The National Institute for Health and Care Excellence (NICE) has published a new draft guidance not recommending MSD’s cancer blockbuster Keytruda (pembrolizumab) for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma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

Professor Kevin Harrington of the institute of cancer research said that he is “disappointed” by the verdict, and that patients will have to wait “even longer before they can access this immunotherapy as the first treatment of choice for advanced head and neck cancer.”

He added that the decision “brings the UK further out of step with clinical practice in the rest of the world, where cancers of the mouth are treated in the same way as other head and neck cancers.”

In November last year the European Commission approved the immunotherapy, which works by increasing the ability of the body’s immune system to help detect and fight tumour cells, as monotherapy or as part of a combination for the first-line treatment of HNSCC.

The list price of Keytruda stands at £2,630 per 100 mg vial, but MSD has a commercial arrangement which makes the treatment available to the NHS with a discount.