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3rd International EBHC Symposium 2008
“Rational behind the reforms”
The Symposium took place in Krakow of November 24-25 2008 from the initiative of:
  • Central and Eastern European Society of Technology Assessment in Health Care (CEESTAHC),
  • Leon Kozminski Academy of Entrepreneurship and Management in Warsaw.
In the last year we had the pleasure of organization of the 2nd EBHC Symposium, which resulted in sharing of experience, establishing of new relations and further cooperation between scientists in Poland and worldwide. Our invitation was then accepted by nearly 300 specialists in HTA and decision-makers as well as scientists from Europe and the USA.
The leading theme of this year’s EBHC Symposium was comparison of experience and discussion concerning development of the reform of health care systems in countries of Central and Eastern Europe and their analysis with respect to rationality and accordance with principles of EBHC. Invitations to deliver lectures had been accepted by many worldwide recognized experts, among them a few pioneers of Evidence-Based Health Care.
Among participants of the EBHC Symposium representatives of public institutions (including the Ministry of Health, the National Health Fund, the Parliament, the Office of the President of the RP and local government) as well as those of the world of medicine, politics and business were present, including potential investors on health insurance market in our country.
On behalf of all the persons and institutions engaged in organization of the Symposium we heartily thank you for taking part in this event, so important for Polish medical environment.


Schedule
  • Session: Planned changes. Is the reform in Poland leading to EBHC?
  • Session: Economic implications of equal access to health care
  • Session: CE thresholds vs rewarding the innovation
  • Session: International cooperation in the pursue for EBHC
  • Session: Rebates and risk sharing agreements between payers and pharmaceutical industry
  • Session: Improving pharmacovigilance in the EU
  • Session: EMB/HTA in the ISO system


Speakers
  • Wynand P.M.M. van de Ven
    Since 1986 professor of Health Insurance at the Erasmus University Rotterdam.
    He serves (served) as member of many advisory committees and the editorial Board of scientific journals. As a consultant, e.g. for the World Bank and the WHO, he has studied the health care systems in Chile, Ireland, Israel, New Zealand, Poland, Russia, South Africa and Sweden. He is one of the founding fathers of the European Risk Adjustment Network.
  • Ad R. Schuurman
    President of the Medical Evaluation Committee (MEDEV). Head of Reimbursement Department of the Dutch Health Care Insurance Board (CVZ).
  • Ken Paterson
    Chairman of the Scottish Medicines Consortium (NHS Scotland, UK)
  • Pietro Folino Gallo
    Director of the Centres for Studies, Italian Medicines Agency (AIFA).
    He has been coordinating European and national projects in the pharmaceutical field.
  • Ulf Bergman
    Professor (adjunct) in Clinical Pharmacology & Pharmacoepidemiology at Karolinska Institutet and Senior Consultant, Department of Laboratory Medicine, Division of Clinical Pharmacology, Karolinska University Hospital, Huddinge.
  • Pia Schneider
    She works for the World Bank as an economist for Europe and Central Asia
  • Brian Godman
    Currently a Research Scientist at the Mario Negri Pharmacology Research Institute in Italy
  • Allan Haycox
    Reader in Health Economics, University of Liverpool Management School, UK
  • Elisabeth George
    Associate Director in the Appraisals team, NICE
  • Predrag Djukić
    Ministry of Health, Serbia
  • Dragana Atanasijević
    Ministry of Health, Serbia
  • Tomáš Doležal
    Department of Pharmacology 3rd Faculty of Medicine Charles University, Czech Republic
  • Petar Miličić
    Department of Nuclear Medicine and Radiation Protection, Croatia
  • Marek Twardowski
    Undersecretary of State, Ministry of Health, Poland
  • Jacek Paszkiewicz
    President of the NHF
  • Rafał Zyśk
    Director of the Department of Drug Policy of the NHF
  • Wojciech Matusewicz
    AHTAPol
  • Joanna Mucha
    Politician, member of Parliament, academic lecturer
  • Jacek Ruszkowski
    Director of the Public Health Center, Leon Kozminski Academy of Entrepreneurship and Management, Warsaw
  • Krzysztof Łanda
    Currently an independent consultant and Team Leader of World Bank project
  • Magdalena Władysiuk
    Vice-president of HTA Consulting. An expert in EBM, HTA and PhE; author of numerous training programs and research analyses in HTA
  • Gabriela Ofierska-Sujkowska
    Main specialist at the Department of Drug Policy in the NHF
  • Katarzyna Bondaryk
    Lawyer, head of the practice of pharmaceutical law and biotechnology at the Hogan & Hartson law office
  • Henryk Warkocz
    Chief Executive of the TÜV NORD Polska Sp. z o.o.
