Access In Europe Research Articles

PSY170 - IMPACT OF MULTIPLE INDICATIONS ON PRICE AND ACCESS OF DRUGS FOR AUTOIMMUNE DISEASES

Launching a drug in multiple indications can have an impact on price and access in Europe. The objective of this research was to identify and analyse analogues within the autoimmune diseases area to understand the factors that determine pricing and reimbursement success of drugs with multiple indications in EU5 countries (France, Germany, UK, Italy, Spain). Secondary research was conducted to identify relevant analogues that launched in 2 or more indications. Once analogues were identified, review of HTA assessments for each indication was performed, along with analysis of launch prices and price evolution using IMS data. Two analogues were identified: secukinumab and apremilast. Secukinumab was launched in three indications consecutively - psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Apremilas was launched in two indications, PsA and PsO, simultaneously. Secukinumab gained access in all 3 indications in EU5, launching at and sustaining a premium price despite the two follow-on indications (PsA and AS) showing no added benefit in HTA assessments. This is due to better HTA outcomes in the first indication (PsO), which had an evidence package that included direct comparative data. In contrast, clinical trials for apremilast were placebo-controlled, with indirect comparative studies indicating inferiority vs biologics, leading to no reimbursement of the PsO indication in Italy and forcing the manufacturer to launch at a significant discount in other markets in order to gain access. Apremilast list price has further dropped in Italy and France post-launch. The research also indicated that to capture the drug’s differentiated values across indications in one combined price, Payers can delay access and price negotiations until all indications have been launched. Strong direct comparative data in one indication can protect against price erosion after the launch of the follow-on indications, even if the follow-on indications do not show additional benefit.

Resource Description and Access in Europe: Implementations and perceptions

This research explored the implementations and perceptions of the Resource Description and Access (RDA) cataloguing standard in Europe. It refers to the development and implementation of the standard among Anglo-American libraries and draws comparisons between them. It examines the spread and application of RDA throughout Europe both by analysing the available literature and by conducting interviews with professionals at 12 European national libraries. The results highlight the issues faced by the European institutions and the unique perspectives that emerge from implementing RDA in different languages and cultures. European institutions demonstrate a higher level of involvement and interest in the development of RDA and a stronger desire to work towards RDA interoperability and alignment with the cultural heritage sector. The European implementation drives forward the internationalisation of RDA by actively seeking solutions to the issues in the new standard arising from the cultural and linguistic diversity.

Strategic Management Key to Success for Kosovo Companies - Expansion in International European Market

A recent signed Stabilisation and Association Agreement (SAA), an platform that promotes harmonious economic relations and gradually development of a free trading areas between EU and Kosovo, encouraged many companies from this country to start thinking big for international business expansion in Europe. Access in Europe via free trade, is a mine of gold opportunity since it allows reaching a large number of customers in a vast and broad market. Getting and even more competing with European and other international companies for a slight market share, obviously it is a hard "piece of cake". Path to be paved attaining business objectives could be more easily headed applying an appropriate management strategy. Strategic thinking, strategic planning, strategic marketing, and international managerial strategy are pillars that could support and craft any company have a proper approach and successive performance into European market environment.

Strategic Management Key to Success for Kosovo Companies - Expansion in International European Market

A recent signed Stabilisation and Association Agreement (SAA), an platform that promotes harmonious economic relations and gradually development of a free trading areas between EU and Kosovo, encouraged many companies from this country to start thinking big for international business expansion in Europe. Access in Europe via free trade, is a mine of gold opportunity since it allows reaching a large number of customers in a vast and broad market. Getting and even more competing with European and other international companies for a slight market share, obviously it is a hard "piece of cake". Path to be paved attaining business objectives could be more easily headed applying an appropriate management strategy. Strategic thinking, strategic planning, strategic marketing, and international managerial strategy are pillars that could support and craft any company have a proper approach and successive performance into European market environment.

