NHS England (NHSE) have reached an agreement to reimburse Novartis’s CAR-T therapy Kymriah (tisagenlecleucel) for patients up to 25 years of age with B cell acute lymphoblastic leukaemia, which will be first time a CAR-T therapy has been routinely available on the NHS.
The decision comes a week after NICE rejected Gilead and Kite Pharma’s Yescarta on cost grounds.
NICE have yet to publish draft guidance on Kymriah, but announcing the deal at Health Innovation Expo in Manchester, Simon Stevens, chief executive of NHS England, said:
“CAR-T therapy is a true game changer, and NHS cancer patients are now going to be amongst the first in the world to benefit. Today’s approval is proof-positive that, in our 70th year, the NHS is leading from the front on innovative new treatments. This constructive fast-track negotiation also shows how responsible and flexible life sciences companies can succeed – in partnership with the NHS – to make revolutionary treatments available to patients.”
The drug has a list price of £282,000 and is one of the fastest funding approvals in the history of the NHS.
MAP are surprised by the timing of NHSE’s announcement, as NHSE have chosen to declare their willingness to pay for treating patients with the drug before the publication of the NICE appraisal consultation document (ACD). NICE have not yet published any preliminary recommendations following the first committee meeting for the product, which took place at the end of August. Under the usual NICE process, NICE would be expected to publish their ACD in 2 weeks’ time indicating whether or not the product is suitable for the Cancer Drugs Fund (CDF) and their perspective on the cost-effectiveness. However, Novartis appear to have made good use of the new NICE/NHSE CDF process in which early engagement around commercial agreements between the company and NHS England are possible.
Positive MAP Insights
This story highlights the importance of engaging with NICE and NHSE early in the appraisal process, and being willing to offer commercial deals that mitigate perceived risks early in the process, before NICE have discussed the product. Other examples of early positive decisions can be found in HTAs where companies proactively raise the Cancer Drugs Fund, speeding up what otherwise could be a difficult conversation.