The National Institute for Health and Clinical Excellence has rejected the appeal made by Merck KGaA‘s UK subsidiary, Bowel Cancer UK and Cancerbacup on the use of Erbitux for the treatment of advanced colorectal cancer and has confirmed that the drug cannot be prescribed on the National Health Service in England and Wales.

NICE, which also said it would not recommend the use of Roche and Genentech’s Avastin (bevacizumab) as a first-line therapy for metastatic colorectal cancer, said that Erbitux (cetuximab) had been turned down again on the grounds of cost effectiveness.

Peter Littlejohns, the agency’s clinical and public health director, said that while NICE is “certainly aware that colorectal cancer is an aggressive disease and that the treatment options available are limited…the assessment of the evidence shows that neither of these drugs represents a good use of NHS resources.”

The rejection was met with astonishment and anger by patient groups and Hilary Whittaker, chief executive of Beating Bowel Cancer said that “this negative appeal decision is scandalous." People with the disease "should have access to the best treatments and this outcome represents the end of a lifeline.” Mark Saunders, a consultant clinical oncologist at Christie Hospital in Manchester, said he was "thoroughly disappointed,” particularly as NICE indicated that it may not be reviewing its decision again until 2009. “This means patients in the UK may have to wait up to two years to gain access to a drug which is prescribed widely in other European countries,” he added.

This point was reiterated by Denise Richard, head of oncology at Merck Pharmaceuticals UK who noted that this is the only country in Europe where cetuximab has been licensed but is not routinely available to patients. “Yet again, we are lagging behind the rest of Europe in terms of access to bowel cancer treatments.” It is thought that Merck may launch a legal appeal against the guidance.

Ian Beaumont at Bowel Cancer UK said that the decision “demonstrates NICE’s continued indifference to people living with advanced bowel cancer. No-one should be in any doubt that the basis for it is financial and bears no relation to the efficacy of the drug, which is well proven.” He added that patients who have been told by their clinicians that they could benefit from Erbitux, Avastin and other treatments are contacting his group “on a daily basis, seeking our support” and he said that the campaign to get the guidance changed will go on.