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Government Gazette

£10.00, €11.00 ISSN 2042-4168

Vol 1; 2017

A roadmap for sustainable healthcare Policymakers and healthcare professionals present a plan for altering the landscape of care and treatment of HIV and cancer patients in Europe

also inside Europe’s future climate Green MEPs discuss the effects of Brexit on environment, agriculture, food and the rural economy

Future of European Development MEP Linda McAvan voices concern over Brexit’s impact on Europe’s development agenda

European Health Report Academics and policymakers make an assessment of the state of cancer care in Europe and discuss what the EU can do differently


Government Gazette Vol 1; 2017

Government Gazette

Editor

Jonathan Lloyd editor@governmentgazette.co.uk (+44) 020 3137 8612

Commissioning Editor

Janani Krishnaswamy janani.krishnaswamy@governmentgazette.co.uk (+44) 020 3137 8653

Publisher

Matt Gokhool matt.gokhool@governmentgazette.co.uk (+44) 020 3137 8611

Subscriptions

subscriptions@governmentgazette.co.uk (+44) 020 3137 8612 © 2017 CPS Printed by The Magazine Printing Company plc, Mollison Avenue, Brimsdown, Enfield, Middlesex, EN3 7NT. The acceptance of advertising does not necessarily indicate endorsement. Photographs and other material sent for publication are submitted at the owner’s risk. The Government Gazette does not accept responsibility for any material lost or damaged.

Translating knowledge to action - Cancer control plan 2017 As Europe’s cancer burden continues to increase at an alarming rate and cancer rates are likely to increase nearly six times faster in women than in men over the next 20 years, this edition of Government Gazette focuses on the latest policy issues relating to prevention, treatment and care of prostate cancer and breast cancer in Europe

what’s inside?

Facing up to AIDS The data on HIV / AIDS is quite astounding. Since the start of the epidemic, more than 70 million people have become infected with HIV; more than 35 million people have died of AIDS-related illnesses. What’s more startling is that significant HIV transmission continues in Europe, though the European Commission has increased its pledge against AIDS by 27% to a total of €475 million for the period 2017-19. Yet, this is not the full picture. The estimate is that there are some 122, 000 people living with HIV across our region who are unaware of their infection. They continue to transmit it to others.

frameworks for action

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Key policy experts and healthcare institutions present their fast-track strategy to end AIDS by 2030

As the world embarks on a fast-track strategy to end AIDS by 2030, the current edition of Government Gazette presents policy solutions to expedite the process. Read on...

being breast aware

European Parliament action on Breast Cancer

also inside

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Emma McClarkin MEP places the issue of metastatic breast cancer high on the European Parliament’s agenda

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Launch of EAU White Paper on Prostate Cancer: Professional groups call for action to lower the risk and mortality rate of prostate cancer

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ECIBC’s latest recommendations for breast screening


contents

04 Linda McAvan MEP Future of European Development Concerned about Brexit’s impact on delivering the sustainable development goals, Linda McAvan MEP raises a few questions that need to be resolved during the negotiations

06 Julie Girling MEP brexit and the environment Julie Girling MEP considers the opportunities that a postBrexit climate might hold for a new CLIMA policy which looks at the bigger picture, covering environment, agriculture, food and the rural economy

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Jos Delbeke, European Commission Future of Europe: Role of EU climate and energy policy Jos Delbeke from the European Commission’s DG CLIMA provides an update on EU strategy towards a low-carbon future

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prostate cancer europe roundtable 2017

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protecting future generations

Boosting Cooperation: Senior policy makers, academics and experts offer recommendations to speeden policy action to unite against Breast Cancer

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environment & brexit MEPs Keith Taylor and Julie Girling evaluate the environmental challenges of Europe

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tackling health inequalities


editorial view

Towards a healthier and sustainable Europe

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isks to global health are advancing at a rapid pace, escalating the need for urgent and harmonised political action. More than eight million people die of cancer every year across the globe – more than AIDS and malaria combined. Recent research reports have warned of an explosion of cancer deaths in women. Over the next twenty years, cancer rates in women are set to climb six times faster than men. With at least one in seven women already likely to develop breast cancer and prostate cancer currently affecting at least one in eight men in Europe, the latest statistics place a heavier burden on families and national economies. Researchers have made tremendous strides in the fight against cancer, particularly in recent years. Innovative therapies and advanced anticancer drugs have reduced the European cancer burden to a great extent. Yet health inequalities and wide-ranging treatment patterns exist across individual member states. Whilst effective treatment exists, insufficient screening mechanisms and unavailability of universal and affordable healthcare have led to lower survival rates. For any change to happen, policies are required to specifically cater to the needs of individual European countries, and address the cross-country variations in treatment, management and care of these deadly diseases. For instance, despite numerous policy resolutions and declarations calling for specialist breast services since 2000, not all EU member states have a high-quality, multi-disciplinary breast cancer centre. Similarly, to date, there are no uniform, population-based screening programmes available for prostate cancer unlike other cancers. Problems relating to timely treatment, appropriate pricing, reimbursement and uniformity in care exist in both the cancers. Urgent policy action is required to correct such inconsistent treatment and unequal access to innovative cancer drugs. To address the mounting challenges in healthcare, Members of the European Parliament, a few senior representatives from the European Commission, healthcare professionals and academics have come together in this special edition of Government Gazette to offer a range of policy solutions. In our exclusive health supplement on breast cancer, MEPs Karen

