Obecabtagene autoleucel (obe‑cel) can be used as an option to treat relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia in people aged 26 years and over. Obe‑cel can only be used if the company provides it according to the commercial arrangement.
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 must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Obe‑cel must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that obe‑cel provides benefits and value for money, so it can be used routinely across the NHS in this population.
Usual treatment for relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia is blinatumomab, inotuzumab ozogamicin or ponatinib. These can be followed by an allogeneic stem-cell transplant for some people. People 25 years and under can have tisagenlecleucel. Obe‑cel would be another treatment option.
The results of comparisons of obe‑cel with other treatments are uncertain. But they suggest that people who have obe‑cel live longer than people who have blinatumomab, inotuzumab ozogamicin or ponatinib. They also suggest that obe‑cel works about as well as tisagenlecleucel.
Compared with tisagenlecleucel, which is usually offered to people aged 18 to 25 years, the most likely cost-effectiveness estimates for obe‑cel are above the range NICE considers an acceptable use of NHS resources. So obe‑cel is not recommended for people aged 18 to 25 years.
For people 26 years and over, when considering the condition's severity and its effect on quality and length of life, the most likely cost-effectiveness estimates for obe‑cel are within the range that NICE considers an acceptable use of NHS resources. So obe‑cel is recommended for people aged 26 years and over.