The number of publications on health technology assessment (HTA) from Central, Eastern, and Southern Europe (CESE countries) is still low compared with the north and west of Europe. It is not surprising, as the idea of HTA originated from high-income Western economies and was afterward adopted by the south-eastern part of Europe, which mostly consists of middle-income countries. These CESE countries, with less capacity and experience with HTA processes, must deal with even tougher decisions on financing health technologies than north-western Europe. There may even be a lack of confidence to open discussions on their specific needs for HTA.

Objectives: Our objectives were to assess the current implementation of health technology assessment (HTA) in Hungary and to identify country-specific patterns of challenges and potential improvements.

Methods: We applied a structure that can be used to create HTA implementation roadmaps to evaluate various issues regarding HTA implementation. A comprehensive description of the Hungarian HTA system is presented according to relevant literature and experiences of the authors.

Results: By investigating eight components of HTA implementation, we identified the most important strengths and weaknesses of the Hungarian system. More specifically, we were mainly focusing on the emergence of HTA capacity, the establishment and current role of Department of HTA, the complex process of decision making, the quality elements developed in the near past, and the activity of Hungarian experts at international collaborations.

Conclusions: We concluded that there is a sophisticated methodological and educational basis for HTA in Hungary. A permanent focus on capacity building and changes to the reimbursement procedure can further improve transparency and the scientific basis of decision making in the country.

Objectives: In the Czech Republic, the health technology assessment (HTA) approaches have been implemented in evaluation of medicinal products since 2008.

The aim of this study was to provide an overview of the implementation of HTA and different levels thereof in the evaluation process conducted by the State Institute for Drug Control (SUKL) and to describe the impact of HTA on the entrance of new medicinal entities into out-patient healthcare system including highly innovative and orphan drugs.

Methods: Materials supporting this overview were collected using the records in the database of administrative proceedings of SUKL, in-house standard operating procedures, and the legislation in force. Based on these sources as well as the hands-on knowledge of the current practice, a brief description of the general rules of administrative proceedings involving HTA of varying complexity was elaborated. Characteristic features of the individual types of proceedings, basic differences in the complexity of HTA employed, and its most important challenges were summarized.

Results: In Czech Republic, HTA in the formal administrative proceedings ensures a transparent process of introduction of new medicinal products into clinical practice and leaves space for restriction of reimbursement conditions to minimize budget impact.

Conclusions: As a robust as well as pragmatic HTA methodology has been implemented by SUKL, relevant stakeholders (marketing authorization holders, Health Care Funds, clinical expert groups) are now able to influence reimbursement of new technologies.

Objectives: The aim of our study was to describe approaches to health technology assessment (HTA) for medicines in the Slovak healthcare system and the related decision-making processes concerning reimbursement for medicines.

Methods: Analysis of the Slovak legislative framework related to HTA and the reimbursement process for medicines was performed. Additionally, current practices of the Working Group for Pharmacoeconomics, Clinical Outcomes and Health Technology Assessment of the Slovak Ministry of Health were evaluated.

Results: In Slovakia, there is always at least one treatment available in each determined therapeutic class with no co-payment. HTA is becoming an established method for the evaluation of cost-effectiveness of medicines in Slovak healthcare policy. The majority of decision makers within Slovakia support the idea of increased use of and the quality and efficiency of HTA methods. However, it is crucial to overcome several practical barriers to facilitate progress in the field of HTA in the Slovak Republic.

Conclusions: It can be seen that participation within the European Network for Health Technology Assessment (EUnetHTA JA 2 and EUnetHTA JA 3 projects) has significantly improved the quality of the process of HTA in Slovakia. Further legislative activities in this field are required due to the approved strategy for European Union cooperation on HTA.

Objectives: The objective of this study is to illustrate and provide a better understanding of the role of health technology assessment (HTA) processes in decision making for drug reimbursement in Poland and how this approach could be considered by other countries of limited resources.

Methods: We analyzed the evolution of the HTA system and processes in Poland over the past decade and current developments based on publicly available information.

Results: The role of HTA in drug-reimbursement process in Poland has increased substantially over the recent decade, starting in 2005 with the formation the Agency for Health Technology Assessment and Tariff System (AOTMiT). The key success factors in this development were effective capacity building based on the use of international expertise, the implementation of transparent criteria into the drug reimbursement processes, and the selective approach to the adoption of innovative medicines based on the cost-effectiveness threshold among other criteria.

