Background Managed entry agreements (MEAs) are a set of instruments to facilitate access to new medicines. This study surveyed the implementation of MEAs in Central and Eastern Europe (CEE) where limited comparative information is currently available. Method We conducted a survey on the implementation of MEAs in CEE between January and March 2017.Results Sixteen countries participated in this study. Across five countries with available data on the number of different MEA instruments implemented, the most common MEAs implemented were confidential discounts (n = 495, 73%), followed by paybacks (n = 92, 14%), price-volume agreements (n = 37, 5%), free doses (n = 25, 4%), bundle and other agreements (n = 19, 3%), and payment by result (n = 10, [1%). Across seven countries with data on MEAs by therapeutic group, the highest number of brand names associated with one or more MEA instruments belonged to the Anatomical Therapeutic Chemical (ATC)-L group, antineoplastic and immunomodulating agents (n = 201, 31%). The second most frequent therapeutic group for MEA implementation was ATC-A, alimentary tract and metabolism (n = 87, 13%), followed by medicines for neurological conditions (n = 83, 13%). Conclusions Experience in implementing MEAs varied substantially across the region and there is considerable Alessandra Ferrario was a Research Officer at the LSE Health at the time this research was conducted. She is now a postdoctoral Research

BackgroundSelection of an appropriate renal replacement modality is of utmost importance for patients with end stage renal disease. Previous studies showed provision of information to and free modality choice by patients to be suboptimal. Therefore, the European Kidney Patients’ Federation (CEAPIR) explored European patients’ perceptions regarding information, education and involvement on the modality selection process.MethodsCEAPIR developed a survey, which was disseminated by the national kidney patient organisations in Europe.ResultsIn total, 3867 patients from 36 countries completed the survey. Respondents were either on in-centre haemodialysis (53%) or had a functioning graft (38%) at the time of survey. The majority (78%) evaluated the general information about kidney disease and treatment as helpful, but 39% did not recall being told about alternative treatment options than their current one. Respondents were more often satisfied with information provided on in-centre haemodialysis (90%) and transplantation (87%) than with information provided on peritoneal dialysis (79%) or home haemodialysis (61%), and were more satisfied with information from health care professionals vs other sources such as social media. Most (75%) felt they had been involved in treatment selection, 29% perceived they had no free choice. Involvement in modality selection was associated with enhanced satisfaction with treatment (OR 3.13; 95% CI 2.72–3.60). Many respondents (64%) could not remember receiving education on how to manage their kidney disease in daily life. Perceptions on information seem to differ between countries.ConclusionsKidney patients reported to be overall satisfied with the information they received on their disease and treatment, although information seemed mostly to have been focused on one modality. Patients involved in modality selection were more satisfied with their treatment. However, in the perception of the patients, the freedom to choose an alternative modality showed room for improvement.

This paper describes and discusses the development and use of health technology assessment (HTA) in five Central and Eastern European countries (CEE): Poland, the Czech Republic, Hungary, Romania and Bulgaria. It provides a general snapshot of HTA policies in the selected CEE countries to date by focusing on country case-studies based on document analysis and expert opinion. It offers an overview of similarities and differences between the individual CEE countries and discusses in detail the role of HTA by assessing its formalization and institutionalization, standardization of methodology, the use of HTA in practice and the degree of professionalization of HTA in the region. It finds that HTA has been to some extent implemented in all five countries studied, with methodologies in accordance with international standards, but that challenges remain when it comes to the role of HTA in health care decision-making as well as to human resource capacities of the countries. This paper suggests that coming years will show whether CEE countries develop adequate national analytical capacity to assess and appraise technologies in the context of local need and affordability, instead of using HTA as a mere administrative procedure to fulfill (inter)national requirements. Finally, suggestions are provided to strengthen HTA in CEE countries through cooperation, mutual learning, a common accreditation of HTA bodies and increased network building among CEE HTA experts.

