Immunotherapy to delay type 1 diabetes onset approved by NICE
A treatment that can delay the onset of type 1 diabetes for up to three years has been approved by NICE.
England is the first country in Europe to recommend disease-modifying therapy teplizumab’s use through a health technology appraisal.
It will be made available for children aged eight and over and adults who have type 1 diabetes in its early, pre-symptomatic stage.
NICE has estimated around 1,100 people could be eligible for teplizumab in the first year with 820 eligible patients being put on the treatment annually after that.
It is thought to be particularly beneficial to delay the onset of type 1 diabetes in children and young people who will have the chance to reach key developmental milestones before having to take on the demands of lifelong diabetes management.
To be eligible patients will need to be screened for type 1 diabetes autoantibodies.
There is currently no national programme of testing or screening, but two large UK studies are exploring 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.
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.
It will also establish new NHS Early-Stage Type 1 Diabetes Clinics, providing families with clinical and psychological support and setting up a pathway from screening through to diagnosis, monitoring and treatment.
Some individuals may have a test for early-stage type 1 diabetes because they have an increased risk, such as a family history.
Teplizumab is a one-off course of treatment given as a daily infusion over a 14-day block with a gradually increased dose.
Helen Knight, director of medicines evaluation at NICE, said: ‘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.’
Lucy Common, clinical nursing advisor at NICE, said early, pre-symptomatic diagnosis can have a significant impact on individuals and their families.
‘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.’
Karen Addington, chief executive of Breakthrough T1D, said the approval of teplizumab was an incredible moment for the type 1 community.
‘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.’
Dr Elizabeth Robertson, director of research and clinical at Diabetes UK, added for the first time in 100 years, we are moving beyond insulin.
‘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.
‘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.’
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