The Fourth International Conference
EVIDENCE BASED DECISION
MAKING IN CENTRAL EASTERN
EUROPE HEALTH CARE
Četvrta međunarodna konferencija
DONOŠENJE ODLUKA ZASNOVANO
NA DOKAZIMA U ZDRAVSTVU
CENTRALNE I ISTOČNE EVROPE
15th and 16th of May 2014
Belgrade, Hotel Zira, SERBIA
15 - 16. maj 2014.
Hotel Zira, Beograd, SRBIJA
Pharmacoeconomics Section
Pharmaceutical Association of Serbia
The Fourth International Conference
EVIDENCE BASED DECISION MAKING
IN CENTRAL EASTERN EUROPE HEALTH CARE
15th and 16th of May 2014
Belgrade, Hotel Zira
The Pharmacoeconomics Section of the Pharmaceutical Association of Serbia (SFE SFUS) is organising the Fourth International Conference with the topic: “EVIDENCE BASED DECISION MAKING IN CENTRAL EASTERN EUROPE HEALTH CARE”, which will take place in Belgrade on the 15th
and 16th of May 2014. (http://www.farmakoekonomija.org and http://www.farmacija.org).
The purpose of the Conference is to present the characteristics of decision making policies
of health care in Europe with strong emphasis upon Central and Eastern Europe and Serbia. To
help participants improve the quality of their healthcare systems by better utilization of pharmacoeconomic studies and Health Technology Assessment reports. The aim of this conference
is also to present best practices in Pricing and Reimbursement decision making in Europe, to
present new pharmacoeconomic methodologies and outcomes research techniques and learn
about the latest standards in health economics modelling.
Participants of the Conference will have the opportunity to meet experts from Health Economics Units from York University and University of Liverpool Management School (United
Kingdom), Hamburg University and Berlin University (Germany), as well as the experts from
World Bank, Australia, Poland, Croatia, Bosnia and Herzegovina and Serbia and exchange their
experience and opinions.
The conference program is targeted at decision and health policy makers, managers of
health care institutions, employees of pharmaceutical companies (employees in the sectors
of health economics, pricing and reimbursement, regulatory, sales and marketing, and market
access). The Conference agenda is tailored to assist doctors and pharmacists who work in the
public and private sectors to better understand the importance of health economics in everyday decision making.
English is official language of the Conference.
We look forward to welcoming you in person at the
Fourth International Conference, organized by
PHARMACOECONOMICS SECTION OF
PHARMACEUTICAL ASSOCIATION OF SERBIA
Sekcija za farmakoekonomiju
Savez farmaceutskih udruženja Srbije
Četvrta međunarodna konferencija
DONOŠENJE ODLUKA ZASNOVANO NA DOKAZIMA
U ZDRAVSTVU CENTRALNE I ISTOČNE EVROPE
15 - 16. maj 2014.
Hotel Zira, Beograd, SRBIJA
Sekcija za farmakoekonomiju Saveza farmaceutskih udruženja Srbije (SFE SFUS) organizuje
Četvrtu međunarodnu konferenciju sa temom: „Donošenje odluka zasnovano na dokazima u
zdravstvu centralne i istočne Evrope“ koja će biti održana 15 - 16. maja 2014. godine, u Beogradu
(http://www.farmakoekonomija.org i http://www.farmacija.org/).
Cilj konferencije je da se predstave osobenosti donošenja odluka u zdravstvu u Evropi sa
posebnim naglaskom na zemlje centralne i istočne Evrope i Srbiju. Takođe cilj konferencije
je da pomogne učesnicima konferencije da unaprede kvalitet zdravstvenog sistema boljim
korišćenjem farmakoekonomskih analiza i izveštaja za procenu zdravstvenih tehnologija. Cilj
konferencije je i da predstavi najbolje prakse prilikom donošenja odluka u procesu formiranja
cena i refundacije u Evropi, da predstavi nove farmakoekonomske metode i tehnike istraživanja
ishoda i novi standard u zdravstveno ekonomskom modelovanju.
Učesnici konferencije će imati priliku da upoznaju poznate eksperte sa katedre za zdravstve­
nu ekonomiju Univerziteta u Yorku i Fakulteta za menadžment Univerziteta u Liverpulu (Velika
Britanija) zatim Univerziteta u Hamburgu i Berlinu (Nemačka), kao i eksperte Svetske Banke,
Australije, Poljske, Bosne i Hercegovine, Hrvatske i Srbije i razmene svoja iskustva i mišljenja.
Program konferencije je namenjen donosiocima odluka, kreatorima zdravstvene politike,
menadžerima u zdravstvenim ustanovama, zaposlenima u farmaceutskim kompanijama (u se­
ktorima zdravstvene ekonomije, formiranja cena i refundacije, regulative, marketinga, prodaje
i pristupa tržišta). Program konferencije je prilagođen i lekarima i farmaceutima koji rade u
javnom i privatnom sektoru u cilju boljeg razumevanja važnosti zdravstvene ekonomije.
Program konferencije je predat za akreditaciju Zdravstvenom savetu Srbije kao međunarodni
kurs I kategorije (7 bodova za učesnike i 12 bodova za predavače).
Velika nam je čast da Vas pozovemo na
Četvrtu međunarodnu konferenciju
SEKCIJE ZA FARMAKOEKONOMIJU
SAVEZA FARMACEUTSKIH UDRUŽENJA SRBIJE!
4
BOARDS
Honorary Board
Prof. dr Ivanka Miletic
Prof. dr Guenka Petrova
Prof. dr Darko Ivanovic
Prof. dr Nada Kovacevic
Scientific Board
Prof. York Zöllner
Mark Parker
Tanja Novakovic
Krzysztof Landa
Magdalena Wladysiuk
Organizing Board
Dragana Baltezarevic
Dubravka Urosev
Gordana Simic
ODBORI
5
Počasni odbor
Prof. dr Ivanka Miletić
Prof. dr Guenka Petrova
Prof. dr Darko Ivanović
Prof. dr Nada Kovačević
Naučni odbor
Prof. York Zöllner
Mark Parker
Tanja Novaković
Krzysztof Landa
Magdalena Wladysiuk
Organizacioni odbor
Dragana Baltezarević
Dubravka Urošev
Gordana Simić
6
FINAL PROGRAM
THURSDAY, 15th May 2014
09:00-09:30
09:30-09:45
Registration
Introduction speech
Prof. dr Ivanka Miletic, President of the Pharmaceutical Association of Serbia (SFUS)
Prof. dr Momcilo Babic, Director of the Republic Fund for Health Insurance, Serbia
MSc. Pharm Tanja Novakovic, President of the Pharmacoeconomics Section (SFE), Galenika a.d., Serbia
PANEL I Health Care Decision Making
09:45-10:15
10:15 -10.45
10:45-10:55
10:55-11:10
HTA for decision making in pricing – the Australian IHPA and the Agency for
Tariffs planned in Poland
Krzysztof Landa, M.D., CEO HTA Audit, Poland
Decision criteria
Mr Mark Parker, Health Economics Unit, University of Liverpool Management School, United Kingdom
Discussion
Coffee networking break
PANEL II Evidence and tools in Decision Making
11:10-11:40
11:40 -12:00
12:00 -12:20
12:20 -12:40
12:40 -12:55
12:55 -13.55
Evidence and tools in decision making
Magdalena Wladysiuk, M.D., HTA Consulting Vice president and CEESTACH president, Poland
Patients registers as a tool to access new medicines
Tarik Catic, MSc., ISPOR Bosnia and Herzegovina President
Market access in CEE countries
Vanesa Benkovic, MSc., Senior HTA and Health research consultant, Croatia
Big data in health care
Tanja Novakovic, MSc., President of the Pharmacoeconomics Section SFUS, Galenika a.d., Serbia
Discussion
Lunch break
PANEL III Clinical data in Decision making
13:55-14:25
14:25 - 14:45
14:45-14:55
Clinical effectiveness in decision making
Janko Samardzic, M.D. PhD., Medical Faculty, University of Belgrade, Republic Fund for Health
Insurance, Serbia
Off-label agents as comparators in health technology assessments and
decision making
Eldon Spackman, PhD, Research Fellow, Centre for Health Economics at University of York, United Kingdom
Discussion
WORKSHOP
14:55-16:40 Discrete event simulations and big data
Mr Mark Parker, Health Economics Unit, University of Liverpool Management School, United Kingdom
FINAL PROGRAM
7
FRIDAY, 16th May 2014
PANEL IV Best Practices in Decision making
09:20-09:45
09:45-10:05
10:05-10:25
10:25-10:45
10:45-11:00
11:00-11:15
Merging theory and practice: Germany’s approach to
evidence-based decision-making
Prof. dr York Zöllner, Professor of Health Economics, Hamburg University of Applied Sciences, Germany
Evidence requirements in pharmaceutical policies across Europe:
implications for the future
Brian Godman, PhD, Division of Clinical Pharmacology, Karolinska Institute, Stockholm, Sweden,
Professor at the Strathclyde Institute of Pharmacy and Biomedical Sciences, Strathclyde University, Glasgow, Scotland
Health Technology Assessment in Serbia
Ruth Lopert, M.D., Department of Health, Principal Adviser, Therapeutic Goods Administration, Australia
