Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs... more Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs will become unsustainable for universal healthcare access. Moreover, early market access of new oncology medicines lacking appropriate clinical evaluation generates uncertainty over their cost-effectiveness and increases expenditure for unknown health gain. Patient-level data can complement clinical trials and generate better evidence on the effectiveness, safety and outcomes of these new medicines in routine care. This can support policy decisions including funding. Consequently, there is a need for improving datasets for establishing real-world outcomes of newly launched oncology medicines.Aim: To outline the types of available datasets for collecting patient-level data for oncology among different European countries. Additionally, to highlight concerns regarding the use and availability of such data from a health authority perspective as well as possibilities for cross-national colla...
The aim of the current study is to analyze the legislation and reimbursed market of medical devic... more The aim of the current study is to analyze the legislation and reimbursed market of medical devices in Serbia and Bulgaria. Comparative legislation analysis was performed focusing on the European Directives, National legislative acts and regulations endorsing the rules for medical devices authorization, classification, quality control, and reimbursement of medical devices. First was analyzed the development and major requirements of European legislation on medical devices since 1990 when the first EU Directive was issued. Next was analyzed the national laws on medicines in both countries and related regulations and institutions for medical devices authorization and quality control. Then was reviewed the legislative requirements for medical devices reimbursement and payment in both countries under consideration. Market analysis was performed towards the officially published data by the health insurance authorizes in both countries for the reimbursed cost by type of medical devices an...
Background Parkinson's disease (PD), which occurs in 1% of the population, is the second most... more Background Parkinson's disease (PD), which occurs in 1% of the population, is the second most common neurodegenerative disorder. Despite the broad spectrum of PD manifestations and high disease prevalence, there are insufficient data on medicine utilization and prescription strategies. The purpose of the current study was to analyze published data concerning treatment approaches and to compare them with Bulgarian therapeutic practice. Design and methods We conducted a systematic review of the PubMed and Google Scholar databases, and we calculated medicine utilization in Bulgaria during 2018 and 2019 using the WHO methodology. Results The literature search identified a total of 311 publications, but only 12 met the inclusion criteria. Eleven studies pointed out that levodopa-containing medicine are the most frequently used, followed by dopamine agonists. The highest rate was found for levodopa-containing products and decarboxylase inhibitor (1.06 and 1.33 DDD/1000 inh/day), follo...
Analyzing the health economic results of the centralized procurement is important for critical as... more Analyzing the health economic results of the centralized procurement is important for critical assessment of the level of achievment of health goals during the tender process. OBJECTIVE : To compare the procurement legislation and its impact on the prices and quantities of procured medicines in the public sector. METHODS: legislation analysis of both procurement laws and regulations for medicines supply issued during 1997 - 2003. Calculation of price and quantities indexes of procured oncology medicines via centralized tenders for the period 2000 - 2003. RESULTS : The tenders are organized in Macedonia by the Health insurance fund for all levels of health care and all medicines included in the procurament list while in Bulgaria Ministry of health is organizing a central drug procurament for 121 INN life - saving and expensive medicines dispensed via specialized clinics. Changes in the price and quantity indexes for oncology products in Bulgaria shows increase in quantity index till ...
Medication non-adherence is associated with almost 200,000 deaths annually and €80–125 billion in... more Medication non-adherence is associated with almost 200,000 deaths annually and €80–125 billion in the European Union. Novel technological advances (smart pill bottles, digital inhalers and spacers, electronic pill blisters, e-injection pens, e-Health applications, big data) could help managing non-adherence. Healthcare professionals seem however inadequately informed about non-adherence, availability of technological solutions in daily practice is limited, and collaborative efforts to push forward their implementation are scarce. The European Network to Advance Best practices and technoLogy on medication adherencE (ENABLE, COST Action 19132) aims to 1) raise awareness of adherence enhancing solutions, 2) foster knowledge on medication adherence, 3) accelerate clinical application of novel technologies and 4) work collaboratively towards economically viable policy, and implementation of adherence enhancing technology across healthcare systems.
The objective of the study is analysis of the prescription patterns in Bulgaria, Romania, Macedon... more The objective of the study is analysis of the prescription patterns in Bulgaria, Romania, Macedonia and Bosnia Herzegovina (BiH). The study discusses the relevance between prescription and morbidity and the rationality of the drug prescription in terms of Essential Drug Concept (EDC). For the assessment of the morbidity influence on the prescription official statistical information was reviewed and prevailing causes of diseases in the observed countries were calculated. To study the patterns geographically selected regions from the countries under consideration were observed during 1998-2000. In all the countries under consideration respiratory tract, nervous system and cardiovascular diseases are playing the leading role. The prescription of cardiovascular drugs, anti-infectious nervous and respiratory system drugs also predominate. Comparison between prescription and morbidity patterns shows a significant relationship between the morbidity and prescription patterns. Prescription m...