Conclusions: While Poland is regarded as a leader in Central and Eastern Europe, there is room for improvement, especially with regard to the quality of HTA processes and the consistency of HTA guidelines with reimbursement law. In the “pragmatic” HTA model use by AOTMiT, the pharmaceutical company is responsible for the preparation of a reimbursement dossier of good quality in line with HTA guidelines while the assessment team in AOTMiT is responsible for critical review of that dossier. Adoption of this model may be considered by other countries with limited resources to balance differing priorities and ensure transparent and objective access to medicines for patients who need them.

In reference to the article A Decade of Health Technology Assessment in Poland by I. Lipska et al. (1), I would like to provide you with some comments and additional information on the changes in reimbursement policies in the Polish healthcare system currently taking place, which is likely to lead to increased number of health technology assessments (HTAs) of medical devices (MDs).

Objectives: The objective of this study was to analyze and present the current state of the implementation of health technology assessment (HTA) in Slovenia, identify its advantages and challenges, as well as potential improvements and developments.

Methods: The HTA structure and processes were analyzed and comprehensively described according to relevant literature, official documents, and experiences of the author.

Results: The important steps in the development and implementation of an HTA system are presented through eight key elements: capacity building; HTA funding; HTA legislation and organizational structure; the scope of HTA implementation; decision criteria; quality, timelines, and transparency of HTA implementation; use of local data; and international collaboration. Based on the current situation, possible further developments are presented.

Conclusions: Currently, there is no systematic HTA in Slovenia; however, some basic use of HTA principles can be found in the decision making. The biggest deficiency in the HTA field is the lack of knowledge and systematic implementation. Legislation and guidelines for study appraisals are needed at decision-making levels. HTA principles across health technologies need to be unified along with a central HTA coordination office being set up to lead and establish priorities for HTA work.

Objectives: The aim of this study was to investigate the analysis, discussion, and challenges of the price and reimbursement process of medicinal products in Bulgaria in the period 2000–15 and health technology assessment (HTA) role in these processes.

Methods: The dynamics of the reform, with respect to the healthcare and pharmaceutical sectors, are tracked by documentary review of regulations, articles, and reports in the European Union (EU), as well as analytical and historical analysis.

Results: Pricing and reimbursement processes have passed through a variety of committees between 2003 and 2012. Separate units for pricing and reimbursement of medicinal products were established in Bulgaria for the first time, in 2013, when an independent body, the National Council at Prices and Reimbursement of Medicinal Products, was set up to approve medicinal products with new international nonproprietary names (INN) for reimbursement in Bulgaria. Over the course of 2 years (2013–14), thirty-three new INNs were approved for reimbursement. In December 2015, a new HTA body was introduced, and assigned to the National Centre for Public Health and Analyses.

Conclusions: Although Bulgaria has current legislation on pricing and reimbursement which is in accordance with the EU rules, there is no mechanism for reporting and monitoring these processes or the financial resources annually, so as to provide an overall objective assessment and analysis by year. Therefore, this financial assessment should become a national policy objective for the future.

Objectives: The aim of this study was to describe and analyze the introduction of health technology (HTA) in Romania.

Methods: Based on a review of the literature and legislative documents and personal experiences and observations, the authors describe, evaluate, and explain the background and evolution of the HTA system.

Results: Initiatives to introduce HTA in Romania date from the early 1990s, but real steps were taken only in 2012 when the European Union Directive 2011/24/ on the application of patients’ rights in cross-border health care had to be passed into Romanian law.

The main developments consist of: the establishment of a national competent authority, the development of a methodology for the rapid assessment of drugs, setting HTA as the main tool for compiling the list of medicines to be covered by the NHIF, and capacity building initiatives. One early result of HTA implementation was an updated list of reimbursed drugs, allowing Romanian patients access to new, innovative medicines.

Conclusions: In Romania, HTA become an issue for all stakeholders: decision makers are interested in cost-containment, patients in obtaining the best care, and producers in receiving acceptable reimbursement remains on the health policy agenda. Further steps are envisaged, especially for international collaboration, which is considered an important factor for HTA development in Romania.

Objectives: The aim of this study was to provide a brief, 7-year history of health technology assessment (HTA) implementation in Croatia through national and international activities.

Methods: We used retrospective descriptive analysis of key documents related to the legal framework, process of decision making, and HTA. Analysis of the Agency's plan for and experience with the implementation of a transparent HTA process in Croatia was performed by addressing seven key components of the HTA implementation scorecard framework. The main challenges and facilitating factors were also assessed.

Results: HTA is not yet fully implemented in Croatia. The main challenges are the insufficient legal framework, limited human and financial resources, and limited stakeholder involvement. Facilitating factors are active international collaboration and education through EUnetHTA and the International Society for Pharmacoeconomics and Outcomes Research and production of national and international HTA reports.

