The National Institute for Health and Clinical Excellence (NICE) has issued preliminary guidance (Appraisal Consultation Document – ACD) rejecting the use of cetuximab (Erbitux®) in combination with radiotherapy for the treatment of locally advanced head and neck cancer. This is contrary to guidance issued by the Scottish Medicines Consortium (SMC) in 2006 approving use of the drug. This new recommendation is made under the new Single Technology Appraisal process and does not supersede decisions made by the SMC. This means that yet again patients in England and Wales are put at a significant disadvantage in terms of access to lifesaving cancer treatments, even in relation to other parts of the UK.
NICE has based its initial proposal for a negative recommendation largely on the assertion that the key international clinical trial is not completely representative of the UK patient population treatment practice. However, the NICE ACD points out that in this study, cetuximab given with radiotherapy significantly prolonged the survival seen with radiotherapy alone, and acknowledges that it was well conducted and the results robust.
In the manufacturer's model, the cost effectiveness of cetuximab was £6,390 per additional QALY, and the NICE cost effectiveness acceptability threshold is less than £30,000 per additional QALY. The cost of a fixed eight-week course of cetuximab in this patient group is approximately £5,000.
Cetuximab is the first treatment in over 40 years that significantly improves patient survival and control of the disease. More than 7,800 people are diagnosed with head and neck cancer in the UK every year. The disease may have a devastating effect on the lives of those affected. The disease itself and surgical removal of the tumour may lead to disfigurement and severe impairment on daily activities such as breathing, eating, drinking and speaking.
Dr Vinod Joshi of Mouth Cancer Foundation said: "Many patients are unable to tolerate chemoradiotherapy so having an effective alternative is essential. The clinicians consulted as part of this NICE review were all in favour of cetuximab but this has not been the driving force behind the decision."
Dr Gerry Robertson, consultant oncologist at the Beatson Oncology Centre in Glasgow, commented: "I am disappointed at the initial recommendation from NICE not to approve cetuximab, particularly as there are so few treatment options for patients with head and neck cancer and cetuximab given with radiotherapy has been shown to increase survival."
Christine Piff, chief executive of the head and neck cancer support group "Let's Face It", commented: "Head and neck cancer continues to be the 'Cinderella' cancer, receiving little or no attention from the NHS. It is outrageous when you consider the emphasis placed on other cancers, why shouldn't people suffering from head and neck cancer have access to a drug that is prescribed in Scotland? It's a scandalous proposal which I hope will be reversed."
Denise Richard, head of the Oncology Business Unit at Merck Pharmaceuticals, commented on the decision: "Yet again we are disappointed by NICE's decisions regarding cetuximab, since a robust trial has shown that cetuximab in combination with radiotherapy may extend survival in head and neck cancer and maintain the quality of patients' lives. We will be working with NICE to present a very strong case as to why it should reconsider this proposal before final guidance is issued."
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