Merck Serono’s Erbitux has been rejected by the UK’s cost-effectiveness watchdog for the treatment of recurrent and/or metastatic forms of squamous cell cancer of the head and neck on the National Health Service.

The National Institute for Health and Clinical Excellence yesterday published its final appraisal determination on the use of Erbitux (cetuximab) plus chemotherapy in this setting, deeming the drug too expensive to use on the NHS in England and Wales following an expert review of all the evidence.

Erbitux is currently recommended alongside radiotherapy as a treatment for locally-advanced head and neck cancer, but an Expert Review Group has now ruled that the drug should not be used to treat patients with recurrent of metastatic forms of the disease.

The decision was based on Erbitux’ failure to fall under the cost-effectiveness boundary of £30,000 per QALY (quality-adjusted life year) gained in these subgroups of the disease. Moreover, an analysis to determine the price for a vial of Erbitux that would generate a cost below this threshold found that a treatment regimen based on the drug appeared not to be cost effective at any price, the ERG said.

This, it claimed, is partially down to the fact that, as Erbitux is administered more frequently than chemotherapy, there are additional infusion costs twice during every cycle, regardless of the drug’s price. In addition, the trial protocol required that Erbitux be given to patients until their disease progressed, further swelling expenses.

As part of the review, recent new advice from NICE on the extension of the cost-effectiveness threshold for so-called end-of-life drugs was also taken into account. Raising the cost-threshold is conditional on a number of criteria, including sufficient evidence to suggest that a treatment is able to extend survival by at least three months compared to standard NHS therapy. Clinical trials of have shown the drug to extend survival by 2.7 months, although economic analysis of the data provided, however, showed a gain in overall survival of 2.2 months.

The ERG also expressed concern over a number of limitations in the evidence submitted by the manufacturer as part of the appraisal, and taking all factors into account said it is unable to recommend the drug as a cost-effective use of NHS resources for recurrent or metastatic forms of the disease. However, patients currently receiving Erbitux should be given the option of continuing treatment, it stressed.

The news will come as a blow to Merck Serono, which said it is “disappointed with the decision". Erbitux, which is also approved for the treatment of colorectal cancer, is one the firm's flagship drugs on which it is counting to boost earnings in the coming years, and the exclusion of patients with recurrent of metatsatic head and neck cancer will make a substantial dent in sales from the drug in this indication, given that these subgroups account for about 40% of all cases.