  • Tomasz Romańczyk
    Consultant in medical market issues for the Board of the TÜV NORD Polska Sp. z o.o.


Sessions
1. Discussion panel: Planned changes. Is the reform in Poland leading to EBHC?
The objective of this panel is to present intended reforms in the Polish health care system. The key issue will be reflection on rationality of the reforms, which will be analyzed with respect to EBHC theory and practice. Representatives of the payer and the legislator as well as experts in health care management will take part in the discussion. Key issues for planned reforms, important for efficient function of the Polish health care system, will be discussed. The following subjects are proposed:
  • benefit packages,
  • supplementary insurances,
  • the list of reimbursed drugs,
  • role of HTA agencies in health care system,
  • therapeutic programs, financing health services.
2. Economic implications of equal access to health care
Access to health care and quality of health care services are among the key issues of the state health policy. Any limitations in access to health care services (e.g. queue system) may have direct effects on the state of health of the society. Delays in diagnosis and treatment usually significantly decrease the chance of successful treatment and thus have a negative effect on the patients’ quality of life.
The session will focus on the issue of access to health care services depending on the solutions applied. The problems will be presented by recognized experts representing both government and independent institutions in Poland and worldwide (e.g. representatives of the World Bank). The speakers will present different models of the health care system, methods of resource allocation to health care services and effects of different solutions on accessibility of health care services.
3. CE thresholds and rewarding of the innovation
Cost-effectiveness and cost-utility thresholds have been discussed for years all over the world. In developed countries annual cost of dialysis used to be regarded as a widely accepted threshold value for the cost of one life year gained (LYG). Recently the WHO, the NICE and numerous payers presented their opinions concerning use of such cost-utility measures as DALY and QALY in assessment of health technologies financed from public means. The opinion of the British National Institute for Clinical Excellence seems to be one of the most comprehensive, taking into account estimation of willingness to reimburse a technology depending on the degree of uncertainty as to its cost-effectiveness or cost-utility in a specific indication. This has implications not only for reimbursement decisions, i.e. placing of various technologies in a basic benefit package (in a wide sense), but also for development of analysis methodology in health technology assessment as well as willingness to pay for innovation and progress in medicine.
Tendency to “reward” innovative health technologies of a specific kind varies between countries. After cost-effectiveness or cost-utility ratio for a technology has been evaluated, other aspects are assessed, innovation being one of the most important. This leads to various questions:
  • To what degree should specific countries (on different levels of economic development) participate in progress of medicine in the world?
  • To what degree should additional aspects influence the final reimbursement decision?
  • Should systems, in which many highly cost-effective health technologies are “underfinanced” (queues, high co-payment), participate in pursue for innovative technologies and to what degree?
During the session various points of view, based on Polish and international experience, will be presented. The most important points will be discussed.
4. International cooperation in the pursue for EBHC
During this session innovative programs, financed from international sources, will be presented.
The first program was conducted by the Ministry of Health of the Republic of Serbia and financed by the World Bank credit. Before an institution for health technology assessment was established, the Ministry decided to perform a feasibility study for system implementation of HTA, based on international experience in this matter. The project consisted of two separate but strongly connected parts. The first part concerned choice of the most suitable (in Serbian circumstances) model of function of an HTA agency. Design of the model was based on experience of similar institutions functioning in the whole world. Results of that analysis allowed for a rational decision concerning the form and function of the Agency, based on practical data. The other part of the project concerned the basic benefit package. Parts of the package already existing in Serbia were described, along with the procedures and criteria for inclusion and exclusion of health technologies. In the next stage possible solutions, tested in other countries, for specific parts of the package were presented. The choice of specific solutions is aimed at introduction of a system with a benefit package functioning according to the EBHC principles. Both parts of the project allow for improvement of the existing basic benefit package in Serbia and the choice of a model of function for the HTA agency in Serbia, adjusted to current possibilities and system solutions.
