SVES · SVEIKATĄ 2020 METAMS KURIAME ŠIANDIEN METINĖ KONFERENCIJA SVES Lapkričio 29-30 d., Vilnius November 29-30, Vilnius, Lithuania CREATING HEALTH FOR 2020 TODAY ANNUAL CONFERENCE

SVEIKATĄ 2020 METAMS KURIAME ŠIANDIEN

MET INĖ KONFERENC I JA

2012Lapkričio 29-30 d., VilniusNovember 29-30, Vilnius, Lithuania

CREATING HEALTH FOR 2020 TODAYANNUAL CONFERENCE













2012





PROCEEDINGSOF THE CONFERENCE OF THE HEALTH FORUM

“CREATING HEALTH FOR THE YEAR 2020 TODAY”

2013 Vilnius

NOVEMBER 29-30, 2012

Vilnius, Lithuania

ZSUZSANNA JAKAB, World Health OrganizationERIO ZIGLIO, World Health OrganizationCHRISTINE ELISABETH BROWN, World Health OrganizationFRANCESCO ZAMBON, World Health OrganizationRICHARD BERGSTRÖM, European Federation of Pharmaceutical Industries and AssociationsTIMOTHY ARMSTRONG, World Health Organization GAUDEN GALEA , World Health OrganizationSYLVIE STACHENKO, University of AlbertaGUY STORME, UZ BrusselsVILIUS GRABAUSKAS, Lithuanian University of Health Sciences, Health ForumEGON JONSSON, Institute of Health Economics FINN BØRLUM KRISTENSEN, EUnetHTAULRIK RINGBORG, Karolinska InstituteANSGAR HEBBORN, F. Ho�mann - La Roche AGFRIEDRICH KÖHLER, Charité Universitatmedizin Berlin

VILIUS GRABAUSKAS, Health Forum; Lithuanian University of Health SciencesLEONAS KALĖTINAS, Health Forum; Innovative Pharmaceutical Industry AssociationLIUDVIKA STARKIENĖ, Health Forum; Lithuanian University of Health Sciences

ADAS VASILIAUSKAS, FokoPersonal speakers’ archives

ISBN 978-609-95504-0-4

AUTHORS

EDITORS

PHOTOGR APHY

CONTENTS

Greetings of H.E. President of the Republic of Lithuania Dalia Grybauskaitė.................................................................................................................................................................

Zsuzsanna Jakab Health 2020: A New European Policy Framework for Health and Well-Being.................................................................................................................................................................................

Erio Ziglio, Christine Elisabeth Brown, dr. Francesco ZambonExternal Evaluation of Lithuanian Health Programme 2020: Insight from World Health Organisation.............................................................................................................................................................

Richard Bergström Industry Vision for Europe 2020.........................................................................................................................................................................................................................................................

Dr. Timothy Armstrong, Dr. Gauden Galea Global and Regional Developments in Non-Communicable Diseases: Implications for National Action...............................................................................................................................................................

Prof. Sylvie Stachenko Intersectoral Collaboration for the Control of Non-Communicable Diseases: Canadian perspectives................................................................................................................................................................

Prof. Guy Storme Cancer Screening Programs: Lessons to be Learned .................................................................................................................................................................................................................

Prof. Vilius Grabauskas Non-Communicable Diseases in the Context of Health Policy: Lithuanian Experience.................................................................................................................................................

Prof. Egon Jonsson Health Technology Assessment: Objectives, Methodology, Expectations and Outcomes...........................................................................................................................................

Prof. Finn Børlum Kristensen Health Technology Assessment: a Useful Tool in Consumer Protection and a Driving Force for Innovation and E�ciency Growthin Health Sector....................................................................................................................................................................................................................................

Prof. Ulrik Ringborg Health Technology Assessment in a Comprehensive Approach to the Cancer Problem.............................................................................................................................................

Dr. Ansgar Hebborn Good Health Technology Assessment Practice – International Examples.........................................................................................................................................................................

Prof. Dr. Friedrich Koehler Implementation of Innovative Technologies: Case of Charité Hospital..............................................................................................................................................................................

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Greetings of H.E. President of the Republic of Lithuania Dalia Grybauskaitė.................................................................................................................................................................

Zsuzsanna Jakab Health 2020: A New European Policy Framework for Health and Well-Being.................................................................................................................................................................................

Erio Ziglio, Christine Elisabeth Brown, dr. Francesco ZambonExternal Evaluation of Lithuanian Health Programme 2020: Insight from World Health Organisation.............................................................................................................................................................

Richard Bergström Industry Vision for Europe 2020.........................................................................................................................................................................................................................................................

Dr. Timothy Armstrong, Dr. Gauden Galea Global and Regional Developments in Non-Communicable Diseases: Implications for National Action...............................................................................................................................................................

Prof. Sylvie Stachenko Intersectoral Collaboration for the Control of Non-Communicable Diseases: Canadian perspectives................................................................................................................................................................

Prof. Guy Storme Cancer Screening Programs: Lessons to be Learned .................................................................................................................................................................................................................

Prof. Vilius Grabauskas Non-Communicable Diseases in the Context of Health Policy: Lithuanian Experience.................................................................................................................................................

Prof. Egon Jonsson Health Technology Assessment: Objectives, Methodology, Expectations and Outcomes...........................................................................................................................................

Prof. Finn Børlum Kristensen Health Technology Assessment: a Useful Tool in Consumer Protection and a Driving Force for Innovation and E�ciency Growthin Health Sector....................................................................................................................................................................................................................................

Prof. Ulrik Ringborg Health Technology Assessment in a Comprehensive Approach to the Cancer Problem.............................................................................................................................................

Dr. Ansgar Hebborn Good Health Technology Assessment Practice – International Examples.........................................................................................................................................................................

Prof. Dr. Friedrich Koehler Implementation of Innovative Technologies: Case of Charité Hospital..............................................................................................................................................................................

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Health 2020: A New European Policy Framework for Health and Well-Being Ms. Zsuzsanna Jakab,

Regional Director, World Health Organization Regional O�ce for Europe

Zsuzsanna Jakab took up her duties as Regional Director on 1 February 2010. Before her election as Regional Director, Ms Jakab served as the founding Director of the European Union's European Centre for Disease Prevention and Control (ECDC)

in Stockholm, Sweden. Between 2002 and 2005, Ms Jakab was State Secretary at the Hungarian Ministry of Health, Social and Family A�airs. She played a key role in the negotiations leading up to the Fourth WHO Ministerial Conference on Environment and Health,

held in Budapest in June 2004. Between 1991 and 2002, Zsuzsanna Jakab worked at the WHO/Europe in a range of senior management roles.

Mrs Jakab holds a Master’s degree from the Faculty of Humanities, Eötvös Lóránd University, Budapest; a postgraduate degree from the University of Political Sciences, Budapest; a diploma in public health from the Nordic School of Public

Health, Gothenburg, Sweden; and a postgraduate diploma from the National Institute of Public Administration and Management, Hungary. She began her career in Hungary’s Ministry of Health and Social Welfare in 1975, being responsible

for external a�airs, including relations with WHO.

Health 2020 was adopted by the WHO Regional Committee in September 2012. This policy received uniform and overwhelming support. It is the European policy framework for supporting action across government and society for health and well-being.

Health 2020 speaks not only to the Ministers of Health; it also speaks to the Presidents, Prime Ministers, the other sectoral Ministers and Mayors. Health is a prerequisite for social and economic development. It confirms that without health and well-being there is no economic growth and there is no development. Health and well-being contribute to the productivity of any society and should therefore be consid-ered as an investment and not as expenditure. The present economic/ financial crisis is a�ecting many countries, in many ways but it can also present an opportunity to do more and better for people’s health. To improve health status, we have to address all determinants, which are outside the health

sector simultaneously. Therefore all sectors and levels of government and society contribute to the creation of health.

The goal of Health 2020 is to significantly improve health and well-being of populations, to reduce health inequities and to ensure sustainable people-centred health systems.

The policy framework is evidence-based and peer-reviewed. It makes the case for investment in health and creating societ-ies where health is valued. It details the ways that good health benefits all in society. Good health is vital for economic and social development and supports economic recovery.It gives policy-makers a vision, a strategic path, a set of priorities and a range of suggestions about what works to improve health, to address health inequalities, and to ensure the health of future generations. It identifies strategies for action that are adaptable to the many contextual realities of the WHO European Region.

HEALTH FORUM 6

HEALTH 2020 IN EUROPE AND LITHUANIAHEALTH 2020 IN EUROPE AND LITHUANIA

Health 2020 highlights:

• Health is a major societal resource and asset; • A strong value base: reaching the highest attainable standard of health; • A strong social and economic case for improving health; • Strategic objectives and common policy priorities; • Working together: adding value through partner-ships; • Health 2020 – a common purpose and a shared responsibility; • Renewing the commitment to health and well-being: the context and drivers; • Applying evidence-based strategies that work and the key stakeholders; • Enhancing effective implementation, requirements, pathways and continuous learning.

The new policy framework of Health 2020 is needed because Europe is changing in many ways that a�ect health and demand new ways of thinking and acting.

First of all, the health gaps are widening. While the WHO European Region as a whole has seen important improve-ments in people’s health over the last few decades, these improvements have not been experienced everywhere and equally by all. Significant inequalities in health remain, and in many places they are getting worse.

Secondly, the health landscape is changing. All countries are being challenged by major social, economic, environmental and demographic shifts. National as well as local health policy-makers often lack the authority and instruments to lead a coherent integrated approach to these important challenges. People live longer and have fewer children. People migrate within and between countries, cities grow bigger. Non-communicable diseases dominate the disease burden. Depression and heart disease are leading causes to healthy life years lost. Infectious diseases, such as HIV, tuber-culosis remain a challenge to control. Antibiotic-resistant organisms are emerging. Health systems face rising costs. Primary health care systems are weak and lack preventive services. Public health capacities are outdated.

Thirdly, there are economic opportunities, but also threats and especially in the light of the threats we are facing today, we need to champion public health values and approaches. The financial crisis adds an additional layer of complexity by the austerity plans and the lack of growth. There is evidence from the previous crises on the relationship between unem-ployment, social welfare and health. Unemployment is associated with doubling the risk of illness and less likelihood to recover from disease. Active labour market policies and well-targeted social protection systems and measures can eliminate adverse e�ects. There is also a strong correlation with alcohol poisoning, liver cirrhosis, ulcer, mental disorders, as well as suicide.

The Health 2020 development journey has been a 2-year participatory process with our Member States and partners. It included unprecedented evidence-review; the evidence was developed in areas where it was lacking and we reviewed all the solutions that work. We tried to integrate and to connect various vertical policies. And there also was an unprecedented stakeholder (peer)-review.

There is a number of key studies that are relevant to every single country in the European Region: Governance for health in the 21st century; Supporting Health 2020: gover-nance for health in the 21st Century; Intersectoral Gover-nance for Health in All Policies: Structures, actions and experiences; Report on social determinants of health and the health divide in the WHO European Region; Review of the commitments of WHO European Member States and the WHO Regional Office for Europe between 1990 and 2010; The Economic case for Public Health Action.

This policy builds on the history of public health in Europe: WHO Constitution, Alma Ata Declaration, Health for All, Health 21, and Tallinn Charter. What we have noted in the past that integrated policy frameworks can and have inspired health generating actions on all levels.

Health 2020 is a unifying policy framework to meet these challenges, mainly to deal with the health divide, which requires a new form of governance as we have to address all the determinant of health simultaneously and they are outside of the health sector in all the other sectors. Therefore the policy has two main strategic objectives: (i) working to improve health for all and reducing the health divide, and (ii) improving leadership, and participatory governance for health.

It has four common policy priorities for health:

• Investing in health through a life course approach and empowering people; • Tackling Europe’s major health challenges of non-communicable diseases and communicable diseases; • Strengthening people-centred health systems and public health capacities, and emergency preparedness, surveillance and response; • Creating resilient communities and supportive environments.

Life expectancy increases in line with income and then flattens at certain income threshold. Lithuania has made and is making significant improvements in life expectancy and the other health indicators, but it is still one of the countries at the lower end of life expectancy and the income levels in Europe. Therefore Health 2020 and Lithuanian Health Program 2020 are very relevant for Lithuania, especially now with the economic recovery starting or restarting again after financial crisis. It is a very good moment for Lithuania to continue to invest. What is needed is (i) to go upstream to address root causes e.g. social determinants; (ii) to invest into public health, health protection, health promotion and disease prevention; (iii) to make the case for whole-of-government and whole-of-society approaches; and (iv) to o�er a framework for integrated and coherent interventions.The new WHO European Social Determinants & Health Divide Review carried out by a Consortium chaired by Prof. Michael Marmot in 2012 has come up with a number of findings, just to quote a few of them:

• Inequities in health between and within countries persist which are socially determined; • Taking a life course approach to health equity; • Inter-generational equity must be emphasised; • Address the processes of exclusion; • Need to build on the resilience, capabilities and strength of individuals and communities.In order to be successful in addressing the root causes and all

HEALTH FORUM 7


Heart disease

Cerebrovasculardisease

Lung cancer

Breast cancer

Cervical cancer

Suicide

Tra�c accidents

Standardized death rate per 100,000 population

Acute respiratoryinfections, pneumonia and

in�uenza in children <5y

EU-12EU-15Lithuania

0 10 20 30 40 50 60 70

Fig. 1. Premature mortality from leading causes of death for Lithuania and European Regions.

the determinants, we have to improve the governance for health. Health is no longer an issue for Health Minister only; health has to be addressed by the Government, and built into the Government programme. The governance has to be much more horizontal, with all the sectors working together, and much more participatory.

The major burden in our Region is due to non-communicable diseases and Lithuania is no exception. Fig. 1 shows the magnitude and relative importance of di�erent specific causes of premature death (before age 65 years) in Lithuania compared to other regional averages. A striking contrast is observed with regards to the magnitude and importance of cardiovascular diseases and injuries, mainly from heart disease and suicide, when compared to other health problems.

Overall, ischaemic heart disease (myocardial infarction-MI) is the most important cause of premature death, except in the EU 15 where lung cancer has also become a leading cause. Premature MI mortality rate is higher in Lithuania than the average in the European regions; premature stroke mortality is also high, but comparable with other new EU member states. Suicides are another prominent cause of premature death in Lithuania, nearly twice as common than in other new EU members and 3 times higher than in the old EU member states. Lung cancer and motor vehicle accidents also play an important role in mortality in Lithuania, the former particularly among men. Among women, of particu-lar note is the high premature mortality from cervical cancer, an avoidable cause of death; in addition, mortality rates of premature mortality from breast cancer are also higher than regional averages.

The economic impact of non-communicable diseases amounts to many hundreds of billions of euros every year in Europe. Many costs are avoidable through investing in health promotion and disease prevention. But yet today governments spend only 3% of their health budgets on prevention. Fig. 2 shows the economic case for health promotion and disease prevention; how much you lose in the economy by not investing into this.

The Figure 3 illustrates the ten Essential Public Health Opera-tions that form the basis of the European Action Plan for Strengthening Public Health Services and Capacity, a key pillar for implementing Health 2020.

The overall vision of the Euroean Action Plan is to promote health and well-being in a sustainable way, now and for future generations. We aim to achieve this by strengthening integrated public health services and capacity, whilst reduc-ing inequalities. There are ten main operations identi�ed for strengthening public health services, at their core are Health Protection, Disease Prevention and Health Promotion. These central services all need to be informed by robust ‘Public Health Intelligence’- based upon monitoring and surveil-lance, and research �ndings; we can use this information to make assessments, in order to make intelligent decisions in policies and plans. EPHOs 6- 10 in the box on the right hand side, can be described as Enablers – these are more generic skills that are applied to many disciplines to make delivery more e�ective. They include strengthening governance, workforce development, �nancing, communications and research. In particular, primary health care can play a greater role in promoting health and preventing disease, whilst strengthening public health workforce development is a key to ensure su�cient and skilled capacity for public health service delivery across the Region.

Supporting Member States to navigate the crisis is central to work by WHO: • Strong economic case for health promotion and disease prevention as economic cost of non-communicable diseases is extremely high (only 3 % investment); • Prevention is one of most cost-effective approaches to improve health outcomes; • Fiscal policy can and should be used like raising taxes of tobacco and alcohol; • “Sin” taxes (unhealthy food and drink) already have bene�ts;

Fig. 2. The economic case for health promotion and disease prevention

VISION: Sustainable Health & Well-Being

CORE EPHOs ENABLEREPHOs

GovernanceEPHO 6

PH WorkforceEPHO 7FundingEPHO 8

CommunicationEPHO 9

ResearchEPHO 10

SERVICE DELIVERYHealth Promotion

Health PromotionDisease

Prevention

INTELLIGENCEEPHO 1 + 2Survellance

Monitoring

Informinghealth

assessmentsand plans

EPHO 3 EPHO 5

EPHO 4

Fig. 3. Strengthening public health services and capacity – the ten essential public health operations (EPHOs)

HEALTH FORUM 8


Alcohol relatedharm

€125 billion annually in the EU: equivalentto 1.3% of GDP

Obesity relatedillness (including

diabetes and CVD)

Over 1% GDP in the US; between 1-3% of healthexpenditure in most countries

Cancer 6.5% of all health care expenditure in Europe

Road tra�cinjuries

Up to 2% of GDP in middle and high income countries

Cardiovasculardisease

€169 billion annually in the EU: healthcareaccounting for 62% of costs

• Try to protect health budgets but if cuts have to be made, avoid across the board budget cuts and target public expenditures more tightly on poor and vulnerable (avoid or reduce out-of-pocket payments, which lead to impoverish-ment); • Think long-term: save in good times and spend in bad times!

