Tzield Not Recommended for PBS Listing in Australia
26 Aug 2026
Teplizumab, sold as Tzield, was submitted for PBS listing for people aged eight years and older with Stage 2 type 1 diabetes, with the aim of delaying progression to Stage 3 disease.
The treatment targets the immune response involved in type 1 diabetes and can delay the onset of clinical disease by an average of around two years. Treatment involves one teplizumab infusion each day for 14 consecutive days.
The application followed approval of teplizumab by the Therapeutic Goods Administration in May.
However, after considering the application at its July meeting, the Pharmaceutical Benefits Advisory Committee recommended against PBS listing.
The PBAC recognised that delaying Stage 3 type 1 diabetes could benefit patients, particularly children and adolescents, by providing more time without symptoms and the need for insulin treatment and blood glucose management.
However, the committee said the evidence submitted did not provide enough support for claims about possible long-term benefits after the onset of Stage 3 disease, including increased life expectancy and lower risks of cardiovascular and other complications.
The PBAC also noted that the benefits of delaying Stage 3 diabetes may vary depending on a patient’s age. It considered the economic evaluation highly uncertain and concluded that the treatment had not been shown to provide value for money at the price requested.
Dr Gary Deed, Chair of RACGP Specific Interests Diabetes, said the decision could provide an opportunity for a future submission to focus more clearly on younger patients and strengthen the economic case.
He also highlighted the potential role of GPs in identifying people at risk and supporting patients with Stage 2 type 1 diabetes, which is characterised by the presence of two diabetes-related autoantibodies without hyperglycaemia.
Dr Deed said he would support another application for PBS listing, describing teplizumab as the first drug class offering the potential to change how early type 1 diabetes is managed.
Sanofi said it is reviewing the PBAC feedback and will decide when to make another submission.
Teplizumab is currently not available through private prescription in Australia.
Tzield Not Recommended for PBS Listing in Australia
Source: RACGP newsGP / Pharmaceutical Benefits Advisory Committee