NICE rejects Novartis' CAR-T in adult lymphoma

NICE has said Novartis’ CAR-T therapy Kymriah cannot be funded by the NHS in adults with an aggressive form of lymphoma, calling for further discussions to get the drug on to the market.

The cost-effectiveness body has recently green-lighted Cancer Drugs Fund reimbursement for Kymriah (tisagenlecleucel) in its other approved use in children and young adults aged up to 25 with refractory acute lymphoblastic leukaemia (ALL), in relapse post transplant or in second or later relapse.

But draft guidance applying to England and Wales recommends against using Kymriah for adults who have relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

A single course of Kymriah costs £282,000 at list price, although Novartis has offered to supply the drug at a confidential discount to the NHS.

NICE added that Kymriah is also ineligible for use within the Cancer Drugs Fund, which provides interim reimbursement if the cost-effectiveness body feels pending clinical trial evidence could help with its calculations.

Although NICE said Kymriah showed significant clinical benefits for adults with lymphoma, there is no data comparing it to salvage chemotherapy, the most common treatment currently used.

NICE’s independent review committee also noted the degree of side effects a person may experience from Kymriah and the need for extensive monitoring by trained specialists.

CAR-Ts involve harvesting a patient’s own T-cells, genetically modifying them to attack cancer, and then injecting them back into the patient – and are considered to be the first truly personalised cancer therapies.

NICE’s committee will consider the comments received on the draft guidance, together with any new evidence, at the next meeting on 23 October 2018, before publishing a second draft.

Last month NICE rejected Gilead’s rival CAR-T, Yescarta (axicabtagene ciloleucel), in DLBCL after two or more therapies.

Both therapies were granted marketing authorisations by the European Commission last month.

Meindert Boysen

Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: “We have seen promising results for CAR-T therapies in early trials and believe there is great potential for tisagenlecleucel to help people who have not responded to other forms of therapy.

“Although we could not recommend tisagenlecleucel for adults with lymphoma, we welcome further discussions around the cost-effectiveness of the treatment and engagement with stakeholders.”