Epistemic communities are an established concept in the study of international relations but can also explain policy change at the domestic level. This article asks why some epistemic communities manage to convince decision makers of their preferred policies while others do not. It suggests that the reason lies in the causal mechanism of epistemic communities' influence on decision makers, mediated by decision makers' demand for expert input. Most epistemic communities scholarship focuses on single case studies where the communities' influence on policy was strong and clear, leading to an overestimation of the groups' influence. To help correct this probable bias, this article compares a successful case of epistemic community influence (health technology assessment in Poland) with an unsuccessful example of the same policy (in the Czech Republic). The juxtaposition allows for unpacking of the necessary parts of the causal mechanism (emergence of an epistemic community, its activity, access to decision makers, and successful suasion) and separating them from the crucial scope condition. Decision makers' uncertainty about the policy issue at hand has traditionally been the key scope condition for epistemic communities but the successful Polish case demonstrates that epistemic communities can be influential even in highly certain areas of routine policymaking, leading to a reconceptualization of uncertainty as policymakers' demand for expert input. Demand can originate from various sources, but any change of it affects individual parts of the causal mechanism, leading to a success or failure of epistemic communities' policy enterprise.

No abstract

Health technology assessment (HTA) is not simply a mechanistic technical exercise as it takes place within a specific institutional context. Yet, we know little about how this context influences the operation of HTA and its ability to influence policy and practice. We seek to demonstrate the importance of considering institutional context, using a case study of Hungary, a country that has pioneered HTA in Central and Eastern Europe. We conducted 26 in-depth, semi-structured interviews with public- and private-sector stakeholders. We found that while the HTA Department, the Hungarian HTA organisation, fulfilled its formal role envisaged in the legislation, its potential for supporting evidence-based decision-making was not fully realised given the low levels of transparency and stakeholder engagement. Further, the Department's practical influence throughout the reimbursement process was perceived as being constrained by the payer and policy-makers, as well as its own limited organisational capacity. There was also scepticism as to whether the current operational form of the HTA process delivered 'good value for money'. Nevertheless, it still had a positive impact on the development of a broader institutional HTA infrastructure in Hungary. Our findings highlight the importance of considering institutional context in analysing the HTA function within health systems.

In the past two decades, setting up independent health technology assessment (HTA) agencies has become a popular tool to inform reimbursement decision-making in health care, spreading from Northern European countries across Western Europe but much less so to post-communist countries. Structural political science explanations leave gaps in clarifying this diffusion pattern. This paper proposes a theoretical model focusing on the influence of domestic epistemic communities mitigating policy diffusion. Based on a review of HTA institutions in the EU, it proposes a chronological taxonomy of HTA agencies in Europe (the forerunners, the mainstreamers and the non-adopters) and asks why there is such an important East-West divide. The paper discusses theoretical explanations from different literatures, finding unsatisfactory many traditional political science answers such as the degree of centralization of a country's health system, its financial organization (Bismarckian or Beveridgian), the attitude toward independent regulatory bodies in general, the influence of international actors, or lack of resources. Finally, it suggests cases for empirical testing of the domestic epistemic communities model.

Background: Social scientists have paid increasing attention to health technology assessment (HTA). This paper provides an overview of existing social scientific literature on HTA, with a focus on sociology and political science and their subfields. Methods: Narrative review of key pieces in English. Results: Three broad themes recur in the emerging social science literature on HTA: the drivers of the establishment and concrete institutional designs of HTA bodies; the effects of institutionalized HTA on pricing and reimbursement systems and the broader society; and the social and political influences on HTA decisions. Conclusion: Social scientists bring a focus on institutions and social actors involved in HTA, using primarily small-N research designs and qualitative methods. They provide valuable critical perspectives on HTA, at times challenging its otherwise unquestioned assumptions. However, they often leave aside questions important to the HTA practitioner community, including the role of culture and values. Closer collaboration could be beneficial to tackle new relevant questions pertaining to HTA.