There's been a yearslong will-they or won’t-they situation between England’s cost-effectiveness watchdog and Gilead’s Kite—as well as Novartis—for their respective CAR-T therapies. Now, Gilead has finally gotten the drug cost gatekeeper to warm up to its blood cancer cell therapy.
After multiple twists and turns in the rival drugs’ coverage saga, Gilead’s Yescarta has scored a clear leg up over its archrival Kymriah. Thursday, the National Institute for Health and Care Excellence (NICE) unleashed final draft guidance blessing Yescarta for routine use through England’s National Health Service (NHS) in “suitable” patients, which is to say: adults with relapsed or refractory large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who’ve tried two or more cancer therapies.
The agency's OK makes Yescarta the first personalized immunotherapy recommended for routine use in adults through England’s national health authority, NICE pointed out in a release. Following the watchdog’s rejection of Yescarta in 2018, NICE reviewed new evidence to reach its amended conclusion. The latest review included clinical data from patients who received the drug through a previous U.K. coverage framework leveraging the country’s Cancer Drugs Fund (CDF).
Yescarta’s U.K. coverage odyssey began shortly after twin European approvals for the therapy and its rival Kymriah back in June 2018. Just one day after the European Union cleared the way for Gilead’s cell therapy, NICE stiff-armed the drug on account of its high price.
The drama didn’t stop there. The following week, NICE green lit Novartis’ Kyrmiah at a list price of £282,000 (at the time, worth around $361,000) in children and young adults with B-cell acute lymphoblastic leukemia. But Novartis’ momentum was short lived. Roughly two weeks later, NICE batted Kymriah back in the same indication in adults over cost concerns.
Then, in a surprise twist, Gilead's Yescarta beat Kymriah to coverage through the specialized Cancer Drugs Fund. Under the CDF, officials grant access to new therapies while they collect additional evidence about benefits and risks.
All the while, Kymriah wasn’t far behind, snagging a similar CDF arrangement in January of 2019.
With Thursday’s decision, meanwhile, Gilead’s med seems to have snagged an edge over Kymriah. Overall, NICE estimates there are some 5,500 people in England diagnosed with DLBCL each year. Thursday’s recommendation opens the door to Yescarta for some “hundreds of people” in the country, the cost watchdog said. That exact patient pool, according to Gilead, numbers around 450 people.
NICE’s latest analysis suggests patients on Yerscarta live longer than people on chemotherapy alone, plus, Yescarta patients enjoy more time before their condition worsens. There are 318 people who’ve been given Yescarta via the National Health Service’s CDF between Dec. 2018 and Oct. 2021 in England, NICE said.