The aim of this paper is to identify the barriers that are specifically relevant to the use of Ar... more The aim of this paper is to identify the barriers that are specifically relevant to the use of Artificial Intelligence (AI)-based evidence in Central and Eastern European (CEE) Health Technology Assessment (HTA) systems. The study relied on two main parallel sources to identify barriers to use AI methodologies in HTA in CEE, including a scoping literature review and iterative focus group meetings with HTx team members. Most of the other selected articles discussed AI from a clinical perspective (n = 25), and the rest are from regulatory perspective (n = 13), and transfer of knowledge point of view (n = 3). Clinical areas studied are quite diverse—from pediatric, diabetes, diagnostic radiology, gynecology, oncology, surgery, psychiatry, cardiology, infection diseases, and oncology. Out of all 38 articles, 25 (66%) describe the AI method and the rest are more focused on the utilization barriers of different health care services and programs. The potential barriers could be classified ...
The goal of this pilot study is to perform a cost analysis by using patients with rheumatoid arth... more The goal of this pilot study is to perform a cost analysis by using patients with rheumatoid arthritis as a source of information. The point of view is that of the patients and society and the time horizon is one year. It is a micro costing study calculating the direct health care cost of pharmacotherapy. The pharmacotherapy includes 6 main therapeutic groups of medicines as corticosteroids (per os or intraarticular injections), disease modifying antirheumatics (DMAR), biological, non-steroidal anti-inflammatory drugs (NSAID), medicines improving bone density, and proton pump inhibitors (PPI).Monthly cost of pharmacotherapy per patient on average is 815.05 (SD 1104.25) BGN, and biological therapy is the most expensive one 2961.03 (SD 1435.46). 25% of the patients are on it. 58 per cent of the patients reported regular physicians' visits at least ones quarterly with average yearly cost of 111.60 BGN (9.30 BGN per month). 56 people were out of work and for 13 of them it was for mo...
Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs... more Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs will become unsustainable for universal healthcare access. Moreover, early market access of new oncology medicines lacking appropriate clinical evaluation generates uncertainty over their cost-effectiveness and increases expenditure for unknown health gain. Patient-level data can complement clinical trials and generate better evidence on the effectiveness, safety and outcomes of these new medicines in routine care. This can support policy decisions including funding. Consequently, there is a need for improving datasets for establishing real-world outcomes of newly launched oncology medicines.Aim: To outline the types of available datasets for collecting patient-level data for oncology among different European countries. Additionally, to highlight concerns regarding the use and availability of such data from a health authority perspective as well as possibilities for cross-national colla...
The aim of the current study is to analyze the legislation and reimbursed market of medical devic... more The aim of the current study is to analyze the legislation and reimbursed market of medical devices in Serbia and Bulgaria. Comparative legislation analysis was performed focusing on the European Directives, National legislative acts and regulations endorsing the rules for medical devices authorization, classification, quality control, and reimbursement of medical devices. First was analyzed the development and major requirements of European legislation on medical devices since 1990 when the first EU Directive was issued. Next was analyzed the national laws on medicines in both countries and related regulations and institutions for medical devices authorization and quality control. Then was reviewed the legislative requirements for medical devices reimbursement and payment in both countries under consideration. Market analysis was performed towards the officially published data by the health insurance authorizes in both countries for the reimbursed cost by type of medical devices an...
Background Parkinson's disease (PD), which occurs in 1% of the population, is the second most... more Background Parkinson's disease (PD), which occurs in 1% of the population, is the second most common neurodegenerative disorder. Despite the broad spectrum of PD manifestations and high disease prevalence, there are insufficient data on medicine utilization and prescription strategies. The purpose of the current study was to analyze published data concerning treatment approaches and to compare them with Bulgarian therapeutic practice. Design and methods We conducted a systematic review of the PubMed and Google Scholar databases, and we calculated medicine utilization in Bulgaria during 2018 and 2019 using the WHO methodology. Results The literature search identified a total of 311 publications, but only 12 met the inclusion criteria. Eleven studies pointed out that levodopa-containing medicine are the most frequently used, followed by dopamine agonists. The highest rate was found for levodopa-containing products and decarboxylase inhibitor (1.06 and 1.33 DDD/1000 inh/day), follo...
