NICE recommends lisocabtagene maraleucel

This week brings the news that the National Institute for Health and Care Excellence (NICE) has approved a new CAR-T cell therapy called lisocabtagene maraleucel, also known as lisocel, in large B-cell lymphomas. It is recommended for people with the following B-cell lymphomas who have not responded to, or who have relapsed within 12 months, of first line chemotherapy and would be fit enough for a stem cell transplant:

•    diffuse large B-cell lymphoma (DLBCL)
•    high-grade B-cell lymphoma
•    primary mediastinal large B-cell lymphoma
•    follicular lymphoma grade 3B.

CAR-T cell therapy uses cells from your own immune system to fight the lymphoma. White blood cells called T-cells are collected and sent to the lab. Here they are changed so that they can recognise and stick to lymphoma cells. These changed cells are called CAR-T cells. They are then given back to you, like a blood transfusion, so that they can attack and kill the lymphoma cells.

There are already some CAR-T cell therapies available for people with relapsed or refractory high-grade B-cell lymphomas but the addition of lisocel gives clinicians another option. It is also found to be well tolerated with fewer side effects as explained by Professor Chris Fox, who was one of the clinical experts involved:

I enthusiastically welcome the NICE recommendation of Lisocabtagene maraleucel for treating relapsed or refractory large B-cell lymphomas. This is a very effective treatment now available for patients in England whose DLBCL has returned within 12 months of completing first-line chemoimmunotherapy, who would previously have been treated with high-dose chemotherapy. This novel CD19 CAR T cell therapy delivers high rates of complete remission and offers patients improved chances of long-term survival. Importantly, Liso-cel is better tolerated by patients, with lower rates of serious side-effects than currently existing treatments. No doubt this news will be warmly welcomed by patients and their Haematologists.

Professor Chris Fox, Consultant Haematologist

The decision by NICE to approve lisocel was made after they conducted a health technology assessment (HTA). A HTA is where an independent organisation such as NICE, who make decisions for England, or the Scottish Medical Council (SMC) who make decisions in Scotland, collects and assesses evidence to decide whether a treatment should be made available. Wales and Northern Ireland often also adopt the NICE decision.

Lymphoma Action is proud to have been a part of this HTA, and all those relating to lymphoma. We were invited to submit a document giving the patient’s perspective, explaining why the additional option of lisocel for patients with large B-cell lymphomas was so important. We achieved this by reaching out to our community on our closed Facebook group to answer some questions for us. We are always so grateful for the response we get, allowing us to make a compelling case to NICE.

Our evidence, along with that from clinical experts, economists and the drug company was carefully reviewed at a committee meeting. Unfortunately, the initial decision was negative but in accordance with the NICE process the evidence was reviewed again. We made it clear that we felt that the importance of having multiple treatment options, especially those with fewer side effects, had not been fully considered. Thankfully the decision was changed and lisocel was approved.

This is the first decision from NICE involving a lymphoma treatment to be made in 2025. The fantastic positive result follows a very successful 2024 where, out of a number of HTAs which Lymphoma Action were involved in, four NICE and five SMC HTAs had positive outcomes. That means there are multiple new treatments available for lymphoma patients in all nations of the UK. Look out for an article in the summer edition of our Lymphoma Matters magazine for more information about the HTA process.