The Sixth International Conference

June2017

THE VALUE OFINNOVATION IN DECISION MAKING

Program

2nd June 2017, hotel Metropol, Belgrade, Serbia www.farmakoekonomija.org • www.farmacija.org

Pharmacoeconomics SectionPharmaceutical Association of Serbia

The Sixt International Conference

THE VALUE OF INNOVATION IN DECISION MAKING2nd June 2017Belgrade, hotel Metropol, Serbia

Conference program will be proactive and it will represent unique event in Serbia and region.Main topics of the Conference are:•• Managed Entry Agreements (MEA)•• Link between MEA and Health Technology Assessment (HTA)•• Access to personalised medicines, orphan drugs and high cost medicines•• Role of patient registries in Access of drugs•• The public economics consequences of health and investments in healthcare

The Conference program is intended for decision makers, makers of health policy design man-agers in health care institutions, employees of pharmaceutical companies (in the sectors of mar-ket access, pricing, health economics, regulation, marketing and sales), doctors and pharmacists who work in the public and private sectors.

Participants of the Conference will have the opportunity to obtain new knowledge from world and local experts and exchange their experience and opinions.

We look forward to welcoming you in person at the Sixt International Conference, organized by

PHARMACOECONOMICS SECTION OF PHARMACEUTICAL ASSOCIATION OF SERBIA

Honorary board

Prof. dr Vesna Matovic

Prof. dr Darko Ivanovic

Prof.dr Nada Kovacevic

Scientific Board

Tanja Novakovic

Krzysztof Landa

Danka Tesic

Danka Stefanovic

Mark Parker

Alessandra Ferrario

Organizing Committee

Jelena Ristic

Vanesa Benkovic

Simo Vukovic

Magdalena Wladysiuk

Dubravka Urosev

4 BOARDS

FRIDAY 2nd June 2017

08.30-09.00 Registration

09.00-09.30 Opening of the Conference Professor Vesna Matovic, President of the Pharmaceutical Association of Serbia Professor Berislav Vekic, Deputy Minister, Ministry of Health of Republic of Serbia Milovan Vujovic, State Secretary of the Ministry of Health of Montenegro Tanja Novakovic MSc Pharm, President of Pharmacoeconomics Section, Serbia

PANEL I

09.30-09.50 The Value of innovations in decision making Tanja Novakovic MSc Pharm, President of Pharmacoeconomics Section, Serbia

09.50-10.20 Managed entry agreements as an instrument to facilitate access to new medicines - The experience of Central and Eastern European countries Alessandra Ferrario, PhD, London School of Economics, UK

10.20-10.40 Managed Access to Health Care and Medicines Bojan Trkulja MD, Managing Director at INOVIA, Serbia

10.40-11.10 RMD (Reimbursement Mode for Development) – HTA-related enhancement tool for industrial investments in a given country Krzysztof Łanda MD, The Board Member of the National Center of Research & Development (NCBiR) of Republic of Poland

11.10-11.25 Discussion

11.25-12.00 Coffee networking break

PANEL II

12.00-12.20 Recent changes in Polish health care system - MEA, patient registries, orphan drugs Robert Plisko, HTA Consulting, Poland

12.20-12.40 The Role of Patient Registries in Access to Medicines and Health Care Jaroslav Duba Ing., OAKS Consulting, Czech Republic

12.40-13.00 Linking Managed Entry Agreements to Health Technology Assessment David Danko, PhD , Ideas & Solutions, Hungary

13.00-13.15 Discussion

13.15-14.45 Lunch break

PROGRAM 5

FRIDAY 2nd June 2017

PANEL III

14.45-15.05 Reform of health care financing Simo Vukovic, PhD MD, Coordinator of the Component Improvement of Health Financing of the Second Serbia Health Project, Serbia

15.05-15.25 The public economics consequences of health and investments in healthcare Nikos Kotsopoulos, Partner at Global Market Access Solutions, USA; Guest lecturer at the University of Athens, School of Public Policy and Administration, Greece

15.25-15.55 Personalized medicine: equity and accessibility Antony P. Martin, University of Liverpool, Management School, Health Economics Unit, UK

15.55-16.10 Discussion

16.10-16.25 Conclusions and closing of the conference

6 PROGRAM

PANEL I

The Value of Innovation in Decision MakingTanja Novakovic

Central and Eastern European healthcare providers face a wide range of unique and difficult challenges which must be addressed in order to meet the ever-growing demands and expec-tations of their services. A key challenge is to achieve and maintain the quality of healthcare including new innovative technologies within constrained budgets, which requires optimal dis-tribution of limited resources.

