Resource impact statement
NICE has recommended tisagenlecleucel within its marketing authorisation as an option for people 25 years and under for treating B‑cell acute lymphoblastic leukaemia that is:
- relapsed after a transplant, or
- relapsed for a second or later time, or
- refractory.
It is only recommended if the company provides it according to the commercial arrangement.
It is estimated that less than 100 children and young people in England are eligible for treatment with tisagenlecleucel.
Tisagenlecleucel is a chimeric antigen receptor (CAR) T‑cell therapy that has been available in the NHS since 2018 through the Cancer Drugs Fund. As a result, there is unlikely to be a substantial shift in treatment as a result of this guidance.
Adverse events were reported for the pooled dataset and showed that 51% of people experienced hypogammaglobulinaemia and 81% of people experienced cytokine release syndrome. The clinical expert explained that they would expect most young people who have a tisagenlecleucel infusion to experience hypogammaglobulinaemia, and around 85% to have intravenous immunoglobulin (IVIg) treatment as some point in the future.
This report is supported by a local resource impact template because tisagenlecleucel has a discount that is commercial in confidence. For enquiries about the patient access scheme, contact the company. Users can enter the discounted price into the resource impact template to calculate the potential resource impact.
This technology for people with acute lymphoblastic leukaemia is commissioned by NHS England. Providers are NHS hospital trusts.
The payment mechanism for the technology is determined by the responsible commissioner and depends on the technology being classified as high cost.
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