Health Technology Assessment System in Romania – From Past to Future
Alin Liviu PREDA, MD, ISPOR Romania Chapter
Ciprian-Paul RADU, MD, PhD, ISPOR Romania Chapter, Romania
Discussion
Coffee networking break
PANEL V DECISION MAKING IN SERBIA
11:15-11:35
11:35-11:55
11:55-12:15
12:15-12:35
12:35-12:55
12:55-14:10
Use of DRG data in decision making
Predrag Djukic, M.D., DILS, Ministry of Health, Serbia
Pricing and Reimbursement of medicines in Serbia
Dragana Baltezarević, M.D., Pharmacoeconomics Section SFUS, Republic Fund for Health Insurance, Serbia
Outcomes of the central public procurement of medicines in Serbia
Biljana Kozlović, M.D., Assistant Director for medicines, Republic Fund for Health Insurance
Deciding to innovate
Bojan Trkulja, M.D., Managing Director of INOVIA, Serbia
Discussion
Lunch break
WORKSHOP
14:10 -16:10
16:10-16:30
Decision making in action (Therapy of rheumatoid arthritis)
Mr Mark Parker, BA Economics and Computer Science, MSc Health Economics, Health Economics Unit,
University of Liverpool Management School, United Kingdom and World Bank experts
Final test, Evaluation and Closing of the Conference
8
FINALNI PROGRAM
Četvrtak 15. maj 2014. godine
09:00-09:30
09:30-09:45
Registracija učesnika
Otvaranje konferencije
Prof. dr Ivanka Miletić, predsednica Saveza farmaceutskih udruženja Srbije
Prof. dr Momčilo Babić, Direktor Republičkog fonda za zdravstveno osiguranje, Srbija
Mr sc. farm. Tanja Novaković, predsednica Sekcije za farmakoekonomiju SFUS, Galenika a.d., Srbija
PANEL I Donošenje odluka u zdravstvu
09:45-10:15
10:15 -10.45
10:45-10:55
10:55-11:10
Procena zdravstvenih tehnologija prilikom formiranja cena – Australijski IHPA
(Independent Hospital Pricing Authority-IHPA) i Agencija za tarife planirane za Poljsku
Dr Krzysztof Landa, HTA Audit, Poljska
Kriterijumi za odlučivanje
Mr sc. Mark Parker, Fakultet za menadžment, Katedra za zdravstvenu ekonomiju,
Univerzitet u Liverpulu, Velika Britanija
Diskusija
Pauza za kafu
PANEL II Dokazi i alati za donošenje odluka
11:10-11:40
11:40 -12:00
12:00 -12:20
12:20-12:40
12:40-12:55
12:55-13.55
Dokazi i alati za donošenje odluka
Dr Magdalena Wladysiuk, HTA Consulting i predsednica CEESTACH, Poljska
Baze i registri pacijenata kao sredstvo za pristup tržištu lekova,
Mr sc. Tarik Ćatić, predsednik ISPOR Bosna i Hercegovina, BIH
Pristup tržištu u zemljama centralne i istočne Evrope,
Mr sc. Vanesa Benković, konsultant za procenu zdravstvenih tehnologija i istraživanja u zdravstvu, Hrvatska
Veliki podaci u zdravstvu,
Mr sc. farm. Tanja Novaković, predsednica Sekcije za farmakoekonomiju SFUS, Galenika a.d., Srbija
Diskusija
Pauza za ručak
PANEL III Klinički podaci i donošenje odluka
13:55-14:25
14:25-14:45
14:45-14:55
Klinička efikasnost u donošenju odluka,
Doc. dr Janko Samardžić, Institut za farmakologiju, kliničku farmakologiju i toksikologiju,
Medicinski fakultet, Univerzitet u Beogradu, Republički fond za zdravstveno osiguranje, Srbija
„Off label“ komparatori pri proceni zdravstvenih tehnologija i donošenju odluka,
Dr sci. Eldon Spackman, Istraživač, Centar za zdravstvenu ekonomiju, Univerzitet u Jorku, Velika Britanija
Diskusija
RADIONICA
14:55-16:40 Simulacija disketnih događaja i veliki podaci
Mr sc. Mark Parker, Fakultet za menadžment, Katedra za zdravstvenu ekonomiju,
Univerzitet u Liverpulu, Velika Britanija
FINALNI PROGRAM
9
PETAK 16. maj 2014. godine
PANEL IV NAJBOLJE PRAKSE U DONOŠENJU ODLUKA
09:20-09:45
09:45-10:05
10:05-10:25
10:25-10:45
10:45-11:00
11:00-11:15
Spajanje teorije i prakse: Nemački pristup u donošenju odluka
zasnovanom na dokazima
Prof. dr York Zöllner, Katedra za zdravstvenu ekonomiju, Univerzitet u Hamburgu, Nemačka
Zahtevi za dokazima u farmaceutskim politikama širom Evrope:
posledice za budućnost
Dr sci. Brian Godman, Odeljenje za kliničku farmakologiju, Institut Karolinska, Stokholm, Švedska,
profesor na Institutu za farmaciju Strathclide i biomedicinskih nauka, Univerzitet Strathclide, Glazgov, Škotska
Procena zdravstvenih tehnologija u Srbiji
Dr Ruth Lopert, Svetska Banka, Ministarstvo zdravlja - Uprava za lekove, Australija
Sistem procene zdravstvenih tehnologija u Rumuniji - od prošlosti do budućnosti
Dr Alin Liviu PREDA, ISPOR Rumunija
Dr sci Ciprian-Paul RADU, ISPOR Rumunija
Diskusija
Pauza za kafu
PANEL V DONOŠENJE ODLUKA U SRBIJI
11:15-11:35
11:35-11:55
11:55-12:15
12:15-12:35
12:35-12:55
12:55-14:10
Upotreba podataka dijagnostički srodnih grupa prilikom donošenja odluka
Predrag Djukić, M.D., DILS, Ministarstvo zdravlja, Srbija
Formiranje cena i refundacija lekova
Dr Dragana Baltezarević, Sekcija za farmakoekonomiju SFUS, Republički Fond za zdravstveno
osiguranje (RFZO), Srbija
Rezultati postupka javnih nabavki lekova u Srbiji
Dr Biljana Kozlović, Svetska Banka, Republički Fond za zdravstveno osiguranje (RFZO), Srbija
Odluka za inovaciju
Dr Bojan Trkulja, Direktor Udruženja proizvođača inovativnih lekova - INOVIA, Srbija
Diskusija
Pauza za ručak
RADIONICA
14:10-16:10
16:10-16:30
Donošenje odluka u praksi (Terapija reumatoidnog artritisa)
Mr Mark Parker, Katedra za zdravstvenu ekonomiju, Fakultet za menadžment, Univerzitet u Liverpulu,
Velika Britanija i eksperti Svetske Banke
Završni test, evaluacija i zatvaranje konferencije
10
ABSTRACTS
HTA for decision making in pricing – the Australian IHPA
and the Agency for Tariffs planned in Poland
Krzysztof Łanda, M.D., HTA Audit
Considering cost accounting of health services and the Pricing Agency cannot be done without the understanding of several primary issues which have significant implications in this regard: One should be aware of what valuation is and what purpose it serves and one must clearly
differentiate between cost of services and valuation of services. Valuation is always arbitrary.
Prices make transactions either possible or impossible. In exchange for payment, somebody
waives their right to certain goods or provides services. If the main aim of setting forth prices is
ensuring the adequate supply of certain services, then valuation does not have to be performed
on the basis of a cost analysis (although in some cases - ca. 10-15% of services - such an analysis will be used; for the majority of services however, it is neither necessary nor possible to be
performed - see information below). One must be aware of the subject matter we are dealing
with, that is: The number of services in the guaranteed benefits package, the variability of the
package’s content and the variability of service costs over time, and consequently the variability in interrelations of health care service costs. Only that can depict the possibilities for cost
accounting of health care services.
Before preparing a draft act on the Pricing Agency, a feasibility study for several possible
scenarios of its functioning should be performed. Among others, one should pose a question of
whether performing functions of the Pricing Agency by different institutions would not impair
the basic functions of those institution which they were primary established to perform, and
most certainly the function of valuation should not be performed jointly with appraisal for the
purpose of reimbursement decisions (i.e. decisions on including a technology in the guaranteed
benefits package). Establishing the Pricing Agency within AHTAPol does not seem to be the
best permanent solution, it can however be considered a temporary one.
Decision Criteria
Mark Parker, MSc. Health Economics Unit, University of Liverpool Management School,
United Kingdom
Decision Making within a healthcare system is a simple matter of life and death, at the
population level. Within a constrained budget healthcare decision makers face the very real
problem that choosing to allocate resources to one area necessarily means those resources are
not available to another.
To address these problems Health Economists have equipped decision makers with an array of tools to enable them to make informed and transparent choices, providing a podium for
discussion whereby each interested stakeholder can ensure their interests are considered, and
place them within the context of the healthcare system.