Within the health care we have to work hard in order to improve e�ciency, which will reduce adverse e�ects of the crisis: (i) to eliminate ine�ective and inappropriate services; (ii) to improve rational drug use; (iii) to allocate more to primary and outpatient specialist care at the expense of hospitals; (iii) to invest in infrastructure that is less costly to run; and (iv) to cut the volume of least cost-e�ective services.It is also important to politicians and policy makers to note that there is a bigger health impact of social welfare spend-ing than of the GDP growth. Each additional dollar per capita spending on social welfare is associated with 1.19 % reduc-tion in mortality. Each 100 dollar per capita increase in GDP results only in 0.11 % reduction in mortality. There is a signi�-cantly greater e�ect of social welfare spending than of GDP growth on mortality reduction.

In conclusion, Health 2020 is adaptable and serves as an inspiration for the Member States. It recognizes that countries engage from a di�erent starting point and have di�erent pathways and approaches but are united in purpose. It is relevant also during the �nancial crisis together with active labour market policies, well-targeted social protection and social welfare spending.

HEALTH FORUM 9


HEALTH FORUM 10


One of the mandates of the World Health Organization (WHO) is to assist Member States to draw and implement policies on how best to improve and promote health. There-fore it was with pleasure that WHO accepted the request of the Lithuanian Ministry of Health to provide comments and feedback to the Draft of the Lithuanian Health Programme 2020.

A main aim of the Ministry of Health in requesting WHO’s feedback was to ensure that the Lithuanian Health Programme re�ects the best available evidence, current thinking and performance measures.

We would like to commend the Ministry of Health and the Lithuanian Government for putting together a Programme which is well aligned with the new European policy for Health 2020. This can indeed be regarded as a valuable example of collaboration between Member States and WHO Regional O�ce for Europe in policy development for improving population health and decreasing health inequities.

The WHO feedback process has been coordinated by the division for Policy, Social Determinants and Governance for Health. The consultation process involved all Divisions of the WHO Regional O�ce for Europe as well as cross programs for non-communicable diseases, communicable diseases, public health and health systems, social determinants, gender, equity and human rights, intelligence and research for health. A �rst set of comments was provided to the National Working Group and Ministry of Health in July 2012. Based on such comments, the Lithuanian Health Programme was revised and then a second set of comments was provided to the Lithuanian counterparts in October 2012.

The Lithuanian Health Programme provides good strategic directions for the improvement of public health. The programme sets health as a human value and basis of life and considers the health status of Lithuanian population as a national asset and capital, whose protection and cherishing is

a State’s strategy. The Programme recognizes that the greatest drivers for health of the Lithuanian population lie outside the sphere of the healthcare sector. This means the strategic objectives of the Programme will be realized through an inter-sectoral approach and through e�ective cooperation of all sectors.

In line with the positive experience of other European countries and with the recommendations of the WHO, the core values which underpin the Programme are: universal coverage, equity, solidarity and sustainability of the system, involvement of society in decision-making, elimination of discrimination, transparency of decision-making, access to and acceptability of health care services, and clear account-ability and reporting.

WHO is pleased to acknowledge that the Lithuanian Health Programme poses particular attention to tackling health inequities. The Lithuanian Health Programme states that radical improvement of population’s health can only be achieved through actions on three main domains: (i) through reduction of social inequalities and health di�erences between social groups; (ii) through increasing the control citizens have over their lives and towards their health; and (iii) through a wide-spectrum of public policies and actions which systematically address social determinants.

In this regard, attention made to direct policies and invest-ments that enable all Lithuanians to lead healthy, productive and ful�lling lives on equal terms, is an aspiration which WHO wholeheartedly supports. On this point we would welcome to see reduced di�erences in healthy life expectancy as one measure of societal progress, re�ected in the Lithuanian National Development Plan 2030. We would also be very pleased to work together with you to advance this proposal if it has your support.

External Evaluation of Lithuanian Health Programme 2020: Insight from World Health OrganizationErio Ziglio, Christine Elisabeth Brown, Dr. Francesco Zambon,

World Health Organization European O�ce for Investment for Health and Development (Italy)

Dr. F. Zambon graduated as a medical doctor in 1998 from Padua University where he continued his post-graduate training in Community Medicine and received his PhD in Health Planning Sciences. He holds master degrees in Safety Promotion (2005) from Karolinska Institutet, Sweden, and in Business Administration (2009) from the Tippie School of Management,

USA.Prior to commencing work at World Health Organization (WHO), Dr. F. Zambon worked as health manager at the Regional

Department for Epidemiology in Veneto, Italy, and at the Epidemiology and Community Medicine Unit of Padua University.Dr Zambon joined WHO in 2008 and managed for the WHO European Region the progression of a large technical report on

injury prevention using a public health approach. Since 2010 he has being coordinating a multi-sectoral project in the Russian Federation on the prevention of road tra�c crashes.

Dr Zambon has broad research experience on evaluations on public health interventions, relation between socio-economic factors and health outcomes, and health service e�ectiveness.

The Lithuanian Health Programme 2020 capitalizes on the previous Program covering the period 1998-2010. The previous Programme put in place speci�c measures to counteract mortality from external causes, to modernize the healthcare sector by implementing new medical technolo-gies and to implement disease prevention measures. Remark-able results were achieved. By 2010, average life expectancy was raised to 73 years, infant mortality was reduced by 30%, and likewise, the number of cases of tuberculosis was reduced by 30%.

However, as the evaluation of the previous plan has showed, these improvements have not been shared across the whole of Lithuanian society. Life expectancy for men is on average 11 years shorter than that for women. Two thirds of Lithuanian men die before they reach 75 years of age, while two thirds of women die after they reach 75 years of age. As of today there remains a 10 year di�erence in life expectancy by level of education. Relative deprivation levels are among the highest among comparative EU member countries. There is repeated strong evidence which links these factors with lower levels of self reported health, as well as increased stress and anxiety level. Addressing these factors as a whole of government priority is particularly crucial given the rate of mental health problems and given that mortality from suicides remains high.

In order to tackle such public health problems, the Ministry of Health conducted a thorough analysis of the factors which a�ects health in the country, with a speci�c focus on under-standing the causal chain across social & environment condi-tions and personal behaviors. This allowed emphasizing an excessive consumption of alcoholic beverages and tobacco use with the need of �rm restriction on the advertising of alcohol beverages and prohibition of advertising of tobacco products.

The need of strengthening the legislations on risk factors for road tra�c crashes and of improving healthy nutrition and improving physical activity of Lithuanians was also highlighted. To counteract such problems there needs to be integrated solutions which foster inter-sectoral and well-concerted cooperation across sectors which lie beyond the health sector. We are pleased to note how the new national health program 2020 sets out actions across public policies and with stakeholders within and outside of govern-ment, nationally and locally.

The new plan is comprehensive and provides a unifying framework upon which to develop a more detailed imple-mentation plan. The Programme is very much inspired by the European Health Policy, Health 2020.

A lifecourse approach and emphasis on the wider determi-nants of health underpin most of the objectives of the Lithuanian Health Programme. These are important approaches for systematically improving population health and reducing inequities. These are fully in line with current thinking and best practice in Europe and internationally.

The Programme identi�es 22 tasks delineating a set of imple-mentation measures, responsible institutions and a number of indicators and targets. Goals and measures of the Lithuanian Health Programme 2020 are grouped according to the strategic directions de�ned as: (i) safer social environ-ment; (ii) healthier physical environment; (iii) healthier lifestyles; and (iv) high quality, patient-oriented health care

system.

The WHO Regional O�ce for Europe recommends that each of these strategic directions is translated into practice always applying a systematic approach to reducing inequities. It is also essential to always monitor the potential di�erential health consequences of policies in the di�erent strata of the population.

Acknowledging the high burden of non-communicable diseases in the WHO European Region and particularly in Lithuania, WHO invites the Ministry of Health to implement some of the proposed core set of NCD best buy interventions that are included in the WHO global status report on NCD. These population wide and individual health care interven-tions are considered to be not only highly cost-e�ective but also feasible to implement within the current constraints of health systems. Not only these interventions have the greatest impact on those with largest disease burden and risks, they also deliver improved equity results.

With regards to monitoring and analysis, the Lithuanian Health Programme 2020 provides a detailed list of indicators for each task, setting measurable target by 2015 and 2020 compared with baseline measures of 2010. WHO promotes, whenever possible, the use of data which are disaggregated by socio economic factors such as education, income and geography. This allows to conduct a thorough situational assessment and to address the social gradient through tailored and equity-proofed interventions.

Through the Lithuanian Health Programme, Lithuania has set ambitious targets. Now there is the need to have a strong implementation plan. This should serve to build and sustain commitment, incentives, capacity and mechanisms to deliver across the health community and with other sectors of government and society. It is essential that such implementa-tion plan is drawn in partnerships with the other sectors and stakeholders whose actions are needed to ensure that the Programme objectives are successful. However, it will be important that the health sector demonstrates how improv-ing health also contributes to achieving other sectoral and societal goals such as:

• increasing social inclusion; • supporting sustainable growth; • developing citizen engagement, • and strengthening community resilience and wellbeing.

In this way the health community will have the opportunity to demonstrate how action to improve health is an asset not an expenditure in Lithuania.

The WHO Regional O�ce for Europe is delighted to see that the European Health Policy Health 2020 has been inspira-tional for the Lithuanian Health Programme. We, together with the international community, are looking forward to following the implementation of the Lithuanian Programme, to working with you to support its progress and to monitor-ing its success.

HEALTH FORUM 11


















Richard Bergström has been the Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) since April 2011. Previously he served for nine years as the Director-General of LIF, the Swedish

Association of the Pharmaceutical Industry, following positions in Switzerland in regulatory a�airs at the pharmaceuti-cal companies Roche and Novartis. Mr Bergström has also been appointed by the Swedish Government to the Board of the Karolinska Institute. He is a pharmacist by training, receiving his MScPharm degree from the University of Uppsala,

Sweden in 1988.

Pharmaceutical sector is one of the top export sectors in Europe. It is growing; it has increased 10-fold over the 20 years. This sector has 600 thousand employees, 100 thousand of which work in research. Pharmaceutical sector spends over one hundred billion euros every year on research; about one third is spent in Europe, including Switzerland. This sector aims to continue to invest in Europe, but it is an increasing challenge.

It is undisputed that we have made great progress in public health over the last two decades. The average life expectancy in Europe is increasing consistently across time. Life expec-tancy at birth has reached its highest level on record in Europe – a new-born male could expect to live to 77 years, whilst a female could expect to live to 83 years of age if born in one of the EU15 countries [1]. Life expectancy in all EU countries has improved over time for both males and females.

Although there are many factors contributing to increased life expectancy (i.e. improvements in public hygiene and reductions in infant mortality), it is clear that innovation in medicine has contributed signi�cantly to the increase. A study considering the impact of innovative medicines in 52 countries calculated that 40% to 59% of the improvement in life expectancy from 1986 to 2000 was due to innovation [2].

The Figure 1a is one of the many attempts to show how diseases are interlinked; the researchers over the last two decades have come to realize that many of the diseases are connected with one another. For example, in�ammation as a mechanism shows up in the number of diseases. So we know that based on signs and symptoms some diseases were connected with one another. But when we start to map the genes, we map through epigenetics, we map the wiring of the brain, we realize, that actually the diseases are connected

in a di�erent way, if you look at reasons for the diseases, causes of the diseases in the genes.

Fig. 1. Human disease network and disease gene network

Disorder Class

Node size

41

34

30

25

21

15

1051

BoneCancerCardiovascularConnective tissueDermatologicalDevelopmentalEar, Nose, ThroatEndocrineGastrointestinalHematologicalImmunologicalMetabolicMuscularNeurologicalNutrilionalOphthamologicalPsychiatricRenalRespiratorySkeletalmultipleUnclassi�ed

a Human Disease Network

b Disease Gene Network

Source: Goh K et al. PNAS 2007;104:8685-8690

Industry Vision for Europe 2020Richard Bergström,

Director General, European Federation of Pharmaceutical Industries and Associations

HEALTH FORUM 12






Figure 1b shows the disease gene network and it is not exactly the same. If you plot cancer diseases, these are typical manifestations of cancer. This is how di�erent cancers interre-late based on signs, symptoms and clinical manifestations (where these cancers show up). In fact, if you plot clinical manifestations of the diseases against the genes they do not necessarily compare. So particularly in oncology we are looking at the ways to develop medicines based on the underlying cause of the disease, as opposed to treating the signs and symptoms. And this is no longer a vision, it is happening today. If you look at the products that are coming now out of the pipeline, last year of this year, new drugs for melanoma where you target, you select the patients, we have the �rst gene therapy product approved by the European Union, so this is happening in the companies today, the pipelines are full of products that are for targeted uses, you can call that personalized medicine, but it’s about �nding the right patient that would bene�t the most. This of course is a challenge to deliver all these medicines to the market; regula-tory models have to be updated, pricing and reimbursement systems have to be adjusted to �t this, but this points to the great optimism in the research community and the research community in the industry. We are actually on to something big. The type of the medicines being developed now is much more sophisticated and very promising. So that is the optimistic side; however the reality is another one. The reality is that we have a �nancial crisis in Europe and this of course has huge impact on health care (Fig. 2).

We still have huge de�cit everywhere and even the countries like the Netherlands are running into �nancial trouble. That tells us that something more profound is going on in Europe. The European Commission (EC) and the World Health Organi-zation (WHO) have really powerful arguments on why the Governments should be really careful by cutting health care expenditure, especially at the time of crisis. And what are Governments doing? It’s all they are doing – cutting the health care costs: slashing wages, stopping reimbursing new medicines, increasing co-payments dramatically, which means that patients don’t take their medications and they show up at the emergency room. The Member States and the people who decide are not taking the advice that they get from the public health side of the EC or from the WHO. These experts are simply not listened to. How could this happen, and maybe this is a subject for another conference, that we have all this knowledge, experience and data, on health is wealth – why is that not followed, when we need to follow this evidence and experience more than ever? The reality is that we are saving big time on health care and we are saving big time on pharmaceuticals. In many countries we have to accept this, because expenditures have been out of control, the models for volumes and prices have been irrational. The other reasons include too high patent prices, too high prices

of generics, and not enough use of generics. Now that’s been �xed. But there is a real issue of the �ow of new products into the market. There is good news, especially for those in the audience who are worrying about the budgets. There will be a huge number of patents expiring till 2018. And all of us know that when the patent expires, the prices fall dramati-cally. On the global level there are 300 billion US dollars’ worth patents that will expire and that will all basically bene�t the payers or the patients (depending on who is paying). This is a lot of money and hopefully at least part of it could be invested into new products. This should be shown to the Governments so that they would know what to expect while planning their realistic budgets. Let’s now re�ect on how the incentives for the operating of pharmaceutical industry in Europe have changed. The follow-ing incentives have changed over the last decade or so: costs of R&Ds have gone up, time to the market extended. The clinical trials that we run now are enormous. I read the other day about the latest phase III trial for the new cardiovascular medicine, which had 136 thousand patients in one trial. That cost a bit of money and it takes time to execute. The evidence must be here, we must make sure that the medicines are safe and e�ective. The success rates are unfortunately not going up and there is a good explanation for that. We are in the era of exploiting new science. We are also moving from the areas that were easier to the areas that are more di�cult. We have collectively wasted 30-40 billion dollars on clinical research on Alzheimer’s disease – nothing has come out of it yet. There have been early promising results from the scienti�c congress two weeks ago, so maybe there is something coming out. So we keep trying in the areas that are very di�cult and we spend a lot of money. We are all educated enough to realize that we have to go on doing that, but when you meet some people on the street they think that this all is a waste – you should dismantle your industry because they are not very productive. As long as our investors, our owners and the politicians allow us, we will continue in the quest for the new medicines. So this is a supply side, where many things can be improved.

More important actually is the demand side of the innova-tion, which is the market. We depend on people who would use our medicines, would pay for them, that is how we fund all this – it’s in the market, we do not live on State subsidies, we live on patients taking our medicines – they may be subsidized from their Governments though reimbursement systems. It’s a system that would reward the winner, you don’t subsidize up front, and you don’t pay for things that fail. But if you make it to the market, if you make a product that adds value, you sell more and then you get the reward. It works very well, it has worked for the decades and we have all reasons to believe it will work in the future. But the inner market factors really trouble us in Europe; the uptake of the innovation is lower, prices are truly squeezed, everyone wants the lowest price in Europe. Germany wants as low prices as Greece. So this is a real issue, but there are solutions to this. On the supply side, on the R&D side, there are very interesting developments going on. We see research collaborations between the companies in the way that we have never seen before. We also do a lot of work together with the EC. Innova-tive medicines initiative is a good example – the industry puts one billion euro of resources and the EC matches with one billion euro of cash, spent on academics, not on the compa-nies. We are now planning for the next public private partner-ship, the next framework programme under Horizon 2020. We know that we have to change the development pathways;

Fig. 2. Growth rates of public expenditure in health across the OECD.

