“CAR-T cell therapy is one of the most promising new treatments in a generation for lymphoma and leukaemia, and NHS patients will now be among the first in the world to benefit.”
– Simon Stevens, Chief Executive of NHS England (05 Oct 2018)
The announcement comes only a month after NHSE announced that it would be funding rival CAR-T Kymriah in patients up to 25 years of age with B cell acute lymphoblastic leukaemia (ALL), and represents the second CAR-T to be available on the NHS.
The announcement indicates that provision of the drug has been agreed with National Institute for Health and Care Excellence (NICE), and will be available via the Cancer Drugs Fund (CDF), which is managed by NICE. NICE have yet to make any comment on the matter.
Cautionary MAP InsightsThis announcement is unexpected for a couple of reasons. First, it preempts a formal recommendation of the drug by NICE – this is very unusual but not unprecedented, as NHSE did the same with Kymriah for ALL last month. Second, in the Kymriah case NICE had not released any drafts indicative of its decision when NHSE made its announcement, and it is yet to be seen how they will report. However in this case NICE had already released an appraisal consultation document (ACD) not recommending the drug, so it is surprising that NHSE have made this announcement without waiting for clarification from NICE.
The primary market access challenge for CAR-Ts is their high development and preparation costs, plus the fact that costs are up-front for these potentially curative therapies. The report from NHSE indicates that it and the company have reached a confidential agreement for reimbursement for the drug. This is likely to constitute a Patient Access Scheme.
Cautionary MAP InsightsThe diffuse large B-cell lymphoma (DLBCL) indication (one of two B-cell lymphoma types Yescarta is licensed in) is particularly interesting as rival Kymriah is also undergoing NICE appraisal and has also not been recommended at the draft stage (ACD).