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PERSONALISED MEDICINES SYMPOSIUM Warwick Medical School Medical Teaching Centre, University of Warwick Wednesday 5th July 2006 Louis Niessen MD PhD Institute for Medical Technology Assessment / Institute of Health Policy and Management, Erasmus MC, Erasmus University, PO Box 1738, 3000 DR, Rotterdam, The Netherlands Email: [email protected] www.bmg.eur.nl/personal/niessen Economic evaluation of existing and future pharmacogenomics-based treatment strategies: Can there be a generic approach? Ken Redekop, PhD and Louis Niessen, MD, PhD Pharmacogenomics tests help to identify patients who will experience important adverse events or who obtain important benefit from drug therapy. For this reason, pharmacogenomics can be viewed as an important means to improve overall effectiveness, safety and cost-effectiveness of many drug therapies. However, policy makers will raise the issue of the actual utility of pharmacogenomics in specific patient situations before widespread admission to clinical practice. In health technology assessment, utility can be defined in different ways, including health gain (e.g., quality of life, QALYs) and cost-effectiveness. In both cases, it is important to remember that pharmacogenomics is not a treatment but more a specialised diagnostic test. Health gain is achieved by making better decisions about therapy. Degree of health gain attainable using pharmacogenomics is therefore dependent on the effectiveness and safety of available therapies. In fact, the potential health gain attainable via pharmacogenomics is dependent on various factors, including the test's sensitivity and specificity, disease prognosis (with or without therapy), and the patient population. Cost-effectiveness of pharmacogenomics testing is dependent on the same factors, as well as the costs of the test and the programme, the treatment and the disease. Development of a generic decision approach would help to standardise and catalyse the estimation of health benefit distribution and costeffectiveness of treatment strategies using existing pharmacogenomics tests and subsequent treatments. The economic methodologies also help to quantify the uncertainty surrounding these estimates. While pharmacogenomics offers exciting opportunities to provide tailor-made medicine, it might not be always be beneficial and its utility will vary greatly between applications. This model could also help in priority setting during the development of new tests, by estimating the potential health gain and cost-effectiveness of pharmacogenomics tests long before these tests exist or have been fully developed.