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Obecabtagene autoleucel for treating relapsed or refractory B-cell acute lymphoblastic leukaemia [ID6347]

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1 Recommendations

1.1

Obecabtagene autoleucel (obe‑cel) should not be used to treat relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia in adults.

1.2

This recommendation is not intended to affect treatment with obe‑cel 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.

What this means in practice

Obe‑cel is not required to be funded in the NHS in England to treat relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia in adults. It should not be used routinely in the NHS in England.

This is because there is not enough evidence to determine whether obe‑cel offers value for money in this population.

Why the committee made these recommendations

Usual treatment for relapsed or refractory B‑cell or B-cell precursor acute lymphoblastic leukaemia is ponatinib, inotuzumab ozogamicin, blinatumomab or tisagenlecleucel. This can be followed by an allogeneic stem cell transplant for some people. Obe‑cel would be another treatment option.

There is no clinical trial evidence directly comparing obe‑cel with any of the usual treatments. Indirect comparisons suggest that people who have obe‑cel live longer than people who have ponatinib, inotuzumab ozogamicin or blinatumomab. But the evidence for this is highly uncertain. There has been no indirect comparison with tisagenlecleucel.

There are also important uncertainties in the economic evidence. These are caused by the assumptions used in the economic model. Because of the uncertainties in the clinical evidence and the economic model, it is not possible to determine the most likely cost-effectiveness estimates for obe‑cel. So, it should not be used.