Open Access for Rail Passenger Services in Europe: Lesson Learnt from Forerunner Countries

Abstract The fourth railway package –still discussed today by the European institutions - plans to open the whole rail transport market to competition in 2022. Currently, only freight transportation and international passenger services are open to competition. According to the fourth package, the market for regional transportation should be organized around franchises and therefore competition “for” the market. On the contrary, competition for long distance services - at least for profitable services – should be “open access”. This paper evaluates the potential consequences of this open access competition at the European level based on the consequences of open access competition in the seven forerunner countries that have already allowed for some form of open access competition. These experiences may give us some clues regarding the impact of open access in Europe. It inventories all the open access services that exist/have existed across Europe. Based on this database, we construct standard profiles and strategies of new entrants. We found that it takes several years for open access competition to settle after legal opening of passenger transportation market. For most of the new entrants, the financial strategy is to minimize risk. Wide-scale entries with brand new rolling stock are extremely uncommon. Bankruptcy (or service interruption) are common. Therefore, it is unlikely that the fourth package implementation leads to a dramatic change in the functioning of the rail passenger transportation market.

Legal and formal factors related to the mineral raw material deposits accessibility in Europe

Abstract Over the last decades, the access to mineral raw material deposits has been increasingly limited by diverse limitations and obstacles. Some of them including: permits, taxes and fees, the ownership of mineral deposits, environmental protection rules and land-use and spatial planning conflicts, are related to state (governmental) activities and others such as protests against the mining activity and NIMBY effect, to societal issues. The legal authorities, governments and regulators are the stakeholders involved in the legislative issues of this process. A major potential matter of dispute lies in land-use issues. Diverse land-use types, for example, nature conservation, tourism and building development, can restrict the area available for exploration and/or mining, and thus access to mineral deposits. The nature of the land-use competition seems to be similar in different countries and regions, and so do the land-use conflicts. However, the scale and the underlying reasons of the land-use conflicts may differ. This also applies to the approaches to solve the problems.

Can the costs of a surgical robot be amortised?

Background Robot-assisted surgery is already performed in many disciplines, especially in urology and gynaecology. Actually, there are two manufacturers whose products have market access in Europe: the da Vinci® Surgical System of Intuitive Surgical® and the TELELAP ALF-X® of Sofar. The aim of our research was to identify the costs for acquisition, maintenance and instruments of robotic-assisted surgery from the perspective of hospitals and to calculate …

What drives Senegalese migration to Europe? The role of economic restructuring, labor demand, and the multiplier effect of networks

1. IntroductionAlthough the literature on migration determinants in sub-Saharan Africa is extensive, most focuses on internal migration (Lucas 2006). Compared to the theoretical and empirical literature of international migration elsewhere, relatively little is known about international African migration, especially that outside the continent (Adepoju 2004; Lucas 2006; Grillo and Mazzucato 2008; Hatton and Williamson 2003). Most existing studies have adopted a qualitative approach, and the few quantitative studies are based either on aggregate data or cross-sectional micro-data (e.g., Hatton and Williamson 2003; Schoorl et al. 2000; van Dalen, Groenewold, and Schoorl 2005). As a result, there is a dearth of knowledge and quantitative empirical evidence about what drives migration from Sub-Saharan Africa, and whether this is similar to migration from other geographical regions.Acknowledging the need for appropriate data to remedy this state of affairs, the Migrations between Africa and Europe (MAFE) project collected rich retrospective biographical data in several locations in Africa and Europe (Beauchemin 2012)3. Here we use MAFE data to examine the drivers of Senegalese migration to Europe between 1976 and 2008. This migration system is an example of migration from Sub-Saharan Africa to developed societies. Although comparatively modest in absolute numbers, this migration stream has developed quickly since the 1980s.In this study we pay particular attention to the links between the micro-level factors that influence migration decisions and political, social, and economic processes in both Senegal and Europe. Very few empirical studies have examined how migration relates to historical social and economic transformations (Sassen 1988; Portes 1997; Castles and Miller 2009). Our perspective highlights the importance of institutions in regulating migration behavior and shaping migration dynamics4. Particularly useful for our purposes are several insights from institutional approaches in economics and development research that analyze how social institutions regulate migration behavior (Stark 1991; de Haan 1999; Ellis 2000). The specific characteristics of the origin and destination labor markets are central to understanding migration (Piore 1979; Portes and Bach 1985; Reyneri 2003; Villarreal and Blanchard 2013). Social groups and relationships, including migration networks and families, greatly influence migration (Massey 1990; Stark 1991). Although different, the perspectives above share several conceptual parallels. They place individual behavior in a wider societal context, analyzing how social institutions function and their role in migration. By highlighting the role of families and social networks they take into account (household) decision-making. We argue that integrating these perspectives can enhance the understanding of migration processes through a more complete consideration of how origin and destination factors interact.Our analyses focus on the following hypotheses.1) Economic Insecurity Hypothesis. The long period of economic recession experienced in Senegal and the associated reshaping of social and economic relationships involved a general deterioration of living conditions and heightened economic insecurity, which created the conditions for increasing out-migration propensities.2) Labor Demand Hypothesis. Labor market restructuring in Europe provided job opportunities in particular niches and locations.3) Social Capital Hypothesis. For Senegalese migrants, social networks link the above processes by channeling job access in Europe.4) Interaction between Labor Demand and Social Capital Hypothesis. The conjunction of periods of strong labor demand and the availability of personal networks in Europe creates a boosting effect on the migration probabilities of the Senegalese to Europe.These hypotheses specify under what conditions particular mechanisms, proposed in previous literature, are activated, leading to the development of the migration system between Senegal and Europe. …

