The National Institute for Health and Care Excellence (NICE) today issued its final draft guidance for the therapy: recommending the Kite treatment be made routinely available on the state-funded health service for suitable patients.
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.
UK data helps NICE recommendation
The chimeric antigen receptor T-cell therapy – which takes a patient’s own immune cells and modifies them to kill cancer cells – is administered as a one-off intravenous infusion.
The therapy has been available in the country on a limited basis through the Cancer Drugs Fund (CDF), which gives patients early access to new treatments while further evidence is collected.
Now, the NHS Commercial Medicines Directorate has struck a deal with Gilead to make the drug available for routine use.
Via the CDF, 318 people received treatment between December 2018 and October 2021 in England. Overall survival rates in the CDF, with data collected over 36 months, showed the median overall survival of people having axicabtagene ciloleucel was 28.5 months and 45% of people were alive after three years.
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
In contrast, Gilead estimates that the median overall survival on best supportive care, which is salvage chemotherapy, is around 6.4 months.
In England every year, around 5,500 people are diagnosed with DLBCL: which progresses quickly and is the most common type of high-grade non-Hodgkin lymphoma. According to Gilead’s estimates, just over 450 people in England will be eligible to receive the treatment under the new recommendations.
“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,” notes the institute as it announced its recommendations this morning. “It suggests that people having axicabtagene ciloleucel live longer than people having chemotherapy and have longer before their condition gets worse.”
Details of the NHS deal and commercial discount have not been disclosed (The list price for axicabtagene ciloleucel is £280,451 ($347,577) per 68-ml single infusion bag).
Hopes for second line therapy
Blood Cancer UK’s Chief Executive, Helen Rowntree, welcomed today's announcement.
“New CAR-T therapies offer hope to people who are often living with the most aggressive forms of blood cancer," she said.
"For people living with diffuse large B-cell lymphoma – a form of blood cancer - the risk of recurrence and uncertainty about which treatment options will be available to them can add distress at an already very difficult time.
"We’re pleased that the first personalized immunotherapy routinely available through the NHS in England can be a viable option for certain blood cancer patients in the long term. It gives people who find themselves in this position more clarity about their treatment options.
"However, we’re still awaiting to see whether this drug will be accepted for use as a second line therapy for people with blood cancer and will be working with policymakers to make this possible.
“This decision also demonstrates the benefit of the NHS England’s Cancer Drugs Fund, which led to many accessing this drug in the period of time when NICE was gathering evidence and deliberating on its cost-effectiveness."
In the UK, there are two other types of CAR-T therapy available, via the Cancer Drugs Fund and other patient access schemes. These are Novartis' Kymriah (tisagenlecleucel) and Kite/Gilead's Tecartus (brexucabtagene autoleucel).