title: Transparency vs. closed-door policy: do process characteristics have an impact on the outcomes of coverage decisions? A statistical analysis.
abstract: The aim of this study was to analyze influences of process- and technology-related characteristics on the outcomes of coverage decisions. Using survey data on 77 decisions from 13 countries, we examined whether outcomes differ by 14 variables that describe components of decision-making processes and the technology. We analyzed the likelihood of committees covering a technology, i.e. positive (including partial coverage) vs. negative coverage decisions. We performed non-parametric univariate tests and binomial logistic regression with a stepwise variable selection procedure. We identified a negative association between a positive decision and whether the technology is a prescribed medicine (p=0.0097). Other significant influences on a positive decision outcome included one disease area (p=0.0311) and whether a technology was judged to be (cost-)effective (p<0.0001). The first estimation of the logistic regression yielded a quasi-complete separation for technologies that were clearly judged (cost-)effective. In uncertain decisions, a higher number of stakeholders involved in voting (odds ratio=2.52; p=0.03) increased the likelihood of a positive outcome. The results suggest that decisions followed the lines of evidence-based decision-making. Despite claims for transparent and participative decision-making, the phase of evidence generation seemed most critical as decision-makers usually adopted the assessment recommendations. We identified little impact of process configurations.
authors.affiliation: Hamburg Center for Health Economics, Universität Hamburg, Esplanade 36, 20354 Hamburg, Germany; Institute of Health Economics and Health Care Management, Helmholtz Zentrum München - German Research Center for Environmental Health, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany. Electronic address: katharina.fischer@wiso.uni-hamburg.de.
authors.forename: Katharina E
authors.initials: KE
authors.lastname: Fischer
authors.forename: Wolf H
authors.initials: WH
authors.lastname: Rogowski
authors.forename: Reiner
authors.initials: R
authors.lastname: Leidl
authors.forename: Björn
authors.initials: B
authors.lastname: Stollenwerk
mesh_terms: D003362:Cost-Benefit Analysis; D003657:Decision Making; D011307:Drug Prescriptions / Q000191:economics; D036262:Empirical Research; D005062:European Union; D055317:Evidence-Based Practice; D006291:Health Policy; D006801:Humans; D019458:Insurance Coverage / Q000191:economics*; D020407:Internet; D018803:Models, Economic; D015233:Models, Statistical; D017063:Outcome Assessment, Health Care; D011795:Surveys and Questionnaires; D013673:Technology Assessment, Biomedical / Q000191:economics*
keywords: Coverage decision-making; Drug reimbursement; Fourth hurdle; Industrialized countries; Logistic regression; Market access; Participation; Public drug formularies