Labour Market Regulation and Credit Access in Europe

The aim of our research is to investigate the impact of employment protection legislation on the firms’ credit access. This research is the first to address this topic by examining the impact of hiring and dismissal regulations on the probability to be denied credit or to be discouraged from applying for a loan in twelve EU countries. We find that greater flexibility in hiring employees and in structuring their working hours reduces the probability that the firm is credit constrained. In addition, we find that whereas banks facilitate credit access in contexts in which the dismissal procedures allow for the protection of the firms’ knowledge, firms tend to be discouraged from applying for a loan if a dismissal entails financial consequences. Our results are robust to selection bias as well as to alternative econometric approaches.

PCN180 - Is there an impact of the Orphan designation in Oncology on market access in Europe?

Orphan drugs (ODs) benefit from incentives from EMA for their development, but in a context of economical restrictions payers are more and more worried by highly priced medicines. The aim of this research was to evaluate whether the orphan designation has an impact on the reimbursement and pricing for drugs in oncology in European coutries. First, a literature review was performed to identify specific methodologies or consideration applied for the evaluations of ODs. Second, a comparative analysis of HTA recommendations for drugs registered for their first indication in oncology between 2006 and 2013 and appraised by four agencies (HAS, G-BA, NICE, SMC) was performed, as well as coverage decisions, treatment cost, and delay between approval and price agreement. In the selected countries, there is no specific methods to assess ODs. However some special considerations are made to accept higher level of uncertainty. 49 drugs were included in the analysis. Significant inter-country variability in the HTA recommendations exists: 20% of drugs received heterogeneous recommendations across countries. The highest concordance scores were obtained between NICE and SMC for ODs (0.9 kappa score), for others concordance was poor. The percentage of rejection for ODs was not higher than the one for non-ODs. Average treatment costs were in favour of orphan oncology drugs, still it was not significant. There was correlation between treatment cost and population size for the non-ODs, but it was not the case for ODs. Delay of appraisal for ODs was slightly shorter, but never significant, except for NICE. In this study we did not show a significant advantage or disadvantage in the market access of ODs in oncology. However, as more ODs will obtain regulatory approval on an accelerated or conditional licensing, providing expanded evidence package to show the value for money to payer will become harder.

Gender and healthcare accessibility in Europe

Objective: Healthcare accessibility is necessary to achieve good health outcomes. However, access to healthcare can be decreased due to distance to healthcare centres, high costs, or waiting lists. The present study explored if there is a gender gap related to healthcare accessibility constraints. Methods: We performed a cross-country transversal study to investigate the existence of gender-related healthcare accessibility constraints using Mann-Whitney U tests. The research was based on self-reported unmet needs for medical examination due to access barriers according to Eurostat. We examined annual observations from 2005 through 2011 from eight European countries: Greece, France, Germany, Ireland, Italy, Portugal, Spain, and the United Kingdom. Conclusions: We found a gender gap related to unmet medical needs due to high costs, with females more likely to have such needs. The difference in mean values related to gender was statistically significant for Greece (5.17% vs. 3.59%; p = .007), France (1.80% vs. 1.23%; p = .007), Ireland (1.53% vs. 1.13%; p = .011), and Italy (4.39% vs. 2.99%; p = .004).

Trends in Time To Market Access In Europe - Is It Getting Better?

Trends in Time To Market Access In Europe - Is It Getting Better?

