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PrEP — where are we at?

In May last year, the Therapeutic Goods Administration (TGA) gave Truvada its tick for use as a drug to protect against HIV. Describing the TGA’s decision as a “revolutionary development”, Darryl O’Donnell, Executive Director of the Australian Federation of AIDS Organisations (AFA0), said at the time: “In registering Truvada, the TGA has confirmed that this is a safe and effective way of preventing HIV transmission through sex. Truvada for PrEP gives people at risk a powerful new option for taking control of their health; it puts them in control to stay HIV-negative.”

PrEP also offers enormous benefits to HIV-positive people as well. “It is an important new method of practicing safer sex with partners,” said Aaron Cogle, Executive Director of the National Association of People with HIV Australia. “Using PrEP with Treatment as Prevention (TasP) allows both partners to share the responsibility for HIV prevention; it reduces the stress and anxiety that can be associated with HIV and sex. This means less pressure on positive people in casual sexual encounters and in serodiscordant relationships.” 

With TGA approval out of the way, the focus of attention quickly shifted to affordability. “For PrEP to have maximum impact, it is vital that anyone who is at high risk of becoming HIV-positive is able to afford it,” said NAPWHA president Cipri Martinez. “The only way for that to be achieved is for Truvada to be placed on the Pharmaceutical Benefits Scheme (PBS) as soon as possible.” O’Donnell agreed: “We have a national, bipartisan commitment to virtually eliminate HIV transmission in Australia by 2020. Affordable, PBS-listed PrEP would make all the difference.”

When the Pharmaceutical Benefits Advisory Board (PBAC) met in August 2016, it was widely expected that PrEP would receive the rubber stamp for subsidy.  However, the submission was rejected. PBAC cited cost as the main reason behind its decision, describing the price submitted by manufacturer Gilead Sciences as not “feasible to clinicians and consumers”. 

O’Donnell expressed “great disappointment” at the news. “Without PBS listing, [PrEP] is a wasted tool,” he said. “This is proven technology.” Calls were subsequently made for Gilead to reapply with a revised financial model. “One that’s more realistic, more sustainable, and puts people before profits,” said Martinez. In reply, PBAC said it would welcome another submission from Gilead, one that addressed “the concerns about cost effectiveness”.

Which brings us to now. Gilead intends to resubmit its application to PBAC within months, with an outcome expected in July. What that outcome will be is still anyone’s guess. One thing is certain though, as O’Donnell said: “People are needlessly getting HIV while we wait for access to this prevention pill.”

 

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