title: THE EARLY BIRD CATCHES THE WORM: EARLY COST-EFFECTIVENESS ANALYSIS OF NEW MEDICAL TESTS.
abstract: OBJECTIVE
  There is little specific guidance on performing an early cost-effectiveness analysis (CEA) of medical tests. We developed a framework with general steps and applied it to two cases.
  
  
  METHODS
  Step 1 is to narrow down the scope of analysis by defining the test's application, target population, outcome measures, and investigating current test strategies and test strategies if the new test were available. Step 2 is to collect evidence on the current test strategy. Step 3 is to develop a conceptual model of the current and new test strategies. Step 4 is to conduct the early-CEA by evaluating the potential (cost-)effectiveness of the new test in clinical practice. Step 5 involves a decision about the further development of the test.
  
  
  RESULTS
  The first case illustrated the impact of varying the test performance on the headroom (maximum possible price) of an add-on test for patients with an intermediate-risk of having rheumatoid arthritis. Analyses showed that the headroom is particularly dependent on test performance. The second case estimated the minimum performance of a confirmatory imaging test to predict individual stroke risk. Different combinations of sensitivity and specificity were found to be cost-effective; if these combinations are attainable, the medical test developer can feel more confident about the value of further development of the test.
  
  
  CONCLUSIONS
  A well-designed early-CEA methodology can improve the ability to develop (cost-)effective medical tests in an efficient manner. Early-CEAs should continuously integrate insights and evidence that arise through feedback, which may convince developers to return to earlier steps.
authors.affiliation: Institute of Health Policy and Management,Erasmus University Rotterdam;Institute for Medical Technology Assessment,Erasmus University Rotterdambuisman@bmg.eur.nl.
authors.forename: Leander R
authors.initials: LR
authors.lastname: Buisman
authors.affiliation: Institute of Health Policy and Management,Erasmus University Rotterdam;Institute for Medical Technology Assessment,Erasmus University Rotterdam.
authors.forename: Maureen P M H
authors.initials: MP
authors.lastname: Rutten-van Mölken
authors.affiliation: Department of Epidemiology,University of Groningen,University Medical Center Groningen.
authors.forename: Douwe
authors.initials: D
authors.lastname: Postmus
authors.affiliation: Department of Rheumatology,Erasmus MC,University Medical Center Rotterdam.
authors.forename: Jolanda J
authors.initials: JJ
authors.lastname: Luime
authors.affiliation: Institute of Health Policy and Management,Erasmus University Rotterdam;Institute for Medical Technology Assessment,Erasmus University Rotterdam.
authors.forename: Carin A
authors.initials: CA
authors.lastname: Uyl-de Groot
authors.affiliation: Institute of Health Policy and Management,Erasmus University Rotterdam;Institute for Medical Technology Assessment,Erasmus University Rotterdam.
authors.forename: William K
authors.initials: WK
authors.lastname: Redekop
mesh_terms: D001172:Arthritis, Rheumatoid / Q000175:diagnosis; D003362:Cost-Benefit Analysis / Q000458:organization & administration*; D003657:Decision Making; D019937:Diagnostic Techniques and Procedures / Q000191:economics*; D006801:Humans; D017059:Models, Econometric; D012008:Recurrence; D012680:Sensitivity and Specificity; D020521:Stroke / Q000503:physiopathology; D013673:Technology Assessment, Biomedical / Q000458:organization & administration*; D013997:Time Factors
keywords: Decision support; Early cost-effectiveness analysis; Manufacturer; Medical test; Research and development; Test developer