Economic impacts of open access in Europe and the United States

The release of the UK Joint Information Systems Committee report Economic implications of alternative scholarly publishing models (Houghton and Oppenheim et al. 2009) generated considerable interest, particularly in the methods used to explore the benefits of open access publishing models, as well as their costs. During 2009, there were a number of follow-on studies. These included national studies in The Netherlands and Denmark, and a three-country comparison, which explored the impacts of alternative scholarly publishing models on one of the larger (United Kingdom), a mid-sized (Netherlands), and one of the smaller European countries (Denmark). This year there have been three further projects. The first focuses on Germany, and brings the German National Licensing Program (NLP) into the mix of alternative scholarly communication models. The second focuses on the United Kingdom, and uses the JISC EI-ASPM model to examine the cost impacts of alternative scholarly publishing models for a sample of UK universities. The third involved further application of some of the underlying methods to exploring the cost-benefit implications of the proposed US Federal Public Research Access Act (FRPAA). This presentation will examine what the methods developed, studies conducted and debate engendered tell us about the viability and sustainability of alternative publishing models, and their potential impacts on research, research infrastructure and the communication and application of publicly funded research findings.

Economic impacts of open access in Europe and the United States

The release of the UK Joint Information Systems Committee report Economic implications of alternative scholarly publishing models (Houghton and Oppenheim et al. 2009) generated considerable interest, particularly in the methods used to explore the benefits of open access publishing models, as well as their costs. During 2009, there were a number of follow-on studies. These included national studies in The Netherlands and Denmark, and a three-country comparison, which explored the impacts of alternative scholarly publishing models on one of the larger (United Kingdom), a mid-sized (Netherlands), and one of the smaller European countries (Denmark). This year there have been three further projects. The first focuses on Germany, and brings the German National Licensing Program (NLP) into the mix of alternative scholarly communication models. The second focuses on the United Kingdom, and uses the JISC EI-ASPM model to examine the cost impacts of alternative scholarly publishing models for a sample of UK universities. The third involved further application of some of the underlying methods to exploring the cost-benefit implications of the proposed US Federal Public Research Access Act (FRPAA). This presentation will examine what the methods developed, studies conducted and debate engendered tell us about the viability and sustainability of alternative publishing models, and their potential impacts on research, research infrastructure and the communication and application of publicly funded research findings.

International Access to Administrative Data for Germany and Europe

In the last years access to research data has made a lot of progress in EU countries. Nevertheless transnational access to confidential microdata – although there are some developments like “Data without Boundaries” – is still complicated and needs improvement. The first part of the paper describes the (international) access to highly sensitive German administrative labour market data and how this international access is expanded within the research data centre in research data centre (RDC in RDC) approach. In the second part a broader view of international access to official microdata in the EU will be given. Starting with a brief overview of the EU-funded project “Data without Boundaries” (DwB) a possible roadmap for international access in Europe and beyond is presented.

Vascular access: choice and complications in European haemodialysis units

<h3>Aims</h3> European and US guidelines emphasise that permanent vascular access in the form of arteriovenous fistulae (AVF) or grafts (AVG) are preferable to central venous catheters (CVC) in paediatric patients on long-term haemodialysis. We report vascular access choice and complication rates in 13 European paediatric nephrology units. <h3>Methods</h3> A survey of units participating in the European Paediatric Dialysis Working Group requesting data on type of vascular access, routine care and complications in patients on chronic haemodialysis between March 2010 and February 2011. <h3>Results</h3> There were 111 patients in 13 participating centres with a median age of 14 years (0.25-20.2 years). Central venous catheters were used in 67 of 111 (60%) patients with 42 (38%) having an AVF and 2 patients (2%) having an AVG. Choice of vascular access was significantly related to patient age with mean age of patients with AVF/AVG 14.8 years compared to 10.6 years for patients with CVCs (p &lt;0.0001). Routine CVC exit site care and catheter lock solution use differed between centres. CVC infections requiring intravenous antibiotics were reported at a rate of 1.9 and exit site infections at a rate of 1.8 episodes/1000 catheter days. Overall infective complications necessitating CVC change occurred at a rate of 0.9 episodes/1000 catheter days. No infective complications were reported in patients with AVF/AVG access. The rate of CVC infections requiring intravenous antibiotics was significantly lower in patients in whom CVC exit sites were cleaned weekly as opposed to every dialysis session (relative risk with every session cleaning versus weekly cleaning 2.58 [95% confidence interval (CI) 1.17-5.69]). Catheter malfunction (inadequate blood flow) was a more prevalent complication necessitating 22.4 thrombolytic interventions/1000 catheter days and 2.1 CVC changes/1000 catheter days. <h3>Conclusions</h3> CVCs remain the predominant choice of vascular access in Europe despite problems of malfunction and infection. AVF/AVG were predominantly used in adolescents without reported complications. More regular exit site cleaning may predispose to CVC infection but this observation requires prospective evaluation.

