New thyroid eye disease (TED) drug Tepezza (teprotumumab) has been recommended for listing on the Pharmaceutical Benefits Scheme (PBS), which is expected to spark a major update to the way patients are treated in Australia.
The therapy – which comes in a powdered form administered by intravenous infusion – was first approved in the US in 2020. It was registered with the Australian Therapeutic Goods Administration (TGA) earlier in 2025 for moderate to severe TED.
At the same time, it was also being considered by the Pharmaceutical Benefits Pharmaceutical Benefits Advisory Committee (PBAC) that advises the Australian Government on which medicines should be subsidised through the PBS.
At the committee’s May 2025 meeting, it recommended listing Tepezza after assessing a submission from its supplier Amgen Australia.
Dr Jwu Jin Khong, a leading oculoplastic surgeon and TED expert in Melbourne, said this was a significant moment for Australia’s TED community. TED is a serious, progressive and vision-threatening rare autoimmune disease. As it progresses, it can cause serious damage – including proptosis (eye bulging), strabismus (misalignment of the eyes) and diplopia (double vision) – and in some cases can lead to blindness.
Typically, patients have been treated with methylprednisolone, a steroid delivered by infusion.
Dr Khong said the PBAC recommendation would likely trigger a change in clinical management guidelines within the Orbital Plastic and Lacrimal Unit at The Royal Victorian Eye and Ear Hospital, where she works.
“This is a big deal. We are likely going to be using teprotumumab as our preferred first-line treatment for patients with active, moderate to severe TED,” she said.
“But we will be needing to screen the patients for safety first, such as having a baseline audiogram to check they don’t have major hearing issue to start with. We will also have to make sure patients are not pregnant because a lot of our patients are women in their reproductive years.”
Tepezza is a monoclonal antibody and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R). A typical course is administered to patients once every three weeks for a total of eight infusions.
Earlier in March 2025, the PBAC knocked back PBS-listing of the therapy, citing “the complexity of the economic model led to a high degree of uncertainty” and that a price reduction would be required to address this and achieve a cost-effective listing.
At the May 2025 meeting, the PBAC appeared satisfied with an amended submission from Amgen.
“The PBAC reaffirmed its previous view that there is a high clinical need in the requested patient population, and that the evidence demonstrated that teprotumumab is more effective in improving proptosis and diplopia compared to current standard of care, which may also lead to a reduction in eye surgery,” the body said.
“The PBAC considered that the economic model remained uncertain. However, the PBAC noted that changes to the economic evaluation and financial estimates had reduced uncertainty and addressed the committee’s concerns. The PBAC considered that teprotumumab would be cost-effective at the price proposed in the resubmission.”
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