The United Kingdom’s government-funded health service isn’t being so nice to Gilead Science’s CAR-T blood cancer treatment Yescarta. The country’s National Institute for Health and Care Excellence (NICE) said the therapy is too expensive for the agency to justify.
The United Kingdom’s government-funded health service isn’t being so nice to Gilead Sciences’ CAR-T blood cancer treatment Yescarta. The country’s National Institute for Health and Care Excellence (NICE) said the therapy is too expensive for the agency to justify.
The announcement by the U.K. agency came one day after Yescarta (axicabtagene ciloleucel) received approval from the European Medicines Agency (EMA) for use across the European Union. Yescarta is the first CAR-T treatment in Europe to be approved for two types of aggressive non-Hodgkin’s Lymphoma. On Monday the CAR-T treatment was approved for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. Each of the 28 European countries will be able to determine how their public-financed health agencies support Yescarta.
Back in the U.K. though, the drug will not be supported by the nation’s publically-funded healthcare agency. In its announcement, NICE said Yescarta “is not recommended, within its anticipated marketing authorization, for treating relapsed or refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma in adults after two or more systemic therapies.” NICE added that the new guidance will not affect those patients who have already been treated with Yescarta prior to the publication of the new ruling. NICE said those patients can continue their treatment without change to funding arrangements already in place.
In the United States, treatment with Yescarta has a list price of about $373,000. It was first approved in the U.S. in October 2017. NICE did not provide an indication of how much the treatment would be in the U.K. CNBC reported that drug manufacturers typically provide discounts to the National Health Service as part of the approval process.
NICE also raised concern over the lack of comparator data. In its rejection, NICE said there is no standard treatment for relapsed or refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma in adults after two or more systemic therapies. NICE said that “best supportive care” usually include “salvage chemotherapy.”
NICE added that evidence from a “small, single-arm study” supports the efficacy of Yescarta. The agency said patients have good response rates and show progress in overall survival, as well as progression-free survival. However, NICE said there is no direct data comparing Yescarta with salvage chemotherapy (referred to as best supportive care by the company), NICE said.
“This means that the exact size of the benefit of axicabtagene ciloleucel compared with salvage chemotherapy is unknown,” NICE wrote in its guidance. “Axicabtagene ciloleucel meets NICE’s criteria to be considered a life-extending treatment at the end of life. However, all the cost-effectiveness estimates are above the range normally considered to be a cost-effective use of NHS resources.”
CNBC reported that Yescarta is the first CAR-T treatment to be assessed by the U.K.’s NICE. The agency is currently examining Kymriah, which is developed by Swiss pharma giant Novartis. The Novartis CAR-T drug was also approved by the EMA on Monday.