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Kadenbach, Miriam Dalli and Emma McClarkin address the problems that exist within breast cancer policy making in Europe, present the European Parliament’s action on breast cancer and identify gaps in current policy. Donata Lerda from ECIBC presents the European Commission’s latest recommendations for breast screening. This section also includes insightful commentary from academics and oncological experts offering valuable suggestions to improve policy making. Our latest policy update on prostate cancer includes the recommendations from the European Association of Urology’s new White Paper on Prostate Cancer, which is now translated in over 50 languages, and offers evidence-based guidelines for urological specialists towards lowering mortality rates of prostate cancer in men. The supplement also makes an in-depth assessment of various challenges within prostate cancer policy in Europe and offers an academic viewpoint in improving treatment and care across the continent. In our extended focus on pandemics and infectious diseases, the current edition focuses on the latest issues in HIV science, policy and practice and has sought to share key research findings, lessons learnt, best practices and identify gaps in knowledge. The section includes an exclusive from Neven Mimica, European Commissioner for International Development and Cooperation. Writing about the EU’s passionate response to AIDS, he presents Europe’s strategies in bending the trajectory of AIDS. The AIDS supplement includes select commentary from UNAIDS, the European Centre for Disease Control, European AIDS Treatment Group and AIDS Action Europe. While addressing the challenges affecting healthcare, the current edition also addresses the challenges facing Europe’s climate, environment and development. Arriving at a consensus on EU’s roadmap for international development until 2030, MEP Linda McAvan, Chair, European Parliament’s Committee on Development, fears that the spectre of Brexit might cast a long shadow over the future of EU development. MEP Victor Negrescu presents an update on investing for Europe. Discussing the climate of the future, MEPs Keith Taylor and Julie Girling analyse some of the challenges and opportunities of Brexit through the prism of air quality and environment. DG CLIMA’s Jos Delbeke presents an update on EU strategy towards a low-carbon future.


towards a better europe

The future of European development The challenges facing the EU and its neighbours over the next two years are numerous and increasing by the day. Linda McAvan MEP fears that the EU cannot deliver the SDGs as planned if Brexit means less development cooperation with our European neighbours

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e stand at a key moment in history for the EU. Buffeted on all sides by the winds of populism, and by economic and political crisis; the EU needs to adapt if it wants to ensure that the next 6o years are as prosperous for its members as the first 60 have been. As with other areas of EU policy, development policy is under pressure to evolve. Many of the international challenges that the EU faces, from conflict in its neighbourhood to migration, are linked to poverty. The EU has recognised that, as the world’s major aid donor, development is a key pillar of its foreign policy. Development, as well as trade policy with developing countries, played a prominent role in the EU’s new “Global Strategy” launched last year by Federica Mogherini. But we can’t allow development policy to be totally subsumed by foreign policy objectives. Yes, there can be no long term solution to the current refugee flows or security crises without effective development aimed at addressing the root causes of these issues, but that is not to say that development policy must be completely refocused on migration or security. As policymakers, we have to make sure that the main aims of development, ending of poverty and inequality, remain the focus of policy. Global development policy in the next fifteen years will be shaped by the UN 2030 Agenda and its Sustainable Development Goals (SDGs) and by the Addis Ababa Action Agenda for development financing both agreed in 2015. The SDGs in particular represent a global rethink in development policy in that they are a universal agenda applicable in the developing world but also in Europe. The challenge for the EU and its member states and for the rest of the world is to translate these commitments to ending poverty and inequality by 2030 into concrete policies. This will require reimagining not just development policy but internal economic and social policies as well.

At the EU level we are already starting with a New Consensus on Development, the EU’s roadmap for international development until 2030, currently being negotiated by MEPs, the Commission and national governments with the hope an agreement will be reached by this summer. Another piece in the puzzle will be to make sure that there is enough money to fund the estimated $1.4 trillion USD per year of investment needed if we are to meet the SDGs. As agreed in Addis, the key will be to bring in private finance and investment, at the same time as helping developing countries increase the amount of money they are able to take in taxes. The EU is currently working on developing new legislation to deliver that extra investment, the European Fund for Sustainable Development (EFSD) aimed at de-risking private sector investment in more fragile countries. It is critical that the next step be effective action against tax evasion by closing legal loopholes that reduce ability to raise domestic spending. Added to this needs to be a renewed commitment within the EU for member states to finally meet their target of spending 0.7% of GDP as development aid. Whilst being the largest aid donor, the EU is able to use the size of its economy to help developing countries by granting them market access. The size of the EU’s market also means that actions taken within the EU can have impacts right up the supply chain. MEPs have recently been successful in getting binding regulations on conflict minerals importers and have started work on examining how to ensure that workers in the supply chain of the clothing sector are protected so that we avoid tragedies like the Rana Plaza disaster of 2013. I was recently in Bangladesh to take a look at the progress in this area, but whilst there I had to field almost as many questions about Brexit. For Bangladeshis, Brexit is a great unknown that they fear may prove to be economically damaging for them. When Britain joined the EU, its former colonies gained a privileged access to the EU market

- a policy which in Bangladesh has allowed the massive expansion of the clothing sector and a corresponding rise in living standards. And within the EU, the UK is one of the biggest markets. Bangladesh, like other developing countries, worries about whether tariff free access will continue after Brexit. So far, there is little certainty and poorer countries fear they may find themselves well down the list of countries with which the UK tries to pursue a trade deal. In this and other areas, the spectre of Brexit casts a long shadow over the future of EU development. The UK has always been a driving force of the EU development policy and one of the few member states to have delivered on its 0.7% promise. We can’t say at this point how Brexit will impact on the EU’s development budget, or whether the EU member states, without the UK, will retain their commitment to development and increase their spending to 0.7% of GDP as promised. There are other open questions that need to be resolved during the Brexit negotiations. Will the UK’s priorities in development continue to be aligned with those of the EU, focusing on poverty reduction? And will it take the opportunities if they arise to work together with its EU partners, pooling resources if necessary? Whatever choices the UK and EU make, when it comes to development, they will still be facing common challenges. The answer to these challenges, and to delivering the SDGs is not to raise the drawbridge against a changing world but to work to make our world safer, more equal and prosperous. We will certainly be no closer to achieving this if Brexit means less development cooperation with our European neighbours, not more.

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european environment report

What does Tory opposition mean to the Dieselgate inquiry? Voting to maintain vital safeguards for European neighbours after Brexit, Keith Taylor MEP expresses his thoughts on the future of Europe through the prism of air quality

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he Dieselgate scandal was extensive in its reach with major car manufacturers implicated in a concerted, deliberate and criminal effort to commit ‘toxic emissions fraud.’ Manufacturers employed so-called ‘defeat devices’ to trick laboratory testing equipment into thinking their vehicles produced much lower levels of nitrogen oxide emissions. In the wake of the scandal, Green MEPs demanded an inquiry on behalf of the European citizens who were made victims of Dieselgate; through their exposure to toxic fumes and the complete contempt for their health and consumer rights. The committee’s final report finds both member states and the EU Commission guilty of maladministration and argues that they were not sufficiently impartial to avert the scandal. It was, obviously, never going to be enough to merely hope our national governments and the European Commission would do better next time. The European Parliament’s vote in April 2017 backs the findings of the report and supports its tough recommendations and is therefore both a vindication and an important step towards an EU-wide approach to ensuring that a similar scandal can never be allowed to happen again. The introduction of an EU-level market surveillance for vehicles helps ensure that the law, which is unambiguous in its prohibition of ‘defeat devices’ and its requirement that emission limits be met on the road as well as in the laboratory, is enforced and is less likely to bend to commercial pressures.

