Lisocabtagene maraleucel can be used as an option for treating relapsed or refractory diffuse large B‑cell lymphoma or primary mediastinal large B‑cell lymphoma after 2 or more lines of systemic treatment in adults. Lisocabtagene maraleucel can only be used if the company provides it according to the commercial arrangement.
Use the least expensive option of the suitable treatments (including lisocabtagene maraleucel and axicabtagene ciloleucel), having discussed the advantages and disadvantages of the available treatments with the person with the condition. Take account of administration costs, dosages, price per dose and commercial arrangements.
Lisocabtagene maraleucel 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. Lisocabtagene maraleucel must be funded in England within 30 days of final publication of this guidance.
There is enough evidence to show that lisocabtagene maraleucel provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
This evaluation is a review of NICE's technology appraisal guidance 987 (TA987).
For this evaluation, the company asked for lisocabtagene maraleucel (liso‑cel) to be considered only for relapsed or refractory diffuse large B‑cell lymphoma or primary mediastinal large B‑cell lymphoma after 2 or more lines of systemic treatment. This does not include everyone who it is licensed for.
Usual treatment at this point in the care pathway is axicabtagene ciloleucel (axi‑cel), which is a chimeric antigen receptor (CAR) T-cell therapy. Liso‑cel is also a CAR-T, so it works in a similar way to axi‑cel and would be offered to the same population.
Evidence from clinical practice in the US suggests people having liso‑cel could have a similar amount of time before their lymphoma gets worse and may live for a similar amount of time as people having axi‑cel.
Liso‑cel has not been directly compared with axi‑cel in a clinical trial. The results of an indirect comparison of 2 separate trials are uncertain because of differences between the trials, specifically:
the use of other treatments given before CAR-T infusion
the trial populations
the number of people in the trials who had the infusions of liso‑cel or axi‑cel
when the trials were done.
Results from the indirect comparison suggest liso‑cel is associated with comparable outcomes to axi‑cel. These results are considered confidential by the company but align with earlier published literature. The indirect comparison also suggests liso‑cel is better tolerated than axi‑cel. So, liso‑cel could be an option for people who are older, frailer or less able to tolerate axi‑cel.
To be recommended as a treatment option, liso‑cel should be likely to provide similar outcomes, and cost less or have similar costs, as axi‑cel (see NICE's manual for technology appraisal and highly specialised technologies guidance). The results of cost-comparison analyses show the costs of liso‑cel are similar to or less than axi‑cel. Because of the uncertainties in the clinical evidence, more analyses were done to explore the impact of changing the assumptions about resource use and costs. These focused on intravenous immunoglobulin use and admission to intensive care units. In all analyses, the costs of liso‑cel are similar to or less than axi‑cel. So, liso‑cel can be used.
For all evidence, see the committee papers. For more information on NICE's evaluation of axi‑cel, see the committee discussion section in NICE's technology appraisal guidance on axi-cel for treating diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after 2 or more systemic therapies.