Budget Impact, Cost Effectiveness/Utility Analysis and now Value Based Pricing and Multi
Criteria Decision Analysis have emerged as the tools of choice to summarise concisely complex
decision problems, emerging from various legal battles between patients, the pharmaceutical
ABSTRACTS
11
industry and health insurance organisations, Health Technology Assessment Agencies are quickly
emerging as a means to keep these problems out of the courts, submissions to the various different agencies across the world effectively now form legal briefs, which lay out in intricate detail
what is meant by “Best Practice”, and by inference the harm caused to a countries population
should healthcare deviate from this practice.
Market access in CEE countries
Vanesa Benkovic, HTA, Health research consultant, Croatia
There is an increased demand for healthcare, owing to the ageing of the population. The rate
of unemployment is quite high in CEE countries, which reduces the numbers of people making contributions for the healthcare system. However, as in many countries, slower GDP [gross
domestic product] growth has affected the availability of money for spending in the healthcare
sector. As a result, there is a lot of pressure on healthcare services, and on prices. Each of the
CEE countries has different profile of health financing percentage from the GDP as well as the
share of public financing, which all comes back to the amount of money reserved for drug
and devices budget. Issues of referencing, pricing and models of reimbursement make similar
hurdles with more-less same level of complexity. On the other hand, state regulation of market
access for drugs and devices is present in CEE countries with many variations. Restrictions are
increasingly being placed on reimbursement; drugs are being approved for smaller target populations, or only following the failure of other agents. Risk sharing and other forms of managed
entry agreements are also becoming more frequent, in relation to the uncertain outcomes of
the use of some products. Under such agreements companies are required to monitor the performance of their products and reimbursement will only be granted for responsive patients. The
development of an electronic health system may come as a transparent solution for managing
prescribing, enabling better overview and control, and may serve as real-time info on consumption, unmet needs and proper follow up of clinical guidelines.
Patients registers as a tool to access new medicines
Tarik Catic, MSc., ISPOR Bosnia and Herzegovina President
Access to innovative medicines is currently limited in CEE countries and different policies
have been set to combat this. The main obstacle is budget limitations but also a lack of HTA
implementation in decision making. Recently some improvements have been made except
most payers base their decision criteria on budget impact.
New approaches in reimbursement of new/innovative and expensive therapeutic options
should be high priority in order to improve therapeutic outcomes and patient satisfaction. Development of risk-sharing schemes, conditional reimbursement and follow up on therapeutic
outcomes could be the chance to increase access to novel therapeutics. Patient data and registries are collections of secondary data related to patients with a specific diagnosis, condition, or procedure, and they play an important role in post marketing
surveillance of pharmaceuticals. Most frequently registries vary in sophistication from simple
12
ABSTRACTS
spreadsheets that only can be accessed by a small group of physicians to very complex databases that are accessed online across multiple institutions. Even when some epidemiology data
exists in CEE countries, the data collected does not meet the requirements to follow up product
performance and outcomes. Mostly, these data are general indexes, but through introduction
of disease/product registries more detailed analysis could be performed. Registries can be associated with pay-for-performance agreements. In order to implement such registries, authorities could develop partnerships with industry, taking care of data confidentiality, ethical and
technical issues.
Big data in Health Care
Tanja Novakovic, MSsc. Pharm President of the Pharmacoeconomics Section (SFE),
Galenika a.d., Serbia
Clinical data from randomised controlled trials represents the gold standard in evidence for
medical decision making, however, these trials represent just a small subset of the data available, and are not necessarily applicable to real life practice.
Furthermore cost data often represents the most uncertain aspects of any health technology assessment, either because such data was not collected during these trials, or the trials
were conducted in countries with a different healthcare structure, and therefore not applicable
in other countries.
Data collected from ongoing clinical practice however is often cumbersome in size, difficult
to interpret due to the lack of control groups and subject to deep privacy concerns. Realising
the value of this data and overcoming these problems will soon help all healthcare providers
better manage their budgets and greatly improve the quality and quantity of services they
provide, by providing a sounder and more current information base for their decisions, and real
time monitoring of the outcomes of their decisions.
Achieving this will require potentially difficult collaborations between the healthcare and
pharmaceutical industries, but turning the emerging and massive streams of incomprehensible
data into valuable information will revolutionise the way healthcare is delivered.
Clinical effectiveness in decision making
Janko Samardžić, M.D.,PhD, Institure of Pharmacology, Clinical Pharmacology and Toxicology,
Medical Faculty, University of Belgrade, Republic Health Insurance Fund, Serbia
In most countries of Europe, physicians have the exclusive right to prescribe medicines. Therefore, they play a crucial role in determining whether medicines are consumed rationally or not.
However, in reality, physicians face different pressures, such as staying objective in the choice of
treatment, being up-to-date with innovations in therapy, keeping the budgets, earning an income,
etc. Thus, there are a number of measures to improve physicians’ prescription behavior, such as
prescription monitoring, prescription guidelines, requirements for prescribing by the international
non-proprietary name (INN), financial, educational and information tools.
ABSTRACTS
13
At least 24 EU Member States already have prescription guidelines. Guidelines consist of
clinical prescription protocols based on evidence and may include financial considerations. In
Austria, Belgium, Germany and Hungary these guidelines are compulsory, which are expected
to be implemented in Serbia soon. Of course, combining different measures, such as electronic
prescription monitoring and guidelines linked with electronic systems appears to be one the
most effective way. The guidelines are mostly based on evidence gathered from randomized
controlled clinical trials from phases I to III. These trials are very good at assessing efficacy, but
it should be taken into account that these trials are not without substantial biases, such as
selective and information bias. Furthermore, efficacy is not the same as effectiveness. Efficacy
means if the drug works in ideal circumstances, and it could be assessed by clinical trials of
phases II and III. Effectiveness means if the drug works in real life and cannot be evaluated in
controlled trials, but through observational studies into phase IV. On the other hand, according
to the procedures of Health Insurance Fund, pharmacological report represents a part of application file for reimbursement lists. The report has to illustrate the completed pharmacological,
therapeutic and social value of drug and it should be based on clinical data and guidelines, in
order to improve the clinical effectiveness of the new medicine vs. comparator.
Should off-label agents be used as comparators in
Health Technology Assessments?
Eldon Spackman, PhD, Research Fellow, Centre for Health Economics at University of York,
United Kingdom
HTA bodies provide guidance and advice to improve health of the population. Their remit is
to compare clinical and economic evidence to provide recommendations on reimbursement of
new technologies. The value of a new technology is dependent on the costs and outcomes of
current practice. To improve overall health a new technology must improve health more than
all the treatments it will displace due to its costs.
In practice, treatment alternatives to the new technology may be off-label. As an example,
twenty-four NICE technology appraisals from 2008-2012 included an off-label comparator
and in 8 (33%) of these appraisals the new technology was rejected. Some question whether
new technologies should be compared to off-label agents since if the new technology is found
to compare unfavourably, then it will be rejected in favour of the off-label agent. NICE does
not have remit to recommend off-label agents however rejection of a new treatment may be
considered an indirect recommendation for use of the off-label agent.
Cost-effectiveness principles suggest that all possible comparators, even off-label agents,
should be included in an evaluation. Pragmatically there may be some issues: some HTA bodies
may be restricted by remit, off-label agents may have less developed evidence and there may
be some risk or liability involved in an indirect recommendation. Cost-effectiveness methods
are ideal for understanding these issues.
14
ABSTRACTS
Merging theory and practice: Germany’s approach to
evidence-based decision-making
York Zöllner, Hamburg University of Applied Sciences, Germany
Since the advent of the new drug pricing & reimbursement law from AMNOG in 2011, the
German pharmaceutical market has ceased to be a “free pricing” market for patented drugs.
While there were earlier attempts to regulate drug pricing, these were highly debated and
relatively short-lived.
In order to portray and interpret the current paradigm in pricing and reimbursement decision-making for newly launched drugs, and discuss whether and how the former can claim to be
a reasonable compromise between scientific judgement and business practicalities:
Market figures (size, trends) will be presented and interpreted (price/volume decomposition,
international comparison).
Regulations will be classified into structural and process-based elements, incentive (dysincentive) based measures to foster innovation (discourage me-too’s) as well as straightforward
interventionist measures to contain or cut expenditures.
The record of payor decisions taken so far including the underlying reasoning will be examined; similarly, as manufacturer reactions thereto will be interpreted.
The role of health economic evaluation as well as other elements of economics – e.g. negotiations, embedded into a game theory framework – will be addressed.
An outlook regarding potential future domestic developments as well the scope for European harmonization will be given.
