title: Points to consider for prioritizing clinical genetic testing services: a European consensus process oriented at accountability for reasonableness.
abstract: Given the cost constraints of the European health-care systems, criteria are needed to decide which genetic services to fund from the public budgets, if not all can be covered. To ensure that high-priority services are available equitably within and across the European countries, a shared set of prioritization criteria would be desirable. A decision process following the accountability for reasonableness framework was undertaken, including a multidisciplinary EuroGentest/PPPC-ESHG workshop to develop shared prioritization criteria. Resources are currently too limited to fund all the beneficial genetic testing services available in the next decade. Ethically and economically reflected prioritization criteria are needed. Prioritization should be based on considerations of medical benefit, health need and costs. Medical benefit includes evidence of benefit in terms of clinical benefit, benefit of information for important life decisions, benefit for other people apart from the person tested and the patient-specific likelihood of being affected by the condition tested for. It may be subject to a finite time window. Health need includes the severity of the condition tested for and its progression at the time of testing. Further discussion and better evidence is needed before clearly defined recommendations can be made or a prioritization algorithm proposed. To our knowledge, this is the first time a clinical society has initiated a decision process about health-care prioritization on a European level, following the principles of accountability for reasonableness. We provide points to consider to stimulate this debate across the EU and to serve as a reference for improving patient management.
authors.affiliation: Institute for Health Economics and Health Care Management, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
authors.forename: Franziska
authors.initials: F
authors.lastname: Severin
authors.affiliation: Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
authors.forename: Pascal
authors.initials: P
authors.lastname: Borry
authors.affiliation: Department of Clinical Genetics, Section Community Genetics, EMGO Institute for Health and Care Research, VU University Medical Center Amsterdam, Amsterdam, The Netherlands.
authors.forename: Martina C
authors.initials: MC
authors.lastname: Cornel
authors.affiliation: Department of Global Health and Population, Harvard School of Public Health, Boston, MA, USA.
authors.forename: Norman
authors.initials: N
authors.lastname: Daniels
authors.affiliation: Service de Génétique Médicale, CHUV, Lausanne, Switzerland.
authors.forename: Florence
authors.initials: F
authors.lastname: Fellmann
authors.affiliation: Department of Medical Genetics, St George's University of London, London, UK.
authors.forename: Shirley
authors.initials: S
authors.lastname: Victoria Hodgson
authors.affiliation: 1] Center for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden [2] Université de Toulouse 3 Paul Sabatier, UMR 1027, Faculté de médecine Purpan, Toulouse, France.
authors.forename: Heidi C
authors.initials: HC
authors.lastname: Howard
authors.affiliation: Institute for Health Economics and Health Care Management, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: John
authors.affiliation: National Institute for Health and Welfare, Helsinki, Finland.
authors.forename: Helena
authors.initials: H
authors.lastname: Kääriäinen
authors.affiliation: Department of Medical Genetics, Istanbul Medical Faculty, Istanbul University, Istanbul, Turkey.
authors.forename: Hülya
authors.initials: H
authors.lastname: Kayserili
authors.affiliation: Genetic Alliance UK, Unit 4D, Leroy House, London, UK.
authors.forename: Alastair
authors.initials: A
authors.lastname: Kent
authors.affiliation: Institute for Health Economics and Health Care Management, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
authors.forename: Florian
authors.initials: F
authors.lastname: Koerber
authors.affiliation: Department of Clinical Genetics, Laboratory Medicine, Region Skane and Lund University, Lund, Sweden.
authors.forename: Ulf
authors.initials: U
authors.lastname: Kristoffersson
authors.affiliation: PHG Foundation, 2 Worts Causeway, Cambridge, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Kroese
authors.affiliation: Clinical and Molecular Genetics, UCL Institute of Child Health and Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.
authors.forename: Celine
authors.initials: C
authors.lastname: Lewis
authors.affiliation: Institute for Ethics, History and Theory of Medicine, Ludwig Maximilians University Munich, Munich, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Marckmann
authors.affiliation: 1] Human Genetics Foundation, Munich, Germany [2] Institute for Medical Genetics, University Medicine, Rostock, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Meyer
authors.affiliation: Institute for Bioinformatics and Systems Biology, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
authors.forename: Arne
authors.initials: A
authors.lastname: Pfeufer
authors.affiliation: Department of Human Genetics, Hannover Medical School, Hannover, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Schmidtke
authors.affiliation: Faculty of Health and Human Science, School of Nursing and Midwifery, Plymouth University, Drake Circus Plymouth, UK.
authors.forename: Heather
authors.initials: H
authors.lastname: Skirton
authors.affiliation: 1] Department of Audiology, Bispebjerg Hospital/Rigshospitalet, Copenhagen, Denmark [2] Institute of Cellular and Molecular Medicine, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Lisbeth
authors.initials: L
authors.lastname: Tranebjærg
authors.affiliation: 1] Institute for Health Economics and Health Care Management, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany [2] Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Clinical Center, Ludwig Maximilians University, Munich, Germany.
authors.forename: Wolf H
authors.initials: WH
authors.lastname: Rogowski
mesh_terms: D064790:Clinical Laboratory Services / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D005060:Europe; D005820:Genetic Testing / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D012941:Social Responsibility