Insight into reimbursement decision-making criteria in Bulgaria: implications for orphan drugs

Искров, Георги; Raycheva, Ralitsa; Стефанов, Румен

doi:10.2478/folmed-2013-0032

Cited by 16 publications

(31 citation statements)

References 15 publications

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“…Mandating the use of local HTA evidence without adequate human resources and permanent educational programs may also negatively influence the quality of technology assessment processes. In such cases (e.g., Bulgaria), stakeholders may not fully rely on HTA recommendations in policy decisions (Iskrov et al, 2013).…”

Section: Patterns Of Health Technology Assessment Implementation Pracmentioning

confidence: 99%

HTA Implementation Roadmap in Central and Eastern European Countries

Kaló

Gheorghe

Huić³

et al. 2016

Health Economics

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The opportunity cost of inappropriate health policy decisions is greater in Central and Eastern European (CEE) compared with Western European (WE) countries because of poorer population health and more limited healthcare resources. Application of health technology assessment (HTA) prior to healthcare financing decisions can improve the allocative efficiency of scarce resources. However, few CEE countries have a clear roadmap for HTA implementation. Examples from high‐income countries may not be directly relevant, as CEE countries cannot allocate so much financial and human resources for substantiating policy decisions with evidence.Our objective was to describe the main HTA implementation scenarios in CEE countries and summarize the most important questions related to capacity building, financing HTA research, process and organizational structure for HTA, standardization of HTA methodology, use of local data, scope of mandatory HTA, decision criteria, and international collaboration in HTA.Although HTA implementation strategies from the region can be relevant examples for other CEE countries with similar cultural environment and economic status, HTA roadmaps are not still fully transferable without taking into account country‐specific aspects, such as country size, gross domestic product per capita, major social values, public health priorities, and fragmentation of healthcare financing. Copyright © 2016 John Wiley & Sons, Ltd.

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Section: Patterns Of Health Technology Assessment Implementation Pracmentioning

confidence: 99%

HTA Implementation Roadmap in Central and Eastern European Countries

Kaló

Gheorghe

Huić³

et al. 2016

Health Economics

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“…The country has only recently started officially implementing HTA in drug reimbursement decision-making (9). The Ordinance on the terms, rules and procedure for regulation and registration of prices for medicinal products was adopted at the end of 2011 to provide a more sophisticated base for reimbursement decisions (12).…”

Section: Drug Reimbursement Decision-making -An Even Bigger Problem Imentioning

confidence: 99%

“…The Council, however, only appraises industry-submitted HTA reports. It does not perform assessment tasks itself (9,12).…”

Section: Drug Reimbursement Decision-making -An Even Bigger Problem Imentioning

confidence: 99%

“…33, No. 1,2016 to the list of reimbursement decision-making variables, currently defined and used in Bulgaria (9,12).…”

Section: Selection Of Respondentsmentioning

confidence: 99%

“…So have the Eastern European countries (7)(8)(9)(10)(11). Nevertheless, challenges remain when it comes to the role of HTA in public health decision-making as well as to human resource capacities of these countries (11).…”

Section: Drug Reimbursement Decision-making -An Even Bigger Problem Imentioning

confidence: 99%

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

Искров

Стефанов

2016

Balkan Med J

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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.

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Criteria and Scoring Functions Used in Multi-criteria Decision Analysis and Value Frameworks for the Assessment of Rare Disease Therapies: A Systematic Literature Review

Zelei¹,

Mendola²,

Elezbawy³

et al. 2021

PharmacoEconomics Open

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Background Traditionally, the economic value of health technologies is assessed with cost-effectiveness (CE) and budget impact (BI) analyses. However, the evaluation of rare disease therapies often considers novel value criteria. Multi-criteria decision analysis (MCDA) is a promising tool in the assessment of value criteria that typically cannot be captured with traditional approaches. Objectives The objective of this research was to investigate the criteria and scoring functions applied in value frameworks and MCDA tools relevant to the evaluation of rare disease therapies. The aim was to gain a better understanding of the domains and measurement of commonly referenced novel value criteria. Methods A systematic literature review was performed covering the period from 2013 to 2019. MCDA or value framework articles and structured review papers on orphan-drug-specific MCDA articles were reviewed. Information sources included MEDLINE, Embase, Scopus, and 26 other gray literature sources. A descriptive review of identified criteria and scoring functions was performed, with special focus on "novel" value criteria that are traditionally not considered in CE or BI analyses. Results In total, 15 relevant value frameworks and MCDA tools were identified. These studies included a large number (n = 56) of individual value criteria. The most commonly included novel criteria were unmet medical need, severity of disease, and reduction in uncertainty. The identified scoring functions (measurement methods) for novel criteria were highly heterogeneous and tailored. Standardized scoring functions were not observed. Additionally, the studies did not provide their rationale for choosing a specific scoring function for a criterion. Conclusions MCDA is a promising tool to include novel value criteria into the health technology assessment of therapies for rare diseases. To support the development of a transparent and justified evaluation process, scoring functions should be further investigated.

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Insight into reimbursement decision-making criteria in Bulgaria: implications for orphan drugs

Cited by 16 publications

References 15 publications

HTA Implementation Roadmap in Central and Eastern European Countries

HTA Implementation Roadmap in Central and Eastern European Countries

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

Criteria and Scoring Functions Used in Multi-criteria Decision Analysis and Value Frameworks for the Assessment of Rare Disease Therapies: A Systematic Literature Review

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