HTA System in Romania – From Past to Future
Alin Liviu Preda, MD, Health Outcomes Specialist, GSK Romania
Ciprian-Paul RADU, MD, PhD, Market Access Manager, Roche Romania
The transition from a Semashkoto Bismarck model health care system began for Romania
after 1989, but, in practice, “the big reform” started in 1998 with the development of the social
health insurance scheme and the organization of National Health Insurance House. Although
in 1992, following a study financed through World Bank, it was identified the need for developing a Health Technology Assessment (HTA) system in Romania, no practical decision was
taken because of lack of involvement at political level. During the period 1992-2002 some form
of mentorship offered by Alberta Heritage Foundation Canada was performed in this area and
HTA was brought in the attention of the authorities (without any initiation of a Governmental
program), but HTA remained a subject only for the academic and research purposes.Very little
words are to be said about HTA in the silent period of 2002-2011, then,in 2011, NICE International (contracted by the Romanian MoH) made a report evaluating the basic health care
package, where among many other recommendations included a strong point on building HTA
capacity and guidelines specific for Romania environment. Consequently in June 2012, MoH
published a new HTA methodology to be used for approval of new drugs or new indications,
considering the fact that no new drugs /indication were approved in Romania from 2008. The
ABSTRACTS
15
Romanian HTA system is based on a scoring card system, taking into consideration 6 aspects:
(1) HTA reports from France and (2) UK; (3) number of EU countries where the submitted drug
is reimbursed; (4) relative effectiveness; (5) relative safety and (6) relative Patient Reported
Outcomes. Beside this, a simple Budget Impact Model is required as an orientation instrument
used for imposing restriction for reimbursement. The dossiers evaluation is done by the new
HTA Unit created within the Ministry of Health, the Specialty Commissions within the MoH
and the National Commission for the coordination of the Specialty Commissions, which in
summarizing the provided evidence for the decision making used some of the EVIDEM Collaboration tools. The first wave of HTA dossiers was submitted in June and July 2013, arriving at over
200 dossiers by the end of 2013. By February 2014, most of the dossiers submitted have been
evaluated by the HTA Unit (167 HTA dossiers) and the MoH has made public results for these
submitted dossiers, which include both new molecules and new indications. There has been an
acceptance rate (score above 6 points) of about 80% and the draft of the new reimbursement
list was published for public debate.The final publishing of the List in the Official Gazette is
still pending because of the changes in the political environment and because the authorities
and Pharma industry are still discussion on the alignment of the new List with the clawback
taxation and price legislation update in Romania. Finally, we can appreciate that even the HTA
process is working in Romania from the technical perspective, there are still a lot of things to
be done in terms of health policy and decision making based on HTA, because the public reimbursement remains a highly political dependent process which leads to large delays in the
access of patients for new therapies. Without a strong commitment from the political officials
to integrate the reimbursement process with the entire health care reform, there is a risk for the
patients to continuously lack access to better technologies.
Evidence requirements in pharmaceutical policies across Europe:
implication for the future
Brian Godman, Institute for Pharmacological Research ‘Mario Negri’, Milan, Italy
Prescribing Research Group, University of Liverpool Management School, Liverpool, UK Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet,
Karolinska University Hospital, Huddinge, Stockholm, Sweden
Pharmaceutical expenditure has been rising steadily across Europe during the past decade.
It has recently fallen following the economic crisis, but due to rise again due to ageing populations and the continued launch of new premium priced products. This has necessitated ongoing
reforms and initiatives across Europe to help ensure the ideals of equitable and comprehensive
healthcare. Measures include new models to optimise the utilisation of new drugs incorporating horizon scanning pre-launch as well as critical evaluation of the health gain alongside
requested prices given that only a minority of new drugs are truly innovative. In addition, evaluation of potential managed entry agreements to enhance reimbursement as well as post launch
follow-up activities. These include monitoring the prescribing of new drugs against agreed clinical guidance, as well as assessing their effectiveness and safety in routine clinical practice. Initiatives for established drugs include measures to improve their rational use with the help of
formularies such as the ‘Wise List’ launched by the regional Drug and Therapeutics Committee
16
ABSTRACTS
in Stockholm, Sweden, combined with extensive communication and education programmes.
In addition, encouraging INN prescribing to reduce patient confusion, especially if patients are
dispensed different branded generics on each occasion, as well as enhance their use versus
originators once multiple sources become available. This alongside transparency in the pricing
of generics to obtain lower prices. These measures, together with numerous examples from
across Europe, will be discussed in the presentation. The objective is to try and ensure sustainable universal access for healthcare across Europe including Serbia
Pharmaceutical expenditure in Serbia - current and future scope for HTA
Ruth Lopert, PhD, Department of Health, Principal Adviser, Therapeutic Goods
Administration, Australia
In Serbia, although per capita spending is low, pharmaceuticals consume a high proportion of health expenditure. A review of current reimbursement lists and expenditure patterns
sought to identify opportunities to improve value for money.
While in the short term major gains are possible through improving procurement mechanisms for off-patent, ‘essential’ medicines, better value for money from patented ‘specialty’
medicines may also be achieved through adapting the results of health technology assessments (HTAs) conducted in other, selected jurisdictions. Rather than setting wholesale prices
by external reference pricing, the application of ‘de facto’ HTA - referencing prices and listing
conditions in another jurisdiction with established HTA processes, and determining a costeffective price by adjusting for relative per capita GDP - could guide both listing decisions and
price negotiations. For drugs yet to be listed, the de facto HTA method could be applied to set
conditions of listing and as a basis for declining listing of drugs for indications not considered
cost-effective or clinically appropriate there.
Although specialty medicines currently represent a small proportion of overall expenditure,
utilization is growing rapidly. Over the medium term building Serbian HTA capacity will be
increasingly important as high cost drugs become a growing proportion of the total drug budget, particularly as off-patent prices are reduced. The development of robust, evidence-based
HTA processes will be important to improve Serbia’s capacity to: Assess value for money in the
selection, listing and pricing of medicines and provide a means of prioritizing expenditure in a
resource limited environment.
Use of DRG data in decision making
Predrag Djukic, M.D.
As part of the overall health reform efforts in Serbia, introduction of different provider payment mechanisms is being planned. There is a national consensus confirmed by National Assembly that diagnostic related groups (DRG) as patient classification system and as funding
mechanism should be introduced for inpatient acute care services. Implementation of a DRG
system in Serbia is under way. It is planned that DRG system should be used at first as reporting
and analytical tool and later as a payment mechanism.
ABSTRACTS
17
DRG is a system based on activities. It provides a variety of data related to the activities and
performance of the hospitals. It provides insight into operations of the hospital and enables
comparison of different hospitals. It can point out differences related to performance and put
forward questions related to reasons for those differences. As a payment mechanism it provides a tool for payment based on performance and not capacities.
Moreover, role of HTA should be very important in defining cost-effective therapies and
paths of care to be included in DRG weights setting procedure, in order to finance provision of
the best possible care with optimal use of scarce resources and avoid paying for inefficiencies
in the system as much as possible.
All of it provides a whole new set of information available for managers and decision-makers that should help managing institutions and health system in general.
Reimbursement of medicines in Serbia
Dragana Baltezarević, M.D., Health Insurance Fund, Serbia
The Serbian healthcare system is based on the principles of equality and solidarity. Citizens
pay health insurance contributions as a percentage of their income while healthcare services
are used according to their needs. Serbia as the poorest country in Europe, disposing of only
300€ per capita for funding the total healthcare system, spends only 50€ per capita for medicines. The Serbian Reimbursement List is still an integral part of the Rulebook on Reimbursement list which is published in the Official Gazette.
The general criteria for listing are: The RFZO financial plan, public health importance,
pharmacotherapeutic and pharmacoeconomics aspects. For the first time the “Rulebook on
criteria” recognizes special agreements and shorter application procedure for generic medicines. The newly established Central Committee for medicines determines which medicines
will be listed, based on the opinion of the Republic Expert Committees and the Committee
for evaluation of pharmacoeconomics reports. In addition, the current structure of the Serbian Reimbursement List, as well as the new “Rulebook on criteria” enable price reduction,
cost control and adoption of the pharmacoeconomic priniples during the decision-making
regarding the reimbursement of medicines. The main goal is still budget reallocation and savings, for listing more new medicines.
Outcomes of the Central Public Procurement of Medicines in Serbia
Biljana Kozlović, M.D., Assistant Director for medicines, Health Insurance Fund, Serbia
As a part of the World Bank Second Serbia Health Project preparation, the Republic Health
Insurance Fund (HIF), as central purchasing body, has successfully completed centralized procurement of the most expensive medicines for hospitals and primary health care centers with
generated savings of close to 3 billion dinars (25 million EUR). This system, introduced as a pilot
project in 2013, has helped to reduce prices on drugs by an average of 27%, compared to the
previous system. In the first and the largest centralized public procurement of medicines from
the Drug List B, 22 bidders competed for 183 lots of medicines. Framework agreements were
18
ABSTRACTS
concluded with the total of 15 suppliers and manufacturers that offered the lowest prices of
medicines and which, based on defined prices of medicines, are concluding individual supply
contracts with health care facilities till the end of 2014. The framework agreements were concluded after open tender procedure, with one supplier for each separate lot. Their enforcement
is mandatory for all health care facilities, and the framework agreements have a validity period
of 12 months. This is only the beginning of the public procurement reform in the health sector
that will be the backbone of the new World Bank Second Serbia Health Project.
BIOGRAPHIES
19
Krzysztof Landa, M.D.
Krzysztof Landa is the CEO of HTA Audit, a company dealing with the quality of HTA (Health Technology Assessment) reports directed to authorities and public institutions in Poland and
the President of the Watch Health Care Foundation. 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 management of basic benefit package and designing a
governmental HTA Agency.
