Gilead Sciences has one-upped Novartis in England’s CAR-T market. The drugmaker reached a deal with NHS England on Yescarta, beating rival Kymriah to become the first CAR-T therapy available to adult blood cancer patients on England’s public health system, albeit via the Cancer Drugs Fund.
The National Institute for Health and Care Excellence (NICE) had in August rejected Yescarta because its price didn’t meet the agency’s cost-effectiveness metrics. But now, NICE has come around to back its use under NHS England’s Cancer Drugs Fund—after a confidential discount off the £300,000 full list price.
The fund, managed by NICE, which operates under NHS England, serves as an extra means for patients to access novel medicines early before a full NICE backing.
With this deal, an estimated 200 patients a year will be eligible for the treatment, according to NHS England. These are adult patients with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) who have failed at least two prior therapies.
In the clinical trial that led to Yescarta’s EU approval in late August, 72% of patients responded to it, and half of them remained cancer-free six months after treatment.
However, almost at the same time Yescarta won EU clearance, NICE gave its thumbs-down to the drug, citing the lack of direct clinical data that compare Yescarta with standard salvage chemotherapy. Though the agency recognized Yescarta as “a step-change in treatment,” the cost police concluded that Yescarta’s price was too high to be considered cost-effective.
Whatever discount Gilead offered to get a deal now, it is obviously enough to win partial endorsement from NICE in adult patients, which rival Novartis’ Kymriah doesn’t have. After stiff-arming Yescarta, NICE in September approved Kymriah at a list price of £282,000, but only in children and young adults with acute lymphoblastic leukemia.
Then, Kymriah’s hope to reach England’s adult patients was also nixed by NICE for the same reason Yescarta faced—it’s too expensive because no data against salvage chemo is available to gauge the drug’s benefit.
Yescarta is currently leading Kymriah in sales. In the first half of 2018—when neither drug had won an EU nod—the Gilead drug sold $108 million in the U.S. But with Kymriah’s second FDA nod in DLBCL in May, the two drugs are now officially vying in the same indication.
Oct 5, 2018