From 2010, 139 new medicines were registered in EU, of these; Bulgaria reimbursed 44, Cro-atia 27 and Serbia only 1. After 5 year of waiting in Serbia, Managing Board of the NHIF made decision to incorporate 23 innovative drug on the positive Drug List, 18 drugs will be put on the list with Managed Entry Agreements and the remaining five drugs intended for the treatment of children will be reimbursed without limitation.

After several years of limited decision making and stalled discussions at what point is bud-get more important than saving and improving lives?

Managed entry agreements as an instrument to facilitate access to new medicines – The experience of Central and Eastern European countriesAlessandra Ferrario

Managed entry agreements (MEAs) are a set of instruments countries worldwide are in-creasingly implementing to improve access to new medicines. They do so by reducing the im-pact of high-prices, uncertainty around effectiveness and use in real-life on coverage decision. Studies have shown that they are widely implemented in Western Europe, Canada and Austra-lia but less evidence is available on Central and Eastern Europe. This presentation will provide the latest findings of a comparative study on the implementation of MEAs in Central and East-ern Europe. Issues of definition of MEAs, administrative burden of their implementation, price transparency and the need for a monitoring framework to evaluate their impact will addressed in the presentation and further discussed in working groups.

Managed Access to Health Care and MedicinesBojan Trkulja

There is a general belief that Managed Entry Agreements (MEA) are a solution in markets where reimbursement is challenging and negotiation is not possible. Serbia has just started to gather experience with MEA and it is therefore very important to properly make those first steps as a foundation for even more successful application in the future.

ABSTRACTS 7

By definition, MEA is an arrangement between a manufacturer and payer/provider that en-ables access to a health technology subject to specified conditions. These arrangements can use a variety of mechanisms to address uncertainty about the performance of technologies or to manage the adoption of technologies in order to maximize effective of their use, or limit their budget impact.

MEAs can be broadly divided into two subtypes – financial based and outcome based agree-ments, but in order for MEAs to be truly successful, several principles must be implemented:

•• Keep it as simple as possible to avoid substantial compliance costs and the potential for unintended consequences

•• There needs to be clarity on what the MEA is trying to achieve, whether this relates to evidence on clinical outcomes, the population size, the offsetting costs, the overall budget or the cost effectiveness of the medicine at the list price

•• Appropriate type of MEA should be chosen, taking into the account all of reasoning mentioned in the previous bullet

•• Implementation should be tailored to the specific country, disease and product needs•• Last but not least, successful use of MEAs requires trust between all parties

RMD (Reimbursement Mode for Development) – HTA-related enhancement tool for industrial investments in a given country Krzysztof Łanda

ICUR (incremental cost-utility ratio) is the most important criterion on reimbursement in EBHC in developed countries. Countries compete in order to attract pharmaceutical and medi-cal devices companies to invest in a given territory. Some countries do better and some worse. In order to improve chances for success in the competition it is possible to use resources for reimbursement in another way, not only to purchase goods or drugs but also to attract compa-nies to invest in production and R&D. There is a simple idea to improve chances of success in reimbursement if a company has become a partner of economy of a given country. It is feasible to multiply effective cost of a new technology by the RMD factor while assessing its cost-utility against comparator. Such developments are pending in Poland.

PANEL II

Recent changes in Polish health care system – MEA, patient registries, orphan drugsRobert Plisko

In Poland, public spending on health accounts for 69,6% of all health spending - private expen-ditures accounts for 30,4% of all health spending. The public spending are on the level of 4,3% of GDP. Poland belongs to the group of countries with the lowest level of public expenditure on

8 ABSTRACTS

drugs in relation to GDP - at comparable to other countries the level of spending on drugs in rela-tion to GDP (1.4%), Poland is at the one of the last places in terms of spending per capita (below EUR 250). Almost 55% of reimbursement drugs pharma revenues (ex-factory prices) are gener-ated by generics. In 2012 Poland has introduce huge reforms regarding the drug reimbursement – introduction of MEA, fix and maximum prices, new mechanism of external and internal reference pricing, new limit group and cup budget for all reimbursement drugs. Now Poland is spending less, but outcomes are about the same, so maybe money is spent better – the results of reform will be presented. Now the new reform is been planned in Poland with revision of MEA (introduc-tion of registries and outcome based schemes) and utilization of saved budget from MEA, general payback for whole open care drugs, development indicator for new coming reimbursement drugs – originals and generic.

