UK regulators propose to reject the treatment tisagenlecleucel-T as a treatment for adults with B-cell lymphoma because it is too expensive, it has been announced.
The National Institute for Health and Care Excellence (NICE) says it would welcome further discussions with the treatment’s manufacturer Novartis.
The guidance applies to treatment of patients who have relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. There were around 11,690 new cases of non-Hodgkin lymphoma (NHL) in England in 2015, with 4,688 of these being for diffuse large B-cell lymphoma.
Although the treatment showed significant clinical benefits, there is no data comparing tisagenlecleucel-T with salvage chemotherapy, NICE said.
This, it says in draft guidance published 19th September, makes it difficult to determine the exact benefits of tisagenlecleucel-T, also known as Kymriah.
Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, says: “We have seen promising results for CAR-T therapies in early trials and believe there is great potential for tisagenlecleucel-T to help people who have not responded to other forms of therapy.
“Although we could not recommend tisagenlecleucel-T for adults with lymphoma, we welcome further discussions around the cost-effectiveness of the treatment and engagement with stakeholders.”
The developers, Novartis, had offered a confidential discount on the list price of £282,000 but the cost-effectiveness estimates were still above the range that NICE considers an acceptable use of NHS resources, NICE said.
Tisagenlecleucel-T is part of a new line of therapies which are specifically designed for each individual patient. It involves taking a patient’s white blood cells and reengineering them so they can recognise and attack cancer cells.
The committee will consider comments received on the draft guidance, together with any new evidence, at the next meeting on 23rd October.
The announcement follows a separate draft decision in August 2018 by NICE to not recommend the use of the CAR-T cell therapy Yescarta for diffuse large B-cell lymphoma and primary mediastinal B-cell lymphoma.
However, NICE has also considered tisagenlecleucel-T (Kymriah) for children who have leukaemia and agreement was reached to recommend its use within the Cancer Drugs Fund.
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