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Dieselgate was a problem of too little Europe - not too much! Greens lobbied for the surveillance agency to be independent of the Commission to provide the most robust protection against future scandals, but our proposal fell short of majority support. It was UK Conservative MEPs that mounted the biggest opposition to not just the creation of an independent oversight body but to the Dieselgate report itself, which excoriates their friends in the car industry. We should not be surprised. In fact, taken with the minister’s promise of a bonfire of regulations, Tory opposition to action on Dieselgate offers an alarming insight into what kind of (lack of ) protections the British public can expect outside of the EU. Despite publishing some of the details of the so-called Great Repeal Bill, the legislation intended to transfer EU laws onto the UK statute books post-Brexit, the government has failed to commit to maintaining vital EU air quality laws. Indeed speaking to the UK House of Commons Environment Committee in January, Environment Secretary Andrea Leadsom indicated that about a third of the EU’s 800 laws on the environment might be too difficult to transpose. The failure to commit to keeping air quality laws is symptomatic of a disturbing indifference to an air pollution crisis responsible for the preventable deaths of equivalent to 50,000 people in Britain every year. Earlier this year, the European Commission was forced to send a final warning to the UK for failing to address repeated breaches of legal air pollution limits in 16 areas including, London, Birmingham and my constituency in the South East. It couldn’t be clearer that Conservative Party politicians left to their own devices will, at best, ignore the air quality crisis and, at worst, advocate on behalf of those responsible for worsening it rather than its

victims. As a member of the European Union, Theresa May’s administration is being held to account for failing to do the bare minimum, as required by EU air quality laws the UK itself helped to set. The bare minimum. Where embraced and enforced, EU air pollution limits are helping to prevent thousands of deaths every year and saving billions of pounds in direct health costs. The government even readily acknowledges that it is EU law that has been the main driver of any positive air quality action in the UK. The Prime Minister’s pursuit of an extreme Brexit puts these air quality regulations at risk. Even if they are maintained, via the Great Repeal Bill, the Prime Minister plans to invoke the ancient, arbitrary powers of Britain’s most infamous despotic Tudor monarch, Henry VIII, to ensure she can repeal them later without parliamentary scrutiny. The other question is what happens in the EU after Brexit. There the news may be somewhat better. The UK has repeatedly sought to block and undermine EU environmental legislation. With our government and right-wing MEPs out of the picture, it’s all the more likely that EU air quality laws will be strengthened and enforced. It’s just too bad that UK citizens may no longer benefit. That’s why I’m fighting for Britain to maintain the closest possible relationship with our European neighbours via membership of the Single Market so that we might maintain these vital safeguards.


brexit and the environment

What would a post-Brexit climate look like? Climate change is certainly beyond boundaries and initial indications point towards a ‘negative environment’ for both Britain and the EU in a post-Brexit scenario. However, Julie Girling MEP says there is a huge opportunity to design a new policy from scratch which looks at the bigger picture covering environment, agriculture, food and the rural economy Repeal Bill”. Whilst it will ensure that existing EU environmental standards will continue to apply in the UK in the immediate aftermath of Brexit, the option for the Government to begin to modify or repeal certain measures brings both opportunities and concerns. On the one hand, there are elements of EU environmental legislation that are, I believe, illthought out or not sufficiently science-based - such as the approach taken to pesticides or GMOs - which I would be pleased to see a more common-sense approach to.

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nvironmental issues do not respect national borders and Brexit does not change this. Climate change, air pollution and invasive species will all continue to pose transboundary problems between the UK and its immediate European neighbours; protected bird species will continue to migrate between different European countries. These issues - and many more will all still require coordinated joint efforts between the UK and the EU post-Brexit. There are further environmental issues which are perhaps less transboundary in nature, but will still need to be addressed if we are to achieve the maintenance of a close trading relationship between the EU and the UK. Of existing EU environmental legislation, around 22% has an internal market dimension - that is, it has been adopted on the specific legal basis of ensuring the smooth functioning of the EU’s single market. This includes environmental standards or safety requirements for marketing certain products in the EU, irrespective of where they are manufactured, such as chemicals, electrical appliances, motor vehicles, food products and medicines. If the UK expects to continue selling such products inside the EU then it is likely that equivalent standards would need to continue to apply at home. Much will depend on the so-called “Great

However, there are also concerns that some pieces of environmental legislation may be targeted in attempts to mitigate any economic fallout from Brexit, as part of a push to reduce “red tape.” This also has a political dimension: many promises were made by Brexiteers to slash “red tape” which they feel the need to deliver, whether justified or not. An example here would be REACH, the EU’s flagship framework for regulating chemicals: it is often cited as one of the most burdensome pieces of EU legislation, but now post-referendum it appears that both industry and environmental NGOs alike are lining up to defend it as preferable to any national alternative. A second concern is national capacity. Defra will be the department responsible for the vast majority of environmental legislation, but its ability to develop and administer new UK-specific rules and take on additional monitoring and enforcement tasks is in question given that its budget has been reduced somewhere between 17-30% since 2010. We are able to exploit economies of scale at the EU level in terms of advice, exchanging best practices and centralising data collection - particularly via the three EU agencies regulating chemicals, food safety and medicines. It is still unclear to what extent the UK will continue to participate in the work of the three EU agencies, or whether it will choose to repatriate their work into new or existing UK bodies. If the latter is the chosen option, there are concerns about how funding and suitably qualified staff will be found nationally.

