11. International EBHC Symposium 2016
Interactions between HTA, coverage
and regulatory processes
12-13 grudnia 2016 | Kraków
12. International EBHC Symposium 2017
HTA: evidence and value in decision-making paradigm
11-12 grudnia 2017 | Kraków
11. International EBHC Symposium took place in Krakow on December 12th and 13th, 2016 in Park Inn Hotel.
All health care systems in CEE countries are currently undergoing dynamic transformation and therefore the directions of changes within the strategic frame are the subject of heated discussions. Furthermore, integration between social, developmental and purely scientific sectors is sought after.
The main reason for changes has been the same for years: the growing crisis of operating costs. While in the past years we focused on different methods of tackling the crisis – from increasing HTA significance, through insurances or harmonising the benefits package – this year we will focus on seeking ways to integrate remedial measures and processes of health care system management. Fixing cash flow problems is similar to repairing a water–supply system – it is not truly fixed until all the holes, not only the biggest and most visible ones, are caulked and filled. We need to look for new values, crucial for decision–making with regards to shaping the guaranteed benefits package (both drug and non–drug technologies) so as to put it into a common legal and financial frame covering reimbursement, participation of science and research and patients’ needs.
In line with this year’s theme we disscused the effectiveness of legislation and implementation processes for introduction of changes in the light of the system’s inertia, the size of the area submitted to regulations and the necessity of engaging different groups of stakeholders.
We need to look for new values, crucial for decision–making with regards to shaping the guaranteed benefits package (both drug and non–drug technologies) so as to put it into a common legal and financial frame covering reimbursement, participation of science and research and patients’ needs.
Przy okazji 11. edycji po raz pierwszy zaproponowaliśmy stałą dyskusję wśród gości EBHC oraz zorganizowaliśmy Forum Ekspertów z krajów regionu CEE.
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11. International EBHC Symposium 2016
Interactions between HTA, coverage
and regulatory processes
12-13 grudnia 2016 | Kraków
11. International EBHC Symposium 2016
Interactions between HTA, coverage
and regulatory processes
12-13 grudnia 2016 | Kraków
The programme of the Symposium will be implemented in five thematic sessions over the course of two days:
- A roadmap for the process of reimbursement and tariffing of health benefits
- CEE Forum: Value-based decision making in CEE countries
- Tools for managing the guaranteed benefits package
- Medical devices: prices, benefits, tariffs
- Better access to services of rare diseases
Przyjęta formuła Sympozjum zakładała dłuższy czas na dyskusję z wybitnymi ekspertami zagranicznymi, co umożliwiło uczestnikom skorzystanie z ich wiedzy w szerszym zakresie niż ma to zazwyczaj miejsce w ramach tego rodzaju spotkań.
Session 1. A roadmap for the process of reimbursement and tariffing of health benefits
The first session titled: “A roadmap for the process of reimbursement and tariffing of health benefits” will cover the planned changes in the field of reimbursement solutions for drugs and medical devices. We will also investigate tools for their implementation – HTA and tariffing and ways to unclutter the package, including elimination of technologies. Apart from national experts, we will host speakers from Hungary, Slovakia, Romania and Bulgaria – countries which are currently building the basis for future changes and are undergoing a constant transformation. .
Due to its exceptional educational value, the participation in the first session will be free of charge. This way we want to encourage those who cannot take part in the entire Symposium – students and fellow scientists – to participate in the event. It is an opportunity to establish direct contact with representatives of the Polish Ministry of Health and The Agency for Health Technology Assessment and Tariff System (AOTMiT). We hope for a lively discussion after the session.
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Session 2. CEE Forum: Value-based decision making in CEE countries
Due to constant modifications of drug policies in CEE countries, during the 11th edition of the Symposium we decided to make the annual meeting of evidence-based healthcare experts from this region a permanent item on the agenda.
A periodic discussion on pricing and reimbursement decision-making in the CEE countries enabled an interchange of experiences related to the introduction of particular modifications and allowed us to learn about existing good practices used in specific European countries. The EBHC Symposium, which is a forum for meetings, serves as a platform for an interchange of experiences and helps improve and creatively adjust the best solutions which have been implemented in other countries.