Source: OECD Health Statistics 2012

1

0

-1

2000-2001 2001-2002 2002-2003 2003-2004 2004-2005 2005-2006 2006-2007 2007-2008 2008-2009 2009-20010

2

3

4

5

6

7

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these 136 thousand patients probably are not needed if you have targeted use. Unfortunately, on the demand side in Europe is some experimentation going on. Clearly the way forward is to have a model where you reward the innovation depending on the added value it has in real clinical life, that’s what we call value-based pricing. We need to have an early assessment of the bene�t – what is that added value, without delaying the introduction. I think it should be without the economics and the number crunching – that is a negotiation thing between us and the Governments. But there could very well be a European collaboration on this – we are open to this and we support very much the work done by the EUnetHTA. We also need to make sure that the drugs are delivered to the right patients and also that the budget is met. There should be a better ways to introduce new medicines, as there have been too many Wild West things in the past. Interest in managed entry schemes is very big across Europe. This is a thing that payers discuss when they get together. You can also call it risk sharing, but it means that things are introduced in pre-agreed way, re-evaluated, introduced quickly and to the right patients. You re-evaluate all the time, you re-adjust the use, the price. This is the spirit, and the industry is very much on the same page as many of the thought leaders of the Governments on this. The overall budget must re�ect the value the medicines had. Now in the short term, maybe yes, we need to cap the budgets, budgets can’t grow more than GDP, but in the long run, if you need to do health investments in the country, you know that you are lagging behind, you know that your diabetic patients are not getting the latest insulins or they don’t get the latest products, maybe you need to invest more. So we need to view this as investment decisions, in which case you will not only look at the price upfront, you would look at the price over the life cycle. Because you know that after those 10-12 years basically the medicines may become cheaper than candy, so this is that you should consider while making the investment decisions –this is just like when you build the hospital or you build the road - you have to think in long-term. Most of these drugs are successful, most of them are on the market still, and some become huge blockbusters and main therapies for decades. The greatest problem we have is that there is a genuine lack of equity and solidarity in the access not only to the health care, but in particularly in the medicines, which is somehow easy to track and to monitor than access to health care in general. Everyone wants to avoid the discussion that we have unequal access to the medicines in Europe.There was a study, which was done for the Belgian Govern-ment. It took �fty drugs, which they considered innovative and asked IMS to look at what was the uptake of these products in the year 2009 (the drugs were approved between 2005 and 2009) (Fig. 3).

There is a huge variation and actually it is worse than that, because for example behind the �gure of Poland you see only

private money and that’s not reimbursed, so even if let’s say new cancer drug or diabetes drug is available in Poland it shows up in this graph – who gets it? Well, people with money or with connections – that’s the reality. This is not sustainable in the long run that we have these private markets, living side by side in the system, which is supposedly a universal health care system with equity and solidarity. Why have we ended up here? One reason is that some countries cannot a�ord it. But it is also because we are imposing one price for all these people, this is a single market and everyone refers to one another, for example, Germany referring to Greece. So there is no way here to equalize the volumes and I think this is a debate that should really happen - how do we get more volume out of the money we spend? What if we can have di�erent prices in these countries? What if the company could make a deal with the Government? You get this for a third of the price, so you get three times the volume. We can’t do that – because then others will want the same price without increasing the volume. When talking about the industrial policy for Europe, the main message is the following - if we want to support innovation in Europe we have to use innovation and it is going to be for the bene�t of the patients. So stop equalizing this curve here - let the new drugs to the market, let the patients get them at di�erent prices. That is going be a huge stimulus for the industry to continue to innovate in Europe.

Fig. 3. Sales of innovative products (launched 2005-2009) per 100,000inhabitants in 2009 per country .

Source: IMS MIDAS; analysis for INAMI

FR DK ES BE IE DE AT SE IT GR SK FI SI UK CK LU NL HU RO EE PT PL BU LT LV

2,5

2,0

1,5

1,0

0,5

0,0

SALE

S PE

R 10

0, 0

00 (m

€)

References:[1] Eurostat (2009) Life expectancy at birth, by gender [tps00025]. Available at: http://epp.eurostat.ec.europa.eu/portal/page/portal/population/data/main_tables. Last updated 30th November 2010 [accessed 13th January 2010].[2] Lichtenberg FR (2005) The impact of new drug launches on longevity: evidence from longitudinal, disease-level data from 52 countries, 1982-2001. Int J Health Care Finance Econ. 5:47-73

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Global and Regional Developments in NCD: Implications for National ActionDr. Timothy Armstrong1, Dr. Gauden Galea2

1Coordinator, Department of Chronic Diseases and Health Promotion, World Health Organization2Director, Division of Noncommunicable Diseases and Health Promotion, Regional O�ce for Europe, World Health Organization

Dr Timothy Armstrong is the Coordinator of the Surveillance and Population-based Prevention Unit, in the Department of Chronic Diseases and Health Promotion, in the Noncommunicable Diseases and Mental Health Cluster, World Health

Organization, a position he has held since 2007. Dr Armstrong �rst joined WHO as a Team Leader in the WHO NCD Surveillance Unit in 2002 and in 2004 he became the Team Leader for the Global Strategy on Diet, Physical Activity and

Health a position he held until 2007.From 2002 until joining WHO he was Senior Manager of the Cardiovascular Disease, Diabetes, and Risk Factor Monitor-ing Unit at the Australian Institute of Health and Welfare Unit (Canberra, Australia). Dr Armstrong’s held post-doctoral research positions at the John Curtin School Medical Research, Australia (1994-1995), the Australian Institute of Sport, Department of Sports Medicine, Physiology and Nutrition (1992-1994) and the University of New England, Armidale,

Australia (1992).He obtained his quali�cations and post-graduate quali�cations in Epidemiological Medical Genetics from the Univer-

sity of New England in 1992.

This paper highlights the World Health Organization’s (WHO) global roadmap and the global events, which are currently taking place in relationship to prevention and control of non-communicable diseases (NCDs). It also focuses on the European strategy and the Framework in NCDs prevention and control.

Fig. 1 gives a short summary of global WHO actions, which have been undertaken over the last decade in relationship to prevention and control of NCDs.

Global Strategy on Diet,Physical Activity and Health

Action Plan 2008-2013 on the Global Strategy for thePrevention and Control of NCDs

Global Strategy toReduce the Harmful useof Alcohol

2000

2003

2004

2008

2009

2010

2011

20132020

WHO Action Plan for the Prevention and Control of NCDs for 2013-2020

Political Declaration on NCDs

Global Strategy for the Prevention andcontrol of Noncommunicable Diseases

Fig. 1. WHO’s global road map on NCDs

NON-COMMUNICABLE DISEASES AND HEALTHY AGEING

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WHO is currently updating Action Plan for the Prevention and Control of NCDs, which will look forward to 2020 and is currently being discussed with WHO Member States and will go for the decision to the WHO Assembly in May 2013. The vision of this document is: a world in which all countries and partners sustain their political and �nancial commitments to reduce the avoidable global burden and impact of NCDs, so that populations reach the highest attainable standards of health and productivity at every age and NCDs are no longer a barrier to socio-economic development.There are six overarching principles: (i) human rights; (ii) NCDs are a challenge to social and economic development; (iii) universal access and equity; (iv) life-course approach; (v) evidence-based action; and (vi) empowerment of people and communities.The overall goal is to reduce the burden of preventable morbidity and disability and avoidable mortality due to NCDs.The second key issue is the comprehensive global monitoring framework, including indicators, and a set of voluntary global targets for the prevention and control of NCDs, which was adopted in the Formal Meeting of the Member States, which took place in Geneva 5-7 November 2012 (Fig. 2).

The Member States also agreed on nine voluntary global health targets. It was agreed that premature mortality from NCDs should be reduced by 25%; harmful use of alcohol – by 10%; physical inactivity – by 10%; salt/ sodium intake – by 30%; tobacco use - by 30%; raised blood pressure – by 25%; and to secure that there is no increase in current diabetes and obesity rates. National health systems response targets were agreed around drug therapy and counseling (50%); and around the availability of essential NCD medicines and basic technologies (80%).

In many countries, in Europe, NCDs rates are amongst the highest in the world. On the other hand, in many countries of Europe, there have been recorded some of the fastest declines in circulatory mortality in the world. There have been rapid falls in age-standardised circulatory mortality seen in many European countries, which invested heavily in NCDs prevention and control in the last three decades. One striking example is the rapid decline in Poland where coronary mortality fell by 25% within �ve years after 1991 as a result of interventions of changing life styles, prevention and also strengthening health system. The experience of the European region in NCDs, thus illustrates some important principles. We have a signi�cant burden measured in absolute terms, but also important di�erences between and within countries. A European health policy must thus address both the absolute gap as well as the relative gradient between and within

countries.

The burden of NCDs represents a major challenge for Europe, but we are also a Region that has shown that these diseases can be brought under control, and even rapidly so.

This is the �rst year of the European Action Plan for the Imple-mentation of the Regional Strategy for the Prevention and Control of NCDs. It is also the year where the World Health Assembly has adopted the historic global goal of a 25% reduction in premature mortality from NCDs by 2025. In this context, it is �tting to note the success of some of the countries in this Region in providing leadership in the achievement of the global target already since a few years. In the Russian Federation, Kazakhstan, and the Republic of Moldova since 2005, we have seen a large and rapid fall, almost large enough to annihilate the rise seen in the early 1990s in the aftermath of independence an recession. The progress in these countries comes from a combination of increased prosperity, increased investment in health services, and to some extent from a change in risk behaviours as lifestyles shift more towards the European average. The success in these countries calls upon us to document these changes, to note that the global goal is indeed achievable, and to focus even more on country related deliverables in the coming years of the NCD Action Plan.

Key points of direct relevance to NCD Action are: (i) equity within and between countries; (ii) social determinants of health (e.g. income inequity, poverty, early childhood devel-opment, unemployment, etc.); (iii) whole of government and whole of society approach and will; and (iv) foundation of health systems strengthening and public health capacity.The four main components of the European NCD Action Plan are (i) planning and oversight; (ii) health in all policies; (iii) healthy settings; and (iv) secondary prevention (Fig. 3)

The importance of the national plan cannot be overempha-sized; this is being supported by the WHO, both at global and at regional level. WHO provides a series of technical products, which can help to inform policy makers at the national level to set up national policies, plans, programs and good gover-nance mechanisms for combating the NCD epidemic.

We must remember of course that to combat NCDs, the prevention is very important, but we also know that up to a third in decline of mortality from NCDs is attributed to treatment and management and we must have a truly

Morality &Morbidity

Risk Factors National SystemsResponse

Unconditional probability of dying

between ages 30 and 70 years from

cardiovascular diseases, cancer, diabetes or chronic respiratory

diseases

Cancer incidence by type of cancer per

100 000 population

Harmful use of Alcohol (3)

Fruits and Vegetables

Physical Inactivity (2)

Salt

Saturated Fat

Tobacco use (2)

Blood glucose/diabetes

Blood Pressure

Overweight and Obesity (2)

Total Cholesterol

Cervical cancer Screening

Essential NCD Medicines

Hepatitis B Vaccine

Marketing to children

Access to palliative care

Drug therapy andcounseling

Policies to limit SFA andvirtual elimination of PHVO

HPV Vaccine

Fig. 2. Comprehensive Global Monitoring Framework

25 IN

DICA

TORS

Health 2020

Planning andoversight

Public Health Action Framework

National plan

Healthinformationsystem with

socialdisaggregation

Healtysettings

Workplaces andschools

Active mobility

Secondaryprevention

Cardio-metabolicrisk assessment

and managment

Early detectionof cancer

Health in allpolicies

Fiscal policies

Marketing

Salt

Trans-fat

Fig. 3. The main components of the European NCD Action Plan.


HEALTH FORUM 16

integrated approach to NCD prevention and control, if we are to meet the 25% reduction in global mortality as has been mandated by the Member States.

The WHO has recently provided a list of best buys package population-based approaches – cost-e�ective, a�ordable and feasible interventions, which, if implemented correctly, can have a major impact on NCD mortality and morbidity. The list includes: (i) smoke-free environments; (ii) warning about the dangers of tobacco use; (iii) bans on tobacco advertising; (iv) raising taxes on tobacco; (v) raising taxes on alcohol; (vi) restricting access to retail alcohol; (vii) bans on alcohol adver-tising; (viii) reducing salt intake and salt content of food; (ix) replacing trans-fat in food with polyunsaturated fat; and (x) promoting public awareness about diet and physical activity.The importance of monitoring surveillance cannot also be underestimated, in recognition that health information systems are crucial. We have the Global Monitoring Frame-work with indicators and global monitoring targets in the framework. It is now for the Member States to work with the WHO to adapt the targets and indicators of Global Monitor-ing Framework to national circumstances.

If we look at the situation in Europe, we can see very good data availability from the existing health information systems for NCD mortality, very good NCD morbidity data, primarily through cancer registries, however, there is still work to be done in terms of data on NCD risk factors. There is a real opportunity to improve public health via �scal policies. For example in Ukraine, in 2008-2011 despite tobacco industry opposition the excises were increased seven-fold and cigarette prices increased three-fold. Tobacco excise revenues in 2007-2011 increased from 2.5 billion to about 15 billion UAH while cigarette production declined by 30%. We have to be very careful though when we talk about �scal policies in terms of public health importance. The matrix, which is being developed currently, looks at three commodi-ties – tobacco, alcohol and foods and suggests some things

we all should think about if we are starting to think about implementing �scal policies around to support healthy behaviors (Fig. 4).

In conclusion, there is a complete coherence between the Global Action Plan for NCDs, the European Action Plan, Health 2020 and the Public Health Action Framework.

Evidence CurrentPractice

SocialImpact

Tobacco

Alcohol

Foods

E�ect onconsumptionElasticityPass throghe�ectsE�ects onrevenueMechanisms:minimumprice, excise

Response to �nancial crisisWhat productsare targeted?Cross-bordersalesSmugglingIllegal productionEarmarkingMonitoringStrategy

RegressivityE�ects ondi�erent SEGWhat is thehealth impact?

Fig. 4. Matrix for �scal policy.


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Intersectoral Collaboration for the Control of Non Communicable Diseases: Canadian perspectivesProf. Sylvie Stachenko,

School of Public Health, University of Alberta (Canada)

Prof. Sylvie Stachenko, Professor at the School of Public Health at the University of Alberta (Canada), visiting Professor, the National School of Public Health (France).

Prof. Sylvie Stachenko is a Public Health expert in the �eld of health promotion and chronic disease prevention with over 20 years of experience in academic, community and government organizations at international, national and local levels. She has led chronic disease policies at national level in Canada including cancer control, diabetes, cardiovascular and AIDS. She also headed a World Health Organization (WHO) Collaborating Centre on Non-Communicable Disease policy and was the

CINDI Canada director.Prior to 2009, she was the Deputy Chief Public Health O�cer at the Public Health Agency of Canada. From 2002-2004 she

was the Director General in the Centre for Chronic Disease Prevention and Control at Health Canada and from 1997 to 2002 Prof. S. Stachenko was the Director of Health Policy and Services, for the WHO Regional O�ce for Europe.

Prof. S. Stachenko earned a Doctorate in Medicine from McGill University. She completed her residency in family medicine at the Université de Montréal and earned a Master’s degree in Epidemiology and Health Services Administration from the

Harvard School of Public Health.


This paper focuses on building blocks for intersectoral action for Non Communicable Diseases (NCDs) in Canada, brings the examples of national and provincial approaches and re�ects key challenges and lessons.

The landscape in Canada for NCDs is no di�erent than in the other countries; the burden is increasing, particularly in high risk groups, in vulnerable communities (e.g. Aboriginals) and in socio-economically disadvantaged groups. It costs economy over 150 billion dollars a year (direct health care costs estimated to be 71 billion dollars; and indirect costs - 85 billion dollars). All these numbers will increase as a result of aging and increased prevalence of some risk factors, such as the obesity rate.

There are some alarming trends: 4 out of 5 Canadian adults have at least one risk major factor for chronic disease; high

blood pressure and Type 2 diabetes occur at younger ages; and 1 out of 4 Canadian children are overweight or obese.

Another issue in Canada, is aboriginal population. We are seeing major health disparities between Canadians with aboriginal status and the rest of the population. For example life expectancy of males is 68.9 years vs. 76.3 years, and of females: 76.6 years vs. 81.8 years. Infant mortality is by 16% higher. Smoking prevalence rates are 62% vs. 24%. Rates of type 2 diabetes are by 3 – 5 times higher and rates of tubercu-losis - by 8 – 10 times higher. Years of life lost to injury are higher by 3.5 times.

So what has been the response in Canada? We have a long history in health promotion and it has in�uenced the design and planning of many initiatives, whether they address single risk factors (e. g. tobacco), or single diseases (e. g. cardiovas-

HEALTH FORUM 18


cular), or speci�c population groups (e. g. children), the health promotion or population health framework has been a key to the way we plan our programs and in many ways that includes intersectoral action. But little by little from those vertical programmes we have moved to the recognition for need for integrated approaches to address common risk factors for NCDs. Obviously CINDI program has been a major paradigm in terms of moving in that direction. In all of our programs we have worked really close with our non-governmental (NGO) sector – that has been a key approach to all our health initiatives. Multisectoral action is certainly not easy and there are many challenges around it; however in Canada over time, little by little, building on success we are now at a place where multisectoral action is becoming mainstream rather than just on community level.

