UK – NICE rejects Keytruda, asks for more info

The National Institute for Health and Care Excellence (NICE) has published a new draft guidance not recommending MSD’s cancer blockbuster Keytruda (pembrolizumab) for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).

The organisation is calling for an urgent reassessment of the evidence for the drug’s benefit, and has asked for more clinical and cost-effectiveness evidence from MSD.

Evidence from the KEYNOTE-048 trial showed that some patients who have a type of metastatic or unresectable recurrent HNSCC – defined as PD-L1 positive, with a combined positive score of one or more – lived longer longer when treated with Keytruda. However, NICE has said that the uncertainty over the drug lies in the evidence, because the comparator drugs in the trial do not reflect what currently happens in practice in the NHS in England.

As a result, the organisation has announced that the trial does not provide enough evidence that the drug would offer a larger benefit than the current, “extreme” form of chemotherapy…