent on adherence, and that it is not clear if subjects at high risk of contracting HIV due to self-reported low adherence to safer sex practices would also have lower adherence to medication”. Ruth responded, and said: “Drawing a comparison between risk behaviour and adherence to medication is illogical. It is wrong and offensive to assume that gay men would not be taking every measure to protect themselves when it comes to HIV, and we view PrEP as the most powerful tool for doing that. PrEP demonstration projects have shown gay men’s adherence to PrEP is extremely high, and comments like this are unhelpful, stigmatising and homophobic.” VAC President Chad Hughes said Victorians have waited too long already to access PrEP. “This is a particularly devastating outcome for states that don’t have a state-sponsored PrEP trial, like South Australia and Tasmania—these states will bear the brunt of new infections the longer we delay listing PrEP on the PBS,” Hughes said. “We’re lucky to have the support of the Victorian Government for the PrEPX trial, particularly now that we will have to wait so much longer for PrEP to be listed on the PBS. PrEPX has had the fastest uptake of any PrEP scheme worldwide—we’ve seen a thousand enrolments in just three weeks. Those numbers and the grass-roots efforts to make generic Truvada more accessible through personal importation show that gay men in Victoria want PrEP now.” “Our community wants to take more responsibility for preventing HIV, we understand that PrEP is a big part of that, and now we just need it to happen.” For more information about how to access PrEP if you are unable to access a clinical trial, visit: www. prepaccessnow.com.au