CAR-T therapy Yescarta get EU green light but meets resistance from NICE


Yescarta® (axicabtagene ciloleucel), a novel personalized CAR T cell therapy has been approved for use in Europe by the European Medicines Agency (EMA) but has received a draft negative guidance from NICE.

Yescarta provides a new treatment option for patients with aggressive forms of non-Hodgkin lymphoma (NHL), including relapsed or refractory diffuse large B-Cell lymphoma and primary mediastinal large B-cell lymphoma, after two or more lines of systemic therapy.

The approval of Yescarta was supported by data from the ZUMA-1 trial in adults with refractory aggressive NHL. In the study, 72% of patients who received a single infusion of Yescarta responded to therapy, with 51% achieving a complete response at a median follow-up of 15.1 months. At 1 year following infusion, 60% of patients were alive and the median overall survival had not been reached.

NICE has agreed that patients had good response rates and there was an unmet need, it said it hadn’t been given enough evidence of benefit compared with other types of treatment, and the initial cost presented to them was much too high. They have therefore issued a draft decision not to recommend CAR T cell therapy for two types of non-Hodgkin lymphoma.

Yescarta was approved in the US last year for certain patients with large B-cell lymphoma, with Gilead pricing the therapy at $373 000.

The NICE committee concluded the cost-effectiveness estimates for axicabtagene ciloleucel compared with salvage chemotherapy (the treatment currently used for people whose disease has returned or not improved after 2 or more courses of chemotherapy) were above £50,000 per year of quality adjusted life (QALY) gained, the upper limit of the specially extended range of cost-effectiveness for cancer treatments.
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As this is a draft decision, Gilead will get another chance at a later date to present data to NICE on clinical and cost-effectiveness.

Commenting on the decision, Raj Chopra, Head of Cancer Therapeutics at The Institute of Cancer Research (London, UK) stated: “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.

“CAR T cell therapy uses a patient’s own genetically modified immune cells to target their cancer. The technique is complex and expensive, but it is also a major advance in cancer treatment that has cured some patients who would otherwise have died.

“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.”

“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,” Meindert Boysen, director of the centre for health technology evaluation at NICE stated.

Sources: www.businesswire.com/news/home/20180827005248/en/Yescarta®-Axicabtagene-Ciloleucel-Receives-European-Marketing-Authorization; www.icr.ac.uk/news-archive/icr-responds-to-nice-decision-about-car-t-immunotherapy-for-non-hodgkin-lymphoma; www.nice.org.uk/news/article/feedback-encouraged-to-allow-use-of-life-extending-treatment-on-nhs-for-those-with-blood-cancer