Cetuximab nel carcinoma ricorrente e/o metastatico a cellule squamose della testa e del collo. Una valutazione di tecnologia singola del NICE * Adrian Bagust, 1 Janette Greenhalgh, 1 Angela Boland, 1 Nigel Fleeman, 1 Claire McLeod, 1 Rumona Dickson, 1 Yenal Dundar, 1 Christine Proudlove 2 e Richard Shaw 3 1 Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, UK 2 North West Medicines Information Centre, Liverpool, UK 3 School of Cancer Studies, University of Liverpool, Liverpool, UK Abstract The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of cetuximab (Merck Serono) to submit evidence for the clinical and cost effectiveness of cetuximab in combination with platinum- based chemotherapy (CTX) for the treatment of patients with recurrent and/or metastatic squamous cell cancer of the head and neck (SCCHN) according to the Institute’s Single Technology Appraisal (STA) process. The Liverpool Reviews and Implementation Group at the University of Liverpool was commissioned to act as the Evidence Review Group (ERG). This article summarizes the ERG’s review of the evidence submitted by the manufacturer. A summary of the Appraisal Committee (AC) decision is provided. The ERG reviewed the clinical evidence in accordance with the decision problem defined by NICE. The analysis of the submitted model assessed the appropriateness of the manufacturer’s approach to modelling the decision problem, the reliability of model implementation and the extent of conformity to published standards and prevailing norms of practice within the health economics modelling community. Particular attention was paid to issues likely to impact substantially on the base-case cost-effectiveness results. Clinical-effectiveness evidence was derived from a single randomized controlled trial (RCT). Results presented for clinical outcomes were strongly supportive of benefits resulting from the use of cetuximab. Cetuximab + platinum-based CTX with 5 fluorouracil (5-FU) extended median overall survival (OS) from 7.4 months in the CTX group to 10.1 months in the cetuximab + CTX group. Median progression-free survival rose from 3.3 months to 5.6 months, best overall response to therapy increased from 19.5% to 35.6%, disease control rate rose from 60% to 81.1% and median time to treatment failure was 4.8 months compared with 3.0 months. * Traduzione dell’articolo Cetuximab for Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck. A NICE Single Technology Appraisal. Pharmacoeconomics 2010; 28 (6): 439-448. PharmacoEconomics – Italian Research Articles 2011; 13 (2): 101-110 1590-9158/11/0002-0101/$49.95/0 ª 2011 Adis Data Information BV. Tutti i diritti riservati.