One of the biggest success stories in Canada, particularly in the �eld of public health, has been Strategy for Tobacco Control. It is an example of real intersectoral action that has been now in place for many years. The key aspect of this approach was that it was multi-pronged (combining measures of access control, advertising and promotion; packaging and labelling; product regulations; taxes; smug-gling; enforcement and education) and multisectoral as well as it was sustained over long period of time. All of this resulted in drastic reduction of smoking prevalence rates and currently 17% of the population is smokers.

Over the last two decades, Canada has supported a range of community programs that were aimed at building commu-nity capacity, addressing the determinants of health, and reducing health disparities. These include the Community Action Program for Children and the Canadian Prenatal Nutrition Project which continue to provide important platforms to address health issues such as obesity, for children living in low income families. Other community-based programs such as Diabetes and Heart Health addressed common risk factors. For example, between 1999 and 2005, the Canadian Diabetes Strategy funded over 160 community-based projects on healthy eating and physical activity. Many of these community programs, such as the Heart Health Initiative, tended to be more on health promo-tion and did not fully engage the health care sector.

Many provinces have focused on the importance of children in school settings, such as New Brunswick’s Healthier Food and Nutrition in Public Schools Initiatives, Newfoundland’s Healthy Students, Healthy Schools Programs, and Action Schools BC incorporating healthy lifestyles in the school environment. Many schools across Ontario are promoting healthy eating and physical activity. In this regard, the Ministries of Education and Health are launching a Healthy School and Education Program. There are also speci�c modi�-cations to school physical activity programs, such as Ontario’s introduction of a minimum of 20 minutes a day of moderate physical activity into the elementary school curriculum. Perhaps the most innovative approach is Quebec’s extension of the school day to allow for a mandatory 120 minutes a week of physical activity. Many provinces have taken actions to alter school cafeteria menus and to regulate the sale of foods in school vending machines. As well, there are a number of schools that are reintroducing physical activity in the school curriculum.

The Canadian Heart Health Initiative was started in 1987 and was inspired by the holistic approach of health promotion. The demonstration programs were established in all ten

provinces and were focusing on four common risk factors. As a result we had 311 projects in 10 provinces and we were able to create the Observatory of community-based comprehen-sive programs as well as tools and methodologies for risk factor surveillance, process evaluation, and implementation research. This initiative was a catalyst for the development of NCD supportive infrastructure. The Heart Health Risk Factor Survey was a precursor to the current Health Measures Survey. It was also a precursor to the very important initiative - the Population Health Intervention Research Initiative for Canada. Coalitions for heart health at all levels expanded to chronic disease alliances (e. g. Chronic Disease Prevention Alliance of Canada) that have been in�uential in advancing the Healthy Living and Chronic Disease Strategy.

The Federal Chronic Disease and Healthy Living Strategy is a balance between broad population-based intersectoral action, e. g. Healthy Living Strategy and disease speci�c strategies, including cardiovascular disease, diabetes, and cancer.

More recently, Canada has responded to the WHO’s call for an integrated approach on diet, physical activity and health. In this regard, we have in place the Pan-Canadian Healthy Living Strategy, which was endorsed by the federal-provincial-territorial Ministers of Health in 2005 with a focus on diet and physical activity. This is an intersectoral initiative which was developed in collaboration with NGOs, the private sector and all levels of Government. An important aspect of the Pan-Canadian healthy living strategy and a critical integrating factor was the establishment of speci�c targets. Speci�cally, within 10 years (2015), the target is a 20% increase in the number of Canadians who are physically active, eat healthily, and are at healthy body weights. The strategy targets people in isolated, remote, and rural areas, and aboriginal communi-ties. Children and youth are designated as deserving special attention under the strategy and schools are highlighted as key settings.

To be e�ective, integrated action for chronic disease preven-tion must have a solid knowledge base. The greatest need is to implement the most promising policies and programs for NCD prevention and control immediately and to the fullest extent possible. To capture the experience base, we have established a learning system based on the many community experiences. In that regard, in Canada, a national best practice consortium for integrated chronic disease and health promotion is currently being implemented. We are also developing jointly with WHO-PAHO an Observatory on chronic disease policy and supporting EURO and PAHO in the implementation of their regional strategies. It is also impor-tant to have supportive infrastructure for NCD preventive research. To that e�ect, in Canada, we have the Canadian institutes for health research that were established in 1999. There is also the health promotion research consortium; knowledge networks are emerging. Another Canadian example to support the knowledge base for NCD prevention is the implementation of new CINDI demonstration site in Alberta to evaluate and monitor integrated prevention approaches.

In terms of surveillance and monitoring, we are working towards establishing an integrated surveillance system for chronic diseases. This integrated system would aim to accommodate existing initiatives building on disease and risk factor surveillance systems but focussing on coordination among di�erent levels and jurisdictions. It will put stronger

HEALTH FORUM 19

emphasis on data analysis, integration and dissemination. And �nally, it will build on, and expand current surveillance systems to capture information on determinants, risk factors, and interventions. The FPT task group on surveillance systems for chronic disease risk factors was established as a �rst step to direct the work towards an integrated surveil-lance system for chronic disease prevention.

Supportive meeting these challenges will require some key policy approaches. One of these is the adoption of whole of government approaches as we have seen in a number of provinces. At the federal level, the Physical Activity and Sport Act (2003) is an important legislative base that gives the Minister of Health authority to work with other Ministries in promoting physical activity and assist in reducing barriers faced by Canadians that prevent them from being active. Environmental policy levers are important and include initiatives such as:

• The new nutrition labelling regulations requiring food manufacturers to list calories and content of 13 core nutrients including trans fats, came into e�ect in December 2005. It is an important tool to inform and in�uence consumer behaviour through informed choices. It also encourages the food industry to innovate and develop products that are lower in calories, sodium, saturated fat and trans fat; • The new fitness tax credit announced in the last budget is another federal lever to encourage families to enrol their children in physical activity programs; • Increasingly, multinational companies are reach-ing children through internet, television and mobile phone. Food and beverage targeted to children are found to accounts for 23% of all advertising. In this regard, it should become a social norm not to market to children. Quebec is a model to follow as they have banned commercial TV advertis-ing for both food products and toys for children under 13 years of age.

Virtually all provinces and territories in Canada have some integrated healthy living and chronic disease strategy. Their targets are consistent or coherent with the targets set out in the integrated Pan-Canadian Healthy Living Strategy. Many provinces have adopted a “whole of government” approach to addressing the broader socio, economic, cultural and physical environment. Di�erent models are emerging. Act Now! British Columbia addresses the common risk factors for chronic disease and sets government-wide goals, with each Ministry expected to achieve certain established targets. Act Now! B.C. provides a unifying framework for strategic cross governmental and cross-sectoral initiatives to support British Columbians to make healthier lifestyle choices. Ontario’s action plan has created a forum to link Cabinet Ministers with mandates to support healthy eating and active living, to improve the coordination of policies and programs. Quebec has adopted a legislated approach where the Minister of Health is mandated to give advice on the health impact of other policies. Last October the Minister launched a govern-mental plan over a period of 10 years, linking several depart-ments to address obesity, with a strong focus on children and families called “Investir pour l’avenir” (investing in our future).So what kind of governance works best? There is no single model, when we talk about multisectoral approach. It really depends on the cultural and historical context; there are di�erent time limits, breadth of involvement, and level of involvement. It is very important to have a strong mandate and sustained leadership, which has to come from the

Government. As this kind of collaboration is labour intensive, adequate resource base is also obligatory.

In conclusion there is still a lot to do in Canada, the main challenges are: (i) capacity gaps to assess, identify, and communicate impacts of gov’t policies on health and health inequalities; (ii) developing e�ective supports for horizontal work: accountability structures, rewards, shared leadership protocols; (iii) willingness to invest su�cient time and resources; (iv) meaningful involvement of other sectors; (v) working with industry.

According to the Agency of Public Health of Canada (2007), the steps for successful implementation of intersectoral action are the following:

1. Create a policy framework and an approach to health that are conducive to intersectoral action. 2. Emphasize shared values, interests, and objetives among partners and potential partners. 3. Ensure political support; build on positive factors in the policy environment. 4. Engage key partners at the very beginning; be inclusive. 5. Ensure appropriate horizontal linking across sectors as well as vertical linking of levels within sectors. 6. Invest in the alliance-building process by working towards consensus at the planning stage. 7. Focus on concrete objectives and visible results. 8. Ensure that leadership, accountability, and rewards are shared among partners. 9. Build stable teams of people who work well together, with appropriate support systems. 10. Develop practical models, tools, and mechanisms to support the implementation of intersectoral action. 11. Ensure public participation; educate the public and raise awareness about health determinants and intersectoral action.


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In this abstract, the lessons from screening programs of breast cancer and prostate cancer are summarized.

Women in the USA have a roughly 12% chance of developing breast cancer at some point in their life. Many factors in�uence a woman’s chance of survival, including how early the tumour is detected and the molecular pro�le of the tumour. Even so, women diagnosed now are much more likely to survive than women in decades past. If tumour is localized (con�ned to primary site), the chance of survival is as high as 98.6%; if tumour is regional (spread to regional lymph nodes) – 83.8% and if tumour is distant (cancer has metastasized) – 23.3%. The cost of breast cancer is expected to rise as the population ages and patients live longer because of better – and more expensive – drugs [1].

Breast cancer. The �rst ever study, which was published on Swedish breast cancer screening programme back in 1991, found that most of the size e�ect occurs in the di�erence between these tumours and those smaller than 2 cm in diameter, when detection by mammography is of greatest relevance. Screening women over 50 years of age every 33 months reduces breast cancer mortality by some 40% (over a 10-year period, for the women screened) [2].

Swedish study, which analysed data of 1960-2010 (screening programme was started in 1976) concluded that mortality statistics showed little evidence that the decrease in breast cancer mortality corresponded to the results of mammogra-phy trials and observational studies conducted in Sweden. In fact, the Swedish breast cancer mortality statistics were consistent with studies that showed limited or no impact of screening on mortality from breast cancer [3].

Norwegian study, which analysed data of 1986-2005 (screening programme was started in 1987) concluded that the di�erence in the reduction in mortality between the current and historical groups that could be attributed to screening alone was 2.4 deaths per 100,000 person-years, or a third of the total reduction of 7.2 deaths. These results supported the evidence that screening mammography reduces the rate of death from breast cancer. However, the magnitude of this bene�t seems modest in the high attendance, nation-wide screening program which was evaluated. Most important, the apparent bene�t conveyed by optimized patient care may be missed unless breast cancer screening is integrated into a well-functioning health care system that is available to the entire population [4].

Prof. Guy Storme has his training in Radiation Oncology as well in Nuclear Medicine at the Jules Bordet Institute from 1973-1978. At the same time Prof. Guy Storme started the buildup of a new cancer center at the University Hospital UZ

Brussels. He developed a cancer research unit in radiobiology and started a translational program based on radiobiology. He received his PhD in 1987 and became full professor in Oncology and president of the Cancer Center.

In the period 1996-1999 he was Vice-president of Organization of European Cancer Institutes, from 1999-2002 President and 2002-2005 - Past-president. Afterwards he became Executive Secretary and works in this position till present.

He was scienti�c adviser at the Ministry of Health in Belgium, Scienti�c advisor at the Ministry of Science in Germany, at the FNCLCC in France, board member of SFC (France), and di�erent national and regional boards of Cancer Societies.

Prof. Guy Storme has published over 190 publications with focus on oncology, nuclear medicine, radiotherapy, and radiation oncology.

Cancer Screening Programs: Lessons to be LearnedProf. Guy Storme,

Department of Radiation Oncology, UZ Brussels (Belgium)

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References:[1]Maxmen A. The hard facts. Nature. 2012 May 30;485(7400):S50-1.[2] Du�y SW, Tabar L, Fagerberg G, Gad A, Gröntoft O, South MC, Day NE. Breast screening, prognostic factors and survival-results from the Swedish two county study. Br J Cancer. 1991 Dec;64(6):1133-8.[3] Autier P, Koechlin A, Smans M, Vatten L, Boniol M. Mammography screening and breast cancer mortality in Sweden. J Natl Cancer Inst. 2012 Jul 18;104(14):1080-93.[4] Kalager M, Zelen M, Langmark F, Adami HO. E�ect of screening mammography on breast-cancer mortality in Norway. N Engl J Med. 2010 Sep 23;363(13):1203-10. [5] Jørgensen KJ, Zahl PH, Gøtzsche PC. Breast cancer mortality in organised mammography screening in Denmark: comparative study. BMJ. 2010 Mar 23;340:c1241.[6] Michaelson JS. Mammographic Screening: Impact on Survival. In: Cancer Imaging: Lung and Breast Carcinomas, Volume 1. Edited by Hayat MA. Elsevier Inc, 2008.[7] Miller AB, To T, Baines CJ, Wall C. Canadian National Breast Screening Study-2: 13-year results of a randomized trial in women aged 50-59 years. J Natl Cancer Inst. 2000 Sep 20;92(18):1490-9.[8] Bleyer A, Welch HG. E�ect of three decades of screening mammography on breast-cancer incidence. N Engl J Med. 2012 Nov 22;367(21):1998-2005.[9]Andriole G et al NEJM 360:1310-19, 2009; Andriole GL, Crawford ED, Grubb RL 3rd, Buys SS, Chia D, Church TR, Fouad MN, Gelmann EP, Kvale PA, Reding DJ, Weissfeld JL, Yokochi LA, O'Brien B, Clapp JD, Rathmell JM, Riley TL, Hayes RB, Kramer BS, Izmirlian G, Miller AB, Pinsky PF, Prorok PC, Gohagan JK, Berg CD; PLCO Project Team. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med. 2009 Mar 26;360(13):1310-9. [10] Andriole GL, Crawford ED, Grubb RL 3rd, Buys SS, Chia D, Church TR, Fouad MN, Isaacs C, Kvale PA, Reding DJ, Weissfeld JL, Yokochi LA, O'Brien B, Ragard LR, Clapp JD, Rathmell JM, Riley TL, Hsing AW, Izmirlian G, Pinsky PF, Kramer BS, Miller AB, Gohagan JK, Prorok PC; PLCO Project Team. Prostate cancer screening in the randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial: mortality results after 13 years of follow-up. J Natl Cancer Inst. 2012 Jan 18;104(2):125-32.[11]Schröder F et al NEJM Mar 15;366(11):981-90, 2012. Schröder FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V, Kwiatkowski M, Lujan M, Lilja H, Zappa M, Denis LJ, Recker F, Páez A, Määttänen L, Bangma CH, Aus G, Carlsson S, Villers A, Rebillard X, van der Kwast T, Kujala PM, Blijenberg BG, Stenman UH, Huber A, Taari K, Hakama M, Moss SM, de Koning HJ, Auvinen A; ERSPC Investigators. Prostate-cancer mortality at 11 years of follow-up. N Engl J Med. 2012 Mar 15;366(11):981-90.[12] Heijnsdijk EA, Wever EM, Auvinen A, Hugosson J, Ciatto S, Nelen V, Kwiatkowski M, Villers A, Páez A, Moss SM, Zappa M, Tammela TL, Mäkinen T, Carlsson S, Korfage IJ, Essink-Bot ML, Otto SJ, Draisma G, Bangma CH, Roobol MJ, Schröder FH, de Koning HJ. Quality-of-life e�ects of prostate-speci�c antigen screening.N Engl J Med. 2012 Aug 16;367(7):595-605.

Danish researchers, which analysed data of 1986-2006, concluded that they were unable to �nd an e�ect of the Danish screening program on breast cancer mortality. The reductions in breast cancer mortality, which were observed in screening regions, were similar or less than those in non-screened areas and in age groups too young to bene�t from screening, and are more likely explained by changes in risk factors and improved treatment than by screening mammography [5].

One year after the single screening experience, the cancers found among these women will be just as large and just as lethal as the cancers found among women who never use screening. Bene�t in days of life saved each year by screening mammography if you do it annually, is 7 days for the whole women population and bene�t in cancer free days of life saved each year by screening mammography is roughly 5 days [6].

Canadian study, which analysed data of over 38,000 women, found that there was no di�erence in the outcomes in mammography plus physical examination group and physical examination alone group after 13-year follow up [7].Despite substantial increases in the number of cases of early-stage breast cancer detected, US study concluded that screening mammography has only marginally reduced the rate at which women present with advanced cancer. Although it is not certain which women have been a�ected, the imbalance suggests that there is substantial overdiagno-sis, accounting for nearly a third of all newly diagnosed breast cancers, and that screening is having, at best, only a small e�ect on the rate of death from breast cancer [8].

Prostate cancer. A US study, which involved over 8,000 men, found that after 7-10 years of follow up, the rate of death from prostate cancer was very low and did not di�er signi�-cantly between the two study groups [9]. Recent update of the same study group found that after 13 years of follow-up, there was no evidence of a mortality bene�t for organized annual screening in the PLCO trial compared with opportu-nistic screening, which forms part of usual care, and there was no apparent interaction with age, baseline comorbidity, or pretrial prostate-speci�c antigen (PSA) testing [10].

