Criteria for Drug Reimbursement Decision-Making: An Emerging Public Health Challenge in Bulgaria

Background: During times of fiscal austerity, means of reimbursement decision-making are of particular inter-est for public health theory and practice. Introduction of advanced health technologies, growing health expendi-tures and increased public scrutiny over drug reimburse-ment decisions have pushed governments to consider mechanisms that promote the use of effective health technologies, while constraining costs. Aims: The study's aim was to explore the current ra-tionale of the drug reimbursement decision-making framework in Bulgaria. Our pilot research focused on one particular component of this process - the criteria used - because of the critical role that criteria are known to have in setting budgets and priorities in the field of public health. The analysis pursued two objectives: to identify important criteria relevant to drug reimburse-ment decision-making and to unveil relationships be-tween theory and practice. Study Design: Cross-sectional study.Methods: The study was realized through a closed-ended survey on reimbursement criteria among four major public health stakeholders - medical profession-als, patients, health authorities, and industry. Empirical outcomes were then cross-compared with the theoreti-cal framework, as defined by current Bulgarian public health legislation. Analysis outlined what is done and what needs to be done in the field of public health reim-bursement decision-making. Results: Bulgarian public health stakeholders agreed on 15 criteria to form a tentative optimal framework for drug reimbursement decision-making. The most appar-ent gap between the empirically found preferences and the official legislation is the lack of consideration for the strength of evidence in reimbursement decisions.Conclusion: Bulgarian policy makers need to address specific gaps, such as formal consideration for strength of evidence, explicit role of efficiency criteria, and means to effectively empower patient and citizen involvement in public health decision-making. Drug reimbursement criteria have to be integrated into legitimate public health decision support tools that ensure the achievement of na-tional public health objectives. These recommendations could be expanded to all Eastern European countries who share common public health problems.

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