NICE recommends first disease-modifying therapy for NHS use to delay the onset of type 1 diabetes
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A first-of-its-kind therapy that can delay the onset of type 1
diabetes for up to three years is to be made available on the NHS,
NICE has said. Clinical trial evidence reviewed by an independent
NICE committee shows that teplizumab can delay the onset of
symptomatic type 1 diabetes by an average of nearly three years.
Teplizumab is the first disease-modifying therapy for type 1
diabetes and England is the first country in Europe to recommend
teplizumab's use through a...Request free trial
A first-of-its-kind therapy that can delay the onset of type 1 diabetes for up to three years is to be made available on the NHS, NICE has said. Clinical trial evidence reviewed by an independent NICE committee shows that teplizumab can delay the onset of symptomatic type 1 diabetes by an average of nearly three years. Teplizumab is the first disease-modifying therapy for type 1 diabetes and England is the first country in Europe to recommend teplizumab's use through a health technology appraisal. Teplizumab (also known as Tzield and made by Sanofi) has been recommended in final draft guidance issued today (Tuesday 23 June 2026), for children aged 8 and over and adults who have type 1 diabetes in its early, pre-symptomatic stage (stage 2). Teplizumab represents a significant step forward, giving people at high risk of developing symptomatic diabetes the chance to delay its onset. 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, and children and young people in particular can have more time to reach key developmental milestones before that point. NICE estimates that around 1,100 people could be eligible for teplizumab in the first year, decreasing to a steady state of approximately 820 eligible patients annually from year three onwards. Screening for type 1 diabetes autoantibodies is the first step to finding out whether someone is eligible for treatment with teplizumab. In the UK there are currently two screening studies set up to do this. The ELSA study, funded by Diabetes UK and Breakthrough T1D, is screening children aged 2-17 years, and the T1DRA study is screening adults between 18-70 years. Teplizumab will be available to NHS patients in England within 90 days of publication of NICE final guidance. Patients in Wales will be able to access it 60 days from today (Tuesday 23 June 2026). Helen Knight, director of medicines evaluation at NICE, said: This is a genuinely exciting recommendation. For the first time, we have a treatment that can give people diagnosed at an early stage of type 1 diabetes precious extra time before they need to manage the full demands of the condition. "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. "We're pleased to be able to recommend it for NHS use, and we will continue to scan the horizon for further innovations so we can continue to get the best care to patients as quickly as possible." Lucy Common, clinical nursing advisor at NICE, said: Early, pre-symptomatic diagnosis can have a significant impact on individuals and their families. This recommendation matters enormously for patients and their loved ones. 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. Elena Boichak, from Newbury, discovered her son Dima had stage 2 type 1 diabetes after signing him up to the ELSA screening study when he was nine years old. Elena said: "As a mother, the most valuable thing teplizumab has given us is time. Every month and every year that Dima can continue being a child without insulin injections, carb counting and the daily burden of Type 1 diabetes is incredibly precious. This recommendation means that other families across the UK may now have access to that same opportunity. Early screening and access to treatment can change the way families experience this diagnosis and help them feel prepared rather than overwhelmed. Amy Norman, 45, from the West Midlands, was diagnosed with type 1 diabetes at the age of 13. She discovered via the Diabetes UK-funded ELSA study that her 12-year-old daughter, Imogen, is in the early stages of type 1 diabetes and has been able to slow its progression with teplizumab. Amy said: Type 1 diabetes is a lifelong condition that brings real challenges. It affects every aspect of daily life, so any opportunity to delay its onset is valuable. If teplizumab had been available to me before I was diagnosed, I would have taken it hands down. For us, teplizumab has been incredible, and we're so pleased that more children like Imogen will now get the chance to enjoy a normal childhood before facing the realities of type 1 diabetes. Imogen was always going to develop type 1 diabetes, but thanks to research, we've been able to slow down the process and prepare. Being forewarned is being forearmed we know what is coming, but we're not scared." Karen Addington MBE, chief executive of Breakthrough T1D, said: "This is an incredible moment for the type 1 community. For the first time, we have an immunotherapy that can delay the onset of symptomatic type 1 diabetes. If it were your child or someone you love, you would want to do everything possible to give them more years without the daily burden of managing this relentless condition. We now have a treatment that can help make that possible. I feel enormously proud of the years of Breakthrough T1D-funded research that have helped bring us to this point. This breakthrough shows that we can intervene earlier in the condition's process, delay the onset of symptoms, and pave the way for new treatments and even more effective approaches in the future. 