The study conducted in eight European countries, which involved 182,160 men between the ages of 50 and 74 years at entry, concluded that PSA-based screening signi�cantly reduced mortality from prostate cancer but did not a�ect all-cause mortality. To prevent one death from prostate cancer at 11 years of follow-up, 1055 men would need to be invited for screening and 37 cancers would need to be detected [11].

Another study concluded that the bene�t of PSA screening was diminished by loss of QALYs owing to post-diagnosis long-term e�ects. Longer follow-up data from both the ERSPC and quality-of-life analyses are essential before univer-sal recommendations regarding screening can be made [12].In conclusion, breast cancer screening is more likely a personal advantage than a societal, then who needs to pay for it? Many studies have found that physical examination is as good as mammographic screening. In case of prostate cancer screening, again it’s a personal advantage in a negligeable amount. Is screening worthwhile the cost, anxiety and quality of life?

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Non-Communicable Diseases in the Context of Health Policy: Lithuanian ExperienceProf. Vilius Jonas Grabauskas,

Lithuanian University of Health Sciences (Lithuania)

The aim of this presentation was to demonstrate the trends of the burden caused by major non-communicable diseases (NCD) as measured by NCD mortality and related determinant/risk factor changes over time. The period of the implementation of Lithuanian Health Programme (LHP) 1998-2010 has been taken as the basis for health policy analysis related to NCDs.

Material and methods. Lithuanian Department of Statistics as well as Lithuanian Health Information Centre data bases were used for NCD mortality analysis. WHO European HFA data base (July 2012 version) was used for international comparisons within the Baltic and the EU context. WHO CINDI Programme data base for Lithuania was used for trend analysis of social determinants of health and NCD risk factors (risk factor population surveys at 5 and CINDI Health Behavi-

uor Monitor at 2 year intervals). The outcome of the LHP 1998-2010 implementation was assessed by measuring the decline in cause speci�c mortality indicators. Decline equal or exceeding the projected target was considered as success-fully achieved, not reaching that level but di�ering less than 10% from the planned - as close to projected, while deviating more than that – not achieved.

Results. NCDs, such as cardiovascular, cancers, respiratory and digestive diseases, combined with risky behaviour related external cause deaths remained the major cause of burden for Lithuanian society all together accounting up to 94% within the mortality structure by the 2011 data. NCD related targets, such as decline in circulatory disease (-20.2%) and ischaemic heart disease mortality (-17.7%) in entire population, cerebrovascular disease mortality in under 65

Professor, dr. habil. Vilius Jonas Grabauskas received his Medical degree in 1966 from Kaunas University of Medicine. Between 1978 and 1986 he was working for the World Health Organization (WHO) starting as a Medical O�cer and

completing his assignment as Director of Division of Non-communicable Diseases (NCD), Geneva, Switzerland. Upon return from WHO, he continued his research in NCD prevention (Director, CINDI-Lithuania), was actively involved in the

formulation of national health policy in Lithuania, served as a chair of newly established National Board of Health. Internationally he continued active collaboration with and through WHO in di�erent capacities (Chair of the Standing

Committee of the Regional Committee for Europe, Member of the Global WHO Executive Board, Chair of the WHO/EURO CINDI Programme Management Committee). He served more than eleven years as a Rector, Kaunas University of

Medicine, later on continuing as a Chancellor as well as a Head, Department of Preventive Medicine. Currently he is Chancellor of Medical Academy of newly developed Lithuanian University of Health Sciences and a Chair of the Senate. In 2011 he was elected as a President of the Health Forum. Prof. V. J. Grabauskas is an honorary member of Polish Academy of Medicine, full-member of A. Sweitzer World Academy of Humanistic Medicine, Member of Scan-Balt Medical Academy.

He has published more than 300 publications, mainly on NCD prevention, health policy, health system management.


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population (-15.5%), lung cancer mortality in entire male (-19.4%) and breast cancer in entire female (-16.8%) popula-tion, cerebrovascular disease mortality in under 65 popula-tion (-15.5%), lung cancer mortality in entire male (-19.4%) and breast cancer in entire female (-16.8%) population as well as transport accident caused deaths in under 65 (-62%) and entire population (-64%), were considered as successfully achieved. Similarly, cerebrovascular disease mortality in entire population (-9.4%), malignant neoplasm mortality in under 65 population (-14.4%) as well as external cause mortality in both, under 65 (-28.4%) and entire population (-26.2%), were considered as close to projected. Unfortu-nately, decline of mortality as projected for targets for circula-tory system disease in under 65 (-6.3%), ischaemic heart disease in under 65 (-2.9%), malignant neoplasms in entire population (-6.6%) and cervical cancer mortality in entire female population (-10.2%), were not achieved. Age standardized total mortality per 100 000 of Lithuanian population was by one third higher than the EU average. Very disturbing is that this di�erence in total mortality indicators is considerably larger in under 65 population – half of all cause deaths in Lithuanian population is recorded in this working age population arriving at two-fold di�erence as compared to EU average.

Almost each second death in Lithuania by the WHO/EURO estimation is smoking related. However, Lithuanian popula-tion studies indicate di�erent smoking habit trends by gender: smoking prevalence within the period of LHP 1998-2010 in adult male population has decreased by 27.4%, while in contrast, it increased by 27.1% in females. Nevertheless, passive smoking rates in home and working environments have decreased by half. Strong alcohol consumption decreased in male population aged 25-64 (-12.6%), however, again, increased by one third in female population. Positive changes were observed in some dietary habits: animal fat use for cooking decreased more than by half, while vegetable oil use and consumption of fresh vegetables continued to be used more frequently in both genders. Similarly, signi�cant increase in physical activity in both genders was observed thus resulting in the decline of overweight and obesity rates. Some positive changes in health behaviours were re�ected in declining trends of biological NCD risk factors, e.g. prevalence of hypercholesterolaemia within that period decreased by 19.6% in females and 14.8% in males. Unfortunately, no changes in prevalence of hypertension were observed – on contrary, even some tendency of increase was recorded (+3.8% in males and +3.7% in females). Positive changes in subjective health indicators as one of the elements of quality

of life were observed: +22.7% in males and +38.5% in females.

Conclusions. General assessment of LHP 1998-2010 imple-mentation demonstrated that majority of NCD related indica-tors were changing in the direction of the planned projec-tions – out of 15 analyzed targets 11 (73%) were achieved or close to projected. Although NCD risk and burden to society still remains high, the positive changes of a number of NCD related indicators demonstrate serious potential of the country to cope with priority health problems (total mortality over this period declined by one tenth). However, the lessons learned clearly indicate that in order to better meet priority health needs the strategic direction of LHP 2020 should be focused on closer and more e�ective collaboration with all socio-economic sectors of the society.


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VALUE-ADDED HEALTH TECHNOLOGY ASSESSMENT FOR HEALTH POLICY

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Health Technology Assessment: Objectives, methodology, expectations and outcomesProf. Egon Jonsson,

University of Alberta, Department of Medicine,University of Calgary, Department of Public Health,

Executive Director & CEO, Institute of Health Economics (Canada)

Introduction and background

For thousands of years humans have been developing technologies to treat and heal illness, wounds, and infections. Some very early practices, such as making medicines of plants and using sewing needles to stitch wounds have survived to now, as have some landmarks and representa-tions of modern technology, such as the invention of the microscope 600 years ago, the stethoscope 200 years ago, and the discovery of x-rays 100 years ago [1,2]. However,

there are literally thousands health technologies, developed in both early and late history, that have proven to be useless or even harmful for people’s health.

With few exceptions, earlier assessments were mainly by trial and error, or by a natural, Darwinistic process in which ine�ective medicines, devices and practices did not survive. Both of these methodologies for assessment are extremely slow and more harm than good may be done before the outcome is known. It was essentially not until the turn of the

Egon Jonsson is President and CEO of the Institute of Health Economics in Edmonton, Alberta, Canada, and Professor of Health Economics at the University of Alberta and the University of Calgary.

He was trained at the Stockholm School of Economics, Sweden, and served as a research associate at Harvard School of Public Health, US.

E. Jonsson is a member of the Institute of Medicine, US National Academy of Sciences, and was for 25 years until recently Editor-in-Chief of the International Journal of Technology Assessment in Health Care.

For 15 years he was Director of the Swedish Agency on Health Technology Assessment, and professor of Health Economics at the Department of Medicine, the Karolinska Institute. He later worked for WHO to establish The Health Evidence

Network. E. Jonsson has served on many missions of the World Bank on the health services in Lithuania and Latvia from the early

1990s to the early 2000s. His main �eld of research has been in health economics. His current research is focused on the policy implications of

investing in the social determinants for health and on the economics of e�ective maternal and child health care, preven-tion of fetal alcohol spectrum disorder, and the macroeconomics of enhancement of early childhood development.


HEALTH FORUM 26

1950s before more scienti�cally strict methods for evaluation, such as randomized controlled trials, and the use of statistics were beginning to be the norm in evaluations. Formal and comprehensive assessments of health technology begun as late as in the early 1970s. Such evaluations have demon-strated that many technologies did not live up to the hopes, promises and predictions of progress that had been invested in them.

At no time in the history of medicine has health technology innovations grown as rapidly as during the past 50 years. While innovations may improve the diagnosis and treatment of disease, the adoption and di�usion of any healthcare technology presents considerable cost and risk unless it comes with scienti�c evidence or other proof of its safety and e�ectiveness, and not with promises only. Governments and other funders of health care therefore see the need to assess and control the di�usion and use of health technology.

There are four basic concepts related to both control and assessment of health technology: safety, e�cacy, e�ective-ness and cost-e�ectiveness. Safety means that the risks, or side e�ects, of a technology are known and fall within an acceptable range. E�cacy means that the technology does what it is supposed to do under laboratory conditions. For example, ultrasound equipment should produce images of the site being examined, and a drug for hypertension should reduce blood pressure. E�ectiveness, which is di�erent from e�cacy, means that use of the technology has a positive impact on a patient’s health outcome. Finally, cost-e�ectiveness means that the costs are known and linked to some measure of a patient’s health outcome.

Control of health technology

Around the world, varying strategies are used for controlling di�erent types of health technology. To regulate pharmaceu-ticals, most countries have introduced legislation requiring that drugs meet certain standards of safety and e�cacy before they can be licensed and marketed. Many countries also require evidence of e�ectiveness and have well-developed systems for reporting unexpected side e�ects. Some countries have even introduced a requirement of cost-e�ectiveness. Pharmaceuticals are thus more strictly controlled than any other healthcare technology [3].

For medical devices and equipment, a basic requirement in most countries is that they be registered at a public institu-tion before they can be marketed and used. Registration procedures usually control for issues of reliability, perfor-mance, e�cacy and safety, including assurance that the technology conforms to international standards of good manufacturing practice, as well as a requirement that manu-facturers report malfunctioning equipment. It is much more complicated to assess the e�ectiveness of non-drug technologies, since their impact on a patient’s health outcome is in general subordinate to the impact of clinical decision making, and the methodology for assessing the e�ectiveness of equipment and devices for use in diagnosing is poorly developed. This �eld is in need of more attention by researchers, both in the health technology assessment community and in industry, to assure evidence of long-term safety and e�ectives, and to make procurement decisions less dependent on cost and more focused on the value of these technologies.

For other technologies in health care, such as screening

programs and medical and surgical procedures, there are generally no laws or regulations unless radiation is involved.

Several measures to control the di�usion and use of technol-ogy have been introduced in di�erent countries. While legislation does not seem to work, other measures tried include health ministry control of speci�c technologies; regionalization of services, capitation payment schemes, prospective payment systems based on a �xed price per diagnosis, certi�cate of need programs, accreditation systems, quality assurance programs and guidelines [3, 4]. In a review of di�erent means to regulate the di�usion and use of technology, the authors concluded that, “The most power-ful means of mastering the dissemination of technology seems to be through �scal restriction; by global budgeting and particularly by limiting hospital budgets. The way provid-ers of health care are paid is also a potent instrument for managing healthcare technology” [3].

Health technology assessment

The multidisciplinary �eld of health technology assessment (HTA), and the evidenced-based health care that it supports, have developed from the need to maintain or improve the quality of health care while at the same time balancing technological advances with available resources. This �eld of research aims to support health policymaking by synthesiz-ing evidence on safety, e�cacy, e�ectiveness and cost-e�ectiveness, as well as the ethical and social implica-tions of both new and established technology. It relates to all technology including devices, equipment, procedures and practices in health care and health promotion in a broader context, including activities supporting population health. It also includes organizational and management issues, and aspects of �nancing and payment for health care and preven-tion.

Health technology assessment began about 40 years ago and is now a well-organized and established discipline in many countries [4, 5]. Depending on demography, culture, resources and other factors, HTA is organized di�erently in di�erent countries. However, most governments have estab-lished arm’s-length agencies for HTA, of which more than 50 have joined together in the International Network of Agencies for Health Technology Assessment (INAHTA) [6].

In the European Union, the European Commission has recog-nized that all countries face similar challenges in maintaining their healthcare systems and assessing the relative costs and bene�ts of technological innovations. Accordingly, the Commission has demonstrated a strong interest in and support of HTA by funding a number of initiatives for collabo-ration among researchers in the �eld [7-14].

A brief history of HTA

Before the 1970s, there were not as much concern about evidence in health care as there is today, nor was there much interest in the social, ethical and economic implications of health technologies, practices and procedures. That changed dramatically when one new, spectacular and very expensive technology suddenly was introduced for commercial use in 1972, namely the computed tomography (CT) scanner. The CT scanner was a great innovation in brain- imaging technol-ogy, and over time it has been improved and its use extended to many �elds of medicine. At the beginning of the 1970s, however, the world had never seen anything like it; the global


HEALTH FORUM 27

medical community was taken by surprise and admiration for its capability, and the policymakers were astonished by its cost - spending millions of dollars for one single medical technology was unheard of. Nevertheless, radiologists and other clinicians wanted CT scanners in their hospitals and clinics, and both the media and patients publicly demanded that CT scanners be installed wherever the technology was supposedly needed. The only alternatives for diagnostics of the brain at that time were invasive procedures that had relatively high risks of complications and often invoked fear, anxiety and substantial pain in patients. The CT scanner was viewed as a much preferred diagnostic alternative by doctors, patients and the general public.

Politicians and policy makers found themselves in a di�cult dilemma that was not much di�erent from situations often faced today: this new technology was no doubt promising, but they felt that they did not know the broader implications of it and they questioned how it would be �nanced. In order to make informed decisions about the use and di�usion of CT scanners, the policy makers raised a number of questions that clinicians were not accustomed to being asked: How many CT scanners are needed? What are the costs of training sta� and of operating this technology? What will be the overall budget impact of such an investment? Which procedures will it replace? Will this technology improve clinical decision making and the subsequent outcomes of treatment?

These types of questions are familiar to the HTA research community today; however, at that time there was no such thing as HTA and no particular body that could provide assistance. For the �rst time in the history of health technol-ogy, the policy makers turned to the scienti�c community of epidemiologists, statisticians, economists, and policy and clinical researchers to jointly analyze the collective medical, social, ethical and economic implications of a technology. A handful of researchers at the US Congress O�ce of Technol-ogy Assessment took on this task. Independently of the actions taken in the US, a group of researchers in Sweden did the same at about the same time. There are of course many other developments in health services research that were important for the establishment of HTA, however, these particular initiatives may be marked as the beginning of health technology assessment [15-18]. By the 1980s, hundreds of researchers in various countries had entered this new �eld of research. They eventually formed an interna-tional society for HTA [19], launched a scienti�c journal on the topic [20], and took several other initiatives to foster the new �eld of research, including international collaborations in HTA.

Early on in the history of HTA it was discovered that it is almost impossible to assess a health technology in isolation from myriad contextual factors. For example, a static snapshot of a technology cannot describe the complex organizational, ethical and economic implications of the rapid advance in health care that a new technology may represent. Further, many, if not all technologies are part of a chain in the diagnosis and treatment of patients. By de�ni-tion, a description of the implications of a technology must include what happens downstream, such as the changing indications for use and the subsequent costing of the technology when it is more widely di�used and its capacity and usefulness are thereby increased. In performing evalua-tions, researchers were led into a much broader �eld of questions than those about the cost, bene�ts and need for a particular technology. Eventually health technology assess-

ment extended to all technologies, procedures and practices in health care, and also to issues of health system e�ective-ness, measures for prevention, and other aspects of public health.

From its beginning to the present day, HTA has been based on �ndings from research and other types of evidence. The �eld has contributed to the development of evidence-based medicine, as opposed to the opinion-based medicine that dominated previously and is still practiced in some areas of health care and public health. Lately, the methodology of HTA has begun to move into education, social services, the legal system and other services generally provided by govern-ments. This is quite natural, since population health is not about health care only, and because HTA has developed a very strong arsenal of analytical tools that are useful far outside of the healthcare system.

