The National Institute for Health and Clinical Excellence has issued a Final Appraisal Determination recommending the use of Merck KGaA’s Erbitux (cetuximab) in combination with radiotherapy for the treatment of locally-advanced head and neck cancer in National Health Service patients in England and Wales who are contraindicated to all forms of platinum based chemoradiotherapy.

The FAD has now been sent to the formal consultees, who have until 5pm on May 15 to decide whether to appeal against it. The full guidance is expected to be published May 29, says Merck.

Dr Nicholas Slevin, consultant in oncology at the Christie Hospital, Manchester, said that, as a clinician treating head and neck cancer, he welcomed NICE’s decision, “as it improves the chance of tumour control without adding to the risk of troublesome radiotherapy-related side effects.”

NICE’s announcement was also applauded by Dr Vinod Joshi, founder of the Mouth Cancer Foundation, “as something that oncologists and patients alike have been fighting for. It will go a long way to correcting the present post-code lottery in head and neck cancer for patients in the UK,” he said. The Foundation had, together with Merck and a number of professional and patient groups, appealed against NICE’s initial decision in May 2007 not to recommend Erbitux for use in these cancers.

More than 7,800 people are diagnosed with head and neck cancer in the UK every year, the majority of which occur in the mouth, pharynx or tongue, and the availability of Erbitux will be the first significant treatment advance since the 1950s for these cancers, say campaigners.

One group which opposed NICE’s original rejection of Erbitux is the National Association of Larygectomee Clubs, which told the Institute that its support for the drug was not about “patients wanting the latest drug,” but rather about how the development of better and less toxic treatments may be progressed as quickly as possible to reduce the need for more serious and traumatic interventions. “It will furthermore give the patient a choice of treatment not available at present,” said the group.

Need for a more flexible review
The Association also told NICE that, given the rarity of these cancers, it needed to view the evidence in a more flexible manner. “It would also appear that, when considering NHS costs, the review failed to take into account the long-term and ongoing costs to primary and social care of supporting patients who undergo conservative surgery for these conditions,” the group added.

In February, the government also asked NICE to look Erbitux as a first-line treatment for metastatic colorectal cancer and advanced non-small cell lung cancer, under its fast-track Single Technology Appraisals process. The procedure is expected to take around six months.

- In June 2006, following the advice of the Scottish Medicines Consortium, Erbitux in combination with radiation therapy was accepted for restricted use within NHS Scotland for the treatment of patients with locally-advanced head and neck cancers.