Analyzing the health economic results of the centralized procurement is important for critical as... more Analyzing the health economic results of the centralized procurement is important for critical assessment of the level of achievment of health goals during the tender process. OBJECTIVE : To compare the procurement legislation and its impact on the prices and quantities of procured medicines in the public sector. METHODS: legislation analysis of both procurement laws and regulations for medicines supply issued during 1997 - 2003. Calculation of price and quantities indexes of procured oncology medicines via centralized tenders for the period 2000 - 2003. RESULTS : The tenders are organized in Macedonia by the Health insurance fund for all levels of health care and all medicines included in the procurament list while in Bulgaria Ministry of health is organizing a central drug procurament for 121 INN life - saving and expensive medicines dispensed via specialized clinics. Changes in the price and quantity indexes for oncology products in Bulgaria shows increase in quantity index till ...
Medication non-adherence is associated with almost 200,000 deaths annually and €80–125 billion in... more Medication non-adherence is associated with almost 200,000 deaths annually and €80–125 billion in the European Union. Novel technological advances (smart pill bottles, digital inhalers and spacers, electronic pill blisters, e-injection pens, e-Health applications, big data) could help managing non-adherence. Healthcare professionals seem however inadequately informed about non-adherence, availability of technological solutions in daily practice is limited, and collaborative efforts to push forward their implementation are scarce. The European Network to Advance Best practices and technoLogy on medication adherencE (ENABLE, COST Action 19132) aims to 1) raise awareness of adherence enhancing solutions, 2) foster knowledge on medication adherence, 3) accelerate clinical application of novel technologies and 4) work collaboratively towards economically viable policy, and implementation of adherence enhancing technology across healthcare systems.
The objective of the study is analysis of the prescription patterns in Bulgaria, Romania, Macedon... more The objective of the study is analysis of the prescription patterns in Bulgaria, Romania, Macedonia and Bosnia Herzegovina (BiH). The study discusses the relevance between prescription and morbidity and the rationality of the drug prescription in terms of Essential Drug Concept (EDC). For the assessment of the morbidity influence on the prescription official statistical information was reviewed and prevailing causes of diseases in the observed countries were calculated. To study the patterns geographically selected regions from the countries under consideration were observed during 1998-2000. In all the countries under consideration respiratory tract, nervous system and cardiovascular diseases are playing the leading role. The prescription of cardiovascular drugs, anti-infectious nervous and respiratory system drugs also predominate. Comparison between prescription and morbidity patterns shows a significant relationship between the morbidity and prescription patterns. Prescription m...
The aim of this paper is to identify the barriers that are specifically relevant to the use of Ar... more The aim of this paper is to identify the barriers that are specifically relevant to the use of Artificial Intelligence (AI)-based evidence in Central and Eastern European (CEE) Health Technology Assessment (HTA) systems. The study relied on two main parallel sources to identify barriers to use AI methodologies in HTA in CEE, including a scoping literature review and iterative focus group meetings with HTx team members. Most of the other selected articles discussed AI from a clinical perspective (n = 25), and the rest are from regulatory perspective (n = 13), and transfer of knowledge point of view (n = 3). Clinical areas studied are quite diverse—from pediatric, diabetes, diagnostic radiology, gynecology, oncology, surgery, psychiatry, cardiology, infection diseases, and oncology. Out of all 38 articles, 25 (66%) describe the AI method and the rest are more focused on the utilization barriers of different health care services and programs. The potential barriers could be classified ...
The goal of this pilot study is to perform a cost analysis by using patients with rheumatoid arth... more The goal of this pilot study is to perform a cost analysis by using patients with rheumatoid arthritis as a source of information. The point of view is that of the patients and society and the time horizon is one year. It is a micro costing study calculating the direct health care cost of pharmacotherapy. The pharmacotherapy includes 6 main therapeutic groups of medicines as corticosteroids (per os or intraarticular injections), disease modifying antirheumatics (DMAR), biological, non-steroidal anti-inflammatory drugs (NSAID), medicines improving bone density, and proton pump inhibitors (PPI).Monthly cost of pharmacotherapy per patient on average is 815.05 (SD 1104.25) BGN, and biological therapy is the most expensive one 2961.03 (SD 1435.46). 25% of the patients are on it. 58 per cent of the patients reported regular physicians' visits at least ones quarterly with average yearly cost of 111.60 BGN (9.30 BGN per month). 56 people were out of work and for 13 of them it was for mo...
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