Mark Parker, MSc
Mark Parker is Senior Economic modeller for the University of Liverpool Health Economic
Unit, Liverpool Cancer Trials Unit and Technical director of Evaluate Econ Ltd, UK. Early background was in software and electronic engineering (University of Manchester) and real time
Digital Signal Processing, along with RF design. Completed the MSc in Health Economics at the
University of York, UK (2009). Currently PhD submission pending in Health Economic Modelling at the University of Liverpool. These roles have mostly involved developing models and
evidence based messages for a wide range of disease areas for global value dossiers and HTA
submissions to NICE, SMC and CVZ, along with internal decision-making. Working with GSK
(vaccines), Sanofi Aventis (Diabetes), Wirral Primary Care Trust (Real world data validation),
CHAMPS (weight management interventions) and Shire (biological in a chronic condition).
Experience in a vast range of disease areas and population modelling, with a strong educational background in economics, software development, distributed systems and computation,
Artificial Intelligence (1st, BSc Economics and Computer Science, UoL). Applying these skills
to develop evidence based value arguments for Health Technology Assessment. This training,
education and experience provide the means to apply the world’s most advanced techniques
to solve complex problems in a methodical, transparent and comprehensible way, with a core
focus on knowledge transfer. Enjoys a wide range of water, snow and motor sports.
20
BIOGRAPHIES
Magdalena Wladysiuk, M.D.
Magdalena Wladysiuk is a president and owner of HTA Consulting. She is the president of the
Central & Eastern European Society of Technology Assessment in Health Care (CEESTACH).
She is a medical doctor with MBA in Technology Management. She is one of the authors of
100 HTA reports for industry and public health insurance and financialanalyses developed since
2001 (some are in Polish and some are available in English). From 2006 till 2008 she provided
consultancy services for the Serbian Ministry of Health (MoH) in respect to evidence based
basic benefit package, design and feasibility study on different models of HTA Agency in Serbia
and quality of best practice guidelines. In addition she was also involved in the Evidence Based
Heath care (EBHC) development, HTA systemic implementation, in-depth training of Serbian
HTA analysts and development of 3 country specific HTA reports.
Currently she closely works with MoH Poland counterparts and private sector, develops
strategic planning, economic analysis, health promotion, standards, cost reduction and clinical/health information systems.
Magdalena Wladysiuk is involved in promotion of HTA in the region of CEE which resulted
in international cooperation in education and HTA. She organized many national and international HTA workshops and conferences and she was a speaker at most of them.
Tarik Catic, MSc
Tarik Catic is founder and president of ISPOR Bosnia and Herzegovina Regional Chapter
and president of Section for pharmacoinformatics and pharmacoeconomics at Pharmaceutical
Society of Federation of Bosnia and Herzegovina. He graduated at Faculty for Pharmacy in Sarajevo, and since 2010 he holds master degree in health economics and pharmacoeconomics,
PompeuFabra University, Barcelona, Spain.
He is employed in pharmaceutical industry working on position of product manager in area
of CNS, rheumatology, osteoporosis, anti-infectives and oncology portfolio, experienced in
pharmaceutical marketing, drug regulatory, market access, clinical trials, and was team leader
in Adriatic region. He was included in different projects in area of business development, market potential analysis and evaluation and portfolio development. Tarik is permanent member
of ISPOR HTA Round table for Europe.
As ISPOR BH president Tarik initiated and actively participated in several projects like translation and adoption of ISPOR Book of Terms, ISPOR Good research practices, ISPOR distance learning
modules, he was firs chief editor of ISPOR BH Newsletter. Tarik participated as organizing committee member for pharmacoeconomic conferences, congresses and scientific meetings. He was
team leader for development of ISPOR BH learning modules for basic pharmacoeconomic course
and is lecturer in this course program as part of continuing medical education. Tarik published a
several scientific papers published in indexed scientific journals, he participated in numerous local
and international congresses and conferences as invited lecturer and poster presenter. He actively
works on promotion of pharmacoeconomics and education in this field and HTA implementation
in decision making in health care in Bosnia and Herzegovina.
BIOGRAPHIES
21
Vanesa Benkovic, MSc Pharm
Vanesa Benkovic, graduated her masters study as manager in health and health services at
Medical Faculty, University of Zagreb. She is currently finishing her PhD thesis on health inequalities at Faculty of Philosophy, Sociology Dpt. University of Zagreb.
Vanesa graduated several educations in field of pharmacoeconomics, health economics and
advanced modeling in HTA in France and Austria. She received Open Society scholarship at
Global Health Economics project by European University of StPetersburg, Russia. She teaches
pharmacoeconomics and health economics at Faculty of Medicine, Faculty of Pharmacy University of Zagreb, and health statistics at European University of StPetersburg GHE courses.
Her field of work includes extensive list of health economic analysis for drugs, devices, technologies and cost of illness studies in Croatia, Slovenia and Bosnia and Herzegovina, as well
as research methodology for various EU JA projects such as Urban health centers Europe and
Cross border patient registries initiative (PARENT). She also designs and performs market and
scientific research in health. Her latest engagements include health business intelligence for a
World Bank project for Croatian Ministry of Health and strategic consultancy both for pharmaindustry and budget holders.
She publishes papers in area of research methodology, public health, pharmacoeconomics
and health economics. Currently Vanesa is setting up business including IT applications for
polypharmacy.
Tanja Novakovic, MSc Pharm
Tanja Novakovic M.Sc. Pharm is the president of the Pharmacoeconomics Section within
the Pharmaceutical Association of Serbia. She is founder of the ISPOR Serbian chapter and
between 2007 and 2009 its vice president. Since 2001 she has been working in Galenika a.d., a
pharmaceutical company, as a product manager for drugs of the central nervous system.
Tanja Novakovic 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
the author of the “Handbook for pharmacoeconomic evaluations”, the first such publication
in the field of pharmacoeconomics in the Serbian language. Through the Pharmacoeconomics
Section she is constantly increasing awareness of health economics, pharmacoeconomics and
the importance of Health Technology Assessment (HTA). She is active in shaping healthcare
policy, writing the first Guidelines for pharmacoeconomic evaluations for Serbia. She was also
co author in one of the three HTA analyses first completed in Serbia, and was engaged to lead a
group of experts to define all existing elements of basic benefit package in Serbia (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.
22
BIOGRAPHIES
Janko Samardzic, M.D., PhD, spec.
Janko Samardzic is a specialist in Clinical Pharmacology at the Institute of Pharmacology, Clinical Pharmacology and Toxicology in Belgrade. He is teaching at the Medical Faculty,
University of Belgrade, Serbia. Dr Samardžić has a master degree in Experimental Pharmacology and PhD in the field of Medical Pharmacology. He completed postgraduate courses in the
pharmaco-epidemiology and clinical trials at Erasmus University Medical Center Rotterdam,
The Netherlands. Currently he holds the position of Chief for Pharmacoeconomics in Republic
Health Insurance Fund.
As a researcher, Dr Samardžic is a member of the Science Project by the Ministry of Education, Science and Technological Development, Republic of Serbia. He is a member of Serbian
Pharmacological Society, Austrian Pharmacological Society and European Colleague of Neuropsycho- pharmacology (ECNP). Also, he is an expert for preclinical and clinical drug evaluations at the regional Agencies for Medicines and Medical Devices.
Dr Samardzic has extensive experience and expertise in Pharmacology, he is the author of a
large number of peer reviewed papers, and also a regular speaker at international medical and
pharmaceutical workshops and conferences.
Eldon Spackman, PhD
Eldon Spackman is a Research Fellow in the Team for Economic Evaluation and Health Technology Assessment at the Centre for Health Economics, University of York. He joined the
Centre for Health Economics in 2010. He holds a BA (2002) and MA (2006) in Economics from
the University of Calgary and a PhD (2009) from the Pharmaceutical Outcomes and Policy
Program at the University of Washington.
His research interests include methods for incorporating uncertainty in the decision making
framework, the effects of investment and irrecoverable costs in HTA and assessments of screening and diagnostics. Eldon has recently worked on empirical estimates of the UK cost-effectiveness threshold and methods to support the UK Department of Health on the implementation
of value based pricing. He has also been involved in model development or clinical trials in a
number of disease areas including Alzheimer’s disease, asthma, psoriatic arthritis, depression
and prostate cancer.
He is an associate editor for BMC Public Health and a member of the PSSRU unit cost advisory group. Eldon is also a member of the Technology Appraisal Committee for the National
Institute for Health and Clinical Excellence (NICE) and supports method development as a
member of NICE’s Decision Support Unit.
BIOGRAPHIES
23
Professor York F. Zöllner
York F. Zöllner is professor of health economics at Hamburg University of Applied Sciences
since March 2010. As such, he will do his share in ‘producing’ the next generation of skilled young health economics experts. Likewise, he will strive to make his own contribution to research
and public health by conducting meaningful analysis in the fields of cost-of-illness, cost-effectiveness of healthcare interventions, and equity issues. Prior to rejoining academia, he was
Research Director with a contract research organization in the HEOR and P&R space. Previously, he was Director of Global Health Economics with a mid-sized European pharmaceutical
company, where he was accountable for the P&R status of the worldwide product portfolio,
ranging from conception of late-phase clinical trials to hands-on payer submissions at national
level. York is member of the editorial board of the Journal of Medical Economics and regular
peer reviewer for a number of other journals.
