Negative NICE guidance on Keytruda

The National Institute for Health and Care Excellence (NICE) today published draft guidance which does not recommend Keytruda (pembrolizumab) for untreated PD-L1-positive metastatic lung cancer.

NICE, the medicines cost-effectiveness watchdog for England and Wales, said its appraisal committee concluded that the exact size of the overall survival gain for Keytruda, developed by US pharma giant Merck & Co (NYSE: MRK), compared to current standard of care was uncertain because of the immaturity of the data. Taking into account this uncertainty and the committee’s preferred assumptions for the economic modelling, the committee concluded that the cost effectiveness estimate for pembrolizumab exceeded the range usually considered to be a cost-effective use of NHS resources.

Pembrolizumab is delivered by intravenous infusion and costs £2,630 ($$3,285) for a 100mg vial. Merck, Sharp & Dohme (MSD), the trading name of Merck outside of the USA and Canada, agreed a confidential patient access scheme with the Department of Health which consisted of a simple discount to the list price. There are around 1,500 patients in England who would be eligible for pembrolizumab.