Tzield and the stages of T1D
Before we dive into the news, here’s a quick refresher on the stages of T1D.
Months or even years before the symptoms of T1D start to show, the attack from the immune system begins on the insulin-producing beta cells in the pancreas. In stage 1, this immune attack has started, but blood glucose levels are stable. By stage 2, enough beta cells have been destroyed that blood glucose levels start to become irregular. At stage 3, so many beta cells are lost that blood glucose levels rise high enough to cause symptoms, and insulin therapy is needed.
In June 2026, a drug called Tzield was approved by the Therapeutic Goods Administration (TGA)Â in Australia for people with aged 8 years and older with stage 2 T1D. On average, Tzield delays progression to stage 3 by 2 years.
Because of its ability to interfere with the underlying disease process in T1D, not just treat the symptoms like insulin does, Tzield is classed as a disease-modifying therapy.
Tzield approved for stage 3 T1D in the US
Thanks to decades of global research and advocacy efforts by Breakthrough T1D, Tzield became the first T1D disease-modifying therapy ever approved in 2022, when the Food and Drugs Administration approved it in the US for people with stage 2 T1D aged 8+ years. Since then, this approval has been extended to children with stage 2 T1D as young as 1 year.
Most recently in the US, Tzield was approved for people aged 8-17 years in the first 8 weeks following their diagnosis with stage 3 T1D.
Read the news story about this from our colleagues in the US.
How Australians with stage 3 T1D can access Tzield
For various reasons, approvals like this often begin in the US and gradually make their way to other countries around the world.
In Australia, Tzield isn’t currently approved for people living with stage 3 T1D. We will advocate for this approval until we have equal access to Tzield in Australia.
In the meantime, people newly diagnosed with stage 3 T1D in Australia may be able to access Tzield through the βETA PRESERVE study. This is a clinical trial in which 2/3 of people involved will be given Tzield, while the other third will receive a placebo. The study is currently running in Queensland, South Australia and Western Australia, recruiting people within 8 weeks of being diagnosed with stage 3 T1D aged 1–17 years.
Tzield subsidised by the UK healthcare system
Over in the UK, the National Institute for Health and Care Excellence (NICE) has recommended that Tzield should be funded by the National Health Service (NHS). This means that people in England and Wales with stage 2 T1D and who are aged 8 years and over will be able to access it free of charge as it will be subsidised by the UK Government.
This is a historic moment as it sets a precedent for other countries with similar national healthcare systems, like Australia, to follow suite.
Tzield under review for subsidisation in Australia
For Tzield to be subsidised by the Australian Government, it must be listed on the Pharmaceutical Benefits Scheme (PBS). The Pharmaceutical Benefits Advisory Committee (PBAC) will consider if Tzield should be included in the PBS at a meeting in July, and will then make a recommendation to the Government.
Breakthrough T1D, along with members of the T1D community, has provided evidence for why we need Tzield to be listed on the PBS. We will do everything we can to make this happen.
We’re delighted by the news that Tzield will be subsidised by the UK Government and hope it encourages the Australian Government to do the same.
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