Brian Godman, PhD
Brian Godman is researcher at Division of Clinical Pharmacology, Karolinska Institute, Stockholm, Sweden and also positions with Mario Negri Institute for Pharmacological Research, Milan,
Italy and Prescribing Research Group, Liverpool University, United Kingdom. Brian Godman is actively working with health authorities and health insurance companies across Europe, South America, UAE (Abu Dhabi) and USA, evaluating the impact of measures to enhance both the quality
and efficiency of prescribing of both new and existing products. This includes Serbia. Prior to active
research, Brian spent thirteen years in European and Global healthcare consultancy undertaking
numerous projects including appraising current and planned reforms to enhance the quality and efficiency of prescribing, their transferability, and implications for all key stakeholders groups. It also
included evaluating developments in the pricing and reimbursement of drugs and their influence
on product development and market access strategies. He is author of 37 scientific journals.
Predrag Djukic, M.D., MSc
Since 2006 Predrag is working on the implementation of the health sector reform projects
of the Ministry of Health of Serbia that are financed from the World Bank loans. He held both
managerial and expert positions in the implementation of those projects. Furthermore, Predrag
also provided consultancy services in Serbia and abroad. His expertise is in Health Financing,
with focus on provider payment mechanisms, including diagnosis related groups in particular.
Other main interests include Health Technology Assessment both in methodological sense and
in the sense of institutionalization of HTA in Serbia.
Predrag is a medical doctor with a Masters degrees in Clinical Anatomy from the University
of Belgrade School of Medicine and in International Health Care Management, Economics and
Policy from the Bocconi University in Milan, Italy. He is a founding member of ISPOR Serbia and
has a close association with CEESTAHC.
24
BIOGRAPHIES
Ruth Lopert, M.D., PhD
Ruth Lopert, a public health physician and pharmacoeconomist, is Principal Adviser at the Australian Therapeutic Goods Administration (TGA). In 2011-12 she was Visiting Professor in Health
Policy at George Washington University (GW), and from 2008-2011 was the chief medical officer
at the TGA. In 2006-07 she held a Harkness Fellowship in Health Policy and in 2005-06 was director of Pharmaceutical Policy in the Australian Department of Health, responsible for developing
policy to support sustainability of Australia’s drug coverage program. She had previously served
as both director of the program, and clinical and technical adviser to the national formulary committee. Ruth is currently also Adjunct Professor of Health Policy at GW.
Dragana Baltezarevic, M.D., spec.
Dragana Baltezarevic is currently employed at the Pricing and Reimbursement Department
at the Health Insurance Fund, Serbia (RFZO). She is a medical doctor. Previously she has been
working at the pharmaceutical company “Hemofarm- STADA” for more than five years, as a
Medical representative, Product (SBU) manager and Medical adviser at the central Portfolio
Service and as a consultant for the DRG system implementation with the World Bank project
“Serbia Health Project – AF”. Meanwhile, she completed postgraduate master degree at the
Faculty of Pharmacy :”Pharmacoeconomics and pharmaceutical legislation”. As a pricing and
reimbursement specialist at the RFZO, she is responsible for analysis of the reimbursement list,
pharmaceutical reimbursement strategy and drug application processing, as well as monitoring
of drug utilisation. She is a member of the Subcommittees for: A, H, M, V groups and central
tender Committees for: blood and blood derivates, oxygen therapy and biological therapy.
She is also a member of the Committees for approving the therapy (adalimumab/infliksimab,
gefitinib/erlotinib and trastuzumab) as well as the Committee for Pharmacoeconomics and
“off-label” use. She also carries out communication between Serbian and other HIFs through
the PPRI network. Dragana enjoys practising Yoga.
Biljana Kozlovic, M.D.
Biljana Kozlovic is a medical doctor with 20 years of experience in management and consulting in pharmaceutical industry and clinical trials. She is engaged as a World Bank consultant
for pharmaceuticals and procurement. As of September 2013, she holds the position of deputy
director in charge of pharmaceutical affairs at Republic Health Insurance Fund in Belgrade.
BIOGRAPHIES
25
Bojan Trkulja, M.D.
Bojan Trkulja, director of the Association of Manufacturers of innovative medicines INOVIA
in Belgrade, Serbia from 1st December 2010. He was born in 1971 in Belgrade, where he completed his elementary, high school and medical university. After a successful intern-ship 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.
Bojan is happily married.
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BIOGRAFIJE
Dr Krzysztof Landa
Krzysztof Landa je generalni direktor kompanije HTA Audit, koja se bavi procenom kvaliteta
izveštaja procena zdravstvenih tehnologija (HTA - Health Technology Assessment) namenjenih državnim institucijama u Poljskoj. Takođe je predsednik Watch Health Care Foundation.
Od 2010. do 2011. bio je predsednik Udruženja CEESTAHC - vodećeg udruženja za medicinu
zasnovanu na dokazima i procenu zdravstvenih tehnologija za centralnu i istočnu Evropu, a
2004. godine je izabran za člana borda direktora međunarodne organizacije za HTA – HTAi i na
dužnosti je bio do 2007. godine.
Dr Landa je bio predsednik naučnog odbora Prvog godišnjeg HTAi sastanka u Krakovu, Poljska. Diplomirao je na Medicinskom fakultetu, a postdiplomske studije iz menadžmenta završio
je na Institutu za javno zdravlje Jagiellonian Univerziteta u Krakovu. Promocija HTA u regionu
centralne i istočne Evrope rezultirala je međunarodnom saradnjom u edukaciji i proceni zdravstvenih tehnologija. Dr Landa je organizovao brojne nacionalne i međunarodne HTA kurseve
i konferencije. Od 2006-2007. godine, dr Landa je bio direktor Odeljenja za lekove u Nacionalnom zdravstvenom fondu Poljske. Od 2006 do 2008. godine, bio je konsultant Ministarstva zdravlja Republike Srbije i vođa tima na projektu Svetske banke za uvođenje HTA u Srbiju,
implementaciju paketa osnovnih zdravstvenih usluga zasnovanih na dokazima i projektovanje
HTA agencije.
Mr sci. Mark Parker
Mark Parker je viši saradnik za ekonomsko modelovanje odseka za zdrаvstvenu ekonomiju
Univerziteta u Liverpulu, Velika Britаnija i Jedinice za kliničke studije iz oblasti kancera, Liverpul.
Tehnički je direktor kompanije Evaluate Econ Ltd. Osnovno obrazovanje završio je iz oblasti
softvera i elektronskog inženjerstva i realnog vremena “digitalna obrada signala”, zajedno sa
RF dizajnom, na Univerzitetu u Mančesteru. Mаgistаrske studije iz zdrаvstvene ekonomije nа
Univerzitetu u Yorku, završio je 2009. godine. Trenutno radi na doktorskoj tezi iz oblasti zdravstveno ekonomskog modelovanja na Univerizitetu u Liverpulu. Mark Parker je autor modela i
poruka zasnovanih na dokаzima za globalne dosijee za širok spektаr bolesti i za HTA izveštaje
koji se podnose NICE, SMC i CVZ, kao i analiza za interno donošenje odlukа. U svojoj profesionalnoj karijeri radio je sa sledećim kompanijama: GSK (vаkcine), Sаnofi Aventis (dijаbetes),
Wirral Primary Care Trust (validacija podataka iz realnog života), CHAMPS (intervencije za regulisanje telesne težine) i Shire (biološka terapija u hroničnim stanjima).
Mark Parker ima veliko iskustvo i stručnost u više terapijskih oblasti, populacionom modelovanju, ekonomiji, razvoju softvera, distributivnim sistemima i računarstvu, veštačkoj intelingenciji (1st, BSc Economics and Computer Science, UoL). Primenjujući stečene veštine i znanja
razvio je argumente zasnovane na dokazima za procene zdravstvenih tehnologija.
Navedene obuke, obrаzovаnje i iskustvo omogućili su primenu nаjsаvremenijih svetskih tehnika zа rešаvаnje složenih problemа na metodički, trаnspаrentаn i rаzumljiv nаčin, sа osnovnim
fokusom nа trаnsfer znаnjа.
Uživa u sportovima na vodi, snegu i vožnji motorom.
BIOGRAFIJE
27
Dr Magdalena Wladysiuk
Magdalena Wladysiuk je vlasnica kompanije HTA Consulting u kojoj je od osnivanja 2001.
godine.
Predsednica je Udruženja CEESTAHC - Central & Eastern European Society of Technology
Assessment in Health Care. Ona je doktor medicine sa završenim MBA programom u upravljanju tehnologijama. Jedan je od autora 100 različitih HTA izveštaja za farmaceutsku industriju i
fondove zdravstvenih osiguranja. Učestvovala je u razvoju metodologije, strukture i inicijalne
namene osnovnog paketa zdravstvenih usluga za Poljsku. Od 2006 do 2008. godine, radila je
kao konsultant za Ministarstvo zdravlja Republike Srbije na implementaciji zdravstvene zaštite
zasnovane na dokazima i osnovnog paketa zdravstvenih usluga, studiji izvodljivosti za različite
modele HTA Agencija, razvoju medicine zasnovane na dokazima, sistemskoj implementaciji
HTA, sveobuhvatnom treningu iz oblasti HTA analize i izradi 3 HTA vodiča čije su teme izabrane
od strane Ministarstva zdravlja.
