BEYOND THE EVIDENCE - THE INFLUENCE OF DECISION PROCESSES ON OUTCOMES IN COVERAGE DETERMINATION OF HEALTH TECHNOLOGIES

Author(s)

Fischer KE1, Rogowski WH2, Leidl R2, Stollenwerk B21University of Hamburg, Hamburg, Germany, 2Helmholtz Zentrum München - German Research Center for Environmental Health, Neuherberg, Germany

OBJECTIVES: Coverage decision processes determine the accessibility of health technologies. Cost-effectiveness considerations have been identified to explain decision outcomes. Beyond the evidence, outcomes may be influenced by the process configurations used by decision-makers. The aim of this exploratory study was to analyse the influences of transparency, stakeholder participation, scientific rigour of assessment and evidence judgments on decision outcomes in coverage decision-making. METHODS: Using survey data of 77 decisions from 13 countries, we examined whether outcomes differ by 14 variables that describe components of coverage decision-making and the technology considered for coverage. Neglecting the level of reimbursement, we analysed the likelihood of committees to cover a technology, i.e. positive (including partial coverage) vs. negative coverage decisions. We performed non-parametric univariate statistical tests and binomial logistic regression. To identify influences on decision outcomes, we applied a stepwise variable selection procedure. RESULTS: We identified associations between the decision outcome and the following variables: the technology is a prescribed medicine (p=0.0097); the health condition is an endocrine, nutritional or metabolic disease (p=0.0311) and the judgment of the evidence after assessment (p<0.0001). The first estimation of the logistic regression model suggested a quasi-complete separation for those decisions where effectiveness and costs/cost-effectiveness were clearly judged favourable or unfavourable. In decisions where the evidence was rated uncertain or was not assessed, we found that the number of stakeholders participating in the voting stage (odds ratio=2.52; p=0.03) and the scientific rigour in assessment of costs/cost-effectiveness (OR=6.25; p=0.06) increased the likelihood of a positive decision outcome. On the contrary, it significantly decreased for prescribed medicines (OR=0.05; p=0.003). CONCLUSIONS: Despite claims for making transparent and participative coverage decisions, the phase of evidence generation and synthesis is most critical for technology appraisal. Decision-makers usually adapt the assessment recommendations. Decision outcomes seem to a large extent independent of how processes are configured.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

RE4

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Multiple Diseases

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