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. Teplizumab offers those in the early stages of type 1 diabetes extra years free from the relentless demands of managing the condition with insulin, as well as valuable time to prepare. Detecting type 1 diabetes early, before symptoms appear, is key to unlocking these benefits and our focus now is ensuring fair and equitable access for everyone who is eligible. "We want a future where everyone with early-stage type 1 diabetes can benefit from immunotherapies. Through our long-term investment in world-class research, and partnership with the NHS and industry, we are working to make a national type 1 diabetes screening programme a reality. What is stage 2 type 1 diabetes? 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. 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. Stage 3 is when symptoms appear, blood sugar levels rise significantly, and most people receive their diagnosis, usually requiring lifelong insulin treatment. Common symptoms include increased thirst and frequent uination, unexplained weight loss, fatigue, and increased hunger. Long term complications of type 1 diabetes include: kidney failure, cardiovascular disease, and damage to the nervous system. Until now, no treatments have been available to delay the onset of symptomatic (stage 3), type 1 diabetes. What is an immunotherapy? Immunotherapies are treatments that work with the body's immune system to fight or manage disease. In type 1 diabetes, the immune system mistakenly attacks the insulin-producing cells in the pancreas, eventually destroying them. Teplizumab works by helping to regulate the immune system. It does this by attaching to a protein called CD3, which is found on the surface of the immune cells responsible for this attack. This helps slow the damage to the pancreas and delay the onset of the disease. Clinical evidence The evidence for teplizumab comes from a clinical trial called TN-10, which followed 76 children aged 8 and over and adults who had been diagnosed with stage 2 type 1 diabetes and had a close family member with the condition. Of the 76 participants, 44 received teplizumab and 32 received a placebo. Teplizumab delayed the onset of symptomatic diabetes by approximately 32 months, or nearly three years. How is teplizumab administered? Teplizumab is given through a drip into a vein once a day for 14 days in a row. Each infusion takes at least 30 minutes. The dose starts low and is gradually increased over the first few days of treatment. Once the 14-day course is complete, treatment does not start again. It is a one-time course. Patients will need to visit hospital every day during the treatment period, including at weekends. The NICE committee recognised that this may be difficult for some people, for example because of the cost or practicalities of travelling to hospital each day. The company has agreed a commercial arrangement with NHS England, meaning teplizumab will be available to the NHS at a confidential discounted price. Who can access teplizumab? Because stage 2 T1D has no symptoms, it needs specific tests to identify and diagnose it. There is currently no national programme of testing or screening. Instead, people are likely to find out they have stage 2 type 1 diabetes in one of three ways:
In addition, research studies are continuing to explore screening and care for early stages of type 1 diabetes. The ELSA study (Early Surveillance for Autoimmune diabetes), co-funded by Diabetes UK and Breakthrough T1D, has been researching what childhood screening for type 1 diabetes might look like in the real world. Building on this, a second phase, ELSA 2, has been launched with £1.5 million in funding, expanding screening to all children aged 2 to 17 across the UK and aiming to recruit a further 30,000 children. ELSA 2 will also establish new NHS Early-Stage Type 1 Diabetes Clinics, providing families taking part in the study with clinical and psychological support and creating a clear pathway from screening through to diagnosis, monitoring and treatment. NICE estimates that approximately 1,100 people could be eligible for treatment with teplizumab in the first year, of whom around 555 are expected to take up the offer. This figure is higher than in subsequent years because it includes people already identified through current screening trials who are waiting for a treatment option to become available. From year three, the eligible population is expected to stabilise at around 820 people annually, with approximately 490 expected to take up treatment. ENDS Embargo
About the guidance
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