In the second part of the session Dr. Ad R. Schuurman, the Chair of MEDEV, will present the principles and results of cooperation between public payers in EU. The main objective of the MEDEV activities (established in 1998) is coordination of activities and exchange of experience concerning medicines policy in the EU member countries. The MEDEV activities include preparation of directives concerning methodology of use of HTA in reimbursement decision making, comparison of national packages of medicines and promotion of transparent, evidence-based principles policy making.
5. Rebates and risk sharing agreements between payers and pharmaceutical industry
Modern tools in “financial engineering” concerning health care services, financed from public means in Poland, still not present in legal acts. Changes in this area should include allowance of risk sharing agreements between the Ministry or the payers and pharmaceutical industry, conditional reimbursement (e.g. coverage with evidence development – CED) and perhaps price-volume agreements or payback (in a modified form). Although centralized purchasing could be organized at present, it is not used in practice due to formal requirements being troublesome and difficult to fulfill. It is therefore important to remove barriers, introduce new legal possibilities and encourage the Ministry and the payers to begin a real active pricing policy.
During the session various tools will be presented and advantages of different arrangements as well as concerns or threats associated will be discussed.
6. Improving pharmacovigilance in UE
Despite awareness of hazards associated with use of any pharmacotherapy, medical personnel remains reluctant to report adverse events associated with use of medicines. The Office for Registration of Medicinal Products estimates that only 10% of the physicians take part in the reporting. Both the Office and pharmaceutical industry agree that expenditure on human resources in pharmacovigilance is still low.
Lessons from history and cases of apparently innovative drugs being withdrawn from the market (vide rofecoxib) forced the decision makers (the EMEA and other institutions involved in registration of medicines) to discuss effectiveness of the present system of pharmacovigilance. The European Commission has developed and is planning to introduce numerous legislative changes presented in a document titled „Strategy to better protect public health by strengthening and rationalising EU Pharmacovigilance” (December 15th, 2007). A Pharmacovigilance Committee will be established (instead of the Pharmacovigilance Working Party) and its decisions will be legally binding for the CHMP Committee. A document titled “Good Vigilance Practice” will contain principles and duties related to good practice for all interested parties in the system of pharmacovigilance. It has been proposed to simplify methods of notification of appropriate authorities (for single cases as well as periodic reports) and a model document “Pharmacovigilance System Master File” has been developed; this would be made available on demand and analyzed during system control in pharmaceutical companies. However, there are two most important changes concerning:
  • introduction of risk management plans along with submission of an application for drug registration and
  • intensification of monitoring by introduction of guidelines concerning post-registration survey and their approval by the authorities,
  • which would have major consequences for pharmacovigilance. The newly established Pharmacovigilance Committee will assess planned studies in at least 2 EU countries. It has also been planned to create a list of medicines to be strictly monitored.
    All these changes at the European Union level are aimed not only at strengthening of the control system, but also at improvement of quality of data received through improved methodology and higher awareness of the problem of pharmacovigilance.
    7. EMB/HTA in the ISO system
    In this session ability to exploit opportunities associated with the ISO certification system in EBM/HTA practice will be discussed. The ISO system, being systematic and comprehensive in its solutions, seems to be an attractive method of categorization of certain problems and issues related to practical application of EBM/HTA principles. Education and training in EBM/HTA seems to be a good example. At present the matter is regulated arbitrarily and therefore it is difficult to decide whether a pharmacoeconomist is “properly” or “adequately” educated, since there are no standards concerning methodology and didactics in this area. Issues of education are strictly associated with harmonization of EBM/HTA terminology, which, in some areas, remains not unified. Translation of terms and concepts from English to Polish entails additional problems.
    The aim of this session is to present plans of systematization of educational process and classification of terminology for this purpose through application of the ISO certification system in the area of EBM/HTA. The session will be chaired by the President of the TÜV Nord Polska company, who – with assistance of the invited guests – will present plans for implementation of the ISO certification system in EBM/HTA.


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