We invite experts in the field of Health Technology Assessment from countries such as: Sweden, Hungary, Slovakia, Poland, Czech Republic, Serbia and Romania.
The session was moderated by Brian Godman – an expert cooperating with the WHO, the government administration and health insurance companies with the aim to optimise the benefits from using limited resources. His speech presented value-based reimbursement decision-making in European countries, with particular focus on the Central and Eastern Europe countries (CEE).
- Dávid Dankó – partner in a Hungarian research and consulting company which provides advisory in the area of pharmaceutical policy and analyses the medical devices market in the CEE region. He delivered a speech on the principles of sustainable development in reimbursement systems of Central and Eastern Europe countries.
- Maria Psenkova presented the Slovakian reimbursement system. She also talked about her experiences gained in the many years of managing pharmaceutical companies.
- Jaroslav Duba shared his experience of the nine-year-long process of introducing a transparent pricing and reimbursement system in the Czech Republic. He also shared his thoughts on sustainability and stability of access to the market from today’s perspective.
- Tanja Novakovic – an expert specialist in the field of Health Technology Assessment, President of the Pharmacoeconomics Section within the Pharmaceutical Association of Serbia, explained the importance of innovation in decision-making processes.
- Ileana Mardare presented the solutions, both existing and those planned for the nearest future, used in health technology assessment and reimbursement decision-making in Romania.
- Magdalena Władysiuk – President of CEESTAHC, delivered a speech on Poland's experiences.
Wystąpienia wszystkich prelegentów zostały podsumowane dyskusją kończącą pierwszy dzień Sympozjum. top
Session 5. Better access to services of rare diseases
This year’s Symposium paid special attention to rare diseases.
Rare diseases are, in accordance with the definition adopted in the European Union, severe and often life-threatening conditions which affect not more than 5 in 10,000 people.
Currently about 8,000 rare diseases have been identified. This number is still growing due to the progress made in the field of genetics. It allows us to understand the mechanism of diseases which previously remained unexplained. Over 80% of rare diseases are genetic disorders and 50% of new diagnoses concern children. Many patients suffer from co-morbidities – this makes diagnosis and treatment even more difficult.
In accordance with the European Commission’s estimates, rare diseases affect 6-8% of the population. Thus there may be even 2-3 million people suffering from rare diseases in Poland, which makes us wonder whether rare diseases are becoming, to some extent, common conditions. Brought together, rare diseases constitute a serious social problem and an extraordinary challenge for the health care and social security system. Only a few rare diseases such as haemophilia and cystic fibrosis have been covered with multi-specialist treatment programmes.
Rare diseases are not as appealing as common conditions to the medical environment because even medical practitioners interested in the topic may never come across such a case. Knowledge about these diseases is still relatively limited and dispersed in narrowly specialised centres. This limited knowledge and scarcity of experts specialising in specific conditions result in difficult access to diagnosis and treatment – the diagnosis itself may drag on for many years. This is why it is vital to implement actions thanks to which patients suffering from rare diseases will no longer face hindered access to healthcare.
The last session focused on answering questions about the current situation as to access to health technologies used in rare diseases, what actions should be taken to facilitate access to primary and secondary healthcare and the challenges faced by researches and the government in connection with the specificity of such conditions.
Both Polish and foreign experts were invited to the discussion.
- Alastair Kent – director of Genetic Alliance UK – an organisation which supports patients and families affected by genetic conditions.
- Piotr Czauderna – paediatric surgeon, former President of the Polish Association of Paediatric Surgeons and the International Childhood Liver Tumours Strategy Group (SIOPEL). Currently, he is a member of the National Development Council established by the President of Poland.
- Alicia Granados Navarrete – Head of Global Health Technology Assessment (HTA) Scientific Strategy at Sanofi Genzyme, lecturer at the Medical Facility of University of Barcelona.
- Mieczysław Walczak – national consultant in the field of paediatric endocrinology and diabetology and head of the Clinic of Paediatrics, Endocrinology, Diabetology, Metabolic Diseases and Cardiology of the Developmental Age at the Pomeranian Medical University.
