The U.K.'s National Institute for Health and Care Excellence, or NICE, rejected Merck & Co. Inc.'s Keytruda, or pembrolizumab, for treating patients with locally advanced or metastatic urothelial carcinoma who have received platinum-containing chemotherapy.
In an appraisal consultation document, the regulator expressed uncertainty about the most likely cost effectiveness estimate for the treatment because the methods and assumptions for the economic modeling were unclear.
The agency also said all plausible cost effectiveness estimates were over £50,000 per quality-adjusted life year gained, higher than what NICE usually considers acceptable. NICE estimated Keytruda to cost £2,630 per 100-milligram vial.
The treatment was also not recommended for the U.K.'s cancer drugs fund due to concerns over the therapy's cost.
Despite the rejection, NICE is convinced pembrolizumab improved overall survival compared to current treatments docetaxel and paclitaxel, and that the treatment can extend lives by more than 3 months.
Keytruda generated $881 million in sales during the second quarter of 2017.
NICE's appraisal committee will conduct another meeting to consider the evidence, along with the appraisal consultation document and comments from consultees. The closing date for comments on NICE's decision is Aug. 24, with a second appraisal committee meeting Aug. 30.
Meanwhile, Roche's urothelial cancer drug Tecentriq was also recently rejected by NICE over cost concerns.