The third concern is oversight and fair enforcement. It has always been the case that it is for the UK competent authorities (normally Defra or its associated bodies) to monitor and enforce the EU environmental legislation. However, there is a second level of enforcement at the EU level whereby the European Commission can begin infringement proceedings against the UK if it feels the UK enforcement or sanctions are insufficient in ensuring compliance with the EU legislation. Such a system of checks and balances ensures that enforcement and monitoring is constantly being reviewed and improved; post-Brexit there will be no one “checking” that the enforcement or sanctions chosen by government are sufficient, leading to a scenario whereby the defendant is also the judge. However, there are some areas where there is more optimism than concern. When it comes specifically to looking at agricultural policy - which evidently has a huge environmental element to it - there are opportunities to improve the state of the British countryside and the environment. Hard Brexit or soft Brexit, the UK will no longer participate in the Common Agricultural Policy and will be required to develop a national farm policy. This is a huge opportunity to design a new policy from scratch which looks at the bigger picture covering environment, agriculture, food and the rural economy. The possibility that farmers could be paid to provide ecosystem services, or receive more results-based payments on the delivery of certain public goods or environmental objectives have been floated in initial discussions. A move towards greater investment in technology and innovative farming and breeding techniques - perhaps even opening the door to GM varieties - could also increase the efficiency of agriculture in the UK, and at the same time limit its impact on water, soil and air. This will, however, depend on the sort of trade deal Theresa May can deliver: if farmers are significantly competitively disadvantaged by a deal we may see that more money goes towards supplementing and stabilising farm incomes than in any real investments in innovation or the environment. Initial indications seem to point towards a

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the climate of the future

negative impact of Brexit for the European environment too. In certain areas such as climate change the UK is considered a leader in the EU and losing some of that ambition in the European Council - especially from such a large member state - may have implications for the future; the UK is also widely viewed as a strong proponent of science-based policy-making in technical areas such as pesticides and GMOs, which may become more politicised - possibly to the detriment of the environment, postBrexit.

Secondly, as a net contributor to the EU budget, the UK is also indirectly responsible for a great deal of funding dedicated to environmental protection. There is the environment-specific instrument known as “LIFE” which funds nature conservation, environmental and climate mitigation projects, but there are also environmental elements of the respective funding instruments of the Common Agricultural and Fisheries Policies too. With a funding shortfall, it is highly likely that some of these environmental projects and measures will see

funding reduced or even cut altogether. To conclude, nothing is certain, but there is much to be concerned about. It is absolutely vital that a good deal is reached between both parties to ensure continued cooperation, and to prevent the negative fallout of a bad deal overshadowing (or in the worst case completely sidelining) environmental priorities.

Role of CLIMA policy in shaping Europe’s future The EU played an instrumental role in shaping the Paris Agreement – the first-ever universal, legally binding climate change deal. Staying at the forefront of the global clean energy transition is an opportunity to strengthen the European economy and help build a more sustainable future for all. Jos Delbeke, Director General, European Commission’s DG CLIMA provides an update on EU strategy towards a lowcarbon future

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n Paris in December 2015, almost all countries of the world – including the EU and all its member countries – agreed on a global action plan to put the world on track to avoid dangerous climate change by limiting global warming to well below 2°C. Now countries around the world are working on turning their Paris pledges into concrete policies and action on the ground. With its strong track record on climate action, Europe is well placed to contribute to this global transition and benefit from the opportunities it offers. From targets to policies The EU has already started implementing its commitment to reduce domestic greenhouse gas emissions by at least 40% by 2030, compared to 1990 levels. Even before the Paris conference, the European Commission presented a proposal to strengthen the EU emissions trading system (EU ETS) – the world’s largest carbon market and our principal tool for cutting greenhouse gas emissions – to ensure it delivers the reductions required as well as

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to promote investments in line with our longer term climate goals. Last year, this was followed by a proposal for setting binding emission reduction targets for each EU country for the sectors not covered by the emissions trading system, such as buildings, agriculture, transport and waste. Moreover, our climate targets are integrated into a wider set of policies that aim to make energy more secure, affordable and sustainable. Further policy proposals aimed for example at boosting low-emission mobility are in the pipeline for this year. Alongside action to cut emissions, and just as important, we are working to make Europe more resilient to the impacts of climate change. The EU adaptation strategy promotes action in key vulnerable sectors and in all relevant policies, and most EU countries have also developed national strategies. Innovation is key The EU experience shows that setting ambitious targets pays off – and that climate action goes hand in hand with economic growth. From 1990 to 2015, EU greenhouse gas emissions decreased by 22%, while our combined GDP grew by 50%. The number of green jobs in the EU has also increased

steadily even through the recession years. Going forward, we need to keep up and step up our efforts. It is clear that making the low-carbon shift a reality in all sectors of the economy will be a challenge. At the same time, it is also an opportunity to attract private investments to support growth and jobs and renew our energy infrastructure. For example, the Commission’s proposal for the revision of the EU ETS includes the creation of an Innovation Fund designed to support large-scale demonstration of activities in carbon capture and storage, innovative renewable energy and low-carbon innovation in energy-intensive industries. The Innovation Fund builds on the experience of the current NER 300 funding programme, which has awarded €2.1 billion to 39 innovative demonstration projects. These include for example a wind farm producing clean energy in Arctic conditions in northern Sweden and a plant turning agricultural waste into biogas in Germany. Another example of innovative funding instruments is the European Fund for Strategic Investments (EFSI), which is at the heart of the Investment Plan for Europe. By providing a guarantee to projects, the fund helps de-risk climate related investments. The fund was established for an initial


towards a better europe

period of three years, but given its success, the Commission has proposed to double its duration and size. This would allow it to provide a total of at least half a trillion euro of investments in Europe by 2020, with sustainability as a key focus. Global solutions These programmes and instruments, along

with many others, are there to help give European researchers, innovators and businesses the support they need to develop the solutions the world urgently needs to tackle its climate and energy challenges. The EU is well placed to be a leading provider of these solutions – both in terms of taking advantage of the new market opportunities and in terms of sharing our

experience and expertise to support other countries in their efforts to reduce emissions and build resilience to the impacts of climate change. The global transition has been set in motion. Now is the time to make sure we keep the wheels turning for a more climate-friendly future.

