Australians will no longer be able to access Truvada through the Pharmaceutical Benefits Scheme (PBS), however, the Australian Federation of AIDS Organisations (AFAO) assures users that generic brands are an equivalent substitute.
Truvada is a brand name for pre-exposure prophylaxis (PrEP), a combination of emtricitabine/tenofovir which has proven to be up to 99 percent effective in reducing risk of HIV transmission.
American pharmaceutical company, Gilead, manufactures Truvada as well as a similar drug, Descovy, which has a slightly modified ingredient base.
A long patent battle has raged in the US between Gilead and other interested parties, making Truvada expensive and inaccessible for many Americans, and heavily government subsidised in Australia.
The patent has effectively expired and emtricitabine/tenofovir is available for general production which means other pharmaceutical companies can manufacture a generic equivalent to Truvada.
On its PBS website, the Australian Government Department of Health describes how it treats premium brand and generic products:
Manufacturers can develop generic equivalents and apply to have them listed on the PBS. In doing this, manufacturers need to ensure that they comply with the relevant legislation applicable to patents. These brands are clinically equivalent and must undergo the same strict quality controls. Although these brands are designed to act on the body in exactly the same way, they are usually cheaper than the originator brands.
The Australian Government, through the PBS, subsidises up to the price of the lowest priced brand (except in those instances where the lowest priced brand has, as part of its price, a therapeutic group premium). This means that consumers may have to pay extra for more expensive brands (those with a brand premium). This extra amount does not count towards their PBS safety net threshold.
Truvada has been delisted from the PBS subsidy as of April 1, 2020, but generic options are still covered.
The National Association of People With HIV Australia released a statement assuring users:
“Community members eligible for PrEP can access generic versions of Truvada supplied by Apotex, Mylan and Lupin Generic Health. The drugs manufactured by these three suppliers contain the same active ingredients as Truvada.”
“PrEP continues to be available to everyone who has a prescription for it in Australia. While four types of PrEP were previously available there are now three. But there is absolutely no disruption to the quality or supply of this important medicine.”
ACON CEO Nicolas Parkhill reiterates that HIV negative people using PrEP can rest assured that this effective HIV prevention tool can still be accessed through the PBS as normal.
“These generic versions of PrEP work no differently to Truvada, providing the same protection. The ingredients contained in generic PrEP work in exactly the same way as Truvada and delivers the same clinical benefits.
People living with HIV that use Truvada as part of their treatment can access the same medication just under a different brand name. We thank those in our communities that choose to take PrEP as part of the HIV prevention strategy, and for continuing to look after their health and the health of their partners.”
People on PrEP wishing to use a generic brand should consult their doctor first. While generic products contain the same active ingredients as premium brands, they may differ in shape, size, colour and packaging, or contain inactive ingredients that should be considered.
Information and support:
HIV and LGBTI Health in NSW – https://www.acon.org.au
HIV and LGBTI Health in Victoria – https://thorneharbour.org
For PrEP – https://getprepd.org.au
For HIV treatment – https://napwha.org.au/treatment
Find your nearest HIV prescriber – https://www.ashm.org.au/prescriber-locator/
For information on HIV prevention – https://endinghiv.org.au/