NICE shoots down Keytruda in head and neck cancer over data concerns

It has been revealed that NICE has chosen to reject MSD’s blockbuster immunotherapy Keytruda (pembrolizumab) for routine use on the NHS as a treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC), citing uncertainty over the data provided by the manufacturer.

Data submitted to the institute argued that Keytruda, either as a monotherapy or in combination with platinum chemotherapy and 5-FU, extended overall survival in those with PD-L1 positive HNSCC compared to Eli Lilly’s Erbitux (cetuximab) plus platinum chemotherapy and 5-FU.

However, these data were called into question due to the fact that the trial did not accurately characterise current clinical practice on the NHS in England with regard to the comparator drugs used. Patients in the comparator arm were given the Erbitux combo regardless of whether their cancer originated inside or outside the mouth, which does not happen on the NHS.

Furthermore, separate data on patients whose cancer originated outside the mouth was not provided, while clinical and cost-effectiveness data on both groups of patients was incomplete.

Thus, NICE could not recommend the drug and has requested that MSD provides additional data on its clinical efficacy and cost-effectiveness.

Matt Fellows