Teplizumab (Tzield)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Tzield not be reimbursed by public drug plans to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years or older with stage 2 T1D.
• Evidence from 1 clinical trial demonstrated that Tzield delayed the time of progression to stage 3 T1D by approximately 2 years, compared to placebo, in adults or children aged 8 years or older with a diagnosis of stage 2 T1D. While this delay could mean extra time without insulin and fewer lifestyle burdens, it’s unclear if it leads to long-term health benefits, such as reducing risk of macrovascular and microvascular complications in stage 3 T1D. Short-term safety data show that Tzield can cause side effects, including serious ones, and there is no information on long-term safety or its impact on quality of life.
• Patient groups emphasized the potential value in delaying stage 3 T1D, and indicated that there is a need for treatments that reduce complications and improve health-related quality of life (HRQoL). The Canadian Drug Expert Committee (CDEC) acknowledged that delaying stage 3 T1D could mean extra time without insulin and with fewer lifestyle burdens. However, CDEC noted that the evidence does not show whether the delay improves outcomes like reducing insulin burden, lowering complications, or helping with education and psychological adjustment. Overall, it remains uncertain whether the potential benefits outweigh the risks and unknowns.