TY - CHAP A1 - Noweski, Michael A1 - Walendzik, Anke A1 - Hessel, Franz A1 - Jahn, Rebecca A1 - Wasem, Jürgen T1 - Approval and Reimbursement of Personalised Drugs: Interim Results of the Adjustment Process BT - critical perspektives T2 - The Ethics of Personalised Medicine N2 - According to drug manufacturers, the pharmaceutical industry is suffering from an ‘innovation crisis’. Nowadays, the development of new products requires significantly more investment than in the past. Most of the simple but useful chemical entities seem to have been discovered already. Moreover, many topselling drugs lose their patent protection (‘patent cliff ’) and, subsequently, prices and sales of the original drug are undermined by competing generics. Producers try to compensate for the loss of sales by launches of new molecular entities (Jimenez, 2012). However, the new compounds generate fewer sales. As market observers calculated, new products launched in the period from 2001 to 2005 achieved annual average sales of USD 208 million after three years. New products of the period from 2006 to 2010 reached only USD 143 million (Rockoff and Winslow, 2013). Development of a drug which yields more than a billion USD per year (‘blockbuster’) succeeds less often. Drugs combined with biomarker-based diagnostic tests, stratifying patients into groups characterised by different drug reactions, appear to be one way out of trouble, because a new generation of patented products seems attainable (Scollen and Phelan, 2014). KW - Medicine KW - Drugs Y1 - 2015 N1 - Volltext aus urheberrechtlichen Gründen nicht verfügbar. Fulltext due to copyright no available. SP - 199 EP - 209 PB - Ashgate CY - Farnham ER - TY - CHAP A1 - Schildmann, Jan A1 - Böttcher, Miriam A1 - Gabriel, Maria A1 - Ganser, Arnold A1 - Hessel, Franz A1 - Gottwald, Sina T1 - "Personalised medicine": Multidisciplinary perspectives and interdisciplinary recommendations on a framework for future research and practice BT - critical perspectives T2 - The Ethics of Personalised Medicine N2 - ‘Personalised medicine’ (PM) has raised great hopes and expectations among researchers, patients, health-care providers and politicians in past years. Although the term ‘person’ in PM suggests an approach of medicine which takes into account psychosocial and value aspects of the patient as human being, most articles refer to PM as strategies limited to biological features of individuals which are used to stratify patient groups for the purposes of prevention, diagnosis and treatment of disease. KW - Medicine Y1 - 2015 N1 - Volltext aus urheberrechtlichen Gründen nicht verfügbar. Fulltext due to copyright no available. SP - keine Angabe EP - keine Angabe PB - Ashgate CY - Farnham ER - TY - CHAP A1 - Hessel, Franz T1 - HTA in Personalized Medicine Technologies BT - Technological, Clinical and Commercial Aspects T2 - Biomarker Validation N2 - Beyond the proof of efficacy and safety for approval purposes health technology assessment (HTA) is a more comprehensive evaluation of all relevant short- and long-term consequences of the application of a specific medical technology. HTA is performed for the purpose of reimbursement decision making. It covers clinical, societal, economic, ethical and legal aspects based on the available scientific evidence. Although there are some special issues to be considered all principles of HTA are equally valid for the evaluation of biomarker tests and personalized medicine technologies. All requirements of evidence-based medicine remain and causality should and could only be demonstrated with high-quality controlled studies, preferably with randomized design. The multimodality of the intervention and by tendency smaller sample sizes lead to an increased amount of uncertainty. Besides the test strategy, itself also questions of test or sample quality, laboratory size, or the platform used, and the specific technology must be taken into consideration. Economic evaluations should also include these aspects. In summary the fundamental principles of HTA and health economic evaluation are also valid and feasible for the evaluation of personalized medicine and genetic biomarker tests, but careful adaptations of the existing HTA and health economic guidelines are required. KW - Medicine KW - Technology Y1 - 2015 N1 - Online: https://www.researchgate.net/publication/300912255_HTA_in_Personalized_Medicine_Technologies SP - 95 EP - 106 PB - Wiley-VCH CY - Weinheim ER -