NICE approves teplizumab for some NHS patients in England and Wales

The National Institute for Health and Care Excellence approved teplizumab on Tuesday for NHS patients in England and Wales who have stage 2 type 1 diabetes. The drug, manufactured by Sanofi and marketed as Tzield, can delay the onset of symptomatic disease by up to three years. Teplizumab is given as a daily intravenous infusion lasting about 30 minutes for 14 consecutive days.

No further treatment is required after the course ends. The approval covers adults and children aged eight and older. NICE estimates 1,100 adults and children could be eligible in the first year. After the initial backlog clears, the figure falls to about 820 patients per year.

Sanofi reached a commercial agreement with NHS England that sets a confidential discounted price below the published £150,000 per course. Dr Elizabeth Robertson, director of research at Diabetes UK, said the decision 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," she said.

Karen Addington, chief executive of Breakthrough T1D, called the approval an incredible moment. Helen Knight, NICE's director of medicines evaluation, said the recommendation followed a rigorous assessment that balanced clinical benefits against value for taxpayers. The guidance does not automatically apply in Northern Ireland.

The Scottish Medicines Consortium expects to issue advice on teplizumab in early 2027. Routine NHS testing for early-stage type 1 diabetes is not yet available, so patients must first show immune attack on the pancreas through a blood test. Dima Boichak from Newbury in Berkshire received the drug on compassionate grounds at age nine after a UK-wide research study identified his risk.