Investing for the future By Victor Negruscu MEP

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he aftermath of the economic and financial crisis had several profound effects on European economies and societies. On the one hand, the crisis accelerated a process of erosion of living standards. The political impact of this reality is undoubtedly relevant for today’s European leaders. The rise of populism and extremism is not only fuelled by the actions of dangerous demagogues. It is also the consequence of a reality we need to acknowledge in order to give new impetus to the European project: people feel let down by Europe. The malaise, the disappointment is not necessarily with the institutions and definitely not with the principles. It is with the results. On the other hand, it is also essential to correctly evaluate the impact of living in an increasingly connected global world. But the fact is that the menace of 19th century isolation and autarchy is no longer possible in a world where the production and supply chains stretch across continents and languages, in a world where ideas and communication are unimpeded by distance or time. Europe is at the centre of this web of connections and globalization, with its advantages and risks. The task for the future is managing its consequences. In this context, the European Fund for Strategic Investments (EFSI) is a welcomed step made by the European institutions in order to support the development of European infrastructure, industry, research and innovation. I believe that bold moves are required in order to show not only the resolve of European institutions to support development and modernisation, but also to build upon the capital of trust generated by this initiative. Therefore, increasing the EU guarantee from €16 to 26 billion and in EIB capital from €5 to 7.5 billion, capable of mobilising investment up to €500 billion until 2020 and effectively increasing funding from 21 billion Euros to 33.5 billion is a move capable of exerting real impact in the near future. Furthermore, it is most opportune that said

funds will not be taken away from vital programs for European research, such as Horizon 2020. One of the most important advantages Europe enjoys both as an economic system and as a group of societies is the emphasis it puts upon science, research and innovation, whose impact is translated not only in pecuniary terms, but also in the vibrant nature of our democratic institutions and our free societies. Programs such as Horizon 2020 are not financial assistance for development. Safeguarding their financing is a covenant between European societies for a better future of our continent. In addition to that, the EC’s proposal to earmark 40% of the guarantees for the financing of programs ran by SMEs and the enforcement of the social dimension of the fund are warranted. I also trust that while the emphasis placed on the social dimension of large European initiatives is most welcome, stronger steps should be taken to ensure that we robustly tackle inequalities in development and living standards. One of the problems is the tremendous inequality in terms of development and living standards, leading to problems associated with social exclusion. In addition, the fact that this program did not take into account the regional dimension of inequalities and disparities at the level of the European Union is equally problematic. Enhancing the geographical coverage is a foremost priority. Many of the issues we are confronted with today originate within this reality and it is wrong that, while discussing the principles of the European project, we forget that its social dimension must be as effective as all the others. While the success of this initiative is rewarding indeed, I think that the philosophy of the program still needs a serious and considerate debate. One of the reasons why European funding is “unseen” by European citizens is the excessive focus on the bureaucratic objectives, instead of the concrete results for societies, communities and citizens. This massive investment program ought to focus more on the specific requirements of communities in terms of development and infrastructure, and less

on trying to achieve general statistical objectives. If Europe wants to make a great step towards a better future it must concentrate on bringing change at the levels where it is most needed, explaining these opportunities to potential beneficiaries, setting clear and well-targeted objectives. Europe requires courageous decisions and not an additional level of bureaucratic procedures incapable of delivering results in communities in great need of investments. European public spending should follow the imperatives of good governance and not the profit imperatives of banking operations! At the same time, I believe that in spite of its success, several improvements should be made to its structure and procedures. While it is important that the European Advisory Hub diversifies its geographical focus and takes into account regional and Europeanlevel disparities, the regional dimension of the investments can be emphasised by taking on board more members with expertise in underdeveloped regions or countries, or by building teams of consultants with expertise in the problems of said areas. While projects financed by other European funding lines can also become eligible for EFSI funding, for transparency reasons and efficiency these financing lines must be made to work together, in order to achieve complementary and long-term results. Last, but not least, there is still work to be done in order to address the necessity for transparency. Given the impact and the size of the initiative, a clearer view of the selection and evaluation procedure is needed, in addition to a more exact list of the projects and initiatives eligible. Europe has made clear that it has understood the voice of its citizens and that it is well prepared to forge a path towards a better future in the 21st century. The EFSI is one of the instruments that can and must translate economic success into socially measurable results. Building upon its success involves, however, a more considerate analysis of its priorities and a real dedication to transparency.

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Government Gazette

Health REport Recommendations to reshape policy making

Improving outcomes in breast cancer Bringing together viewpoints of healthcare policy makers, researchers and key stakeholders to reach a consensus for improved diagnosis, treatment and care in breast cancer within Europe


What’s inside Prescription for change

11 An overview of the ICPS Breast Cancer Europe Roundtable 2017

European Parliament Viewpoint

14 Emma McClarkin MEP on treating metastatic breast cancer 15 Miriam Dalli MEP on 365-day awareness 16 Karen Kadenbach MEP on health inequalities

European Commission Viewpoint

17 Donata Lerda on ECIBC’s new screening recommendations

Call to action

19 Dr Fatima Cardoso, Director of the Breast Unit of the Champalimaud

Clinical Center and EUSOMA’s Lorenza Marotti et al., call on policymakers to take immediate action 21 Dr Martine J Piccart and Dr Noam Ponde from Institut Jules Bordet on universal access to affordable healthcare 23 Agendia’s Dr Marjolaine Baldo, offers solutions to reduce treatment inequalities within Europe 24 Francesca Colombo, Head of OECD’s Health Division and Rie Fujisawa, Health Statistician present objectives for change in EU action 26 Carole Mathelin, Vice President for Europe, International Society of Senology, et al, discusses the plight of the elderly with breast cancer 27 Carole Mathelin, Vice President for Europe, International Society of Senology, et al, writes about the Big Data revolution in breast cancer 28 Alexander Roediger and Dr Christian Hosius from MSD, on the part of policy cooperation in attempting to tackle the disease


Uniting Against Breast Cancer

Prescription for change

Breast cancer is the most common cancer in women worldwide, and is the most common cause of cancer among women in most countries. If this situation is to change, urgent action is required at the policy level and broader collaboration is essential among policy makers, professional societies, healthcare professionals and patient organisations. Canvassing for change in the world of oncology policy making, the International Centre for Parliamentary Studies recently brought together key stakeholders to discuss strategies to improve prevention, treatment and care of breast cancer. J anani K rishnaswamy, Commissioning Editor, Government Gazette, highlights the major recommendations tabled at the roundtable

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Breast Cancer Health Report

Studies brought together Members of the European Parliament, senior representatives from the European Commission, medical and clinical experts, patient groups and other key stakeholders in Brussels at the Breast Cancer Europe Roundtable 2016 on 28th November 2016. In order to extract more value from healthcare budgets, Europe needs to find more ways to put its health systems onto a sustainable footing. Governments need detailed and actionable outcomes data to make informed decisions. With this in mind, the ICPS Roundtable provided a forum to effectively debate unsolved clinical and policy dilemmas and discuss the challenges that exist in preventing and treating breast cancer patients across Europe.

