Teplizumab is set to become the first disease modifying treatment for type 1 diabetes available on the NHS in England and Wales. Following a review of clinical trial evidence, NICE has recommended the treatment in final draft guidance for people aged 8 years and over who have type 1 diabetes in its early, pre-symptomatic stage.
The progression of type 1 diabetes is commonly described in three stages. Stage 1 is marked by the onset of the immune system attacking insulin-producing pancreatic beta cells, with normoglycaemia and no symptoms. In stage 2, dysglycaemia develops, although individuals remain asymptomatic. Clinical diagnosis typically occurs during stage 3, when significant beta-cell loss has occurred and hyperglycaemia leads to the common symptoms of the condition.
Teplizumab (Tzield) is an anti-CD3 monoclonal antibody that modulates the immune response involved in beta-cell destruction. It is administered as a once-daily intravenous infusion over 14 consecutive days, which can be challenging for some patients.
In clinical trials, teplizumab has been shown to delay progression from stage 2 to stage 3 type 1 diabetes by an average of 32 months. This provides individuals with valuable additional time before the onset of symptoms and the need for lifelong insulin therapy. For children and young people, this delay may be particularly important, allowing more time to reach key developmental milestones before diabetes management becomes part of daily life.
Access to teplizumab will depend on identifying those with pre-symptomatic disease. There is currently no national screening programme in the UK, but children aged 2–17 years can be screened through the ELSA study and adults aged 18–70 years through T1DRA. Testing may also occur in people with an increased familial risk or where clinicians have concerns about dysglycaemia. Work is underway to build the infrastructure needed to support new testing and treatment pathways to make teplizumab available in practice.
NICE estimates that around 1100 people could be eligible in the first year, reflecting those already identified through screening studies. Annual eligibility is expected to stabilise at about 820 from year 3. Around 555 people are expected to take up treatment in year 1, falling to approximately 490 annually thereafter.
Teplizumab will be available in England within 90 days of publication of final NICE guidance. In Wales, people will be able to access it 60 days from 23 June 2026. In Scotland, the Scottish Medicines Consortium expect to publish advice in early 2027, while in Northern Ireland a process exists for reviewing and adopting NICE guidance.
The final draft guidance from NICE can be read here.
