Scottish Medicines Consortium rejects YESCARTA®

image of a hand holding a gavel about to hit it to show CMA welcomes EU Court ruling in pay-for-delay drug case

The Scottish Medicines Consortium (SMC) has issued a negative decision on YESCARTA® (axicabtagene ciloleucel).

Patients in Scotland, with certain aggressive forms of blood cancer who have potentially exhausted all treatment options, will be unable to access this technology through the NHS in Scotland.

YESCARTA is a new type of personalised cell therapy, manufactured by Kite, a Gilead company, which re-engineers a patient’s own immune cells to fight cancer. CAR-T therapies such as this harness the immune system to detect and destroy cancer cells, through a new process in which a patient’s blood is collected, re-engineered in a lab, and then returned to their body in a single infusion.

It 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. In many cases, these patients have run out of treatment options and are unlikely to survive the next six months.

In August last year, the European Commission granted Marketing Authorisation for YESCARTA for use on the EU, Norway, Iceland and Liechtenstein. The National Institute for Health and Care Excellence (NICE) issued a positive final decision on YESCARTA for use in NHS England in December 2018, making it available to NHS patients in England and Wales.

Reacting to the Scottish Medicines Consortium’s decision on Yescarta® (axicabtagene ciloleucel), Hilary Hutton-Squire, General Manager, Gilead Sciences UK & Ireland, said:

“YESCARTA® (axicabtagene ciloleucel) is a pioneering personalised cell therapy that provides a potential lifeline to adult patients with certain aggressive forms of blood cancer who, in most cases, have run out of treatment options and may only have months to live.

“As they did for Acute Lymphoblastic Leukaemia (ALL) for children, we hope that SMC will maintain their efforts to give access to CAR-T therapies in Scotland for adult patients with Diffuse Large B-Cell Lymphoma (DLBCL). Gilead remains truly committed to working with the SMC to make Yescarta available to eligible patients in Scotland as we have for patients in England and Wales.”