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Background Efficiency and transparency of pricing and reimbursement (P&R) rules and procedures as well as their implementation in South-eastern Europe (SEE) lag substantially behind Western European practice. Nevertheless, P&R systems in SEE are rarely critically assessed, warranting a detailed and wider-encompassing exploration. Objective Our study provides a comparative assessment of P&R processes for patent-protected medicines in ten SEE countries—EU member states: Croatia, Slovenia, Hungary, Romania and Bulgaria ; and non-EU countries: Albania, Montenegro, Serbia, North Maceodina, Bosnia and Herzegovina. P&R systems are compared and evaluated through a research framework that focuses on: (1) public financing of patent-protected medicines, (2) definition of benefit packages, (3) requirements for the submission of reimbursement dossiers, (4) assessment and appraisal processes, (5) reimbursement decision making, (6) processes that occur post reimbursement, and (7) pricing. The study aims to contribute to the discussion on improving the efficiency and quality of P&R of patent-protected medicines in the region. Methods We conducted a non-systematic literature review of published literature, as well as policy briefs and reports on healthcare systems in the SEE region along with legal documents framing the P&R procedures in local languages. The information gathered from these various sources was then discussed and clarified through structured telephone interviews with relevant national experts from each SEE country, mainly current and former senior officials and/or executives of the funding and assessment/ appraisal bodies (total of 20 interviews conducted in late 2019). Results Capacity building through sharing knowledge and information on successful reforms across borders is an opportunity for SEE countries to further develop their P&R policies and increase (equitable) access to patent-protected medicines (especially expensive medicines), increasing affordability and containing costs. Simple yet robust and systematic decision-making frameworks that rely on international health technology assessment (HTA) procedures and are based on the pursuit of transparency seem to be the most cost- effective approach to strengthening P&R systems in SEE. Conclusions Further reforms aiming to develop transparent and robust national decision-making frameworks (including oversight) and build institutional HTA- related and decision-making capacity are awaited in most of SEE countries, especially the non-EU members. In non-EU SEE countries, these efforts could increase access to patent-protected medicines, which is—at the moment —very limited. The EU-member SEE countries operate more developed P&R systems but could further benefit from developing their procedures, oversight and value- for-money assessment toolbox and capacity, hence further improving the transparency and efficiency of procedures that regulate access to patent- protected medicines.

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry.Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures.Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab.Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80–90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 – €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures.Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.

Introduction: There are growing concerns among European health authorities regarding increasing prices for new cancer medicines, prices not necessarily linked to health gain and the implications for the sustainability of their healthcare systems. Areas covered: Narrative discussion principally among payers and their advisers regarding potential approaches to the pricing of new cancer medicines. Expert opinion: A number of potential pricing approaches are discussed including minimum effectiveness levels for new cancer medicines, managed entry agreements, multicriteria decision analyses (MCDAs), differential/tiered pricing, fair pricing models, amortization models as well as de-linkage models. We are likely to see a growth in alternative pricing deliberations in view of ongoing challenges. These include the considerable number of new oncology medicines in development including new gene therapies, new oncology medicines being launched with uncertainty regarding their value, and continued high prices coupled with the extent of confidential discounts for reimbursement. However, balanced against the need for new cancer medicines. This will lead to greater scrutiny over the prices of patent oncology medicines as more standard medicines lose their patent, calls for greater transparency as well as new models including amortization models. We will be monitoring these developments., peer-reviewed

This cost-effectiveness study analyses the expected impacts of activities proposed by the Croatian National Plan Against Cancer (NPAC) on cancer incidence and survival rates, as related to their respective costs. We evaluated the impact of the NPAC on two main outcomes, namely, reduced incidence and the improved survival of cancer patients, expressed as life years gained (LYGs), which enabled the calculation of incremental cost- effectiveness ratios (ICERs) in the form of cost per LYG. In the analysis of costs, we considered both the direct costs of NPAC activities as well as the wider indirect societal costs of cancer, thus permitting the calculation of the ICER both from the narrower national health insurer’s perspective (accounting only for the direct costs) and the wider societal perspective (accounting both for the direct and indirect costs). We estimated that on average, for all patients benefiting from the implementation of the NPAC in Croatia, an additional LYG would be yielded at the additional cost of €1.021 (societal perspective). The NPAC can, for some sites, even be considered a dominant intervention due to the negative cost/LYG ratio, meaning that it generates additional LYGs while at the same time, reducing total societal costs. Taking a narrower health insurer’s perspective (i.e., accounting only for the direct costs), the NPAC produces an additional LYG at an additional cost of €1.408. Both cost per LYG estimates can be considered cost-effective investment options.