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reast cancer affects more than 360,000 women per year in the European Union and causes more than 90,000 deaths every year. The World Health Organisation estimates that breast cancer incidence will increase by at least 11% in the EU between 2012 and 2025. Despite receiving high levels of media support, breast cancer continues to remain a major burden for European healthcare, with more than twice as many new breast cancer cases annually than new cases of other cancers in any other continent. (1) Whilst improvements in diagnosis and treatment have led to a reduction in mortality rates for breast cancer, efforts to prevent the disease have not been uniform across the continent. Treatment modalities across Europe do not seem to exhibit significant differences. However, national guidelines in each European country exist, exhibiting discrepancies in screening, diagnosis, surveillance and treatment of breast cancer.

Chaired by John Bowis OBE, Former Member of European Parliament and Minister of Health (United Kingdom), over 40 breast cancer experts coming from more than 20 countries, examined a wide assortment of issues ranging from prevention and surveillance mechanisms to effective and active treatment, need for greater collaboration, reimbursement for treatment, data-sharing and the need for increased funding for patient-centred research. The delgates also discussed facts about lifestyle and breast cancer and modifiable risk factors such as alcohol consumption and the increasing number of alcohol-related cancer deaths in Europe. (2) Following a series of policy updates from representatives from the European Society of Breast Cancer Specialists (EUSOMA) and European Commission Initiative on Breast Cancer (ECIBC) and the European Parliament, clinicians, pathologists and researchers at the roundtable had a unique opportunity to appraise their work and provide solutions to some of the pressing challenges in treating breast cancer in

Europe. The delegates agreed that proven means of fighting cancer exist at every stage of the cancer continuum and tabled a few significant recommendations for policymakers. 1. Prevention: While there is no sure way to prevent breast cancer, there are things one can do that might lower the risk of developing cancer. Breast cancer prevention should be integrated into comprehensive breast cancer control programs and complement breast cancer awareness and early detection efforts. Participants of the roundtable agreed that prevention – i.e. identifying and addressing risk factors at an early stage is the best way to reduce mortality rates. Improving health-literacy and raising awareness about risk factors can reduce stigma, myths and misconceptions about breast cancer. Prevention and education is fundamental in reducing the burden of cancer, and across all pathologies will save money. It is also important for us to have a good understanding of how to reach the population. Perhaps, developing guidance on prevention could be helpful: It should be evidence-based and updated as new research informs clinical practice; 2. Equal access: Numerous barriers to timely and equitable access to quality breast health care exist across the cancer care continuum and often negatively impact cancer outcomes. Improving access to care and reducing disparities in outcomes requires identifying, understanding and addressing those barriers. Policymakers should aim to address these barriers and ensure equal access across Europe to standard care, expertise and clinical research; 3. Innovative treatments: There’s a need to introduce safe, effective and innovative treatments into standard care. Pathologists agreed that active surveillance is a good thing and having consent from patients at every stage of treatment is crucial;

The breast cancer landscape is changing. For change to happen, we need policies that reduce the uncertainty around guidelines for screening, greater prevention, increased funding for clinical research and drug development. Urgent action is required at a policy level and broader collaboration is required among policy makers, professionals, patient organisations and other key stakeholders. In order to find ways to reduce the European burden of breast cancer and improve care, surveillance and treatment of breast cancer, the International Centre for Parliamentary

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Call For Urgent Action

4. Increase patient-centred research: There’s a need to encourage qualitative and quantitative patient-centred research so that collectively, we can build an evidence base. In order to identify and improve support and care gaps, we must all support increased collaboration in research and data-sharing; 5. Delegates noted that it would be wise to have recommendations on genetic testing which can be updated from time to time. The European Commission should provide indications on how to perform genetic research; 6. There’s a need for effective and increased collaboration at every stage of the cancer conundrum; 7. Optimising treatment: The issue of overdiagnosis and treatment of breast cancer received much attention among delegates as some commonly used treatments, from the use of a double mastectomy or even a combination of mastectomy and radiation might put patients at adverse risks. Policy intervention in treatment mechanisms can help reduce EU’s health burden; 8. Need for harmonised reimbursement policies: As reimbursement policies often influence choice of treatment, policy makers should address this to help spare patients from unnecessary treatment, and reduce their financial burden. Further, a patientoriented review process, more transparency of requirements for test developers and a roadmap for approval process could empower patients; 9. More emphasis should be laid on education and role of GPs in treating breast cancer; 10. Multidisciplinary care should be evidence-based and co-ordinated at all stages of the care process from the point of diagnosis onwards, encouraging patients to take an active role; 11. Addressing male breast cancer: Male breast cancer is relatively rare, accounting for less than 1% of all breast cancer cases and 1% of all cancer cases in men. There is little awareness among men, and even among physicians, regarding the occurrence

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of breast cancer in males, given the ratio of female to male breast cancers is approximately 100:1. (3) Though symptoms, diagnosis and treatment are similar to female breast cancer, male patients are often diagnosed at a later stage when their cancers are more advanced, thereby leading to worse outcomes. Only greater literacy, increased research and active discussion among men’s health forums can transform the situation. 11. Increasing number of breast cancer cases may be due to changes in lifestyle habits, increase in sedentary lifestyle, weight gain and obesity. Further, meta analyses show that breast cancer risk increases by around 7-12% per unit of alcohol per day. Governments should urgently counter public ignorance about the link between drinking and cancer and introduce minimum pricing to prevent the number of alcohol-related deaths; 12. When discussing the economics of therapies it is important to distinguish between ‘cost’ and ‘cost-effectiveness’ – the latter taking into account patient outcomes. The cost-effectiveness of all cancer therapies is under particular scrutiny in light of the constraints on healthcare budgets; 13. When assessing and optimising the cost-effectiveness of cancer care, decisionmakers should consider how service redesign might contribute to improved care and costs savings, and thereby support investment and further research. References: 1. Stewart BW, Wild CP, editors (2014). World Cancer Report 2014. Lyon, France: International Agency for Research on Cancer 2. Alcohol-related cancers will cause about 135,000 deaths and cost the NHS £2bn over the next 20 years in England, unless concerted action is taken to highlight the dangers of drinking, health campaigners have warned. 3. Major differences between male and female breast cancers uncovered, but male patients still disadvantaged by lack of research, say investigators, European CanCer Organisation, March 2016