Conclusions: The HTA process is not yet sustainable in Croatia and HTA reports are still not mandatory for reimbursement/investment or disinvestment decision processes. There are still barriers to overcome.

Objectives: This study provides an overview of the Republic of Serbia healthcare system and describes the process of developing and conducting health technology assessment (HTA).

Methods: The authors performed pragmatic, nonsystematic literature review based on available statistical data, legislation, and studies.

Results: Healthcare law creates conditions that allow implementation of the principle “value for money.” The institutions directly vested in the implementation of HTA are the National Health Insurance Fund (NHIF) and the Ministry of Health (MoH). There are some reflections of the efforts by NHIF and MoH toward achieving this goal.

Conclusions: Despite the highly set objectives, there is still a lot of work to be done to build an adequate model to support decision-making processes to bridge the discrepancies between broadly defined rights to health care and limited resources in the country.

Objectives: The aim of this study was to describe the healthcare system and health financing in Bosnia and Herzegovina and recent trends in health technology assessment (HTA) placement in the system.

Methods: A short review of PubMed published literature has been conducted using key words related to reimbursement, HTA, and health policy. We also revised legislation in Bosnia and Herzegovina published in Official Gazettes related to healthcare financing and organization.

Results: A deecentralized system in Bosnia and Herzegovina led to high differences in health policy. HTA has been recognized in legislation in Bosnia and Herzegovina, but it still has not been introduced in practice in full capacity. A small number of publications are found in PubMed treating these issues, but generally the problem of introduction of HTA in Bosnia and Herzegovina is lack of experts, as well as the political environment and education in this field.

Conclusions: HTA in the Federation of Bosnia and Herzegovina and the Republic of Srpska has a short history because of a huge political impact in the decision-making process, decentralized system, and multiple decision makers in these regions. Challenges remain in assessments, in development of more transparent approaches in different areas of the health system in these regions, and in consistent application of appropriate standards especially in education of professionals who will provide establishment of HTA in the health system of The Federation of Bosnia and Herzegovina and the Republic of Srpska.

Objectives: The aim of this study was to describe the current regulatory environment in Greece to evaluate the potential introduction of health technology assessment (HTA) for medicinal products for human use.

Methods: Data sources consist of national legislation on pricing and reimbursement of health technologies to identify the potential need of establishing HTA and its relevant structure.

Results: The pricing procedure regarding medicinal products for human use is based on an external reference pricing mechanism which considers the average of the three lowest Euorpean Union prices. Currently, a formal HTA procedure has not been applied in Greece, and the only prerequisite used for the reimbursement of medicinal products for human use is their inclusion in the Positive Reimbursement List. To restrict pharmaceutical expenditure, a variety of measures—such as clawback mechanisms, rebates, monthly budget caps per physician, generics penetration targeting—have been imposed, aiming mainly to regulate the price level rather than control the introduction of medicinal products for human use in the Greek pharmaceutical market.

Conclusions: Greece has the opportunity to rapidly build capacity, implement, and take advantage of the application of HTA mechanisms by clearly defining the goals, scope, systems, context, stakeholders, and methods that will be involved in the local HTA processes, taking into account the country's established e-prescription system and the recently adapted legislative framework.

Objectives: The healthcare transformation program in Turkey has shown its success with improvements in important health indicators, increased access to healthcare services and expansion of coverage to all citizens. Turkey has been relatively able to bear the burdens associated with this due to rapid economic growth. The need for health technology assessment (HTA) was believed as a result of the expansion of coverage, pressure of new technologies, and increased expenditures. This study outlines the background and current formalization of HTA and shares the current use of HTA in decision making, while summarizing the transformation of the Turkish healthcare system for developing a high-quality, equal, and accessible care system.

Methods: We reviewed and analyzed policy changes in the Turkish healthcare system, universal health coverage, healthcare expenditures, and pricing and reimbursement policies to identify the changes leading to HTA. We reviewed existing HTA functions in Turkey and outlined their activities. Finally, we outlined a set of major challenges for HTA in Turkey over the next decade.

Results: HTA was formalized in Turkey in 2012–2013 with three national HTA structures and one hospital-based HTA unit. These functions currently run independent from each other. There are three major challenges in this country for HTA in the next decade: clarification of the assessment scope and methods, building a strong supporting system for HTA, and defining the role of HTA in the future vision of Turkish healthcare policy.

Conclusion: HTA, despite challenges, has a good opportunity to develop further with clear action plans and strong political will.