title: The role of health technology assessment in coverage decisions on newborn screening.
abstract: OBJECTIVE
  The role and impact of health technology assessment (HTA) in health policy has been widely discussed. Researchers have started to analyze how decisions on coverage of new technologies are made. Although the involvement of HTA may be an indicator of a well established decision process, this hypothesis requires validation. Also, it is not known whether HTA involvement is associated with other characteristics of decision making like participation or transparency. The primary objective of this study was to develop and test statements on the association between the publication of an HTA and coverage decision making for newborn screening tests in European Union countries.
  
  
  METHODS
  Five statements were defined on the relative role of HTA during the steps of decision processes: trigger, participation, publication, assessment, and appraisal. For this purpose, data on twenty-two decision processes in the area of newborn screening across Europe were analyzed, defined as a coverage decision for a given disorder in a specific country. Decision processes were compared by whether the decision was accompanied by the publication of an HTA report. To test differences, nonparametric statistical tests were used.
  
  
  RESULTS
  The decision steps of trigger, participation and publication differed between the HTA and the non-HTA groups. No clear association between HTA and assessment methods in coverage decision making was identified.
  
  
  CONCLUSIONS
  It appeared that there is an association between HTA and coverage decision processes that are more explicit, inclusive, and transparent. It is unclear whether HTA is associated with formal evidence reviews and economic evaluations.
authors: Helmholtz Zentrum München, German Research Center for Environmental Health, Institute of Health Economics and Health Care Management, Neuherberg, Germany. Katharina.Fischer@helmholtzmuenchen.de
authors: Katharina E
authors: KE
authors: Fischer
authors: Scott D
authors: SD
authors: Grosse
authors: Wolf H
authors: WH
authors: Rogowski
mesh_terms: D003657:Decision Making; D005060:Europe; D006291:Health Policy; D006801:Humans; D007231:Infant, Newborn; D019458:Insurance Coverage / Q000706:statistics & numerical data*; D007348:Insurance, Health / Q000706:statistics & numerical data*; D008659:Metabolic Diseases / Q000175:diagnosis; D015997:Neonatal Screening / Q000191:economics / Q000706:statistics & numerical data*; D053719:Tandem Mass Spectrometry; D013673:Technology Assessment, Biomedical / Q000706:statistics & numerical data*