Vascular access: choice and complications in European paediatric haemodialysis units

European and U.S. guidelines emphasise that permanent vascular access in the form of arteriovenous fistulae (AVF) or grafts (AVG) are preferable to central venous catheters (CVC) in paediatric patients on long-term haemodialysis. We report vascular access choice and complication rates in 13 European paediatric nephrology units. A survey of units participating in the European Pediatric Dialysis Working Group requesting data on type of vascular access, routine care and complications in patients on chronic haemodialysis between March 2010 and February 2011. Information was complied on 111 patients in 13 participating centres with a median age of 14 (range 0.25-20.2) years. Central venous catheters were used in 67 of 111 (60%) patients, with 42 patients (38%) having an AVF and two patients (2%) having an AVG. Choice of vascular access was significantly related to patient age, with patients with AVF/AVG having a median age of 16 years compared to 12 years for patients with CVCs (p < 0.001). Routine CVC exit site care and catheter lock solution use differed between centres. CVC infections requiring intravenous antibiotics were reported at a rate of 1.9 and exit site infections at a rate of 1.8 episodes/1000 catheter days. Overall infective complications necessitating CVC change occurred at a rate of 0.9 episodes/1000 catheter days. No infective complications were reported in patients with AVF/AVG access. The rate of CVC infections requiring intravenous antibiotics was significantly lower in patients in whom CVC exit sites were cleaned weekly as opposed to every dialysis session (relative risk with every session cleaning vs. weekly cleaning 2.58, 95% confidence interval 1.17-5.69). Catheter malfunction (inadequate blood flow) was a more prevalent complication necessitating 22.4 thrombolytic interventions/1000 catheter days and 2.1 CVC changes/1000 catheter days. Central venous catheters remain the predominant choice of vascular access in Europe despite problems of malfunction and infection. AVF/AVG were predominantly used in adolescents without reported complications. More regular exit site cleaning may predispose to CVC infection, but this observation requires prospective evaluation.

Media Literacy and Universal Access in Europe

The promotion of media literacy as way of increasing access to the range of services available via today's media and communication technologies is currently an emphasis in Europe's information society policy debates. The notion of media literacy heralds a shift in the communications policy arena, especially with regard to media access as a policy goal. Taking into account the situated origins of the inherited regulatory concepts of access, this article argues that the way in which we operationalize media access must reflect how individuals engage with convergent electronic media services. It proposes a context- and user-sensitive approach, where the situation of media (non)users is assessed in terms of the technological and social infrastructure needed to support their access to particular media services.

Dialysis Access in Europe and North America: Are We on the Same Path?

Large differences in dialysis access exist between Europe, Canada, and the United States, even after adjustment for patient characteristics. Vascular access care is characterized by similar issues, but with a different magnitude. Obesity, type 2 diabetes, and peripheral vascular disease, independent predictors of central venous catheter use, are growing problems globally, which could lead to more difficulties in native arteriovenous fistula placement and survival. Creation of dedicated dialysis access teams, including a vascular access coordinator, is a fundamental step in improving vascular access care; however, it might not be sufficient. The possibility that factors other than patient characteristics and surgical skills are important in determining outcomes is likely; it might explain apparent contradictions of end-stage renal disease (ESRD) practices (kidney transplant, peritoneal dialysis, patterns of vascular access use in hemodialysis), where some countries excel in one area and score poorly in another. We are on the same path, but we have a long way to go.

Essential Facility Access in Europe: Building a Test for Antitrust Policy

Abstract This paper investigates the evolution of competition policy decisions in the US and, particularly, in the EU, concerning mandatory access to an essential facility held by a dominant firm. Based on some recent and controversial EU antitrust decisions, we outline a comprehensive test for identifying an essential facility and consequently imposing a mandatory access obligation on dominant firms.