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Gilead's Yescarta rebuffed by NICE, second orphan drug setback in August

August 31, 2018 6:49 PM UTC

One day after the European Commission approved CAR T therapy Yescarta axicabtagene ciloleucel from the Kite Pharma Inc. unit of Gilead Sciences Inc. (NASDAQ:GILD), U.K.'s NICE published draft guidance recommending against the use of therapy. The guidance applies to adults with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who have received two or more lines of systemic therapy.

While the list price of Yescarta is undisclosed for the orphan disease indication, NICE said that the drug's incremental cost-effectiveness ratio (ICER) is beyond the threshold of £50,000 per quality-adjusted life year (QALY) gained compared with standard of care. NICE uses the threshold in its standard review process, while ultra-orphan diseases are afforded £100,000 per QALY gained in NICE's highly specialized technology review (see "Ultra-Rare, Ultra-Slow")...