title: Factors influencing coverage decisions on medical devices: A retrospective analysis of 78 medical device appraisals for the Austrian hospital benefit catalogue 2008-2015.
abstract: BACKGROUND
  Health technology assessments of medical devices (MD) present a well-recognized challenge to evaluators: the evidence on safety and clinical effectiveness is often of lower quality than for pharmaceuticals making a reliable assessment of the risk-benefit ratio difficult. Thus other factors might gain importance in decision making.
  
  
  OBJECTIVE
  To analyse which factors impact MD reimbursement decisions within the Austrian appraisal programme on "extra medical services" (procedures reimbursed in addition to case flat rates) for inpatient care over the past eight years.
  
  
  METHODS
  We collected variables on evidence base and device characteristics from all MD appraisals and assessed their impact on the reimbursement decision by means of odds ratios. Separate analyses were carried out for subgroups based on the risk class of the medical device subject of the assessment or the number of randomised controlled trials (RCTs) available for the assessment.
  
  
  RESULTS
  Of 59 devices, 23 (39%) were accepted for reimbursement (18 with restrictions) and 36 (61%) were rejected. Variables addressing the quality of the evidence base were positive predictors for risk class II devices only, whereas no significant association could be determined in devices of risk class III. Inversely, high risk device characteristics were positive predictors in the subgroup not supported by RCTs only.
  
  
  CONCLUSIONS
  Our data indicate that the combination of high risk characteristics and a low evidence base are factors favouring a positive reimbursement decision of MD, albeit with restrictions. Further research should analyse if these restrictions are appropriate to generate evidence development and to contain risks associated with early access to these MD.
authors.affiliation: Ludwig Boltzmann Institute for Health Technology Assessment, Austria. Electronic address: agnes.kisser@hta.lbg.ac.at.
authors.forename: Agnes
authors.initials: A
authors.lastname: Kisser
authors.affiliation: Ludwig Boltzmann Institute for Health Technology Assessment, Austria.
authors.forename: Heinz
authors.initials: H
authors.lastname: Tüchler
authors.affiliation: Ludwig Boltzmann Institute for Health Technology Assessment, Austria.
authors.forename: Judit
authors.initials: J
authors.lastname: Erdös
authors.affiliation: Ludwig Boltzmann Institute for Health Technology Assessment, Austria.
authors.forename: Claudia
authors.initials: C
authors.lastname: Wild
mesh_terms: D001317:Austria; D003659:Decision Making, Organizational; D004864:Equipment and Supplies / Q000592:standards*; D055317:Evidence-Based Practice; D006761:Hospitals; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012189:Retrospective Studies; D018570:Risk Assessment; D013673:Technology Assessment, Biomedical / Q000379:methods / Q000592:standards*
keywords: Austria; Decision making; Health technology assessment; Medical devices