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The content on this page is not current guidance and is only for the purposes of the consultation process.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 Autologous anti-CD19-transduced CD3+ cell treatment is not recommended, within its anticipated marketing authorisation, for relapsed or refractory B‑cell acute lymphoblastic leukaemia in people 26 years and over.

1.2 This recommendation is not intended to affect treatment with autologous anti-CD19-transduced CD3+ cells 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 clinician consider it appropriate to stop.

Why the committee made these recommendations

Standard treatment for B‑cell acute lymphoblastic leukaemia includes inotuzumab, blinatumomab, and ponatinib. This can be followed by allogeneic stem cell transplant for some people. Autologous anti-CD19-transduced CD3+ cells would be offered as an additional treatment option.

Evidence from a study of autologous anti-CD19-transduced CD3+ cells does not compare the treatment with anything else. It suggests that people having it may live longer and have more time before their disease relapses, but this is uncertain. There is also not enough evidence to tell if this treatment can cure B‑cell acute lymphoblastic leukaemia.

The most likely estimates are higher than what NICE normally considers an acceptable use of NHS resources and these results are uncertain. So, autologous anti-CD19-transduced CD3+ cells cannot be recommended for routine use.

The cost-effectiveness estimates are higher than what is normally considered an acceptable use of NHS resources. So autologous anti-CD19-transduced CD3+ cells cannot be recommended within its anticipated marketing authorisation for use in the Cancer Drugs Fund.