Health technology assessment in cross-border settings

HOPE, Brussels

Maastricht 

University,

the Netherlands

Today’s hospitals operate in a highly stimulating environment. An expanding range of expensive and sophisticated health technologies are available, including pharmaceuticals, medical devices, organisational and supportive systems. The possibilities of responding effectively and efficiently to health needs are improving and, as a consequence, needs and expectations of patients and citizens are increasing. Nonetheless, the expanding demand has to cope with scarce resources. The cooperation between healthcare organisations and between different regions, within and across borders, is more and more valuable, especially in a time of economic and financial crisis. At the same time, the Directive on the application of patients’ rights in cross-border healthcare is creating a new legal environment for patient movement, and hospitals and healthcare institutions need to question levels of quality of care and safety and be ready to face possible new flows of patients. Some challenges are common to all Member States, while others are specific. However, for a long time these trends have been visible in border regions, with some of them being defined as ‘testing laboratories’ for the future of European integration.

In response to these changes, national and regional governments and local authorities are improving the mechanisms involved in the evaluation of new health technologies. The number of national institutions involved in these evaluative processes is increasing. In some cases, hospitals have created new departments responsible for the analysis of new technologies. Furthermore, the European Union (EU) supports and facilitates cooperation in the development and exchange of scientific information, in particular as regards Health Technology Assessments (HTAs). At the same time, the EU institutions aim at fostering openness and healthcare cooperation between countries and in cross-border regions.

In response to both these trends, one of the objectives of the European project EUREGIO II ”Solutions for improving healthcare cooperation in border regions”  (Box 1) – which has been completed in November 2011 – was to stimulate and promote cross-border cooperation in healthcare by fostering the application of HTAs. Cross-border regions face specific problems linked with patient mobility, workforce migration, investment and resource allocation. The technical development and the usage of HTA reports by local decision makers, as well as by healthcare providers, would reduce costs and increase the effectiveness of the assessments.

Before this project, there was not any experience across Europe with HTAs focusing on cross-border use of technologies. Work Package 5 (WP5) of the EUREGIO II project – led by HOPE – aimed at bridging the gap between the rising need for cooperation between healthcare institutions situated on two or more sides of border regions and the lack of instruments aimed at fostering and facilitating this cooperation.

During the project, a Guideline for the use of HTA in the decision-making process in border regions has been created. The Guideline has been designed to inform decisions about the introduction of new technologies in cross-border and local settings. It aims to empower all decision makers in border regions to develop and implement technologies effectively and support the work of healthcare professionals who have no specific expertise in the field of HTA. This Guideline was developed after a literature review and empirical analysis concerning the HTA methodologies and the needs of hospital decision makers in cross-border settings. Once created, it was tested and validated in two case studies, developed by Saskia Knies in the Departments of Nuclear Medicine and Neurosurgery of the University Hospitals of Maastricht and Aachen. These case studies represent the first and only examples of HTAs in local cross-border settings.

HTA is a form of policy analysis in the multidisciplinary field of healthcare. It embraces all aspects of analysis – clinical, technical and economic – associated with the introduction of a (new) technology, but it also considers the social, ethical and organisational implications, the legal framework and the use and implementation needs related to the technology. The International Network of Agencies for Health Technology Assessment (INAHTA) defines a health technology as any intervention that may be used to promote health, to prevent, diagnose or treat disease, or for rehabilitation or long-term care. This includes pharmaceuticals, medical devices, procedures and organisational systems used in healthcare. The main purpose of HTA is to inform technology-related policymaking processes in healthcare. Therefore, HTA can be defined here as a type of research that aims to support decisions, to overcome potentially existing resistance and to moderate discussion around the wishes to implement (new) technologies.

While many HTA agencies were initially established at the national level, having as a priority the authorisation of new technologies (mainly pharmaceuticals) on the market and the determination of their level of reimbursement, hospitals and local authorities have started to use HTA especially (but not solely) when taking decisions about dismissing and replacing an old technology and in the case of purchasing decisions, in various cases establishing HTA departments. At the same time, the interest in HTA methodologies has increased at the European and international levels. International networks have arisen, such as the International Society for the promotion of HTA (HTAi), while the European Commission and the Member States of the EU have foreseen the need of sharing HTA objectives and methodologies.

