1 Recommendations

1 Recommendations

1.1 Treatment with autologous anti-CD19-transduced CD3+ cells is recommended for use within the Cancer Drugs Fund as an option for relapsed or refractory mantle cell lymphoma in adults who have previously had a Bruton's tyrosine kinase (BTK) inhibitor. It is only recommended if the conditions in the managed access agreement for autologous anti‑CD19‑transduced CD3+ cells treatment are followed.

1.2 This recommendation is not intended to affect either treatment in preparation for or 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 until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

There is no standard treatment for relapsed or refractory mantle cell lymphoma after a BTK inhibitor. Rituximab, bendamustine and cytarabine (R‑BAC) is the most common treatment option. Autologous anti‑CD19-transduced CD3+ cells are a chimeric antigen receptor (CAR) T‑cell therapy. The therapy uses the patient's own T cells, which have been modified to attach to and kill cancer cells.

Evidence from a study of autologous anti-CD19-transduced CD3+ cells, which does not compare the therapy with anything else, suggests that people having it may live for longer and have more time before their disease relapses. However, the evidence is not certain because of the:

  • short follow up

  • small number of patients

  • uncertainty around how long people actually live

  • lack of evidence comparing autologous anti-CD19-transduced CD3+ cells directly with the most common alternative treatment.

There is also not enough evidence to tell if people having treatment with autologous anti-CD19-transduced CD3+ cells can be cured.

Autologous anti-CD19-transduced CD3+ cells meet NICE's criteria to be considered a life-extending treatment at the end of life. This is because people having it are likely to live for less than 24 months, and this treatment could extend their life by at least 3 months. The most likely cost‑effectiveness estimates for autologous anti‑CD19‑transduced CD3+ cells compared with the most common alternative treatment are not known because the final survival data for autologous anti‑CD19‑transduced CD3+ cells are not yet available. However, early estimates suggest it could be cost effective, and collecting further data on progression-free survival, overall survival and age when treatment starts will reduce the uncertainty in the evidence. Therefore, autologous anti-CD19-transduced CD3+ cells are recommended for use as an option within the Cancer Drugs Fund.

  • National Institute for Health and Care Excellence (NICE)