Objectives

Biomedical advances and rapid technological change have brought about impressive improvements in the delivery and quality of medical care, and therefore essentially all new medical technologies are viewed as scienti�c achievements. However, far from all innovations turn out to be important advances in the sense of improving health outcomes in patients. There are numerous examples of technologies that �ourished for many years, even decades, before strict scienti�c studies demonstrated that the bene�ts envisioned when they were introduced were not realized, or that more harm than good was achieved by their use. This is one of the main rationales for health technology assessment. Another is that many established technologies were introduced long before the current requirements of evidence of e�ectiveness and have never been subjected to any formal evaluation of their relative costs and bene�ts. A consequence of this is that �nancial and other resources, which are being used for old and never-assessed technologies, therefore are not available for investment in new and perhaps more e�ective and cost-e�ective technology. Moreover, new technologies often carry high and clearly visible investment costs, while the cost of many established technologies is not fully known. This is a serious problem since it might be more di�cult to withdraw an expensive and relatively ine�ective technology than to introduce an equally expensive but more e�ective technol-ogy.

It is therefore necessary to review critically the assumptions, the promises and the evidence of safety and bene�ts to the patient of both new and established health technologies. This is the aim of HTA. The objectives are to conduct comprehen-sive assessments of health technologies:

1) To assist policy makers by providing evidence-based information on the costs and bene�ts, the medical, ethical, social and broader economic implications of investing in speci�c technologies.2) To speed up the di�usion and use of safe and e�ective technology, and thereby enhance quality of care, reduce risks and waiting times, and eliminate waste.3) To identify, on the basis of �ndings from research, the indications for appropriate use of a technology.4) To provide the epidemiological basis for appropriate di�usion of a technology.5) To identify technologies in need of more robust evidence of e�ectiveness.


HEALTH FORUM 28

Methodology

While the methodology of HTA is fairly straightforward, it requires the coordination of a multidisciplinary team with extensive education, skill and training. The following is a summary of activities that are typically performed in select-ing technologies for evaluation and conducting assessments:

1) Identi�cation of technologies in need of assessment.2) Development of criteria for prioritizing the technologies in need of assessment.3) Systematic reviews of available evidence in the scienti�c literature on the subject, using predetermined exclusion and inclusion criteria. The following types of studies are usually included (in order of their ability to provide reliable scienti�c evidence): • Already performed systematic reviews based on good randomized controlled trials (RCTs) (strong evidence); • Published meta-analyses based on good RCTs (strong evidence); • Large RCTs (strong evidence); • Controlled clinical trials (moderate evidence); • Cohort studies (moderate evidence); • Case-controlled studies (weak evidence); • Cross-sectional studies (weak evidence); • Case reports (no evidence).4) A review of published economic analyses, including costing studies and cost-minimization, cost-e�ectiveness, cost-utility and cost-bene�t analyses.5) A country-relevant economic evaluation (including a budget-impact analysis), since published studies of economic issues are usually context- speci�c.6) Consideration of potential ethical and social implications of the technology.7) The development of a synthesis of the medical, social, ethical and economic implications of the technology.8) The development of policy options and policy implications.9) Dissemination of the �ndings to various target groups, including health policy makers, the appropriate professions, other key stakeholders and the general public.10) Monitoring and evaluation of impact.

As mentioned above, models of health technology assess-ment vary from country to country. Most common is to estab-lish independent agencies that have the competence to conduct full-scale HTAs. In some jurisdictions, a government ministry identi�es the need for an HTA and commissions the various research tasks to independent organizations such as university departments. Some governments or agencies use di�erent types of assessments that range in scale from rapid reviews performed over a couple of months to full assess-ments that may take a year or more to complete. In many HTAs there is a need to establish special advisory or expert committees that include, for example, representatives from academia, the medical profession, industry and the general public.

The principles and practices of HTA are taught at universities, in specially designed degree programs, as well as in many other settings such as at conferences and through HTA agencies [6, 21].

Expectations

The driving forces behind health technology assessment are primarily concern about e�ective, a�ordable and sustainable health services; the elimination of inappropriate practices

and procedures; the reduction of waste and waiting times. The overall need is to deal with constantly increasing cost of health care and the wish to make informed decisions at the policy level about fair and e�ective resource allocation based on evidence.

The expectation is that HTA will provide useful information for decision making on the appropriate use and di�usion of drugs and other technologies, practices and procedures in health care. In particular, HTA should be able to respond with evidence to questions such as the following:

1) What need is served by this particular new technology?2) What bene�ts does it add for patients?3) What evidence is there that the proposed technology is safe, e�ective and cost-e�ective?4) Is training available in the use of the new technology in both the short and long run perspective?5) What are the implications for medical indications as the technology di�uses and become more broadly available and accessible?6) What are the potential social, ethical and equity implica-tions of the proposed investment?7) What are the potential long-range organizational, manage-rial and economic consequences of the di�usion of the technology?8) What is the budget impact of the technology?9) Is the proposed investment a�ordable?10) Which are the alternatives to this investment?

The success of HTA in meeting these expectations is re�ected in the increasing use of �ndings from health technology assessments in health policy making, industry and the medical professions, and in the increasing number of HTA agencies being established.

Outcomes

The most obvious outcome of HTA is the increased ability to make informed decisions on potential investments. It is more di�cult to isolate the impact of HTA on the overall quality; i.e. the safety, e�ectiveness and cost-e�ectiveness of the health-care system. However, there are studies demonstrating that �ndings from HTAs have led to a relatively rapid elimination of technologies and practices that are of limited or no bene�ts to the patient or the physician [22, 23, 24]. The current interest in disinvestment of obsolete and less e�ective health technologies also indicates that substantial increases in quality of care and associated cost savings may be achieved by HTAs [25 - 28].

Without rigorous assessment of health technologies patients and professionals will not be able to make evidence informed decision making. Only history will tell whether more harm than good was achieved by the use of the technology or treatment provided. The following list includes a few of the classical examples of health interventions, that were widely in use in recent history of health technology, but now deemed ine�ective or harmful [29]:

-Autologous bone marrow transplant with high-dose chemo-therapy for advanced breast cancer;-Diethylstilbestrol (DES) to prevent miscarriage;-Electronic fetal monitoring during labour without access to fetal scalp sampling;-Routine episiotomy for birth;-Extracranial–intracranial bypass to reduce the risk of


HEALTH FORUM 29

ischaemic stroke;-Gastric bubble for morbid obesity;-Gastric freezing for peptic ulcer disease;-Hydralazine for chronic heart failure;-Lidocaine to prevent arrhythmia and sudden death in acute myocardial infarction;-Mammary artery ligation for coronary artery disease;-Optic nerve decompression surgery for non-arteritic anterior ischaemic optic neuropathy;-Quinidine for suppressing recurrences of atrial �brillation;-Radiation therapy for acne;-Monitoring uterine activity at home to prevent preterm birth;-Supplemental oxygen for healthy premature babies;-Thalidomide for sedation in pregnant women;-Triparanol (MER-29) for cholesterol reduction;-Chelation therapy to prevent or reverse atherosclerosis;-Spinal manipulation to treat migraine or cluster headaches;-Traction to treat low-back pain;-Antihistamines and oral decongestants to treat otitis media with e�usion;-Fen�uramine plus phentermine to treat obesity;-Subcutaneous interferon alfa-2a to treat age-related macular degeneration.

In a review of 150 currently existing low value practices the authors listed the following 13 technologies as being doubt-ful of providing value for money [30]:

1. Testing of patients for factor V Leiden gene mutation;2. Arthroscopic surgery for knee osteoarthritis;3. Testing for C-reactive protein;4. Use of chest x-ray for acute coronary syndrome, preopera-tively, or in diagnosing respiratory infections;5. Chlamydia screening;6. Exercise electrocardiogram (ECG) for angina;7. Imaging in cases of (unspeci�c) low back pain;8. Liver function tests;9. Blood, urine or plasma testing in end-stage renal disease;10. Radical prostatectomy;11. Radiotherapy for patients with metastatic spinal cord disease;12. Routine dilatation and curettage;13. Surgery for obstructive sleep apnoea.

In the same study the following technologies were judged to be candidates for formal assessment, since there is evidence that they possibly are ine�ective or not cost-e�ective:

1. Antidepressant medications in treatment of mild-moderate depression;2. Tympanostomy tubes (ear grommets) for �uid in the inner ear in children;3. Implantable cardioverter de�brillators for ischaemic cardiomyopathy;4. Overprescribing of proton-pump inhibitors for dyspepsia;5. Tension-free repair versus watchful waiting for inguinal hernia.

Although HTA is not primarily about cost control, but rather about value, equity, access and quality of care, the elimina-tion of unnecessary or harmful practices certainly results in cost savings. This was illustrated in studies performed at one HTA agency that found limited or no bene�t to patients in for example; routine pre-operative testing, imaging and a range of other diagnostic procedures and treatments for back pain, light therapy for depression, inpatient care for mild head

injury, and medical treatment of osteoporosis in the elderly. It was estimated that appropriate use of technologies available in these areas would alone generate substantial annual cost savings; about ten times the annual budget for that agency [31 – 34]. In a report from the US it was estimated that signi�-cant cost savings could be achieved by replacing ine�ective technologies with more e�ective and cost-e�ective technol-ogy [35].

Concluding remarks

HTA has expanded and come a long way since the CT scanner was introduced in the early 1970s; however, many of the questions raised at that time are still relevant in the assess-ment of today’s innovations. The methodology of health technology assessment has improved enormously and has shown to be useful also in areas other than health care. The number of researchers in HTA far exceeds the handful who initiated the �eld: now there are thousands of people working on health technology assessments in agencies, universities, industry and in private consulting institutions. The scienti�c society draws at least 1000 members to its annual meetings. The International Network of Agencies for Health Technology Assessment has more than 50 member agencies in about 30 countries worldwide, including Lithuania, and many of these agencies have more than 100 employees. The International Society for Pharmacoeconom-ics and Outcomes Research (ISPOR), which mainly focuses on the assessment of drugs, has 11,000 members; and in the US, the comparative e�ectiveness research program of the Agency for Healthcare Research and Quality may include even a higher number of researchers in HTA [36].

The growing interest in the principles, practices and outcomes of HTA is probably a re�ection of the scarcity of other powerful measures to assure quality, e�ectiveness, cost-e�ectiveness and sustainability in healthcare systems. The greatest value with HTAs, and in its underlying scienti�c studies from clinical research, is not cost savings or the elimination of waste; it is about informed decision making at the policy level, and that it can provide patients with options and a choice when well founded alternatives for treatment are available.

HTA in Lithuania

Researchers and policy makers in Lithuania demonstrated an early interest in HTA, and many acquired training abroad in the �eld [37]. A number of important HTA initiatives have been undertaken in the country, such as the establishment of university courses on the subject, the provision of other educational activities, and the hosting of a series of national and international conferences on HTA since the beginning of the 1990s. These and other events on HTA in Lithuania were not part of a strategic plan for HTA, but rather fragmented nevertheless important initiatives, which now forms a set of pillars that may be coordinated in the future. Worth mention-ing in this respect are some legislation made in the �eld; the relatively early access to Cochrane Collaboration at the Medical Library; the formation of teams interested in HTA at the Health Sickness Fund, the State Accreditation Service, the State Pharmaceutical Control Agency, and at the Hygiene Institute. The training available in the �eld has made it possible for some students to reach the level of a Ph.D by defending their thesis’s on HTA at their Universities [38].


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References:[1.] Reiser, SJ. Medicine and the Reign of Technology Cambridge. University Press, 1981.[2.] Reiser, SJ. Technological Medicine. The Changing World of Doctors and Patients. Cambridge University Press, 2009.[3.] Jonsson, E., and Banta D. Management of health technologies: an international view. British Medical Journal 1999; 319;1293.[4.] Banta, D., Battista, R., Gelband H., and Jonsson E. (Eds). Health care technology and its assessment in eight countries. United States Congress, Washington DC, 1995.[5.] Banta, D., and Jonsson, E. History of HTA. Int J of Technology Assessment in Health Care 25: Supplement 1, 2009.[6.] www.Inahta.org[7.] Banta, D., et al. Introduction to the EUR-ASSESS report. Int J of Technology Assessment in Health Care 1997; 13:133-143.[8.] Banta, D., and Oortwijn, W. Health technology assessment in the European Union. Int J of Technology Assessment in Health Care 2000: 16, 299-635. 15. [9.] Jonsson, E, Banta, HD, Henshall, C, Sampietro-Colom, L, eds. Report of the ECHTA Project. Int J Technol Assess Health Care. 2002;18:171–183.[10.] Jonsson, E., et al (Eds.). European collaboration for health technology assessment: developing an assessment network. Int J of Technology Assessment in Health Care 2002; 18: 213-455.[11.] Jonsson, E. Development of Health Technology Assessment in Europe. Int J of Technology Assessment in Health Care. Vol. 18:2, Spring 2002.[12.] Velasco Garrido, V., and Busse, R. Health technology assessment: An introduction to objectives, role of evidence, and structure in Europe. European Observatory on Health Systems and Policies, Policy Brief 2005. [13.] Banta, D., Kristensen, FB., and Jonsson, E. A History of health technology Assessment at the European Level Int J Technology Assessment in Health Care Vol.25, Suppl I; 68-74, 2009[14.] Kristensen, FB., et al. Practical tools and methods for health technology assessment in Europe: Structures, methodologies, and tools developed by the European Network for Health Technology Assessment, EUnetHTA Int J Technology Assessment in Health Care. Volume 25, Supplement 2, 2009.[15.] Jonsson, E., Marke, LA: Computer Assisted Tomography of the Head: Economic analysis for Sweden. Swedish Planning and Rationalization Institute (SPRI) Spri report, Stockholm 1976. [16.] Jonsson, E., and Marke, LA. CAT Scanners: The Swedish Experience. Health Care Management Review 2:37, 1977.[17.] O�ce of Technology Assessment, US Congress. Policy Implications of the Computed Tomography (CT) Scanner, GPO stock No.052-003 -00565-4, Washington, DC 1978. [18.] Jonsson, E. History of health technology assessment in Sweden Int J of Technology Assessment in Health Care Vol.25, Suppl I, 42-53, 2009[19.] Banta, D., Jonsson, E., and Childs, P. History of the international societies in health technology assessment Int J of Technology Assessment in Health Care Vol.25, Suppl I; 19-24, 2009[20.] Jonsson E., and Reiser, S. The history of the International Journal of Technology Assessment in Health Care. Int J of Technology Assessment in Health Care Vol.25, Suppl 1, 2009.[21.] www.Ulyssesprogram.net/careers.html and www.HTAi.org and Mykolas Romeris University.[22.] Britton, M, Jonsson, E. Impact of health technology assessments. Int J of Technology Assessment in Health Care. 2002;18: 824–831.[23.] Polisena J, Cli�ord T, Elshaug AG, Mitton C, Russell E, Skidmore B: Case studies that illustrate disinvestment and resource allocation decision making processes in health care; a systematic review Int J of Technology Assessment in Health Care, March 2013.[24.] Brorsson, B, Arvidsson, S. The e�ect of dissemination of recommendations on use. Preoperative routines in Sweden 1989–91. Int J of Technology Assessment in Health Care. 1997;13:547–552.[25.] Ibargoyen-Roteta N, Gutierrez-Ibarluzea I, Asua J, Benguria-Arrate G, Galnares-Cordero L: Scanning the horizon of obsolete technologies: Possible sources for their identi�cation. Int J of Technology Assessment in Health Care,Volume 25, Issue 03. June 2009, pp 249 – 254. [26.] Elshaug A.G, Hiller J, Moss J R: Exploring policy-makers’ perspectives on disinvestment from ine�ective healthcare practices. Int J of Technology Assessment in Health Care Volume 24, Issue 01, January 2008, pp 1 - 9 [27.] Watt AM, Willis CD, Hodgetts K, Elshaug AG, Hiller JE: Engaging clinicians in evidence-based disinvestment; role and perceptions of evidence. Int J of Technology Assessment in Health Care. Volume 28, Issue 03, June 2012, pp 211 - 219 [28.] Legget L, Noseworthy M, Zarrabi M, Lorenzetti D, Sutherland LR, Clement FM: Health Technology Reassessment of non-drug technologies: Current practices. Int J of Technology Assessment in Health Care Volume 28, Issue 03, June 2012, pp 220 – 227. [29.] Elshaug A, Moss JR, Littlejohns P, Karnon J, Merlin TL, Hiller J: Identifying existing health care services that do not provide value for money. Med J Aust 2009; 190 (5): 269-273.[30.] Elshaug A, Watt AM, Mundy L, Willis CD: Over 150 potentially low-value health care practices: an Australian study. Med J Aust 2012; 197 (10): 556-560.[31.] Nachemson, A, Jonsson, E. Neck and back pain: The scienti�c evidence of causes, diagnosis, and treatment. Philadelphia: Lippincott, Williams and Wilkins; 2000.[32.] Britton, M, Asplund, K, Brorson, B, et al. Sa paverkade SBU praxis i varden. Konsekvenserna av sju rapporter granskade (Swedish language, summary in English). Lakartidningen. 2002; 99: 4628–4634.[33.] Rehnqvist, N, Marké, L-Å. Kan inverkan av evidens matas? (Swedish language), Stockholm: SBU; 2006.[34.] Norlund, A, Marke, LA, af Geijerstam, JL, Oredsson, S, Britton, M; OCTOPUS Study. Immediate computed tomography or admission for observation after mild head injury: Cost comparison in randomised controlled trial. BMJ 2006;333:469[35.] Schoen C, Guterman S, Shih AJ, Kasimow LS, Gauthier A, Davis K: Bending the Curve: Options for Achieving Savings and Improving Value in U.S. Health Spending, The Commonwealth Fund, December 2007[36.] www.ahrq.gov[37.] Jonsson E. Usonis V, Jankauskiene D et al: First steps of HTA in Lithuania. Medicinos Praktikos Vertinimas Lietuvoje. Pirmieji Zingsniai.Kastai, Nauda Valstubine Svedijos medicinos technologiju vertinimo tarnyba. Ministry of Health, Vilnius 1993.[38.] Jankauskiene D; Development of health technology assessment in Lithuania. Int J of Technology Assessment in Health Care, 25: Supplement 1, (2009). 140 – 142.

