NHS funding for Gilead’s freshly approved CAR-T therapy Yescarta has been turned down in draft guidelines by the National Institute for Health and Care Excellence.

The drug as just won EU approval having been shown to be clinically effective in treating diffuse large B-cell lymphoma and primary mediastinal B-cell lymphoma in people who have had two or more systemic therapies.

Along with Novartis’ Kymriah (tisagenlecleucel), it is the first CAR-T therapy – a process by which T cells are drawn from a patient's blood and reprogrammed in the lab to create T cells that are genetically coded to hunt the patient's cancer cells -to be cleared for use in the region.

However, in draft guidelines, NICE said there is no direct data to compare Yescarta (axicabtagene ciloleucel) with the current standard treatment - salvage chemotherapy, which mean the exact size of the benefit the therapy would offer patients is unknown.

Also, while NICE’s independent appraisal committee recognised that Yescarta “represents a step-change in treatment”, it also stressed that its potential associated side effects “will need careful management”.

The committee concluded that cost-effectiveness estimates for Yescarta compared with salvage chemotherapy were above £50,000 per year of quality adjusted life (QALY) gained, the upper limit of the specially extended range of cost effectives for cancer treatments, which means that the cost is “too high for it to be considered a cost-effective use of NHS resources”.

Also, the committee concluded that Yescarta “does not have the plausible potential to be cost effective,” at this stage, which would be necessary for it to be considered for conditional funding available in the Cancer Drugs Fund.

“Although promising, there is still much more we need to know about CAR-T, and unfortunately, in this case, we are not able to recommend axicabtagene ciloleucel for use in the NHS in England at the cost per patient set by Kite Pharma,” said Meindert Boysen, director of the centre for health technology evaluation at NICE.

“It’s disappointing that patients with non-Hodgkin lymphoma who have exhausted all other treatment options will not be able to access CAR-T cell therapy – a brand new type of treatment for blood cancers," said Professor Raj Chopra, head of Cancer Therapeutics at The Institute of Cancer Research, London.

“If we’re going to see CAR T therapy widely available on the NHS, we need to find ways to reduce the costs. I hope NICE and the manufacturer will be able to work together both to bring the costs of treatment down and continue to build a stronger evidence base for it, so it can be made available to NHS patients as quickly as possible.”