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6th International EBHC Symposium 2011
“East meeting West”
The Symposium took place in Krakow on October 10th and 11th, 2011 in Qubus Hotel.
The Symposium, organised for the sixth time, is a unique educational initiative for participants from Poland and other countries of Central and Eastern Europe. Participation in the Symposium provides an opportunity to meet experts from all over the world and freely exchange opinions with representatives of ministries, insurers and payers, as well as those of European medical and business communities. In addition, the Symposium for the first time became a forum for the presentation of HTA development and experience in this field in CEE countries.
This year’s title – "East meeting West" – underlines international character of the Symposium and a trend towards increasing geographical diversity observed during five editions organised till now. Our guests from distant lands – East as well as West in its wide sense, including the "old" European Union, the United States and Australia, made it possible to have a close look at development and changes in HTA that in recent years took place in Central and Eastern Europe, in the context of parallel changes observed all over the world. This may allow for identification of the most important differences and common features of health care systems in specific countries. Examples of solutions applied in other countries may also stimulate reflection on directions of further development. Thus, perhaps, we may be able to take advantage of experience gathered in Western countries and give a chance for development of new, better solutions for countries of Central and Eastern Europe.

The scientific program of the Symposium was presented over two days in seven thematic sessions:
  1. Have EBM and HTA changed the face of medicine? – a debate
  2. Polish presidency of the EU Council – discussion on cooperation and the role of EBHC solutions in realisation of priorities in health care
  3. Polish way to HTA
  4. Comparative effectivenes or relative effectivenes?
  5. International cooperation in view of new challenges
  6. "Heavy" and "light" HTA agencies – agency models worldwide
  7. Changes in the function of HTA in reimbursement and pricing systems

  • Duncan Neuhauser, USA
  • David Banta, France
  • Adam Fronczak, Poland
  • Łukasz Andrzejczyk, Poland
  • Dante Cornago, France
  • David Danko, Hungary
  • Isabelle Durand-Zaleski, France
  • Karen Facey, UK
  • Eric Van Ganse, France
  • Brian Godman, Italy
  • Wojciech Matusewicz, Poland
  • Krzysztof Mączka, Poland
  • Tanja Novakovic, Serbia
  • Ken Paterson, Scotland
  • Andrea Rappagliosi, Italy
  • Alric Ruther, Germany
  • Bolesław Samoliński, Poland
  • Laura Sampietro-Colom, Spain
  • Jean Slutsky, USA
  • Mitchell Sugarman, USA
  • Magdalena Władysiuk, Poland
  • Prof. Michał Marczak
    Faculty of Health Science, Medical University of Lodz, Poland

1. Have EBM and HTA changed the face of medicine? – a debate
Research in medicine was initially based on observational studies, which only after the second world war were replaced by experiments. Studies by Archie Cochrane in Great Britain, A. Feinstein in the USA or D. Sackett in Canada established the position of a randomised controlled trial as the main experimental study and the methodology of RCT as essential in the area of clinical trials. A book by Archie Cochrane published in the 1970s, in which the consequences of the lack of assessment of treatment effects in experimental therapy of patients and the question of justification of financing of such therapies by NHS were discussed, made it possible to view the health care system from a different perspective. The term "Evidence-Based Medicine", coined in 1980s by D. Sackett on McMaster University in Canada and first used by G. Guyatt in 1991, introduced a new area in medicine and led to division of EBM into the "British" model, related to the Cochrane’s idea of "efficient health care" (and indirectly to Health Technology Assessment), and the "Canadian-American" model, in which more attention is paid to clinical application of epidemiology. Development of EBM resulted in an explosion of new institutions dealing with health technology assessment (NHS CRD in the UK, ANDEM in France, IMTA in the Netherlands, SBU in Sweden, HCOHTA in Hungary, AHTAC in Australia and CCOHTA in Canada). Has introduction of EBM and HTA changed the face of medicine and allowed for actual improvement of the systems’ functioning? Our special guest will be one of the "fathers of EBM", who may help us to answer this significant question.
