A drug manufacturer failed to take the advice of top HIV/AIDS organisations when it made a submission for a highly effective HIV prevention drug to be subsidised by the government, those organisations say.
Truvada, also known as PrEP (pre-exposure prophylaxis), is a drug found to be highly effective at preventing the contraction of HIV when taken daily.
A listing on the PBS would have made the drug widely available, especially to the people most likely to contract HIV: gay men and transgender women on low incomes, sex workers, and injecting drug users.
Gilead Australia's application to the Pharmaceutical Benefits Advisory Committee (PBAC) to have Truvada included on the Pharmaceutical Benefits Scheme (PBS) was rejected last Friday.
PBAC cited Gilead's proposed pricing structure as the main reason for rejecting the submission, and found Gilead's attempts to restrict subsidised access to Truvada to people whose behaviour was deemed high risk was unacceptable.
"PBAC considered that [Gilead's] cost-effectiveness estimates were unreliable and
that attempts to restrict the eligible population... and limiting access to those with a predicted annual risk of infection of 3% or higher, may not be feasible or acceptable to clinicians and consumers," it said.
Australia's top HIV body, the Australian Federation of AIDS Organisations (AFAO), says Gilead did not consult adequately with it, meaning its submission was doomed from the start.
AFAO CEO Darryl O'Donnell told BuzzFeed News that a group of community representatives and clinicians was convened by Gilead for advice, but that advice was ultimately ignored.
"The consideration by PBAC ... was ultimately dependent on [Gilead] having put forward a reasonable price and a good argument, and from all the evidence we’ve seen since the decision has come through, that reasonable price and good argument simply wasn’t forthcoming," he said.
BuzzFeed News understands a letter sent in April by the AFAO seeking access to Gilead's submission so as to better inform the AFAO's own submission was rebuffed by the pharmaceutical giant.
The relevant HIV/AIDS organisations were only granted access to the submission after it had been made and when it was too late for those organisations to inform the submission in order to give it a better chance of being accepted.
Simon Ruth, CEO of the Victorian AIDS Council, agreed that Gilead had failed to consult adequately.
"It certainly appears on the available evidence that Gilead pitched the price too high and didn't do the necessary legwork to ensure the submission was approved," he said.
A spokesperson for Gilead said the company will work closely with PBAC and community stakeholders before resubmitting to PBAC.
"Information from a wide range of sources helped inform the submission, and Gilead gave the submission every possible chance of success," the spokesperson said.
O'Donnell said that as Gilead prepares to resubmit its application, thousands of at-risk Australians will continue to have restricted access to a life-saving drug.
Currently, people at risk of contracting HIV can enrol in clinical trials in NSW, Queensland, Victoria, and the ACT, or can import the drugs – at a high cost – from overseas.
"For us to have an ideal form of access we need [Truvada] to be available at scale, and we need that to be available in the ways that we’re all used to accessing treatment for different conditions, and that means being able to see a doctor then walk into a chemist [and buy the drug]," O'Donnell said.