Delegates present at the Breast Cancer Europe Roundtable 2016 included: Commercial Vice President EMEA, Agendia, Consultant, Ankara Oncology Training and Research Hospital, Coordinator - Gynacological Oncology, Antwerp University Hospital, Senior Oncologist, Antwerp University, Head of Department of Pathology, Antwerp University Hospital, Consultant Breast Surgeon, Athens Medical Center Clinical Director / Breast Surgeon, AZ Sint-Blasius, Head of Pathology, AZ Sint-Jan Brugge, Clinical Director, Brustzentrum Marienhospital Bottrop, Professor of Surgery, Breast and Endocrine Surgery Unit, Bulent Ecevit University - The School of Medicine, Head Breast Surgeon, Champalimaud Foundation, Manager, Oncology Corporate Affairs (Europe), Eli Lilly, EU Regional Advocacy and Professional Relations Oncology, Eli Lilly, Head of Unit, Health, DG Research and Innovation, European Commission, Group Leader, ECIBC, European Commission , Chief Executive Officer, European CanCer Organisation, Member - Austria, European Parliament, President, European Society of Breast Cancer Specialists, Dean, Faculty of Medicine, University of Prishtina, Professor of Plastic, Reconstructive and Aesthetic Surgery, Gent University Hospital, Breast Surgeon, ISALA Center, General Surgeon, Istanbul University, Professor, Dept of Breast and Endocrine Surgery / Senior Consultant, Kalolinska Institutet, Professor / Senior Physician, Kalolinska Institutet, Gynaecologist and Researcher ‘Cancer during Pregnancy’, Leuven University Hospital, Head, Oncology, Mather Teresa Hospital, Head, Breast Clinic, Mitera Hospital, Policy Lead - Oncology for Europe, Middle East, Africa, and Canada, MSD, Regional Director Medical Affairs, Oncology, Europe and Canada, MSD Associate Professor, National & Kapodistrian University of Athens, Chief SIS, National Cancer Institute, Full Professor, Netherlands Comprehensive Cancer Organisation, Clinical Director, Over Srl Italy, Radiation Oncologist, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Surgical Oncologist, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Breast Radiologist, The Netherlands Cancer Institute, Professor / Hospital practitioner, University Hospitals of Strasbourg, Technical Officer, WHO Regional Office for Europe, Health Economist & Health Policy Specialist, World Bank The next edition of the Breast Cancer Roundtable will be taking place in June 2017. If you wish to attend, please contact information@parlicentre.org


Breast Cancer Health Report

Changing the policy landscape for people with metastatic breast cancer Placing the issue of metastatic breast cancer firmly on the European Parliament’s agenda, Emma McClarkin MEP writes that politicians should highlight the psychosocial needs of sufferers and strive to understand their lives to ensure better policy making

cancer, it is also absolutely necessary to ensure regular examinations to detect cancer at the earliest stage for treatment.

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ver recent years, organisations, politicians and patients have worked hard to raise awareness of the challenges faced by metastatic breast cancer patients both in terms of the impact on physical health and their everyday life. The current challenge at hand is to ensure that this momentum continues and metastatic breast cancer remains high on the political agenda. Through this we can achieve clear and concrete improvements in the screening, monitoring and diagnosis of breast cancer along with policy changes to improve the lives of those living with the illness. The European Parliament achieved notable success with a 2015 Written Declaration which 9 other MEPs and myself coauthored. It represented an important step forward in the battle against the terrible disease and set forward a framework for notable policy change. One of the major aspects within this was the implementation of a nationwide breast screening in line with the EU guidelines. Whilst it is extremely important that member states continue to promote healthy lifestyles in the fight against

Whilst the European Union had presented recommendations for national screening programmes in the early 2000’s, by the time the 2015 Written Declaration was initiated there were a few member states that had fallen short of examination targets and had room for improvement. There is a clear desire amongst all member states to detect breast cancer early and limit the chances of metastatic breast cancer, however there is always a need to continue to share best practices and raise awareness. One thing I have realised through my work in the European Parliament is that sometimes you need to go beyond simple statistics and understand what individuals with metastatic breast cancer go through on a daily basis. We should strive to know how they continue to live rich and full lives, whilst identifying areas for improvement. That was why it was important for me to host a roundtable discussion inside the European Parliament and meet these

individuals personally. The Dutch Breast Cancer Association were able to present a screening of “The Book is not yet finished,” a documentary capturing the patient’s perspective of living with metastatic breast cancer and their daily challenges. More should be done in identifying this illness early and understanding the lives of those with metastatic breast cancer. One issue that was raised on numerous occasions is the lack of data on the number of metastatic breast cancer patients and the sharing of statistics across member states. This will be crucial to ensure that we progress towards better policy that will offer greater benefit to those suffering with metastatic breast cancer. We must also ensure that information is readily available for all across the European Union on what breast cancer is, how it can be detected, and how it can be treated. Technology must also be readily available to work in conjunction with this. Member states are making strong and positive strides but it is as important as ever to ensure that this is kept on the political agenda to ensure positive and concrete policy is being created to detect cancer as early as possible and help those living with it.