2. Polish presidency of the EU Council – discussion on cooperation and the role of EBHC solutions in realisation of priorities in health care
This year's EBHC Symposium will take place halfway in the Polish presidency in the European Union. This coincidence will be an excellent opportunity to discuss the possibilities of application of health technology assessment (HTA) in realisation of priority health care-related tasks undertaken during the Polish presidency. Prominent experts in various areas of medicine and representatives of DG Sanco as well as those of institutions and organisations dealing with health care will take part in the discussion. We will also be honoured by a special guest – Professor Bolesław Samoliński – Chairman of the Subcommittee for Priorities in Health Care of the Polish Presidency in the UE.
The main discussed problem will be the ways in which HTA may be applied in order to improve health of children with non-infectious respiratory diseases. In addition, gathering of such prominent experts at one table will provide an opportunity to tighten current cooperation, exchange experience and review the activities undertaken by specific countries in the area of health care as well as the effect of health technology assessment on decisions concerning structure of health care systems in Poland and other European countries.
During the session Evidence-Based Health Care solutions important for public health will be discussed as they are often treated also as a remedy for differentia specifica – differences in health care between the countries of Eastern and Western Europe.
3. Polish way to HTA
During the session titled “Polish way to HTA” Polish achievements in development of health technology assessment will be presented. Difficulties on the way to create the Agency for Health Technology Assessment in Poland were similar to that faced earlier by other countries and were mainly due to political circumstances and the fact that the necessity of such solutions in the health care system was largely not understood. Invaluable support of Western HTA experts cooperating with individuals and public institutions in Poland, including David Banta, Egon Jonsson and others, greatly contributed to development of the strongest HTA Agency in the region. From 2006 till August 2009 activities of AHTAPol were regulated by the Instruction of the Minister of Health issued in 2006 and the Agency was only an advisory body involved mainly in assessment of drug technologies on commission of the Ministry of Health; therefore, its role in decisions concerning development of the guaranteed benefit package was limited. An undoubted breakthrough in the system came with the change of the legal status of the Agency – AHTAPol was granted a separate legal entity and involved in assessment of each health care service qualified for the guaranteed benefit package; these changes were introduced by the Act of Parliament of June 25th, 2009, changing the act concerning health care services financed from public means. A new act on reimbursement of medications, special food products and medical devices, according to which the Minister of Health will be obliged to apply the principles of HTA in evaluation of drug and non-drug technologies, will further strengthen the role of AHTAPol in the system.
4. Comparative effectivenes or relative effectivenes?
In recent years in Europe as well as in the USA growing interest, dissemination and more frequent implementation of „relative effectiveness” (EU) or „comparative effectiveness” (USA) has been observed. This term refers to the assessment of efficacy and safety of the use of health technologies in everyday clinical practice. EMA, Medev and other international and national organisations (including HTA agencies) discuss and implement new tools intended for assistance in decision-making – including reimbursement – based on comparative data concerning new, recently introduced health technologies (especially medicines) in relation to currently applied treatments.
In 2002 the G10 High-Level Group on innovation and provision of medicines recommended that the European Commission (recommendation no. 7) should consider sharing health care information among the member states; particular attention was paid to cooperation and exchange of information in the field of HTA. In 2005 and 2007 the High Level Pharmaceutical Forum referred to the G10 recommendations adding the concept of introduction of a system for the assessment of innovation and its actual reward, i.e. „relative effectiveness”. A Relative Effectiveness Working Group has been created in order to establish good practice principles for implementation of such solutions. As a practical approach, the working group will consider development of a set of tools for assistance to make the best use of data concerning effectiveness. In the United States the first publications and initiatives appeared at the turn of the years 2007/2008 and the idea of comparative effectiveness found a place in the presidential campaign. The importance of this concept has been confirmed by signing of the American Recovery and Reinvestment Act (ARRA) by president Obama in 2009 and allocation of 1.1 billion USD to research.
