National Institute for Health and Clinical Excellence (NICE)
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More than 400 people set to benefit after NICE approves ground-breaking CAR-T therapy to treat aggressive form of blood cancer

Hundreds of people set to benefit after NICE recommends first personalised immunotherapy for lymphoma

Hundreds of people with an aggressive form of lymphoma are set to benefit from the first personalised immunotherapy treatment to be recommended for routine use in the NHS.

Axicabtagene ciloleucel (Yescarta, Kite) is a CAR-T therapy for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who have had two or more lines of systemic therapy.

CAR-T – chimeric antigen receptor T-cell – therapy takes a patient’s own immune cells and modifies them so that they attach to and kill cancer cells. It is administered as a one-off intravenous infusion.

NICE has today (Thursday, 26 January) issued final draft guidance recommending the treatment be made routinely available on the NHS for suitable patients. It was previously available through the Cancer Drugs Fund and will commissioned routinely to patients in England after the NHS Commercial Medicines Directorate struck a confidential commercial deal with the company.

NICE’s independent appraisal committee considered new evidence, including data from a clinical trial and from people having axicabtagene ciloleucel through the Cancer Drugs Fund (CDF) before making the recommendation. It suggests that people having axicabtagene ciloleucel live longer than people having chemotherapy and have longer before their condition gets worse.

A total of 318 people received treatment through the CDF between December 2018 and October 2021 in England. Overall survival rates in the CDF, with data collected over 36 months, show the median overall survival of people having axicabtagene ciloleucel was 28.5 months and 45% of people were alive after three years.

The company estimates that the median overall survival on best supportive care, which is salvage chemotherapy, is around 6.4 months.

There is currently no standard treatment for relapsed or refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma after two or more systemic therapies. Best supportive care usually includes salvage chemotherapy, which is given after the cancer has not responded to other treatments.

Around 5,500 people are diagnosed with DLBCL each year in England. It is an aggressive disease which progresses quickly and is the most common type of high-grade non-Hodgkin lymphoma (NHL). It can develop at any age, but most people diagnosed with DLBCL are 65 or over.

This positive recommendation shows the benefits of NICE and NHS England’s approach to entering promising treatments into the CDF through managed access agreements so that further vital data can be gathered ahead of a full evaluation for routine use in the NHS.

The company estimates that just over 450 people in England will be eligible to receive this new treatment.

Helen Knight, director of medicines evaluation, at NICE, said: “I am delighted that we have been able to recommend this pioneering treatment for people. The evidence from its use in the CDF and clinical trials shows it can offer an effective treatment, helping people live longer and with a better quality of life.

“This news illustrates how NICE is determined to get the best care to patients fast, while ensuring value for money for the taxpayer.”

NHS England’s Director of Specialised Commissioning and interim Commercial Medicines Director, John Stewart said: “Five years ago the NHS led the way in Europe by striking commercial deals for revolutionary CAR-T cancer treatment and today we have used our commercial capabilities to reach a deal that secures long-term patient access to this personalised therapy.

“This advanced therapy has been commissioned through the Cancer Drugs Fund since 2018, allowing evidence to be collected that confirms its benefits for patients facing this aggressive form of lymphoma and now enables the NHS to provide routine access at a fair price for taxpayers."

You can read the full draft guidance on axicabtagene ciloleucel for treating diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after two or more systemic therapies on the NICE website.

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