Polish system is one the most restrictive system in CEE countries with strong hurdles re-garding the HTA process, prices negotiation and indication coverage.

The Role of Patient Registries in Access to Medicines and Health CareJaroslav Duba

Since 2008 in Czech Republic all medicines, reimbursed from public healthcare, must past through proceedings guided under the law what makes system predictable and transparent despite the time and procedural complexity. Originator products or in case of new indication, it is obligatory to submit data from clinical trials as well as cost-effectiveness (CUA) and budget impact analyses (BIA) and Real-World Evidence (RWE) data become to be critical input.

To obtain RWE data is not always easy but Czech Republic has big advantage and ahead start compared to many other countries mainly due to the following facts: (1) there is legally enshrined free access to public information, (2) during past decade there was boom of registries and since 2016 some of them became to be part of “National Healthcare Information System” under MoH, (3) RWE data is requested by SUKL and payers and considered as relevant source.

The main sources of RWE data are: registries owned by medical associations or HC providers (several tens); data from payers (7 payers); data from HC providers (several hundred); data col-lected by MoH upon the obligation under the law (currently 21 national registries). Except intro-duction of wide RWE platform which can be exploited internationally, the aim of the presentation is to introduce to participants the detailed content of National Oncology Registry (since 1976); registry for rheumatoid arthritis ATTRA (since 2002); registry for psoriasis BIOREP (since 2005) and National Registry for Diabetes (key strategic registry stablished by MoH in 2016).

Linking Managed Entry Agreements to Health Technology AssessmentDavid Danko

Policymakers in Central and Eastern Europe and the Middle East often ask the question how managed entry agreements (MEA) and health technology assessment (HTA) are related, whether they should be implemented together or separately. The short answer is that although HTA and MEA’s serve different purposes and can very easily exist without each other, MEA’s can

ABSTRACTS 9

indeed be used to mitigate clinical and economic uncertainties related to the health technol-ogy which the HTA process has revealed. MEA’s can be used to ‘improve’ the cost-effectiveness or to alleviate the budget impact of a health technology—many patient access schemes (PAS) in the United Kingdom serve this purpose through relatively simple arrangements. In a more complex patient-level and/or outcome-based forms, MEA’s can serve to bridge the gap be-tween clinical efficacy and real-world effectiveness. For HTA and MEA’s to optimally support each other, the pricing & listing decision process must be constructed in a way that HTA cap-tures relevant uncertainties so that MEA negotiations can be seamlessly connected to, or even integrated into, the technology assessment and appraisal phase. This of course enhances the role of deliberative element in the decision process and is likely to introduce a negotiating ele-ment into it. The presentation will investigate into the possible ways of linking MEA’s to the as-sessment and appraisal process and highlight some conceptual and methodological questions that must be answered.

PANEL III

Reform of Health Care FinancingSimo Vukovic

During the last decades major reforms of health care systems have been implemented in almost all European countries. Concerning the inpatient sector, these reforms were in most cases combined with the introduction of diagnosis-related group (DRG) systems.

Prolonged health care reform in Serbia has had as a result lack of effects on increasing of efficiency, quality and transparency. One of the key reasons was unchanged, historical way of public hospital financing. During 2017 , within the Second Serbia Healt Project (loan of World Bank), MoH started with implementation of DRG which comprised all public hospitals, Health Insurance Fund and Public Health Institute . The introduction of per case payments through DRG system represents a major change in the way that Serbian hospitals will be paid. Payment rates will be fairer and will consequently increase the distinction between well-managed and poorly managed hospitals. The new payment method may have more effective ways of audit-ing and introduction of new types of payment for intensive care and non-acute inpatient care and increase complexity and fairness od pyments. Hospital’s revenue will more closely reflect the cost of good care. DRG-based reimbursement system will be introduce to control health-care expanditure, increase activity levels and standardise care. DRG system will provide valu-able data for the analysis and comparson of hospital performance accross the whole hospital system. DRG implementation also means creating prices based on the costs of cases treated by hospitals, which entails costing and data collection and development of a refernce price and DRG price list.

