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The National Institute for Health and Care Excellence recently rejected National Health Service’s funding of Kymriah for diffuse large B-cell lymphoma (DLBCL) despite recognizing that the drug has significant clinical benefits.
Following the European Medicines Agency’s (EMA) approval of Novartis’ Kymriah (tisagenlecleucel) for refractory/relapsed (R/R) diffuse large B-cell lymphoma (DLBCL) in adults in September 2018, the National Institute for Health and Care Excellence (NICE) rejected National Health Service’s (NHS) funding of Kymriah for DLBCL.
According to GlobalData, a data and analytics company, NHS was preparing to embrace the CAR-T cancer treatment, and the company offered a confidential discount on the list price of £282,000 (US$372,000). However, the discounted price was still above the range that NICE considers an acceptable use (no more than £50,000 per year, or US$66,000) of NHS funds on an end-of-life drug.
NICE based its decision on the lack of data comparing Kymriah to the gold-standard chemotherapy and concluded that Kymriah is not cost-effective for routine NHS funding or use within the Cancer Drugs Fund, GlobalData reports.
In contrast, in September 2018, NICE gave the green light to Kymriah for patients with R/R B-cell acute lymphoblastic leukemia (ALL) up to 25 years old, a much smaller market, within 10 days after it obtained marketing authorization from EMA.
“NICE’s rejection of Kymriah for DLBCL does not come as a complete surprise after a series of dismissals of other immune-oncology drugs for regular NHS funding, including Gilead/Kite’s Yescarta (axicabtagene ciloleucel) in R/R DLBCL and R/R primary mediastinal large B-cell lymphoma,” said Dr Edit Kovalcsik, managing analyst at GlobalData, in a Sept. 25, 2018 press release. “Amid the uncertainty of access to new cancer drugs, on the other hand, the UK is keen to become a global hub in biotherapeutics.”
According to GlobalData’s report, PharmaFocus: Visual Analysis of Immuno-Oncology Development and Opportunities, the United States has historically led the development of CAR cell therapies, but China has recently become the most significant contributor to their development, with 126 clinical trials started prior to the second quarter of 2017 in comparison with 121 in the US. The UK is the third country in terms of development, far behind, with nine clinical trials exploring CAR cell therapies.