Trenutno blisko sarađuje sa kolegama iz Ministarstva zdravlja Poljske i privatnog sektora na razvoju strateškog planiranja, ekonomskih analiza, promociju zdravlja, standarda, redukcije troškova
i kliničko - zdravstvenog informacionog sistema. Dr Wladysiuk učestvuje aktivno u promociji HTA
u CEE regionu što je rezultiralo međunarodnom saradnjom u oblasti obrazovanja i HTA. Organizovala je brojne nacionalne i međunarodne HTA kurseve i konferencije na kojima je i predavač.
Mr sci. Tarik Čatić
Tarik Čatić je osnivač i predsednik ISPOR Bosna i Hercegovina regionalnog ogranka i rukovodilac Sekcije za farmakoinformatiku i farmakoekonomiku Farmaceutskog društva Federacije
Bosne i Hercegovine.
Diplomirao je na Farmaceutskom fakultetu u Sarajevu, a 2010. godine stekao je zvanje magistra nauke iz farmakoekonomije i zdravstvane ekonomije na Univerzitetu Pompeu Fabra,
Barcelona, Španija. Zaposlen je u farmaceutskoj industriji gdje je radio na poslovima produkt
menadžera za centralni nervni sistem, reumatologiju, osteoporozu, antiinfektive i onkološki
portfolio, poseduje iskustvo vezano za marketing, registraciju lekova, pristup tržištu, klinička
istraživanja, i kao rukovodilac tima u regionu Adriatik. Bio je uključen u projekte razvoja poslovanja, analize tržišnih potencijala i razvoja portfolija.
Stalni je član ISPOR HTA Okruglog stola za Europu. Kao predsednik ISPOR BH inicirao je i
učestvovao u nekoliko značajnih projekata kao što je prevod i adaptacija ISPOR knjige termina
na jezike naroda BiH, prevod ISPOR dobrih istraživačkih praksi, vodio je projekt prevoda i adaptacije ISPOR modula za učenje na daljinu, urednik je ISPOR BH Newsletter-a, učestvovao je u
organizaciji ISPOR BH konferencija, kongresa i stručnih skupova. Kao rukovodilac tima ISPOR
BH učestvovao je u razvoju edukativnih modula u okviru kontinuirane medicinske edukacije, i
kao predavač. Objavio je nekoliko naučnih članaka u indeksiranim časopisima, učestvovao u
brojnim međunarodnim skupovima kao predavač po pozivu, prezentovao je nekoliko poster
prezentacija. Aktivno radi na promociji farmakoekonomije i edukacije iz ove oblasti, kao i na
implementaciji HTA u sistem odlučivanja u zdravstvu u BiH.
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BIOGRAFIJE
Mr sci. Vanesa Benković
Vanesa Benković je magistrirala menadžment u zdravstvu na Medicinskom fakultetu u Zagrebu. Trenutno završava doktorsku disertaciju iz zdravstvenih nejednakosti na Odsjeku za sociologiju Filozofskog fakulteta u Zagrebu.
Završila je niz edukacija iz oblasti farmakoekonomije, zdravstvene ekonomije i naprednog
modelovanja procene zdravstvenih tehnologija u Francuskoj i Austriji. Dobitnica je stipendije
Otvorenog društva za trogodišnji program Global Health Economics koji sprovodi European
University of St.Petersburg, u saradnji sa LSE i MIT fakultetima. Predaje farmakoekonomiju,
finansiranje i zdravstvenu ekonomiju na Medicinskom fakultetu i Fakultetu za farmaciju i biokemiju u Zagrebu, kao i zdravstvenu statistiku na kursu European University of St.Petersburg
- GHE. Njeno područje rada uključuje iscrpnu listu zdravstveno ekonomskih analiza lekova,
pomagala, tehnologija i studija tereta bolesti za Hrvatsku, Sloveniju i BiH, kao i niz istraživačkih
metodologija za razne EU JA projekte kao što su Urban health centers Europe i Cross border
patient registries initiative (PARENT). Vanesa se takođe bavi dizajnom i sprovođenjem tržišnih
i naučnih istraživanja u zdravstvu. Njeni nedavni angažmani uključuju poslove analitike zdravstvene poslovne inteligencije za projekat Ministarstva zdravlja HR finansiran od Svetske banke,
strateška savetovanja za farma industriju i zdravstvene upravne autoritete u regionu.
Objavljuje radove iz područja metodologije, zdravstvenih registara, farmakoekonomije i zdravstvene ekonomije. Trenutno radi na primeni IT rešenja na području polifarmacije i adherencije.
Mr sci. farm. Tanja Novaković
Tanja Novaković je od osnivanja 2006. godine predsednica Sekcije za farmakoekonomiju
Saveza farmaceutskih udruženja Srbije. Osnivač je udruženja ISPOR Srbija i od 2007 do 2009.
godine bila je potpredsednica ISPOR Srbija.
Od 2001. godine radi u farmaceutskoj kompaniji, Galenika a.d., kao produkt menadžer za
neuropsihijatrijske lekove. Tanja Novaković je diplomirala na Farmaceutskom fakultetu Univerziteta u Beogradu i završila poslediplomske studije na Farmaceutskom fakultetu Univerziteta u
Gentu, u Belgiji. Ona je autor “Priručnika za farmakoekonomske evaluacije”, prve takve publikacije iz oblasti farmakoekonomije u Srbiji. Kao predsednica Sekcije za farmakoekonomiju kroz
aktivnosti Sekcije učestvuje u razvoju zdravstvene ekonomije, farmakoekonomije i procene
zdravstvenih tehnologija.
Kao autor prvog Vodiča za farmakoekonomske evaluacije, Tanja Novaković učestvuje u kreiranju zdravstvene politike u Srbiji. Koautor je u jednom od prva tri HTA izveštaja za Srbiju.
Takođe je bila angažovana da vodi grupu eksperata za definisanje postojećih elemenata paketa
osnovnih zdravstvenih usluga u Srbiji (projekat Svetske banke i Ministarstva zdravlja Srbije).
Tanja Novaković je organizovala i bila govornik na mnogim nacionalnim skupovima i međunarodnim konferencijama koje su rezultirale u međunarodnoj saradnji u oblasti obrazovanja i
razvijanju farmakoekonomije i HTA u Srbiji.
BIOGRAFIJE
29
Dr sci. med. Janko Samardžić, spec.
Janko Samardžić je lekar - specijalista kliničke farmakologije na Institutu za farmakologiju, kliničku farmakologiju i toksikologiju u Beogradu i predavač na Medicinskom fakultetu,
Univerziteta u Beogradu. Dr Samardžić ima zvanje Akademskog specijaliste eksperimentalne
farmakologije i Doktora medicinskih nauka iz oblasti Medicinske farmakologije. Poslediplomska usavršavanja iz oblasti farmakoepidemiologije i kliničkih ispitivanja završio je na Erasmus
Univerzitetu, Medicinskog Centra Roterdam, u Holandiji. Trenutno je na poziciji načelnika za
farmaekonomiju u RFZO.
Kao istraživač, Dr Samardžić je uključen u realizaciju projekta Ministarstva prosvete, nauke i
tehnološkog razvoja, Republike Srbije. Član je Srpskog farmakološkog društva, Austrijskog farmakološkog društva i Evropskog udruženja za neuropsihofarmakologiju (ECNP). Ekspert je za
procenu pretkliničke i kliničke dokumentacije za lekove pri regionalnim Agencijama za lekove i
medicinska sredstva.
Dr Samardžić ima sveobuhvatno iskustvo i stručnost u oblasti farmakologije, autor je brojnih reprezentativnih publikacija i predavač po pozivu na međunarodnim medicinskim i farmaceutskim seminarima i konferencijama.
Dr sci. Eldon Spackman
Eldon Spackman je od 2010. godine istraživač u timu za ekonomske evaluacije i procenu
zdravstvenih tehnologija u Centru za zdravstvenu ekonomiju Univerziteta u Yorku, Velika Britanija. Završio je diplomske studije iz ekonomije 2002. godine, master studije 2006. godine
na Ekonomskom Univerzitetu Kalgari, a 2009. godine i doktorat iz oblasti istraživanja ishoda i
farmaceutske politike na Univerzitetu u Vašingtonu. Njegov naučno-istraživački rad uključuje
metode inkorporiranja neizvesnosti u okvir donošenja odluka, efekata investiranja i nenaplativosti troškova u proceni zdravstvenih tehnologija, kao i proceni skrininga i dijagnostike.
Eldon je nedavno radio na empirijskim procenama granične vrednosti isplativosti u Velikoj
Britaniji i metodama za podršku Ministrastva zdravlja Velike Britanije na implementaciji tzv.
“value based pricing”-a. Radio je na razvoju modela u kliničkim istraživanjima brojnih bolesti:
Alchajmerova bolest, astma, psorijazni artritis, depresija i karcinom prostate.
