Despite an initial knock back, Burnet’s Associate Professor Mark Stoové is confident the antiretroviral drug Truvada will be subsidised under the Pharmaceutical Benefits Scheme (PBS) to facilitate its availability in Australia.
Last Friday the Pharmaceutical Benefits Advisory Council (PBAC) announced it would not recommend Truvada for listing on the PBS.
Truvada is used in HIV pre-exposure prophylaxis (PrEP) by people who are HIV negative and at high risk of contracting HIV. PrEP may reduce the chance of HIV transmission by up to 99 percent to lower their chances of becoming infected.
PBAC cited the manufacturer Gilead Sciences' cost-effectiveness model which includes the cost of the drug as a key factor in its determination. Gilead now has the opportunity to prepare a new submission for consideration by PBAC later in 2016.
“While the PBAC decision will obviously be a disappointment to many, Gilead and PBAC have clearly indicated an ongoing committed to work together to ensure equitable access to Truvada for people at risk of acquiring HIV in Australia,” Associate Professor Stoové, Burnet’s Head of HIV research, said.
“The key now is to develop a better cost-effectiveness model and negotiate a reduced price for Truvada that will satisfy Australians that PrEP is a worthwhile and cost-effective spend of Australian health funds.
“While the delay in PBS listing for Truvada is not ideal, I am very confident that subsidised PrEP will be available in Australia in the near future. When this happens it will a major advance in HIV prevention in Australia.”
Currently, Truvada is available in Australia at a cost of hundreds of dollars per private prescription, or via research trials such as PrEPX, and through online pharmacies that provide cheaper generic versions of Truvada from overseas.
Research and trials have shown that Truvada is highly effective if taken daily.
In a statement, PBAC nominated “unacceptable and uncertain cost effectiveness” among the reasons for its decision and noted that the efficacy of Truvada is highly dependent on adherence.
PBAC commented that “based on the evidence provided, pre-exposure prophylaxis could reduce the risk of acquiring HIV when used in combination with safer sex practices and regular HIV testing, but as a strategy, PrEP was not always effective in preventing the acquisition of the virus”.
PrEPX Study leader Associate Professor Edwina Wright said it’s important to understand that the PBAC decision is not an indication that PrEP is not safe or not effective.
“PrEP is the most efficacious prevention strategy that is available preventing a person from acquiring HIV,” Associate Professor Wright said.
“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.”