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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    1 Recommendations

    1.1

    Teplizumab should not be used for delaying the onset of stage 3 type 1 diabetes in people 8 years and over with stage 2 type 1 diabetes.

    1.2

    This recommendation is not intended to affect treatment with teplizumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop. For children or young people, this decision should be made jointly by the healthcare professional, the child or young person, and their parents or carers.

    What this means in practice

    Teplizumab is not required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

    This is because there is not enough evidence to determine whether teplizumab is value for money in this population.

    Why the committee made these recommendations

    There is no treatment available for delaying the onset of stage 3 type 1 diabetes in people 8 years and older with stage 2 type 1 diabetes.

    For most people, type 1 diabetes is diagnosed at stage 3. But it may be diagnosed at stage 2. Usual treatment for stage 2 type 1 diabetes includes blood glucose monitoring, education and psychosocial support.

    Clinical trial evidence shows that, compared with placebo, teplizumab delays progression to stage 3 type 1 diabetes.

    But there are uncertainties in the economic model about the:

    • population eligible for teplizumab

    • costs of managing stage 3 type 1 diabetes

    • effects of stage 3 type 1 diabetes on quality of life.

    Because of the uncertainties in the economic model, it is not possible to determine the most likely cost-effectiveness estimates for teplizumab.

    So, teplizumab should not be used.