10 ABSTRACTS

The public economics consequences of health and investments in healthcareNikos Kotsopoulos

Changes in health status have economic costs that can extend beyond the health service. Previous studies have indicated that poor health in working aged adults, and similarly with children who represent future workers, represent the major costs of ill-health to government. For example, a study by the UK government reported non-health costs £62-76 billion annually (2007) of which £29 billion was workless benefits and £28-36 billion in lost tax revenue from poor health. The health sector costs included in typical NICE type cost-effectiveness analysis represented only 8-15% of total government costs.

These figures suggest a “government perspective” framework that accounts for transfer costs and lost tax revenues might be more suitable for informing the benefits of healthcare in tax finance public health systems. To address the value of health and healthcare investments for government, we have developed a fiscal health analytic framework that captures how changes in morbidity and mortality influence tax revenue and transfer costs (e.g. disability, allowances, ongoing health costs). The framework can be used to evaluate the marginal impact of discrete investments or a mix of interventions in healthcare to inform governmental budgetary conse-quences. In this context, the framework can be considered as a fiscal budget impact, and/or cost-benefit analysis model that accounts for how morbidity and mortality linked to specific programs represent both ongoing costs and tax revenue for government. Several examples applying the public economic impact of vaccines, women’s health, and behavioral disorders will be discussed. Applications of the fiscal modelling approach will be discussed and implications for allocation decisions based on public economic consequences and priority setting will be discussed.

Personalized medicine: equity and accessibilityAntony P. Martin

Personalised Medicine (PM) tailors care for each individual patient based on clinical, environ-mental and genetic information. PM offers to revolutionize healthcare by ensuring the ‘right treatment, for the right patient, at the right time.’ The aim is to improve the effectiveness of treatments whilst simultaneously reducing side effects, avoid inappropriate treatment and prevent the need for a trial-and-error approach to medical care. However, the PM revolution has also raised important legal, ethical and social questions that need to be explored, particu-larly related to the criticism of contributing to widening health disparities.

While significant medical advances have been made across therapeutic areas, inequities re-main in health outcomes according to sociodemographic, psychosocial and other factors. Mini-mizing modifiable health disparities is deemed fundamental for an equitable and progressive healthcare system. There are concerns PM may be taken up less quickly and in lower numbers in different populations due to challenges in access, ability to pay privately, availability and understanding of healthcare information. Moreover, the translation of genomic research may also be hindered by insufficient study participation across diverse racial and ethnic populations.

ABSTRACTS 11

Proponents accept that deprived populations may temporarily suffer lower initial access but argue that PM will eventually become accessible. However, history has shown that some health disparities take years to rectify and concentrated efforts are required for remediation. Therefore, monitoring how PM work across different groups is paramount to ensure that ben-eficial aggregate population effects do not conceal widening disparities. Further, initiatives are required to redress any imbalances that widen the equity gap.

12 ABSTRACTS

Tanja Novakovic

Tanja Novakovic MSc Pharm is the president of the Pharmacoeconomics Section within the Pharmaceutical Association of Serbia (from 2006 - to date). She is a founder of the ISPOR Serbian chapter and between 2007 and 2009 its vice president. Tanja is a graduate of the University of Belgrade, Faculty of Pharmacy finishing her postgraduate studies at the Faculty of Pharmacy at Ghent University in Belgium. She is employed at Galenika as product manager for CNS drugs.

She is the author of the “Handbook for pharmacoeconomic evaluations”, the first such pub-lication in the Serbian language. She was active in shaping healthcare policy, writing the first Guidelines for pharmacoeconomic evaluations for Serbia. Tanja participated in several projects in different fields: big data, disease areas such as oncology, rare diseases, nutrition, rheumatogy, biosimilars and also in World Bank/Ministry of Health of Serbia projects. Tanja has organized and presented in many national meetings and international conferences which have resulted in international cooperation in education and the developing of pharmacoeconomics and HTA in Serbia and the region.