- Maria Libura – head of the Institute of Interdisciplinary Studies on Rare Diseases at Łazarski University, lecturer at the Centre for Postgraduate Education at Łazarski University, President of the Polish Association for Patients with Prader-Willi Syndrome, health expert of the Centre of Analysis of the Jagiellonian Club.
We have also invited non-governmental organisations to participate in the discussion to help cover all aspects and problems regarding availability of diagnostics and treatment of rare diseases. To date the following organisations have confirmed their participation:
- Watch Health Care Foundation (WHC) http://www.korektorzdrowia.pl/
- SMA Foundation https://www.fsma.pl/
- Dina Radziwiłłowa The Heart of a Child Foundation http://www.sercedziecka.org.pl/
- Alba-JuliaAssociation of patients suffering from Neurofibromatosis type I and other neurocutaneous disorders http://alba-julia.pl/
- Orphan Rare Diseases Poland http://www.rzadkiechoroby.pl/
- Healthy Aging Foundation http://www.zdrowestarzenie.org/
- Polish Association for Patients with Phenylketonuria and Rare Diseases Ars Vivendi http://www.fenyloketonuria.org/
- Polish Association of Patients with Pulmonary Hypertension and Friends http://www.tetniczenadcisnienieplucne.pl/
11. International EBHC Symposium 2016
Interactions between HTA, coverage
and regulatory processes
12-13 grudnia 2016 | Kraków
Prezentacje:
- Open pharmacy market: 5 years experience of drug reimbursement reform /
1,2 MB // Stefan Bogusławski, Poland - ERNs – Europejskie Sieci Referencyjne – jako przykład podejścia do chorób rzadkich /
6 MB // Piotr Czauderna, Poland - Overview of the Hungarian pricing and reimbursement system /
200 kB // Dávid Dankó, Hungary - Market Access in Czech Republic /
2,7 MB // Jaroslav Duba, Czech Republic - Koszyk świadczeń gwarantowanych jako narzędzie optymalizacji zabezpieczenia zdrowotnego /
300 kB // Dominik Dziurda, Poland - Medical devices in Germany – coverage and innovation /
5,3 MB // Wolfgang Frisch, Germany - Value-based decision making among European countries with a special focus on CEE countries /
2,6 MB // Brian Godman, UK - Collaboration in HTA in Europa – national and regional implications /
2,3 MB // Wim Goettsch, Netherlands - Methodological challenges and alternatives to assess rare diseases treatments /
5,8 MB // Alicia Granados Navarrete, Spain - Value-based pricing for drugs and medtech at the national level /
2,2 MB // Mikael Hoffman, Sweden - Better access to services for patients and families with rare diseases /
170 kB // Alastair Kent, UK - Are horizon scanning tools useful in reimbursement process? /
7,8 MB // Anna Kordecka, Poland - Reumatologia – Mapy Potrzeb Zdrowotnych i koordynacja opieki /
1 MB // Brygida Kwiatkowska, Poland - Adult patients with rare diseases – an urgent challenge for the healthcare system /
2,4 MB // Maria Libura, Poland - Health Technology Assessment and drug reimbursement policy in Romania – present and perspectives /
1,6 MB // Ileana Mardare, Romania - Taryfikacja świadczeń opieki zdrowotnej /
130 kB // Gabriela Ofierska-Sujkowska, Poland - Reimbursement system in Slovakia /
3,0 MB // Mária Pšenková, Slovakia - Horizon Scanning for innovative non-drug technologies /
2,2 MB // Paulina Rolska, Poland - Wycena świadczeń medycznych w opiece koordynowanej na przykładzie koordynowanej opieki nad kobietą w ciąży /
1 MB // Daniel Rutkowski, Poland - Centralna koordynacja terapii wybranych chorób ultrarzadkich /
5,3 MB // Mieczysław Walczak, Poland - Reimbursement in Poland /
1 MB // Ewa Warmińska, Poland - Medicines: 5 years experience with Reimbursement Act /
1,7 MB // Magdalena Władysiuk, Poland - Ocena Technologii Medycznych – zmiany systemowe /
2,8 MB // Wojciech Wysoczański, Polan - ISPOR CEE Network MCDA initiatives: Multi-criteria decision payer preferences for rare diseases in Central East Europe countries /
2,6 MB // Vladimir Zah, Canada