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Novartis’ CAR-T Kymriah scores SMC approval

Will now be available on NHS across the UK


Novartis’ Kymriah (tisagenlecleucel) has received routine reimbursement for all eligible UK patients on the NHS, following appraisal from the Scottish Medicines Consortium. 

The SMC approved the CAR-T therapy for use in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), who have not responded to two or more prior treatments.

The medicine went through the SMC’s Patient and Clinician Engagement (PACE) process, which considers medicines that treat end of life and rare conditions. The process involves a meeting with patient groups and clinicians – the PACE meeting for Kymriah highlighted the poor prognosis of patients with this condition and the current limited treatment options.

“From the testimonies given by patient groups and clinicians through our PACE process, we know that treatment for diffuse B cell lymphoma at this stage of the condition impacts heavily on both patients and their carers,” said Alan MacDonald, chairman of the SMC.

“We hope that our decision on tisagenlecleucel, as a potentially curative medicine, will be welcomed,” he added

The drug picked up EU approval for Kymriah last August, with Novartis quickly setting up a new manufacturing facility following production issues. The Swiss pharma then struck a deal with NHS England, which came just ten days after the European approval.

NICE initially recommended the drug for use within the Cancer Drugs Fund for the treatment of relapsed or refractory B-cell acute lymphoblastic leukaemic (ALL) in patients up to age 25. Following this recommendation, the cost-effectiveness watchdog then recommended Kymriah for adults with relapsed or refractory DLBCL, in the same patient population included in the SMC appraisal.

The cost of Kymriah is £282,000 per patient at full list price, but the level of discount offered to the NHS has not been disclosed. Novartis’ CAR-T rival from Gilead, Yescarta, has a UK list price of nearly £300,000 per patient.

Gilead faced an initial hurdle when initially NICE rejected the use of its CAR-T therapy, but later reached an agreement with NHS England for use in the treatment of DLBCL. There is no doubt that both companies had to make some major concessions on price, although the exact financial details of these deals remains confidential.

Article by
Lucy Parsons

10th September 2019

From: Regulatory



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