The establishment of the State Health Care Accreditation Agency (VASPVT) is an important step in controlling medical devices and equipment by registration, regulation and surveillance. The agency’s mandate also includes the accredi-tation and licensing of health care organizations and profes-sionals, as well as a responsibility for quality and patients rights in health care. The existence of this agency marks a �rst formal and promising step by the government of Lithuania towards the broader issues of HTA.

The current Health Forum is a good example of both the widespread interest in and knowledge about HTA in Lithuania. This and many other successful initiatives represent a solid base for stronger governmental support and coordination of HTA activities in Lithuania. That would certainly bene�t the Lithuanian patients, and contribute to the sustainability and improvement of safety, e�ectiveness and cost-e�ectiveness of the healthcare system in the country [38].

A main challenge for Lithuania, as for most countries, will be to ensure that evidence is incorporated into practice, which may require a mechanism of accountability for making use of evidence and �ndings from HTAs. That may be achieved for example by links to performance, and principles for payment of evidence based health services. Better information and feedback of performance is key to improvements and the use of evidence. Without data and information, of best possible practices based on evidence, no organization or system will be able to learn.

Based on personal experience and testimonies from many leaders of HTA agencies around the world, a successful program for HTA needs strong political support; indepen-dence; transparency and trust; and engagement with many stakeholders, including clinicians, researchers, industry, health policy makers, and the general public


HEALTH FORUM 31

HTA: a useful tool in consumer protection and a driving force for innovation and e�ciency growth in health sectorProf. Finn Børlum Kristensen,

Director, Secretariat for EUnetHTA, Danish Health and Medicines Authority, Copenhagen Adjunct professor, University of Southern Denmark Chairman, European network for HTA (EUnetHTA) Executive Committee (Denmark)

HTA is a multidisciplinary process that summarises informa-tion about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. The aim of HTA is to inform the formulation of safe and e�ective health policies that are patient-focused and seek to achieve best value. Despite its policy goals, HTA must always be �rmly rooted in research and the scienti�c method.

When discussing how to do international collaboration in this �eld, the late Director of AHRQ in USA, J. M. Eisenberg said “Globalize the evidence, localize the decision”. And what is meant with this is that the information based on science, on interventions in health care can be shared, it can be globalized, it’s typically based on published literature and that literature is shared by everyone. But when it comes to providing the information, it’s very important to localize

where the decision is made. Consequently, the application of the knowledge through HTA needs to be context-speci�c. That’s a challenge that we are working on at the EUnetHTA.

The EUnetHTA partner organisations see HTA reports as contributions to improve the health of European citizens by providing information to decision making in national context that promotes: good quality care; adoption of new health technologies; abandoning of obsolete technologies; equity in access to health; best value for money; and implementa-tion according to the principle of subsidiarity. Hence HTA contributes to high quality, safe, accessible, sustainable, ethical and e�cient healthcare for citizens.

Creation of sustainable and permanent HTA network in Europe started in 2005. The general objective of EUnetHTA from 2005 onwards was to establish an e�ective and sustain-

Dr. Finn Boerlum Kristensen has been a Director of the Coordinating Secretariat of European Network for Health Technology Assessment (EUnetHTA) in Danish Health and Medicines Authority, Copenhagen, since 2006. He also is a chairman of the

EUnetHTA Executive Committee and adjunct professor in health services research and health technology assessment (HTA) at University of Southern Denmark from 1999.

He was a Director of Danish Centre for Health Technology Assessment (DACEHTA), Danish Health and Medicines Authority, Copenhagen in 1997-2009. He is a University graduate in medicine and received his PhD degree in Epidemiology. He is also a

primary care physician and specialist in Public Health. He was a chairman of International Network of Agencies for Health Technology Assessment (INAHTA) in 2003-2006. Since 2011 he has been appointed as a Board Director, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). He was an editor of HTA Handbook (English, translated, published

in 2007), and chief editor of three peer reviewed publication series from DACEHTA 1998 - 2009. He has authored and co-authored numerous scienti�c publications in HTA, health services research, epidemiology and

policy analysis.


HEALTH FORUM 32

able European Network for Health Technology Assessment – EUnetHTA - that informs policy decisions. The general strate-gic objective of the Network was to connect public national/regional HTA agencies, research institutions and health ministries, enabling e�ective exchange of information and support to policy decisions by the Member States. The next step after an initial project period was EUnetHTA Joint Action 1: 2010-12. Its general objective was to put into practice an e�ective and sustainable HTA collaboration in Europe. It focused on HTA in Europe to facilitate e�cient use of resources available for HTA; and to create a sustainable system of HTA knowledge sharing, and promote good practice in HTA methods and processes. This collaboration continues through EUnetHTA Joint Action 2: 2012-15.

We have now developed common tools and approaches for doing HTA and for what is called relative e�ectiveness assessment (REA) of pharma-ceuticals, we have particularly developed tools to do rapid relative e�ectiveness assessment, that could be done within duration of three months (Fig. 1). We have developed tools to coordinate collection of additional data in situations when technologies are introduced and we still have some questions of their “real life” e�ectiveness. And increas-ingly there is also early scienti�c advice from HTA to the sponsors of the technologies, especially pharmaceutical companies, in the later phases of their development of drugs for the market.

One thing that I would like to underline again is that the issue of obsolesce, the issue of questioning the usefulness of existing technolo-gies is a way that can be used to free resources that could be used for introduction of new technologies.

In order to be able to share the information, we have discussed how we can share it before a �nal national or regional report is published. And in order to be able to share while we do our work, we need to have common understanding of the sharing of information by way of the Core HTA Model® (Fig.2)

Fig.3 shows the nine domains of the HTA core model. The �rst four domains are used for rapid HTA, which very often for assessment of single technologies are considered to be enough by decision makers. If we want to look at therapeutic �elds or indications, it is more important also to look at the other �ve domains.

According to the report “HTA capacity building: facilitation of national strategies for HTA sustainability”, there are several objectives that need to be addressed when developing HTA in a country.

The �rst objective is involvement of stakeholders: • Identify relevant supporters and opponents regarding the HTA organisation’s place in health care system; • Seek increased support from politicians, decision makers and scientists, establish an on-going relationship between partners; • Adjust the communication strategy to target group; • Regulate the uneven data access with legislative initiatives; • Establish formal processes to disclose conflict of interests.

The second objective is gaining political interest: • Strengthen trust between scientists and politicians and improve the use of scienti�c evidence in decision-making; • Define a clear position of HTA in the health care system; • Counteract improper or insufficient use of HTA, which may result in loss of political interest; • Disseminate HTA products to prove their usefulness; • Promote transparency to make agreement with policymakers easier to reach; • Use different approaches that raise awareness of politicians as bene�ciaries of the HTA products.

The third objective is funding: • Involve HTA in the decision making process to ensure stable funding; • Prepare an organisation-specific business plan; • Seek additional sources of funding; • Use external financial advisors to manage the organisation’s budget; • Try to precisely determine resources consumed to produce the organisation’s products; • Consider implementation of a performance budget or re-negotiations of workload; • Avoid competition for funding among institutions by clearly dividing responsibilities and seeking cooperation to share work-load.

The fourth objective is shortage of trained sta�: • Use motivating factors (encouraging salaries, friendly atmosphere, stability, prestige, intellectual challenges); • Create an appropriate sense of mission; • Invest in people (external and internal trainings); • Allow flexible hours or part-time job; • Employ people with experience from other areas; • Develop a new mind-sets in the society encouraging capacity building; • Exchange staff with other institutions, involve external experts, use the results of others.

In conclusion, the listed recommendations are general guidelines, not a case-study of HTA condition in the responding countries in the survey behind the recommendation; not institution-tailored – but a basis for developing a strategy of sustainable development in national settings. HTA organisations should also include their speci�c opportunities and threats, strengths and weaknesses, and their own experiences. EUnetHTA can have positive in�uence on facilitating the development of sustainable HTA in member organisations

ONTOLOGY METHODOLOGICALGUIDANCE

REPORTINGSTRUCTURE

How to presentthe answers

How to answerthe questions

Questions that an HTAshould answer

Fig. 2. The HTA core model®

Earlyscienti�c

advice

RapidREA

Additionaldata

collection

HTA / REA

Time line of innovation

Use

of t

echn

olog

y in

hea

lth c

are

Basicresearch

Appliedresearch

Experi-mental

Investiga-tional

Nearlyestablished

EstablishedTechnology

Obsolete???

Fig. 1. Health technology life cycle

FULL

RAPI

D

1. Health problem and current use of technology2. Description and technical characteristics3. Safety4. Clinical e�ectiveness5. Costs and economic evaluation6. Ethical analysis7. Organisational aspects8. Social aspects9. Legal aspects

Fig. 3. Domains of the HTA core model


HEALTH FORUM 33

Health Technology Assessment in a Comprehensive Approach to the Cancer ProblemProf. Ulrik Ringborg,

Cancer Centre, Karolinska Institute (Sweden)

Epidemiological analyses show that both the cancer incidence and the number of deaths caused by cancer will increase with about 60% within the next two decades. Number of patients living with a cancer disease will increase still more. This means that present preventive, health care and research strategies are not able to balance an increasing cancer problem. Strategies are needed to make cancer medicine more predictive and personalized. We must also be preemptive and focus on prevention as well as early detec-tion and therapeutics. The concept of comprehensive cancer centre is important for the optimal integration of cancer care and prevention with research and education.

Health technology assessment (HTA) is complex in the cancer area. We have to deal with primary treatment as well as treatment of recurrent disease. The multidisciplinarity

increases the complexity and in future advanced diagnostic technologies will be still more important. For a good HTA we need a complete outcomes research delivering detailed information on clinical e�ectiveness of separate treatments. So far cancer medicine has been evidence-based by large comparative clinical trials. We are now moving towards personalized cancer medicine with strati�cation of patients and treatment of small subgroups of patients. We move towards molecular pathways driven clinical trials and the adaptive clinical trials methodology, which means that treatment is modi�ed dependent on the biology of the tumour. As a consequence, comparative randomized clinical trials in future will be to a large extent replaced by observa-tional studies on detailed and quality assured clinical cancer registries.

Prof. Ulrik Ringborg earned his doctoral degree at Karolinska Institute in 1971. He quali�ed as an oncology specialist in 1979. He became Professor of Oncology and was appointed as a Head of the Department of Oncology in Karolinska Hospital in

1992. Since 1994 he has been appointed as a Director Cancer Center Karolinska.Prof. U. Ringborg was a chairman of the Swedish Melanoma Study Group in 1976-2003. He was appointed as a member of the Nobel Assembly from 1993 to 2008. Since 2005 he has been Vice Chairman of the Swedish Cancer Society. He was a president

of the European Society of Skin Cancer Prevention in 2002-2003. He also was a president of the Organization of European Cancer Institutes in 2005-2008, Past President in 2008-2011, and currently he is a co-opted member of the board. He has been a Chairman of the Advisory Board for UV-protection, Swedish Radiation Protection Authority since 2006, a Secretary General

of the European Academy of Cancer Sciences since 2009, and a co-ordinator of the EurocanPlatform project since 2010. Prof. U. Ringborg has published over 290 publications, mainly with scienti�c focus on malignant melanoma.


HEALTH FORUM 34

The background is the increasing complexity when knowl-edge is expanding in cancer biology. Gene alterations are driving the tumour and speci�c deranged molecular pathways determine the prognosis and are targets for treatment. We need to bring in bioinformatics and systems biology into the clinical research and combination treatment with targeted drugs will be necessary. Heterogeneity within the tumour cell population is linked to both inherited and acquired treatment resistance. Treatment prediction is a key issue for present and future research. We need the biomarker discovery and validation in order to identify the patients who should be treated and the optimal treatment (“the right treatment to the right patient at the right time”). We need to structure the implementation of new diagnostic and treatment methods in the clinical practice for evaluation of e�ectiveness and costs to complete the translational cancer research. For treatment at an early stage of the disease we need new diagnostic technologies for early detection of metastatic disease, early detection of invasive disease and also identi�cation of relevant premalignant lesions. Preven-tion research will integrate cancer biology - molecular genet-ics, biological e�ects of exposures, adaptive responses - and new methods for identi�cation of high risk individuals will innovate prevention.

In order to overcome the present fragmentation in European cancer research, the EurocanPlatform consortium, a structure for translational research, is funded since 2011 by the European Commission. The consortium links 23 cancer research centres, comprehensive cancer and basic/preclinical cancer research centres, and �ve cancer organisations in Europe for collaborations to overcome the present problems with lack of critical mass and suboptimal translational cancer research. For e�ective research collaboration European regulatory issues are important. We need quality assured structures for diagnostic methods and molecular pathways driven clinical trials. Omics technologies will be more involved in the clinical research and also in the daily cancer care for identi�cation of optimal treatment. There are regula-

tory problems related to sharing of clinical and biological data. Clinical trials directive should be adjusted to the need of innovative clinical trials and patients should be supported to cross the borders in order to participate in clinical trials. An important strategy for the European platform is late transla-tional cancer research which is considered an unmet need. We need clinical e�ectiveness data of speci�c treatment as well as involvement of health economy for comparative and cost-e�ectiveness research. This means that quality assured comprehensive cancer registries are required. We need agree-ments between regulatory authorities, pharmaceutical indus-try and academic centres regarding information for bene�t and risk estimations of new anticancer agents. With such an agreement HTA can start at an early stage of drug develop-ment and consensus at the European level should be a goal. An important mission for the cancer research centres is estab-lishment of harmonized comprehensive clinical cancer registries for compilation of data to reach the necessary critical mass when approaching personalized cancer medicine. Such registries should contain data on patient characteristics, tumours, primary treatment, treatment of the current disease, outcomes of treatments, both individual treatment as well as integration of complete clinical pathway, and follow-up. The registries will be the basis for an advanced outcomes research which should be linked to health economy research. Due to a larger population of cancer patients living with chronic disease quality of life assays will be still more important in future. It may be concluded that a European outcomes research structure is an obligatory infrastructure for translational cancer research as well as for high quality HTA.


HEALTH FORUM 35

Introduction

The introduction and e�ective utilization of Health Technol-ogy Assessments (HTA) in support of better informed health care decision making is a major theme in current European health policy discussions. Lithuania is not the only country that is considering the introduction of a more systematic HTA framework, others are in a similar situation or have more recently introduced formal pricing and reimbursement regulation for pharmaceuticals involving HTA. Other countries had introduced formal HTA processes already many years ago and are currently revisiting the underlying principles (e.g. in the UK) which provides ample opportunity for other countries to learn from experience gathered abroad. In this article I focus on challenges that decision makers usually face and explain the potential and the limitations of HTA to address these challenges. Selected examples of how HTA is used in the “real world” of today will illustrate positions developed in this article.

Potential and limitations of HTA

In all countries considerable parts of health care budgets are spent on health care services whose bene�ts are either unknown or at least questionable. Other technologies currently widely utilized have to be considered obsolete because new technology with demonstrated superior outcomes has been introduced in parallel. The �nancial crisis with its dramatic consequences on public budgets in general and health care budgets in particular provides an important opportunity to reconsider how scarce resources are allocated in the health care system.

Other than frequently claimed, health care decision makers have a set of relevant choices when addressing the impact of the economic �scal crisis on their budgets. Obviously, one decision alternative would be a set of “across the board” cost containment measures, equally a�ecting every sector of the health care system with a primary focus of short-term budgetary relief (“static” e�ciency). This policy alternative may be politically most acceptable because of their distribu-tional consequences. At the same time a major opportunity

Good Health Technology Assessment Practice – International ExamplesDr. Ansgar Hebborn,

Head Market Access Policy, F. Ho�mann-La Roche AG, Pharma Division (Basel, Switzerland)

Dr. Ansgar Hebborn is Roche Pharma’s Head of Market Access Policy based in Basel, Switzerland. In this role he is respon-sible for the development of Roche’s external policy positions and engagement projects on a number of market access

subjects including Health Technology Assessment (HTA) and pricing. Dr. A. Hebborn currently represents Roche in relevant industry associations e.g. in EFPIA as a member of the Economic and Social Policy Committee and the HTA Working Group.

During the past couple of years, he has taken an active role as advisor and stakeholder representative in various HTA collaboration networks e.g. EUnetHTA and the HTAi Policy Forum, and also has been involved in the foundation of other

initiatives in this �eld e.g. the Green Park Collaborative and SwissHTA.Prior to his industry career, Dr. A. Hebborn has been managing director of the Institute of Social Security Law and Health

Economics at the University of Bayreuth, Germany. Dr. A. Hebborn is a graduate of the University of Bayreuth in Germany, holds a Diploma in Business Administration and a

PhD in Economics. He has authored or co-authored publications in the areas of health policy, health economics and pharmaceutical outcomes research.