Two important patterns have evolved. Under the umbrella of the European Commission, the European Network on Health Technology Assessment (EUnetHTA) has been developed with the aim of finding a common understanding and a common agreement, among Member States, of the core elements of a HTA, with the ultimate purpose of enhancing the comparability of studies and the transferability of results. The network has developed the HTA Core Model, which tackles two problems that are often found in HTA reports from different countries: (i) variation in the contents; and (ii) lack of a detailed and standardised structure (EUnetHTA, 2008). While the work performed by EUnetHTA with the Core Model is a comprehensive effort which involves the HTA Agencies of all European Member States, the mini-HTA framework has been developed by the Danish Centre for Evaluation and Health Technology Assessment (DACEHTA) as a support tools for decision makers and management teams at hospital level who are considering the introduction of a new technology. It was born as a form or checklist, with questions concerning the prerequisites for and consequences of new technologies, as it was impractical to perform a comprehensive HTA every time the introduction of a new device was considered (DACEHTA, 2005).

Hospital decision-making processes and HTAs

Even if examples of frameworks for the use of HTA applications in local settings are sometimes available, in general the decision-making pathways in local settings are very different, and in the majority of cases investment choices are taken without following a structured and coherent decision process. Hospital decision makers are all confronted with the same challenges: cost-containment, quality and safety of care, and legitimisation of decisions. Hence, the decision to invest in new technologies is not limited to economic and financial aspects: it is also a strategic choice and it needs to be supported by internal and external stakeholders.

Even if the final choice about the introduction of an innovation is the responsibility of the hospital Board, the most important role in the decision-making process is played by hospital professionals, whose needs are also influenced by the expectations they have towards their working environment. Often, physicians requiring a new technology are asked to gather technical and clinical information about it. Only a few hospitals have a HTA department, but in the majority of hospitals there is either no or limited level of formality, and an ad hoc process has to be set up each time a decision has to be made. Discussions are mostly held within the Board of the hospital, in some cases involving stakeholder representatives, other relevant professionals, financial advisors, consultants or hospital professionals already using the technology in another, similar context. These discussions consider in the first instance the necessity and usefulness of the technology, the importance it has for the hospital, the way it would affect hospital performance and the adjustments or organisational changes that would be needed in relation to its introduction. For new technologies, cost-effectiveness analyses are often developed, whereas sometimes organisational studies examine the available and required manpower, the ability of the existing professionals to deal with the new technology and the interoperability and connection with other tools. Social, ethical and legal aspects are often not formally taken into consideration, but they are embedded in the knowledge and personal background of people involved in the decision. When they exist, national guidelines and HTA products developed at national level are taken into account.

In situations where a hospital is collaborating, competing, competitively collaborating or just servicing the population on the other side of the border, decision makers might want or might need to justify their actions to not only their local, regional or national stakeholders, but also stakeholders across the border. However, hospitals in border regions might not want to assess the situation on the other side of their border. This might be because of a lack of interest, or because there are no skills and resources available for this activity. When there is cross-border cooperation, the combined situation of two or more hospitals needs to be considered, and the concept of profitability would need to be extended to all hospitals in the cross-border region. A HTA would help decision makers to take the right decision for the interest of citizens and patients, preserving efficiency and economic sustainability of both hospitals and if possible improving them.

When seeking health care, the choice of patients is normally based on proximity, on expectations concerning quality of care, on differences regarding the cost of certain services and, in some instances, on the need of overcoming organisational or legal issues existing in the country of residence. 

Hospitals in cross-border regions might attract patients from different sides of the border because only one hospital provides certain services in a border area, or because of the patient’s choice. The placement of a (new) technology in a border region can influence patient flows and can help optimise the use of health resources in the entire border region.

