title: [Whole-genome sequencing in German clinical practice : Economic impacts of its use in selected areas of application].
abstract: BACKGROUND
  The diagnostic use of whole-genome sequencing (WGS) is a growing issue in medical care. Due to limited resources in public health service, budget-impact analyses are necessary prior to implementation.
  
  
  OBJECTIVE
  A budget-impact analysis for WGS of all newborns and diagnostic investigation of tumor patients in different oncologic indications were evaluated.
  
  
  METHODS
  A cost analysis of WGS based on a quality-assured process chart for WGS at the German Cancer Research Center (DKFZ), Heidelberg, constitutes the basis for this evaluation. Data from the National Association of Statutory Health Insurance Funds and the Robert-Koch-Institute, Berlin, were used for calculations of specific clinical applications.
  
  
  CONCLUSIONS
  WGS in newborn screening leads to costs of € 2.85 bn and to an increase of total expenditure by 1.41%. Sequencing of all tumor patients would cost approximately € 0.84 bn, which corresponds to 0.42% of total expenditures. In all scenarios, the sole consideration of procedure costs results in increasing costs. However, in cost discussions potential savings (reduction of disease-related follow-up-costs, improved cost-effectiveness of medical measures etc.) should be considered. Such considerations are the subject of economic indication-specific evaluations. WGS has the potential to generate a large number of deterministic findings for which treatment options are limited. Hence, it is necessary to limit indications, in which WGS has proven medical evidence.
authors.affiliation: Center for Health Economics Research Hannover (CHERH), Leibniz University Hannover, Otto-Brenner-Straße 1, 30159, Hannover, Deutschland. mp@cherh.de.
authors.forename: Marika
authors.initials: M
authors.lastname: Plöthner
authors.affiliation: Center for Health Economics Research Hannover (CHERH), Leibniz University Hannover, Otto-Brenner-Straße 1, 30159, Hannover, Deutschland.
authors.forename: Martin
authors.initials: M
authors.lastname: Frank
authors.affiliation: Center for Health Economics Research Hannover (CHERH), Leibniz University Hannover, Otto-Brenner-Straße 1, 30159, Hannover, Deutschland.
authors.forename: J-Matthias
authors.initials: JM
authors.lastname: Graf von der Schulenburg
mesh_terms: D002874:Chromosome Mapping / Q000191:economics* / Q000706:statistics & numerical data; D017281:Cost of Illness; D005820:Genetic Testing / Q000191:economics* / Q000706:statistics & numerical data; D005858:Germany / Q000453:epidemiology; D017048:Health Care Costs / Q000706:statistics & numerical data*; D059014:High-Throughput Nucleotide Sequencing / Q000191:economics* / Q000706:statistics & numerical data; D006801:Humans; D007231:Infant, Newborn; D015997:Neonatal Screening / Q000191:economics* / Q000706:statistics & numerical data; D010818:Practice Patterns, Physicians' / Q000191:economics* / Q000706:statistics & numerical data
keywords: Budget-impact analyses; Genetic diagnostics; Newborn screening; Oncology; Whole-genome sequencing