BioCentury
ARTICLE | Company News

NICE rebuffs Kadcyla as too expensive

August 9, 2014 12:31 AM UTC

The U.K.'s NICE issued a final appraisal determination recommending against Kadcyla trastuzumab emtansine from Roche (SIX:ROG; OTCQX:RHHBY) to treat HER2-positive, unresectable, locally advanced or metastatic breast cancer in patients previously treated with the pharma's Herceptin trastuzumab and a taxane -- Kadcyla's approved indication in the EU. In April draft guidance, NICE said Kadcyla was too expensive. The committee said Roche argued in response that NICE should take into account the 2014 Pharmaceutical Price Regulation Scheme (PPRS), under which industry underwrites NHS expenditures above an annual limit in exchange for the ability to set any price at launch. NICE said that terms of the 2014 PPRS do not supersede the committee's role of evaluating the cost-effectiveness of technologies (see BioCentury, Nov. 18, 2013).

NICE said Kadcyla is estimated to cost more than L90,000 ($151,416) per patient at its full list price. Roche agreed to a patient access scheme under which it would provide Kadcyla at an undisclosed discount. But even with the discount, the committee said the most plausible incremental cost-effectiveness ratio (ICER) for Kadcyla compared to Roche's Xeloda capecitabine in combination with Tyverb lapatinib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) was L166,400 ($279,951) per quality-adjusted life year (QALY) gained -- above the limit normally considered cost-effective. Roche said it would have to discount Kadcyla by 60% to meet NICE's cost-effectiveness threshold. ...