During this session Jean Slutsky from the Agency for Healthcare Research and Quality (AHRQ) will present tasks of the Agency and its invaluable experience gathered during research conducted within the Effective Health Care program. Eric van Ganse will present equally valuable (from the Polish point of view) experience and results of studies conducted in everyday clinical practice and their effect on reimbursement decisions in France.
5. International cooperation in view of new challenges
In this session basic assumptions for European and worldwide cooperation in the area of HTA and EBHC will be discussed. International institutions, such as WHO (HEN) or World Bank, have introduced and conducted numerous programs concerning education, promotion of EBHC and systemic implementations of HTA in Central and Eastern Europe. At the same time activities initiated by HTAi and mainly EUNetHTA meet new challenges concerning cooperation between Ministries of Health (DG Sanco) as well as HTA Agencies aimed at creation of the European HTA Agency. The main objective of EUNetHTA was to unify methodology of HTA reports and to create space and possibilities for communication between public and private institutions. Alric Ruther (Chair of the EUNetHTA Plenary Assembly) will present plans, achievements and potential limitations concerning cooperation between EUNetHTA members. Undoubted benefits of closer cooperation between the Ministries of Health and HTA Agencies include increased exchange of information and experience between the countries.
Cooperation of public institutions was also established in order to exchange experience in drug policy in the EU member states. MEDEV is an organisation consisting of representatives of the Ministries of Health or public insurance institutions. This session will also provide an opportunity to listen to a lecture on benefits of exchange of information (such as HTA reports or information concerning prices and reimbursement status of medicinal products and medical devices) between countries represented in MEDEV.
6. "Heavy" and "light" HTA agencies – agency models worldwide
The main activity of HTA Agencies is advisory or decisive function in elimination of ineffective and/or cost-ineffective health care services from the area financed from public means. Depending on the authorship of HTA reports and financing of their development, two types of HTA Agencies may be discerned, i.e. "light" (reactive) and "heavy" (proactive) agencies. The main task of a "light" HTA Agency is to evaluate analyses submitted along with applications for financing of health technologies from the means of public or private health insurance, and the responsibility for development of adequate documentation lays with the applicant. A "light" agency is relatively cheap as the costs related to analysis are incurred by the applicants for a privileged market position (i.e. usually reimbursement) for their products. Another of its advantages is relatively high efficiency. This type is represented by the Australian (MSAC and PBAC), Dutch, Canadian (CADTH) and Swiss (BSV) Agencies. The main function of a "light" HTA Agency is therefore to ensure appropriate quality (i.e. credibility, objectiveness and completeness) of analyses submitted to decision makers.
"Heavy" HTA Agencies are present in very high-income countries as they are costly (i.e. taxpayers are burdened with costs related to analyses and research) and their efficiency is lower (despite hundreds of employees). The main activity of "heavy" HTA Agencies is to prepare analyses (financed from public means) and to issue related recommendations, thus laying the burden on taxpayers. Examples of such institutions are the American AHRQ, British NICE, French HAS, or Swedish SBU.
This classification, although clear, does not include all possible structural or functional types of HTA agencies worldwide. During the session changes in the structure and function of these institutions will be discussed, as well as problems related to efficiency and new tasks undertaken by HTA agencies.
7. Changes in the function of HTA in reimbursement and pricing systems
Crisis in the world’s economy and continuous increase of expenses on health care (including reimbursement of medications) imposed on the EU decision makers the necessity to introduce new regulations concerning reimbursement and pricing of medications and medical devices. Germany, France, Ireland and Austria provide excellent examples as they not only proposed new solutions tightening their pricing policy, but also introduced mandatory use of HTA-based arguments in the process of decision-making concerning financing of health care procedures from public means. During the session the role and importance of clear rules of function of the reimbursement and pricing system will be discussed in view of demographic and epidemiological changes as well as changes on the pharmaceutical market. Issues concerning changes in regulation of reimbursement, pricing criteria and the use of new EBHC-related instruments in selected countries will also be discussed.

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