The Guideline for the use of HTA in cross border settings developed by EUREGIO II – WP5 aims to be an effective reference tool for hospitals and decision makers to perform HTA in cross-border settings.(1) It has been based on mini-HTA, but the structure and checklist used in the mini-HTA framework has been, in fact, adapted to the use, needs and peculiarities of border regions. The main reason for this choice is that, when discussing the implementation of an intervention in a local setting, policy makers need to make decisions in a timely manner. A full-blown HTA study would, on average, last for several years. Mini-HTA is based on the reasoning involved in HTA, but it is simpler and more focused, and requires less time to complete.

The Guideline for the use of HTA in cross-border settings is designed specifically, but not exclusively, for hospitals. It supports decision makers who want to decide whether or not to introduce a (new) health technology and guides hospitals in border regions in identifying the consequences of the introduction of a (new) technology, supporting them in making the decision by systematically analysing the existing evidence. When it is decided by two cooperating hospitals to introduce a technology, the Guideline advises the decision regarding the best location for the relevant health technology. The Guideline can be used by different healthcare professionals, including nurses and medical doctors. It is helpful to have the support of trained (health) economists, epidemiologists or statisticians in the hospital.

The Guideline is structured in two parts: the first part, How to use the Guideline, gives concise indications about the use and significance of the Guideline, the setting and situations where it can be used and the ways in which users can gain the maximum potential from it; the second part is the core Guideline for the use of HTA in border settings and consists of three different sections of questions. Section 1 is obligatory for any hospital introducing a (new) health technology in a cross-border region. Section 2 applies only to hospitals introducing a (new) health technology in a border region without the cooperation of another hospital across the border. Section 3 applies to a situation where two or more hospitals are cooperating across a border in a cross-border region. Finally, there are two technical Annexes and three Annexes for more detailed information on how to complete the Guideline, with indications and suggestions on how to answer the questions and where to find more information, with examples of the application of the Guideline and with two case studies.

HTA and clinical evaluation can give an important contribution to cost control and decision making in border regions; this is especially the case for financing, policy, planning and regulatory governance.

Overall, HTA applications can also help to generalise knowledge and make it more transferable across jurisdictions. Nevertheless, products are more and more specified for a unique local setting that is not comparable to other settings. This Guideline is a first attempt to stimulate interdisciplinary collaboration between fields affected by the introduction of the (new) technology and to demonstrate that a more encompassing discussion between all relevant stakeholders is also possible.

During the project EUREGIO II, the Guideline has been applied in two very different case studies, both developed between the University Hospitals of Maastricht (The Netherlands) and the University Hospitals of Aachen (Germany). The first case study explored the issues concerning the implementation of one, two or no cyclotrons in the Departments of Nuclear Medicine of the two hospitals. Consideration of the impact on hospital economics and organisation has been crucial. The second case study explored the issues concerned with the implementation of a neurosurgical procedure in the two hospitals. In this case, the legal and liability aspects have been dominant.

These case studies demonstrate the utility of the Guideline and the way it can help to assess new technologies in border regions, taking into account all relevant elements. They also have revealed that further research is needed to improve the useability of this Guideline for a broad range of users and to ensure that decision makers can easily work with it.

EUREGIO II Solutions for improving healthcare cooperation in border regions ran from 1 December 2008 to 30 November 2011 and was funded by the EU in the framework of the Seventh Public Health Programme 2008–2013.

The output of the project includes: a Handbook for the effective use of EU Structural Funds; a legal report on the effects of tort and data protection rights in the provision of cross border healthcare services; a Guideline for the utilisation of HTA in the decision-making process in border regions. The Guideline was developed by Gloria Lombardi (HOPE – European Hospital and Healthcare Federation), Saskia Knies and Chibuzo Opara (Maastricht University, The Netherlands), and Wija Oortwijn (ECORYS Nederland BV, the Netherlands) and Hans-Peter Dauben (DIMDI – Deutsches Institut für Medizinische Dokumentation und Information, Germany), with the cooperation of many other project partners.

1. The Guideline for the use of HTA in border regions is available at www.euregio2-conference.eu/info/.