title: Unifying Research and Reimbursement Decisions: Case Studies Demonstrating the Sequence of Assessment and Judgments Required.
abstract: BACKGROUND
  The key principles regarding what assessments lead to different types of guidance about the use of health technologies (Only in Research, Approval with Research, Approve, or Reject) provide an explicit and transparent framework for technology appraisal.
  
  
  OBJECTIVE
  We aim to demonstrate how these principles and assessments can be applied in practice through the use of a seven-point checklist of assessment.
  
  
  METHODS
  The value of access to a technology and the value of additional evidence are explored through the application of the checklist to the case studies of enhanced external counterpulsation for chronic stable angina and clopidogrel for the management of patients with non-ST-segment elevation acute coronary syndromes.
  
  
  RESULTS
  The case studies demonstrate the importance of considering 1) the expected cost-effectiveness and population net health effects; 2) the need for evidence and whether the type of research required can be conducted once a technology is approved for widespread use; 3) whether there are sources of uncertainty that cannot be resolved by research but only over time; and 4) whether there are significant (opportunity) costs that once committed by approval cannot be recovered.
  
  
  CONCLUSIONS
  The checklist demonstrates that cost-effectiveness is a necessary but not sufficient condition for approval. Only in Research may be appropriate when a technology is expected to be cost-effective due to significant irrecoverable costs. It is only approval that can be ruled out if a technology is not expected to be cost-effective. Lack of cost-effectiveness is not a necessary or sufficient condition for rejection.
authors.affiliation: Centre for Health Economics, University of York, York, North Yorkshire, UK. Electronic address: claire.mckenna@york.ac.uk.
authors.forename: Claire
authors.initials: C
authors.lastname: McKenna
authors.affiliation: Centre for Health Economics, University of York, York, North Yorkshire, UK.
authors.forename: Marta
authors.initials: M
authors.lastname: Soares
authors.affiliation: Centre for Health Economics, University of York, York, North Yorkshire, UK; Department of Economics and Related Studies, University of York, York, North Yorkshire, UK.
authors.forename: Karl
authors.initials: K
authors.lastname: Claxton
authors.affiliation: Centre for Health Economics, University of York, York, North Yorkshire, UK.
authors.forename: Laura
authors.initials: L
authors.lastname: Bojke
authors.affiliation: Centre for Health Economics, University of York, York, North Yorkshire, UK.
authors.forename: Susan
authors.initials: S
authors.lastname: Griffin
authors.affiliation: Centre for Health Economics, University of York, York, North Yorkshire, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Palmer
authors.affiliation: Centre for Health Economics, University of York, York, North Yorkshire, UK.
authors.forename: Eldon
authors.initials: E
authors.lastname: Spackman
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics*; D060050:Angina, Stable / Q000175:diagnosis / Q000191:economics* / Q000628:therapy*; D035843:Biomedical Research / Q000191:economics* / Q000592:standards; D057189:Checklist; D002755:Choice Behavior; D003362:Cost-Benefit Analysis; D015908:Counterpulsation / Q000191:economics*; D016527:Drug Costs; D017048:Health Care Costs; D005102:Health Expenditures; D006302:Health Services Research; D006801:Humans; D007600:Judgment; D018803:Models, Economic; D010975:Platelet Aggregation Inhibitors / Q000191:economics* / Q000627:therapeutic use*; D019057:Quality-Adjusted Life Years; D012051:Reimbursement Mechanisms / Q000592:standards; D013222:State Medicine / Q000191:economics; D013673:Technology Assessment, Biomedical / Q000191:economics* / Q000592:standards; D013997:Time Factors; D016896:Treatment Outcome; D035501:Uncertainty
chemical_list: D010975:Platelet Aggregation Inhibitors
keywords: cost-effectiveness; coverage with evidence development; health technology assessment; only in research; reimbursement decisions; research decisions