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NICE rejects Merck KGaA's bowel cancer drug

Cancer charities Cancerbackup and Bowel Cancer UK have appealed a decision by the National Institute of Clinical Excellence (NICE) to reject Merck KGaA's cancer drug Erbitux

Cancer charities Cancerbackup and Bowel Cancer UK have appealed a decision by the National Institute of Clinical Excellence (NICE) to reject German pharmaceutical company Merck KGaA's cancer drug, Erbitux (cetuximab), for use on the NHS to treat advanced bowel cancer.

The ruling was made in August 2006, citing a lack of cost-effectiveness as the reason. The decision was widely criticised as being indifferent to the suffering of people with bowel cancer, which has been described by patients as ìlife-savingî. Bowel cancer is the third commonest cancer in the UK, with 35,000 new cases diagnosed annually. Over 50 per cent of these cases go on to develop more advanced disease, with only 12 per cent alive after five years.

Erbitux costs approximately GBP 700 (USD 1,366/ EUR 1,055) a week for a 16-week course of treatment and can extend survival by four months in 50 per cent of advanced cancer cases. A report in The Guardian Newspaper said this would cost the NHS GBP 3 million (USD 5.9 million/ EUR 4.5 million) a year, compared with breast cancer drug, Herceptin, which costs around GBP 93 million (USD 181.6 million/ EUR 140.2 million) annually.

According to The Guardian, doctors have said that the decision is ironic because British scientists had led on Erbitux trials. Dr Mark Saunders of the Christie Hospital NHS trust was reported as saying that NICE would not review the decision before 2009.

Developed by the US biopharmaceutical company ImClone Systems, Erbitux is a chimaeric monoclonal antibody (MAb) targeted at epidermal growth factor receptor (EGFR). One of several new cancer biotherapies, Erbitux is indicated for the treatment of metastatic colorectal cancer and locally advanced cancer of the head and neck.

Merck KGaA has threatened legal action, which would make it the second such company to seek legal address over a NICE decision. In late 2006, Japanese drug maker Eisai began legal proceedings against NICE for its refusal to make anti-Alzheimer's disease drug Aricept (donepezil) available on the NHS, according to co-promotion partner, US pharmaceutical company Pfizer.

In the US, Erbitux is approved for use in conjunction with irinotecan in irinotecan-refractory metastatic colorectal cancer or as single agent therapy in patients with EGFR-expressing colorectal tumours, who are intolerant to irinotecan-based chemotherapy. In Europe, it is licensed for use in combination with irinotecan after failure of irinotecan-containing chemotherapy (second-line therapy). Bristol-Myers Squibb (BMS) has marketing rights to Erbitux in North America, while Merck KGaA has rights to the drug outside the US and Canada, as well as joint rights with BMS in Japan.

Erbitux remains unapproved in Scotland, but was approved in Wales in mid-2006. The NICE ruling will overrule the Welsh decision, however, says UK newspaper, The Guardian.

31st January 2007

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