Alessandra Ferrario

Alessandra Ferrario has recently completed her PhD at the London School of Economics (March 2017) and will start her postdoc at Harvard Medical School in July 2017 on the intensity of end-of-life care in breast cancer patients. She has been working as a Research Officer at LSE from 2011-2017 on pharmaceutical policy issues and non-communicable diseases. Alessan-dra’s PhD investigated issues around access to new cancer medicines in Europe. In particular, cross-country variations in access, the use of risk-sharing and managed entry agreements and strategic procurement. Alessandra has worked with the World Health Organization on pricing and procurement at global and European level and on availability, affordability and quality use of medicines in Estonia, the Republic of Moldova and Tajikistan. She holds an MSc in Health Policy, Planning and Financing (LSE/LSHTM), MSc in Epidemiology (Swiss Tropical and Public Health Institute, University of Basel) and BSc in Molecular Biology (University of Basel).

Bojan Trkulja

Bojan Trkulja is managing director of INOVIA (Association of Innovative Drug Manufactur-ers in Belgrade, Serbia). He was born in 1971 in Belgrade, where he completed his elementary, high school and medical university. After a successful internship and passing the state exam, he worked in the office of F. Hoffmann – La Roche in Belgrade, from December 1999. Over the last 11 years he held a variety of positions, from associate through the Medical Product Manager, Compliance Officer and Market Access Manager.

BIOGRAPHIES 13

Krzysztof Landa

Krzysztof Landa is the Board Member of the National Center of Research & Development (NCBiR) of Republic of Poland. Dr Landa held the position of Deputy Minister of Health of Re-public of Poland for last two years. He is The Founder of Watch Health Care Foundation (www.WatchHealthCare.eu). The CEO of MedInvest Scanner Ltd. General partner in HTA Audit, a com-pany dealing with quality of HTA (Health Technology Assessment) reports directed to authorities and public institutions in Poland; expert of BCC on health care system. From 2010 till 2011 he was President of Central & Eastern European Society of Technology Assessment in Health Care. In 2006-2007 Dr Landa was the Director of Drug Policy Department in the Central Office of National Health Fund. In 2004 Krzysztof Landa was elected to the Board of Directors of Health Technology Assessment International (HTAi) and performed his duties till mid-2007. He was the Chairman of the LOC of the first HTAi Annual Meeting 2004, held in Krakow, Poland. Dr Landa is a graduate of the University School of Medicine and received his management education at the Postgraduate School of Public Health of Jagiellonian University in Krakow. Promotion of HTA in the region of CEE resulted in international cooperation in education and HTA. Dr Landa organized many national and international HTA workshops and conferences. In years 2006 – 2008 Dr Landa provided consultancy for the Serbian Ministry of Health. He was team leader of the World Bank project aimed at introduction of HTA in Serbia, implementation of EBHC principles to the man-agement of basic benefit package and designing a governmental HTA Agency.

Robert Plisko

Robert Plisko is president of HTA Consulting since 2006, he is one of the founders of the company. Master of economy by education (Cracow University of Economics), started his career in the Polish National Centre for Quality Assessment in Health Care. He is the author of many publications on HTA and health care and as advisor to the World Bank he participated in projects conducted in Serbia. Head of the Economic Analyses Department at HTA Consulting and carries out projects in Europe, USA, Asia and Australia. HTA Consulting provides wide scope of service to planning, collecting, analyzing and presenting clinical, cost data, health technology assessment report to public and private sector - healthcare professionals, payers, hospitals, and employers.

Jaroslav Duba

Jaroslav Duba is owner and CEO at OAKS Consulting s.r.o. Jaroslav founded OAKS Con-sulting s.r.o. in 2009, after more than 15 years of experience in top management positions in Wyeth, Zentiva and Glaxo. OAKS Consulting has become in short time the leading consult-ing company providing full scope of services in MARKET ACCESS in Czech Republic. The team currently consists of 15 specialists with professional background in medicine, pharmacology, mathematical modeling and health-economy.

14 BIOGRAPHIES

David Danko

Dávid Dankó is managing partner of Ideas & Solutions (I&S), an independent research and consultancy firm which provides health policy and market access advisory services to pharma and medical device companies with a focus on emerging and middle-income markets. He also holds a position as research leader at the Corvinus University of Budapest, Hungary, where he lectures pharmaceutical policy and funding.

