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

Abstract

Background: During times of fiscal austerity, means of reimbursement decision-making are of particular interest for public health theory and practice. Introduction of advanced health technologies, growing health expenditures and increased public scrutiny over drug reimbursement 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 rationale 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 reimbursement decision-making and to unveil relationships between theory and practice. Study Design: Cross-sectional study. Methods: The study was realized through a closedended survey on reimbursement criteria among four major public health stakeholders -medical professionals, patients, health authorities, and industry. Empirical outcomes were then cross-compared with the theoretical 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 reimbursement decision-making. Results: Bulgarian public health stakeholders agreed on 15 criteria to form a tentative optimal framework for drug reimbursement decision-making. The most apparent 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 national public health objectives. These recommendations could be expanded to all Eastern European countries who share common public health problems.

Multi-Criteria Decision Analysis for Assessment and Appraisal of Orphan Drugs

“…Preferences for weights and scores are country specific, as local resources, needs, and expectations strongly differ from one national health system to another. These differences impact the level of importance of individual criteria, making any value measurement model unique for its own public health settings ( 4 ). Nevertheless, our relative big sample could provide important insights for health policy stakeholders from various countries, as today all health-care systems face a common challenge – to balance limited budgets and increased expectations, formal requirements, and informal constraints ( 34 , 35 ).…”

“…The initial list of reimbursement decision criteria was made through a previous closed-ended survey among four stakeholder groups (medical professionals, patient representatives, health authorities, and industry representatives), reported elsewhere ( 4 ). This study yielded 15 criteria to form a tentative optimal model for drug reimbursement decision-making.…”

“…Innovative health technologies complicate this problem further. They require additional consideration of context and implementation attributes, which go far beyond ICER ( 3 , 4 ).…”

“…The objective of this study was to create an MCDA value measurement model to assess and appraise orphan drugs. This research built upon two previous studies in Bulgaria – one analyzing reimbursement decision-making on orphan drugs under current HTA legal framework ( 17 ) and second identifying important criteria that are relevant to local stakeholders ( 4 ). Therefore, the present study’s aim was achieved by exploring the preferences on decision criteria’s weights and performance scores through a stakeholder-representative survey and a focus group discussion.…”

Health Economic Data in Reimbursement of New Medical Technologies: Importance of the Socio-Economic Burden as a Decision-Making Criterion

“…In all countries, choices in the allocation of resources are necessary. Health technology assessment (HTA) has been introduced as a concept to address rising health care costs and growing fiscal concerns ( Iskrov and Stefanov, 2016 ). Health economic data play a crucial role in this process and the subsequent reimbursement decision-making ( Jakovljevic and Getzen, 2016 ).…”