Refereed/Peer-reviewed Background and Objective Managed entry agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high-priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective of this article is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high- and middle-income countries. Methods An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was 'What are the health technology MEAs that have been applied around the world?' This review was supplemented with studies not retrieved in the search known to the senior-level co-authors including key South American markets. It also involved senior-level decision makers and advisers providing guidance on the potential advantages and disadvantages of MEAs and ways forward. Results Twenty-five studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%) and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. Conclusions We are likely to see a growth in MEAs with the continual launch of new high-priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome-based MEAs could be an important tool to improve access to new innovative medicines, there are critical issues to address. Comparing knowledge, experiences, and practices across countries is crucial to guide high- and middle-income countries when designing their future MEAs.

Introduction This research examines three distinct programs focused on integrating care in Croatia, seeking to understand how they were developed, implemented and sustained; and in particular what factors contributed to and challenged their implementation, impact, scale up and sustainability. To this purpose, it draws on detailed case studies of a) the Croatian national family medicine based primary care service, b) a community mental health center in Zagreb and c) the county (region) based program of palliative care provision.Theory/Methods The research uses an adapted analytical framework developed by Nolte et al. in 2016 . In March and April 2017, a total of 21 structured interviews were conducted face-to-face with a group of 6 policy makers and 15 providers (doctors, nurses, coordinators and a social care worker) working in primary care, palliative care and the Mental Health Centre hosted by the Zagreb-West Primary Care Centre. Questions focused on understanding the “process of care" in an integrative healthcare setting and the overall design of the integrated care programs. In addition, an anonymous online survey was carried out among family medicine doctors to develop better understanding of care integration across the system with the assistance of two Croatian primary care doctors’ associations Their members (a total of around 700 family medicine specialist/ general practitioners out of a total of 2,400 working in the health system) were asked to participate, and a total of 118 responded.Results The following issues were assessed in terms of results for all 3 programs: design features, financing arrangements, organisational structures/processes and implementation, governance and performance monitoring and provider behaviour and practicesDiscussionBased on the above analysis, we evaluated enabling factors and constraintsConclusions (comprising key findings) Good identified practices across the programs included: Strategic planning, creating ownership, working with patients, financial incentives and capacity building.Lessons learned The following practices were identified as having scope for improvement: Leadership and coordinating change, standardization, prioritizing planning, patient empowermentinvesting in information systems and improving managementLimitations Sampling in the family medicine internet survey and the fact that our research did not measure health outcomes as these are not recorded in the system.Suggestions for future research Focus on health outcomes

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 ATCA, 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 scope for greater transparency, sharing experiences and mutual learning. European citizens, authorities and industry should ask themselves whether, within publicly funded health systems, confidential discounts can still be tolerated, particularly when it is not clear which country and party they are really benefiting. Furthermore, if MEAs are to improve access, countries should establish clear objectives for their implementation and a monitoring framework to measure their performance, as well as the burden of implementation., peer-reviewed

Getting the most out of the pharmaceutical budget is critical across all countries as the financial pressures on healthcare systems intensify. In this paper, we review global practice on encouraging the use of low costs generics versus branded pharmaceuticals, including patented products in the same class where care is not compromised across countries to guide future practice. Our review ranges widely across European countries as well as other high income countries, including Abu Dhabi, Japan and the USA, and other low and middle income Countries. There is a particular focus on Scotland, building on previous publications. We conclude based on multiple publications, including several case studies, that achieving efficiency in pharmaceutical spending is possible in virtually all environments, although there are examples of technologies where generic or therapeutic substitution should not be encouraged. However, there is no magic bullet to achieving full and appropriate use of generics. Countries have to be prepared to use a number of different education, economic, engineering and enforcement methods including prescribing restrictions to achieve success. Similarly, different approaches to achieve low prices for good quality generics given the considerable price differences that currently exist. The combination of low prices and increased use of generics will help achieve or attain universal healthcare, benefiting all key stakeholder groups. We conclude with a call for greater cross-country learning in pursuit of what should be a common goal for all health systems.