Dávid has 14 years of experience in health care management & the funding of pharma-ceuticals and medical devices. Until 2010 he was member of the executive team for phar-maceutical reform in Hungary as deputy director of reimbursement at the national health insurance fund. He speaks regularly at conferences and workshops on pharmaceutical and medical device policies, gives payer communication and negotiation trainings to multina-tional companies and authorities.

Focuses:•• Pragmatic value assessment and HTA systems for middle-income markets•• Process and data transparency of pharmaceutical decision-making processes•• Linking managed entry agreements to value assessment of pharmaceuticals•• Negotiations and communication with payers and other governmental stakeholders•• Alternative funding strategies for middle and low-income countries

Dávid has lectured at the European Market Access University Diploma (EMAUD) programme, the Semmelweis University of Budapest, Debrecen University, Eötvös Loránd University and the former Vienna School of Clinical Research. He graduated in Economics from Corvinus Univer-sity of Budapest and earned a PhD degree in 2012 with his thesis on resource management in pharmaceutical research & development.

Dávid is peer-reviewer and editorial board member of three health economics and market access journals. He is also co-editor of a university textbook titled ‘Pharmaceutical Reimburse-ment’ and co-author of the Pharmacoeconomics and Outcomes Research Guidelines for India.

Simo Vukovic

Simo Vukovic is coordinator of the Component Improvement of Health Financing of the Second Serbia Health Project. Dr. Vukovic is a Specialist Doctor of Gynecology and Obstet-rics, and he obtained a PhD title in Health Management from the European Center for Peace and Development of UN University for Peace. He started his professional engagement in the Clinical Center of Serbia, continuing his work as Assistant Professor in the European Center for Peace and Development, and later as the Director of International ECPD Summer School of Management in Healthcare Institutions and the founder of the clinic Vanna Care. He has been a member of the Serbian Medical Chamber since 2008, and he gained significant professional experience at the positions of Advisor to the Minister of health of Montenegro, MP in the National Parliament of Serbia, member of City Council of the City of Belgrade,

BIOGRAPHIES 15

President of Managing Board of the Clinical Center of Serbia and State Secretary in the Min-istry of Health. He is the founder of non-government organization Health Monitor. He is the winner of NALED’s Top Reformer award for 2013, now acting as NALED-s expert consultant for healthcare.

Nikos Kotsopoulos

Nikos Kotsopoulos is a health economist with 15 years of experience in the pharmaceutical industry and related consulting. Nikos has held global and regional positions for the pharma-ceutical industry and has conducted several health economic studies in both developed and developing countries. He also is a guest lecturer at the University of Athens, School of Pub-lic Policy and Administration. In recent years Nikos has contributed to the development of a novel analytic framework that assesses the macroeconomic and fiscal effect of investments in healthcare. The analytic framework developed by Nikos and his team has been incorporated into the WHO framework on broader impact of vaccination to inform decision-makers. Nikos is a partner at Global Market Access Solutions, with licensed offices in Switzerland, UK and US. He has received formal post-graduate training in health economics at the University of Groningen (PhD), and City University, London (MSc).

Antony P. Martin

Antony P. Martin is Research Fellow in Health Economics at Liverpool Health Economics. Since joining LHE, Antony has made significant contributions towards several innovative proj-ects. He completed his BSc in Economics at the University of Liverpool and his MSc in Health Economics at City University London, funded by a scholarship from the NIHR. Previously, he worked for a leading health economics and outcomes research consultancy company, gain-ing experience in cost-effectiveness model adaptations, budget impact models, systematic literature reviews and health technology assessment reports. Antony is undertaking a PhD to examine the clinical and cost-effectiveness of pharmacogenetic tests. In addition, he is look-ing to explore issues surrounding equity in the delivery of personalized healthcare. Antony has experience working within a range of health areas such as alcoholism, hepatitis C, HIV/AIDS, pre-term birth, and he has developed a keen interest in health policy debate. He has also de-veloped an international profile after spending extended periods of time studying and working abroad in Brazil, Hong Kong and Peru.

16 BIOGRAPHIES

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