Zamenik je urednika za BMC Public Health i član PSSRU (The Personal Social Services Research Unit) odeljenja za savete u oblasti troškova. Eldon je član Komisije za procenu zdravstvenih
tehnologija i Jedinice za podršku donošenja odluka u NICE-u.
30
BIOGRAFIJE
Prof. dr York F. Zöllner
York F. Zöllner je od marta 2010. godine profesor zdravstvene ekonomije na Univerzitetu
primenjenih nauka u Hamburgu. Njegov cilj je da edukuje i “produkuje” naredne generacije
mladih kvalifikovanih zdravstveno ekonomskih eksperata i da doprinese istraživanju i javnom
zdravlju sprovođenjem analiza troškova bolesti, analiza isplativosti intervencija i istraživanja
pitanja jednakosti. Pre akademskog angažmana, bio je direktor Sektora za istraživanje u kompaniji za sprovođenje kliničkih istraživanja za oblasti zdravstvene ekonomije, politike cena i
refundacije (P&R).
Na početku svoje karijere je radio kao globalni direktor za zdravstvenu ekonomoju u farmaceutskoj kompaniji gde je bio odgovoran za P&R status produkt portfolia na globalnom
nivou, od početka kasne kliničke faze do podnošenja zahteva za stavljanje leka na listu na nacionalnom nivou. York je član uredništva časopisa Medicinska ekonomija i redovni recenzent
brojnih časopisa.
Dr sci. Brian Godman
Brian Godman je istraživač pri Odseku za kliničku farmakologiju, Univerzitet Karolinska,
Švedska i takođe sa pozicijom na Institutu za farmakološko istraživanje ‘Mario Negri’, Italija i
na Univerzitetu u Liverpulu, Velika Britanija. Osnovne studije je završio na King’s College, London, Velika Britanija iz oblasti farmakologije, a zvanje doktora nauka je ostvario 2011. godine na
Open University, u Velikoj Britaniji. Brian aktivno sarađuje sa zdravstvenim autoritetima i zdravstvenim osiguravajućim društvima u Evropi, Južnoj Americi, UAE (Abu Dabi) i SAD, procenjujući
uticaj mera da bi se poboljšao kvalitet i efikasnost propisivanja novih i postojećih proizvoda,
uključuju i Srbiju. Pre aktivnog istraživačkog rada, Brian je proveo trinaest godina u evropskim
i svetskim konsultantskim agencijama preduzimajući brojne projekte, uključujući ocjenjivanje
trenutnih i planiranih reformi kako bi se poboljšao kvalitet i efikasnost propisivanja, njihovu
prenosivost i implikacije za sve ključne interesne grupe. Takođe je radio na proceni kretanja
cena i refundacije lekova i njihovog uticaja na razvoj proizvoda i strategije pristupa tržištima.
Autor je oko 37 radova objavljenih u celosti u međunarodnim naučnim časopisima.
BIOGRAFIJE
31
Dr Predrag Djukić
Od 2006. godine Predrag radi na implementaciji reformskih projekata Ministarstva zdravlja
Republike Srbije koji su finansirani iz zajmova Svetske banke.
Bio je i na ekspertskim i na upravljačkim pozicijama u implementaciji pomenutih projekata.
Predrag je, takođe, pružao konsultantske usluge u Srbiji i inostranstvu. Primarno se bavi finansiranjem u zdravstvu, sa fokusom na mehanizme plaćanja pružalaca usluga, uključujući naročito
dijagnostički srodne grupe. Druga interesovanja uključuju procenu zdravstvenih tehnologija
(PZT) kako u metodološkom smislu, tako i u smislu institucionalizacije PZT u Srbiji.
Predrag je lekar. Magistar je medicinskih nauka sa magisterijumom iz oblasti kliničke i primenjene anatomije sa Medicinskog fakluteta Univerziteta u Beogradu. Završio je i master studije iz oblasti međunarodnog zdravstvenog menadžmenta, ekonomije i politike na Univerzitetu Bokoni u Milanu, Italija (Universita Commerciale Luigi Bocconi). Predrag je osnivač srpskog
ogranka Međunarodnog društva za farmakoekonomiju i istraživanje ishoda (ISPOR Serbia), i
blisko sarađuje sa Društvom za procenu tehnologija u zdravstvenoj zaštiti centralne i istočne
Evrope (CEESTAHC).
Dr Dragana Baltezarević, spec.
Dragana Baltezarević radi u Odeljenju za lekove, u Republičkom Fondu za zdravstveno osiguranje (RFZO) Republike Srbije. Nakon završenog Medicinskog fakulteta i obavljenog lekarskog
staža, radila je u farmaceutskoj kompaniji „Hemofarm AD - član STADA grupe“ kao medicinski
predstavnik, produkt (SPJ) menadžer i medical adviser, a zatim i na projektu Svetske Banke „Razvoj zdravstva Srbije“, kao konsultant na uvođenju novog načina izveštavanja i finansiranja po
sistemu „dijagnostički srodnih grupa“ (DSG). U međuvremenu, dr Baltezarević je stekla zvanje
akademskog specijaliste iz oblasti Farmakoekonomije i farmaceutske legislative na Farmaceutskom fakultetu Univerziteta u Beogradu.
Organizovala je i bila predavač na brojnim nacionalnim i međunarodnim konferencijama.
Danas radi na poslovima obrade zahteva za stavljanje lekova na Listu lekova i praćenju njene
primene. Zadužena je za analizu potrošnje lekova van liste lekova. Član je stručnih podkomisija
za lekove za ATC grupe: А, V, H i M, Komsije za farmakoekonomiju, Komisija RFZO za odobravanje upotrebe neregistrovanih lekova i biološke terapije: adalimumab i infliksimab u lečenju
obolelih od Crohn-ove bolesti i ulceroznog kolitisa, gefitinib i erlotinib u lečenju karcinoma pluća kao i novoformirane Komisije za uvođenje leka trastuzumab u terapiju karcinoma dojke. Od
2013. godine, član je PPRI mreže i projekta EURIPID, čime je omogućila da i Srbija pristupi bazi
cena zemalja EU. Od 2007. godine, član je Sekcije za farmakoekonomiju Saveza farmaceutskih
udruženja Srbije.
Uživa u časovima joge i čitanju.
32
BIOGRAFIJE
Dr Biljana Kozlović
Biljana Kozlović je doktor medicine sa 20 godina iskustva u menadžmentu i konsaltingu u
farmaceutskoj industriji i kliničkim ispitivanjima lekova. Angažovana je kao konsultant Svetske
banke za lekove i nabavke. Od septembra 2013. godine je na poziciji zamenika direktora za poslove u oblasti lekova u Republičkom fondu za zdravstveno osiguranje u Beogradu.
Dr sci. Ruth Lopert
Ruth Lopert, specijalista javnog zdravlja i farmakoekonomista, glavni je savetnik u Upravi za
lekove Therapeutic Goods Administration – TGA, u Ministarstvu zdravlja Australije. Od 2011 do
2012. radila je kao gostujući profesor na katedri za zdravstenu politiku na George Washington
Univerzitetu, SAD. Od 2008 do 2011. godine kao šef medicinskog odeljenja u Upravi za lekove.
Od 2006 do 2007. godine, bila je stipendista Harkness Fellowship-a, a od 2005 do 2006. radila
je kao direktor Sektora za farmaceutsku politiku u Ministarstvu zdravlja Australije, gde je bila
odgovorna za podršku održivosti Australijskog programa za lekove.
Prethodno je radila i kao direktor, klinički i tehnički savetnik u Komisiji za izradu Nacionalnog Registra lekova. Ruth je trenutno profesor zdravstvene politike na George Washington
Univerzitetu.
Dr Bojan Trkulja
Bojan Trkulja je direktor Udruženja proizvođača inovativnih lekova – INOVIA, od 2010. godine. Rođen je 1971. u Beogradu, gde je završio osnovnu i srednju školu i Medicinski fakultet Univerziteta u Beogradu. Po obavljenom stažu i položenom državnom ispitu, od decembra 1999.
godine radio je u predstavništvu kompanije „F. Hoffmann La Roche“ u Beogradu. Tokom narednih 11 godina radio je na različitim pozicijama, od stručnog saradnika, preko Medical i Product
Manager-a, Compliance Officer-a i Market Access Manager-a.
Bojan je srećno oženjen.
NOTES / BELEŠKE
33
34
NOTES / BELEŠKE
NOTE
•• Program of the Conference is accredited by the decision of the Health Council of
Serbia as a First category International course, for pharmacists and physicians with 7
points for participants and 13 points for lectures.
•• English is official language of the Conference.
NOTES / BELEŠKE
35
OBAVEŠTENJE
•• Program Konferencije akreditovan je Odlukom Zdravstvenog saveta Srbije kao
Međunarodni kurs I kategorije, za ciljnu grupu farmaceute i lekare sa 7 bodova za
slušaoce i 13 bodova za predavače.
•• Zvaničan jezik konferencije je engleski.
General Sponsor / Generalni sponzor
Golden Sponsor / Zlatni sponzor
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Lunch break Sponsor / Sponzor pauze za ručak
Other Sponsors / Ostali sponzori
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