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This paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of cetuximab plus radiotherapy for the treatment of locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) considered inappropriate for chemoradiotherapy but appropriate for radiotherapy, based upon the evidence submission from Merck Pharmaceuticals to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The manufacturer's submission was generally of good quality and was an accurate representation of the original reference data. One good-quality randomised controlled trial comparing radiotherapy plus cetuximab with radiotherapy alone in patients with stage III or IV non-metastatic LA SCCHN was included, demonstrating that the duration of locoregional control was significantly longer with radiotherapy plus cetuximab than with radiotherapy alone; also, overall and progression-free survival were significantly longer and the overall response rate was significantly better with the combination therapy. Cetuximab did not exacerbate the common toxic effects associated with radiotherapy of the head and neck. No supporting evidence for these findings are available. The patient population in the trial included a high proportion of patients who would be expected to be suitable for chemoradiotherapy and therefore does not match the population described in the submission's decision problem. Also, the radiotherapy regimens used in the trial are not typical of current UK practice. The ERG considered the manufacturer's economic evaluation to comprise the only relevant evidence to consider for the purposes of this STA. The economic model was considered appropriate for the decision problem. The results suggested that cetuximab plus radiotherapy was cost-effective compared with radiotherapy alone under a broad range of different assumptions on the basis of a cost-effectiveness threshold of 20,000 pounds. In the base case the incremental cost-effectiveness ratio of cetuximab plus radiotherapy compared with radiotherapy alone in the treatment of patients with LA SCCHN was 6390 pounds per additional QALY. Simple sensitivity analyses to examine the robustness of the results were undertaken, suggesting that areas of uncertainty that emerged in the modelling are unlikely to have a material effect on the conclusions. The guidance issued by NICE in May 2007 as a result of the STA states that cetuximab in combination with radiotherapy is not recommended for patients with LA SCCHN.

Cetuximab plus radiotherapy for the treatment of locally advanced squamous cell carcinoma of the head and neck