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Fig. 1. Transforming health care into a “learning system”.

Science Evidence Care PatientExperience

Missed Oppurtunities, Waste, and Harm

insightspoorly

managed

Evidencepoorlyused

Experiencepoorly

captured

Source: IOM, 2012

to send strong signals about “what constitutes value” to the health care system is missed.

Alternatively, decision makers could take the opportunity to structurally adjust the allocation of resources within the health care system in line with their contribution to improved patient- and system-relevant outcomes. Based on the already existing evidence about the value of health care services, selective investment and dis-investment decisions can be taken with the aim to optimize the overall spectrum of health care services accessible to patients. This policy choice rewards added value services in a meaningful manner; incen-tivises patient- and system-relevant product and service di�erentiation; and sends 5 important signals to health care providers and health technology developers, eventually aligning their behaviour and innovative e�orts with the overall outcomes objectives for the health care system (“dynamic e�ciency”). In order to e�ectively improve the situation in a sustainable manner, health care systems have to be transformed into learning systems. This will ensure that scienti�c insights trigger the generation of relevant evidence, which can be considered in health care decision making that will ultimately allow patients to bene�t through the more e�cient and more e�ective provision of health care services. Unfortunately, in the health care systems of today scienti�c insights are too frequently ignored, evidence is not systematically generated or only poorly used in decision making ultimately leading to suboptimal patient outcomes (Fig. 1).

HTA can make an important contribution towards a “learning” health care system but only if appropriately implemented and e�ectively utilized. If systematically utilized, HTA can be an important driver of e�ectiveness and e�ciency in a health care system. But this will only be the case if all relevant stakeholders in a health care system are aligned in their focus on patient-relevant health outcomes by means of a compat-ible set of incentives and disincentives. Unfortunately most health care systems of today are focused on managing resource inputs rather than on patient- and system-relevant outcomes. And of course, without relevant health care outcomes data and without resources to analyse variation of these outcomes and to identify best practice, it is impossible to transform health care into a “learning system”. Without being able to mobilize and direct the self-interest of the various stakeholders towards improved health outcomes it will be impossible to improve the overall outcome of the system in a sustainable manner. If health care providers are reimbursed simply based on the number of CT scans performed (“input-based”) then this will obviously lead to a di�erent level of diagnostic investment and activity than if the same providers would be reimbursed based on the ultimate health outcomes of their activities, which may or may not require more or less CT scans (“outcomes- or performance-based”). Simple comparisons of the local CT

diagnostic infrastructure with that in other countries will also not lead to the optimal level in CT scanner investment in Lithuania because the health care infrastructure in other countries is a mere re�ection of the same problem. It is a health care systems’ ability to e�ectively align incentives and dis-incentives of all stakeholders around the goal of improved patient-relevant outcomes that will ultimately make some health care systems more productive and more successful than others. HTA committees are certainly able to evaluate the consequences of alternative sets of incentives and help identify those incentives that bring the health care system closer to the ideal of an outcomes-focused learning system. While investing into HTA infrastructure and resources is important in this respect, it is by no means su�cient. Decision makers (payers, providers, physicians, patients) need to be incentivized to take the results of HTAs into account and to act upon recommendations should HTA investments ever pay-o�.

Some EU member states have focused most of their HTA resources on the assessment of the e�ectiveness and cost-e�ectiveness of pharmaceuticals based on a rather narrowly framed concept of clinical bene�ts and economic implications. This was done based on the assumption that HTA �ndings can be e�ectively utilized to negotiate a medicine’s budget impact (price and volume) with the manu-facturer. Unfortunately, the complex interdependency of the national pharmaceutical price regulations schemes of the various EU member states including international reference pricing and parallel trade considerations as well as their unintended consequences - rather uniform high prices leading to unequal patient access in di�erent countries – have usually been ignored when setting up or reforming national pharmaceutical pricing and reimbursement systems and principles. As a consequence, prices of pharmaceuticals in Europe are much more uniform than they might be if there would be a sustainable framework for di�erential pricing between EU member states. In the absence of such frame-work, access to innovative medicines will inevitably be less equal than it could and also should be in the spirit of a more equitable access of EU citizens to state-of-the-art health care resources and outcomes. HTA can certainly not solve this problem. It ultimately requires solidarity between member states and a concerted e�ort to establish a sustainable frame-work of international price di�erentiation in line with relevant wealth indicators to improve the situation.

Best practice examples for the introduction and further evolution of national HTA systems

An important potential of HTA lies in the ability to overcome the so called “silo-budget mentality”. Health care budget holders focus very much on their own budgets when evalua-tion the impact of introducing new health technologies. This often means that they face strong dis-incentives to recognize bene�ts that positively a�ect the outcomes of other areas in the health care system while negatively a�ecting their very own budget. If the positive and negative budget and outcome consequences of a health technology are only partially considered in their evaluation, then a systematic over- or under-investment is the likely consequence. Some countries have actively addressed this issue in by adopting speci�c HTA principles, others completely ignore it. For a long time, HTA in France has solely centered on the added therapeutic value of a new technology. Other countries went further and have put the total value for the health care system value in the center of their HTAs. Some countries have gone


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References: [1] http://www.pcori.org [2] http://www.eunethta.eu [3] http://www.swisshta.ch

Fig. 2. Spectrum of Value (Payers) – Broad Sources and Perspective of HTAs.

PharmaceuticalBudget

Health SystemBudget

Other Budgets(e.g. pensions,social security)

Comlexityand breadthof datarequired todemonstratevalue

Societal ValueHealth System ValueTherapeutic Value

Sour

ce o

f Val

ueRe

lativ

eBu

dget

SwedenRepresentativeCountry

France UK

Spectrum of Value (Prayers) - BroeadSources and Perspective of HTAs

Source: Kanavos, Persson, Drummond 2009

even further and made an attempt to capture the overall societal value of a health technology. Sweden has been such a country (Fig. 2).

Anther good example for the thoughtful investment and deployment of HTA resources can be identi�ed in the US. With its massive investment into comparative e�ectiveness research (CER) as part of the American Recovery and Reinvestment Act of 2009 (“economic stimulus package”) the US government aims at the production of high quality evidence that can be used by stakeholders and decision makers at all levels. This initial investment into CER was later supplemented by foundation of a “Patient-Centered Outcomes Research Institute” (PCORI) through the US Health Care Reform legislation (A�ordable Care Act). The strict focus on the assessment of outcomes with relevance for patients is the underlying principle of all of PCORI’s activities and is visibly anchored in the name of the institute [1]. In Europe, EUnetHTA should be highlighted as a good example of international collaboration of HTA aiming at a more e�cient utilization of scarce HTA resources in many EU member states [2].

SwissHTA is a stakeholder-initiated process, which was estab-lished to advance HTA as a valuable tool for health care decision making in Switzerland. It was jointly initiated by the pharmaceutical industry together with the Sickness Funds (“payers”). They invited decision makers and other relevant stakeholders e.g. the Swiss “Department of Health” (BAG) and the regions of Switzerland (“Kantons”)), physician associa-tions, academia, and politicians to join forces and to establish a formal consensus on the future design of a framework for systematic production of HTAs [3].

But best practice examples for managing and directing HTA resources can also be identi�ed where systems have demon-strated their ability to revisit the role and principles of HTA if outcomes are no longer in line with “societal” expectations. One of these examples is certainly the attempt to establish value-based pricing of pharmaceuticals in the UK, based on a more thorough understanding and re�ection of societal preferences. Other than most other countries, the UK HTA system – largely represented by NICE and the Scottish Medicines Consortium - have relied on a rather simplistic concept of health economics as the key “sign post” for

decision making. The theoretical concept is based on a very speci�c and simplistic assumption about the preferences of UK citizens for allocating the budget of the National Health Service. It had been assumed that they would want the budget to be invested so that it results in a maximum of health bene�t as measured in QALYs irrespective of which patients would be receiving these bene�ts. After being in operation for ten years citizens in the UK – not only patients - had expressed their concerns with the availability of innova-tive treatment options in the UK. These serious concerns have been picked up by the current government which plans to introduce a new pricing and reimbursement system for pharmaceuticals early in 2014. The intention is that value-based pricing will include a broader assessment of new medicines’ bene�ts, incorporating health outcomes and wider societal bene�ts. It will also seek to encourage innova-tion in areas of greatest unmet need by including concepts like ‘burden of illness’ and ‘therapeutic innovation and improvement’. The system has the potential to considerably change the way how health economics is used in HTA in the UK. In addition the UK government has taken further time-limited emergency measures to address the current dissatisfaction with the access to modern oncology treatment options considered to be not at par in comparison with the access that patients in other EU member states have. Already in early 2011 a 200 million pound a year NHS Cancer Drugs Fund system has been established to provide access to cancer drugs which NICE either had not yet been able to assess or that NICE had recommended against based on its “outdated” health economic assessment methodology.

Too often these problematic aspects of existing HTA systems like NICE in the UK are either not known or completely ignored when some of them are considered to be role models for the introduction of HTA systems in other countries. While it is of considerable value to re�ect on the design elements of HTA systems in other countries, it is certainly not advisable to establish 1:1 copies in another health care system with funda-mentally di�erent cultural, legal and �nancial constraints.

Conclusions

The systematic utilization of HTA can certainly not make up for the unintended distributional consequences of question-able national pricing and reimbursement practices of other countries. However, if appropriately implemented, HTA can make considerable contributions towards a substantially improved articulation of societal expectations towards the health care system, and can guide outcomes-oriented health care systems to become more e�cient and e�ective. Smart health care systems introduce HTA with a transparent and well de�ned set of objectives in mind, involve stakeholders right from the beginning, build on the experience with HTA gathered in other countries without simply copying these HTA systems and promote the e�cient use of existing national and international HTA resources. At the same time, policy makers have to be fully aware of need to accompany HTA with a set of incentives and disincentives to ensure that HTA information is acted upon, not only by decisions makers but also all other stakeholders operating in the “real world” of health care systems.

OPTIMAL IMPLEMENTATION OF INNOVATIVE TECHNOLOGIES

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Chronic Heart Failure has a major impact on the German society and its health care system. In terms of mortality, chronic heart failure is the third most common cause of death [1]. It has a prevalence of 1.2 million patients with a sharply rising incidence at the age of 75. Due to the aging of Germany’s population, there will be an increasing incidence over the next decades [2]. Cardiovascular diseases, which include chronic heart failure, caused the highest costs in the health care system in comparison to other diseases. When focusing on chronic heart failure, the costs for hospitalization account for approximately 85% of the total costs [3]. The decline of hospitalization therefore is an important factor in order to reduce the burden on the health care system and improve or maintain health-related quality of life.

One solution is Remote Telemedicine Management (RTM) as an approach to reduce health care costs, which contributes to a

guideline based medical service in terms of tertiary preven-tion especially in rural, structural weak areas. The rationale of RTM is that heart failure patients perceive their condition deferred compared to the objective deterioration of their cardiac function. This gap represents the period for interven-tion before a signi�cant deterioration occurs. At this point, RTM can intervene early and hence lower the rate of hospital-ization. In the RTM intervention, relevant health determi-nants, which are being assessed daily by the patient using the measurement devices at home, are transferred to the physician or a telemedical center via cell phone technologies. Until now, you can di�erentiate between four generations of RTM: the earliest generation transfers the patient’s data directly to the cardiologist whereas the fourth generation preprocesses the data together with the following storage in an electronic health record. This record is being administered by a telemedical center which can contact the attending

Optimal implementation of innovative technologiesProf. Dr. Friedrich Koehler,

Department of Cardiology and Angiology, Centre for Cardiovascular Telemedicine,Charité Universitätsmedizin Berlin (Germany)

Prof. Friedrich Koehler studied medicine at the Humboldt-University Berlin and is a specialist for cardiology. He spent time for research and training in Guildtfort and Munich. From 1997 to 2003 he was the Coordinator of a telemedicine project for know-how transfer between Germany and Baltic States, sponsored by the German Ministry of Health. From 2005 to

2011 he was the head of the Consortium „Partnership for the Heart“. Aim of the project was the development and clinical trial of a new telemonitoring system for patients with heart failure: Telemedical Interventional Monitoring in Heart Failure

(TIM-HF, NCT00543881), sponsored by the German Ministry of Economics and Technology. Since 2009 he is the head of the Consortium “Health Region of the Future Northern Brandenburg – Fontane”, a research and development project in

patients with heart failure and preeclampsia sponsored by the German Ministry of Education and Research. Since 2011 he is Professor for Cardiovascular Telemedince at the Charité – Universitätsmedizin Berlin.

by a telemedical center which can contact the attending

OPTIMAL IMPLEMENTATION OF INNOVATIVE TECHNOLOGIES

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References:[1] DESTATIS (Statistisches Bundesamt): Todesursachen. Available at:https://www.destatis.de/DE/ZahlenFakten/GesellschaftStaat/Gesundheit/Todesursachen/Tabellen/SterbefaelleInsgesamt.html ; access date: 12/02/2013.[2] Dickstein, K., Cohen-Solal, A., Gerasimos, F., et al., ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008. European Heart Journal, 2008. 29(19): p. 2388-2442.[3] Neumann, T., Biermann, J., Neumann, A., et al., Heart failure: the commonest reason for hospital admission in Germany: medical and economic perspectives. Dtsch Arztebl Int., 2009. 106(16): p. 269-75.[4] Koehler, F., Schieber, M., Sechtem, U., et al., Telemedical Interventional Monitoring in Heart Failure (TIMHF), a randomized, controlled intervention trial investigating the impact of telemedicine on mortality in ambulatory patients with heart failure: study design. Eur J Heart Fail., 2010. 12(12): p. 1354-62.[5] Koehler, F., Winkler, S., Schieber, M., et al., Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation, 2011. 123(17): p. 1873-80. [6] Koehler, F., Winkler, S., Schieber, M., et al., Telemedicine in heart failure: pre-speci�ed and exploratory subgroup analyses from the TIM-HF trial. Int J Cardiol., 2012. 161(3): p. 143-50.[7] For further information visit the project website at http://telemedizin.charite.de

cardiologist or general practitioner if needed. In case of parameters reaching a critical value, an alarm is set o� and the telemedical center can intervene promptly.

“Telemedical Interventional Monitoring in Heart Failure“ (TIM-HF) trial. In order to analyze the superiority of additional RTM intervention in stable patients with chronic heart failure compared to “usual care only”, the Charité conducted the clinical trial TIM-HF (NCT00543881) from 2008 to 2010. The trial was part of the research and development project “Partnership for the Heart”, funded by the German Federal Ministry of Economics and Technology. The RTM was compared to the usual care in terms of mortality, hospitaliza-tion, quality of life and cost e�ectiveness in a randomized, controlled trial. Patients were followed up for at least 12 months and max. 28 months.

The basis of the RTM-system was a Bluetooth operating transmitter (mobile medical assistant – MMA), devices for blood pressure and ECG with SpO2 sensor, a weighing scale as well as a self-assessment questionnaire. The MMA gathered the measured parameters and transferred them via cell phone technology to a telemedical center. The center provided a 24h/7d physician-led medical support for the entire study period. If required, this medical support got in touch with the patient (e.g. to verify data or change treatments) and contacted the patient’s local physician at least every three months [4].

The result of this study was that the RTM-intervention, when applied to stable, guideline-based treated, ambulatory chronic heart-failure patients, did not reduce mortality compared with the usual care group (primary endpoint) [5]. Instead, a subgroup, which could bene�t from this interven-tion, could be identi�ed. This subgroup is characterized by following characteristics [6]: • hospitalization because of heart failure in the previous 12 months; • lack of depressive symptoms (questionnaire PHQ-9 ≥10); • Left ventricular ejection fraction (LVEF) between >25% and <45%.

“Telemedical Interventional Monitoring in Heart Failure II“ (TIM-HF II) trial. In the context of the project “Fontane” (sponsored by the German Federal Ministry of Education and Research, the State Brandenburg and the European Regional Development Fund), the trial TIM-HF II will be carried out from 2013 to 2015 [7]. It is considerably larger than the �rst trial, since it includes 1,500 patients (TIM-HF: 710 patients). This study examines the superiority of a new ambulatory care model for underdeveloped rural areas without resident cardiologists compared to metropolitan areas with resident cardiologists in regard of clinical and health economic e�ectiveness. Especially rural areas like Brandenburg are characterized by a large part of aging population with a lack of cardiologic care at the same time. The identi�ed subgroup of TIM-HF �ts the inclusion criteria of the TIM-HF II trial. Additionally, the RTM system generation developed further into the 4th generation. This generation is characterized by the inclusion of additional parameters for medical care: biomarkers and telemedical implant data. In the TIM-HF II study, the patient again holds an active role: in his home environment, his measured vital data (ECG, blood pressure, self-assessment and weight) are transferred to the PhysioGate (a kind of touchpad). Here the data is being preprocessed and afterwards forwarded to the telemedical center. In addition, the patient can answer to several questionnaires send by the telemedical center to the PhysioGate. First results are expected for autumn 2015.

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