Key Summary
- Teplizumab will be available to NHS patients in England within 90 days of publication of NICE final guidance.
- Screening for type 1 diabetes autoantibodies is the first step to finding out whether someone is eligible for treatment with Teplizumab.
- By delaying the onset of symptomatic type 1 diabetes, people will benefit from extra time before taking on the demands of lifelong diabetes management.
The National Institute for Health and Care Excellence (NICE) has approved teplizumab, an immunotherapy drug that can delay the onset of symptomatic type 1 diabetes by an average of nearly three years.
In its final draft guidance issued on Tuesday (23), NICE has recommended teplizumab for children aged 8 and over and adults who have type 1 diabetes in its early, pre-symptomatic stage (stage 2).
England is the first country in Europe to recommend teplizumab, manufactured by Sanofi, and is administered to patients by infusion.
This immunotherapy drug will be available to NHS patients in England within 90 days of publication of NICE final guidance, while patients in Wales will be able to access it 60 days from 23 June.
Screening for type 1 diabetes autoantibodies is the first step to finding out whether someone is eligible for treatment with teplizumab.
Screening and three stages
In the UK, there are currently two screening studies - the Early Surveillance for Autoimmune diabetes (ELSD) for screening children aged 2-17 years, and the T1DRA study for adults between 18-70 years.
Type 1 diabetes progresses through three stages. At stage 1, there are no symptoms and blood sugar levels are normal, but blood tests show the immune system has begun attacking the insulin-producing cells in the pancreas.
At stage 2, this immune attack has progressed further. There are still no symptoms, but blood tests now show early changes in blood sugar levels, indicating a high risk of developing symptomatic diabetes.
Stage 3 is when symptoms appear, blood sugar levels rise significantly, and most people receive their diagnosis, usually requiring lifelong insulin treatment.
Teplizumab is used to delay the onset of stage 3 type 1 diabetes in children aged 8 years and over, and adults, with stage 2 type 1 diabetes.
By delaying the onset of symptomatic type 1 diabetes (stage 3), people will benefit from extra time before taking on the demands of lifelong diabetes management.
Landmark treatment
Helen Knight, director of medicines evaluation at NICE said, "The evidence shows teplizumab can delay the onset of symptomatic diabetes by an average of nearly three years. As always, our decision is rigorous, transparent and based on the best available evidence, striking a balance between clinical benefit and value for the taxpayer."
Lucy Common, clinical nursing advisor at NICE said, “Having time before the onset of stage 3 diabetes is not just a clinical benefit; it can make a meaningful difference to people’s lives, their mental wellbeing, and the wellbeing of the families and carers who support them. It is encouraging to see a treatment that has the potential to be made available across the NHS.”
Dr Elizabeth Robertson, director of research and clinical at Diabetes UK said, "Today’s landmark approval of teplizumab marks the start of a new age of type 1 diabetes treatment. For the first time in 100 years, we are moving beyond insulin, with a medicine that targets the root cause of the condition.
"This is an extraordinary moment for celebration in the type 1 diabetes community and represents a shift towards a future where type 1 diabetes can be prevented altogether."
She said that detecting type 1 diabetes early, before symptoms appear, is key to unlocking these benefits, and our focus now is ensuring fair and equitable access.