This article summarizes the epidemiology of HIV among men who have sex with men (MSM) in 27 central and eastern European countries. For each country, the summary includes general information about the extent of the HIV epidemic, particularly among MSM; a brief overview of recent HIV-related biobehavioral studies conducted in the MSM population; and information on the current stigmatization of MSM. Reports of deeply rooted stigmatization of MSM in almost all 27 countries point to it as a serious obstacle in this population's access to proper treatment and care for STIs, including HIV.

Objective To assess the impact of two different automated dispensing machines (‘robots’) on safety, efficiency and staff satisfaction, in a UK hospital setting. Setting An NHS teaching hospital trust with two main sites each comprising 450 beds. A Swisslog Pack Picker automated dispensing machine was installed in the dispensary at site 1 in December 2003, and a Rowa Speedcase at site 2 in October 2005. Method A before-and-after study design was used on each site, with site 2 acting as a control for site 1. Staff recorded data on dispensing errors identified at the final-check stage; an observer recorded the time taken to label, pick and assemble dispensed items; we recorded turnaround times for the different types of prescription and assessed storage space efficiency. We also used questionnaires to explore staff views. Key findings The robot resulted in a significant decrease in dispensing errors on each site (from 2.7 to 1.0% of dispensed items on site 1, and from 1.2 to 0.6% on site 2). Reductions occurred in errors involving wrong content; there was no clear effect on labelling errors. There were reductions in the time required to pick items for dispensing; there was no impact on labelling or assembly times. There was no conclusive effect on turnaround times. Increases in storage capacity occurred on each site; staff on site 2 were more satisfied following introduction of the robot; there was no difference on site 1. Conclusion Installation of a dispensary robot has modest benefits in terms of reduced dispensing errors, reduced picking times, increased staff satisfaction and increased storage capacity; there was no conclusive impact on turnaround times. These findings seem to be independent of the type of robot installed.

European countries strive to enhance prescribing efficiency. This includes renin–angiotensin drugs following the availability of generic angiotensin-converting enzyme inhibitors (ACEIs). Aims: To compare angiotensin receptor blocker utilization and expenditure patterns in Austria and Croatia following prescribing restrictions, as well as with other European countries introducing different supply- and demand-side measures. Lastly, to appraise the impact of generic losartan in Croatia on utilization of patented angiotensin receptor blockers. Method: Observational retrospective study principally between 2001 and 2007, using defined daily doses and €/1000 inhabitants/year. Demand-side measures were based on the four ‘E’s – education, engineering, economics and enforcement. Results: Greater intensity of followup of prescribing restrictions in Croatia enhanced utilization of ACEIs versus Austria. There was high utilization of ACEIs in Scotland following intensive demand- side measures, similar to Austria and Croatia. Demand-side measures in Spain (Catalonia) and Sweden also appeared to moderate angiotensin receptor blockers utilization. The combination of measures helped stabilize expenditure on renin–angiotensin drugs when adjusted for population sizes despite appreciable increases in volumes. The only exception was Portugal, with less intensive measures. Conclusion: Multiple and intensive demand-side measures enhanced prescribing efficiency. The more intense follow-up of ARB prescribing restrictions in Croatia had a greater influence on subsequent utilization patterns than Austria. Both findings confirm earlier studies. Reforms also favorably enhanced the prescribing of generic losartan once available.

Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction. Objective: To (i) review authority activities across countries, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications based on post-launch activities. Methodology: (i) Descriptive review and appraisal of activities regarding dabigatran, (ii) development of guidance for key stakeholder groups through an iterative process, (iii) refining guidance following post launch studies. Results: Plethora of activities to manage dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions and monitoring of prescribing post launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice. Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding. © 2014 Godman, Malmström, Diogene, Jayathissa, McTaggart, Cars, Alvarez-Madrazo, Baumgärtel, Brzezinska, Bucsics, Campbell, Eriksson, Finlayson, Fürst, Garuoliene, Gutiérrez-Ibarluzea, Hviding, Herholz, Joppi, Kalaba, Laius, Malinowska, Pedersen, Markovic-Pekovic, Piessnegger, Selke, Sermet, Spillane, Tomek, Vončina, Vlahović-Palčevski, Wale, Wladysiuk, van Woerkom, Zara and Gustafsson.

Considerable variety in how patients respond to treatments, driven by differences in their geno- and/ or phenotypes, calls for a more tailored approach. This is already happening, and will accelerate with developments in personalized medicine. However, its promise has not always translated into improvements in patient care due to the complexities involved. There are also concerns that advice for tests has been reversed, current tests can be costly, there is fragmentation of funding of care, and companies may seek high prices for new targeted drugs. There is a need to integrate current knowledge from a payer’s perspective to provide future guidance. Multiple findings including general considerations ; influence of pharmacogenomics on response and toxicity of drug therapies ; value of biomarker tests ; limitations and costs of tests ; and potentially high acquisition costs of new targeted therapies help to give guidance on potential ways forward for all stakeholder groups. Overall, personalized medicine has the potential to revolutionize care. However, current challenges and concerns need to be addressed to enhance its uptake and funding to benefit patients

Since 2002, the Croatian social health insurance system has undergone substantial reforms, initiated for the most part with the aim of addressing the perpetual financial deficits of the state health insurance fund. While the reforms focussed heavily on increasing the inflow of private funds into the health care system, underlying inefficiencies contributing significantly to poor financial performance have been largely ignored. Furthermore, contrary to demographic trends and developments in social health insurance schemes in other countries, funding health care became even more dependent on its main collection mechanism-payroll tax-and consequently on the employment ratio and wage level. Little effort has been made to diversify the revenue base or to increase the efficiency of revenue collection. Like other countries, Croatia is facing difficulties in adjusting its 'Bismarck' system to its changing demographic and socioeconomic context. Instead of targetting a comprehensive effort at improving revenue collection and limitating unnecessary expenditure and system inefficiencies, simplified approaches to balance the budget have been implemented at a high price to users and with limited effect. As a result, the Croatian health insurance system now offers a lower level of financial protection, while still facing the problem of spending more than can be collected through the current mix of revenue collection mechanisms. The authors suggest that, in order to meet the sustainability requirement of the health financing system, measures affecting both revenue and expenditure should be considered and implemented. On the revenue collection side, the Croatian government must make further efforts to improve collection from the informally employed to broaden the base of contributing members ; equally important is the diversification of revenue sources by increasing transfers from general taxation revenues. On the expenditure side, exploring inefficiencies of the delivery system can be delayed no longer, and the introduction of effective cost-control mechanisms and financial discipline would seem to be unavoidable.

Even the most socially aware countries in the World have noticed the gap increase between the poorest and the richest population groups. The purpose of this study was to investigate the presence of inequity and to identify main barriers for equitable health care utilization by economic status, region and area of living, controlled for health needs in the Croatian adult population. The data from the Croatian Adult Health Survey 2003 were used in this study. The results show that among the respondents with higher health needs, those with economic status above average had higher proportion of regular annual general practitioner and medical specialist visits. In contrast, highly frequent visits to physician were more common in respondents who were below average economic status. Economically worse-off women, regardless on their health care needs reported gynecologist visits less regularly than the better-off women. Long waiting and the large distance from the health care facilities were the most commonly reported barriers in health care utilization. High expenses were present as the main barrier at dentist and inpatient health services utilization. Suburban and rural settlements were more burdened with long distance from the health care facilities and high expenses for all health services, aggravated by the long waiting time for visits to GP. Respondents from the urban settings reported long waiting time and unkindness of the health personnel as the main barriers. The results of this study clearly show the main barriers in the equitable health care delivery to Croatia population from the health care users perspective.