It is important to ensure the issue of metastatic breast cancer is kept firmly on the Parliament’s agenda. More should be done in identifying breast cancer early, addressing research gaps and understanding the lives of those with metastatic breast cancer

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Translating Knowledge To Action

Being breast cancer aware, 365 days a year Why should we restrict all breast cancer awareness programs to the month of October? Emphasising the importance of education, screening and early detection of breast cancer, Dr Miriam Dalli MEP addresses the policy issues in managing breast cancer in Europe and sets out a policy plan to help member states improve their cancer survival rates

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ancer is likely to remain one of the biggest killers of the 21st century. More specifically, breast cancer, continues to be the deadliest malignancy for women of all ages. This reality will get even worse in the coming years as it is estimated that as things stand today, by 2030 there will be an estimated 805,116 people worldwide who would die of breast cancer. This is a 43% increase from 2015. These figures are not only worrying, they are shocking! All around the world a special effort is made every year throughout the month of October to maximise Breast Cancer Awareness. This initiative is aimed at helping to increase attention on the first signs of this disease and to focus more on preventive measures. It is an important month for all breast cancer patients and their families as well as for survivors of this malady and healthcare providers. October also provides an excellent opportunity for the general public to educate themselves about facts and realities related to this condition. However, all of these initiatives should be part of a continuous process and should not limited only to the month of October. Breast cancer is the most common type of female cancer, second only to lung cancer as the leading cause of death (by cancer) in women. Although the vast majority of patients are women, men should not be forgotten, as they too have specific needs such as the right to access personalised care and a care pathway to follow. Breast cancer awareness is one of the most important aspects in the holistic approach towards treating and fighting the disease. Education on recognition of breast cancer signs and symptoms will hopefully lead to the early detection of the condition, timely treatment and higher long-term survival rates. Women should be breast aware, commencing

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It is unfortunate that not enough women worldwide are aware of the importance of lifestyle choices for their breast health. Being active, eating a wellbalanced diet and avoiding weight gain are three simple choices that can positively impact the future

with self-breast examination on a monthly basis. Moreover, it is equally important to understand risk factors related to breast cancer, which include age and family history. It is unfortunate that not enough women worldwide are aware of the importance of lifestyle choices for their breast health and associated risk factors, such as excess alcohol, smoking and obesity. A growing body of evidence points to the link between healthy lifestyle choices and a lower risk of developing breast cancer. Therefore, being active, eating a wellbalanced diet and avoiding weight gain are three simple but crucial lifestyle choices that can positively impact the future of a woman’s breast health. Air quality has also been linked to a number of health problems and may have significant negative effects on our health. The International Agency for Research on Cancer (IARC) has classified outdoor air pollution as a cancer-causing agent (carcinogen). A recent ground-breaking study by top researchers in the field suggests that air pollution may place women at risk of breast cancer. Their findings show that the incidence of breast cancer was higher in areas with elevated air pollution levels. Air pollution remains a detrimental public health problem. For this reason, I implore our authorities to take strong measures aimed at the better regulation of air quality. In fact, such action requires leadership and action at both national and international levels. Hence, we need to introduce measures to reduce air pollution to levels within EU

limits in order to safeguard our population’s health and well-being. I will do all I can to help reach these objectives especially through my work in the ENVI committee which discusses and debates issues related to public health and the environment. Prevention through European policy, aims to reduce the incidence of cancer by tackling the major determinants of the disease or by early detection through population-wide screening. Such regular and systematic examinations can detect the disease at a point in time when it is more responsive to less aggressive treatment. However, fewer than half of the minimum number of the European Commission’s recommended examinations are taking place across all EU Member States. We should not be afraid of mentioning or dealing with the word ‘cancer’. Failing to meet the needs of survivors will prevent us from delivering improved outcomes that must be central to our governments’ focus for the National Health system and social care. By commissioning and providing the right supportive care, based on needs and not solely on diagnosis, we can improve survival rates, quality of life and patients’ overall experience. This must be achieved in a sustainable and cost-effective manner so as to ensure this service is provided to future generations. Evidence must be gathered from survivors of breast cancer to record services that they used. This will lead Member States to improve their cancer survival rates whilst ensuring that all patients are offered a package that


Breast Cancer Health Report

includes advice, educational information, support and continuity of care. Yet, this will only happen if the authorities together with all relevant entities and organisations work together to better understand patients’ needs so as to improve outcomes as well as personalised care. Studies from the International Agency for Research on Cancer (IARC) have shown that

a third of all (approximately 165,000 each year) breast cancer cases in Europe can be prevented. Therefore, Breast Cancer could be defeated! We are duty bound to empower our citizens to make healthy lifestyle choices since this is a necessity for improved breast health. No matter what your underlying risk of breast cancer is, a healthy lifestyle and being breast aware are crucial choices.

The options for raising awareness on breast care are infinite and much more can be done on a regional level, national level as well on a European level. The unmet needs of patients must be addressed properly paired with the correct policy framework. May we ultimately arrive at a point where we manage to beat breast cancer.

‘Let’s strive to reduce inequalities in access to medicines’ Increasing patient literacy and reducing inequalities in access to drugs and treatment mechanisms is crucial in fighting breast cancer in Europe. K aren K adenbach MEP, co-chair of the European Parliament Interest Group on Access to Healthcare and Member of MEPs Intergroup against Cancer (MAC), explains why

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hough mortality rates have significantly decreased over the years, breast cancer is still the leading cause of death from cancer among women. The reason for this and the pathophysiology of breast cancer is still not entirely understood by clinicians as well as scientists. As a co-chair of the European Parliament’s Interest Group on Access to Healthcare and as a member of MEPs Intergroup against Cancer (MAC), I attach particular importance to health literacy. In my opinion, we should provide standardised care, up to date scientific

Informed patients as well as informed health care professionals are not only fundamental in optimising diagnosis and treatment of breast cancer, but also crucial in saving costs for the health care system

knowledge and data at the European level. Informed patients as well as informed health care professionals are not only fundamental in optimising diagnosis and treatment of breast cancer, but also crucial in saving costs for the health care system. We also need to take into consideration that uninformed patients can often lead to problems such as medication errors, misdiagnosis due to poor communication between providers and patients, low rates of treatment adherence, hospital readmissions, and other related complications or conditions. It is therefore important to ensure easy public access to data on all clinical trials carried out for new and existing medicines. With the patient becoming an active subject in the healthcare system, we should engage and empower them, rather than leaving them uninformed.

core is essential. The European Parliament has raised the issue and called for action on several occasions. Health literacy was integrated in the European Commission health strategy for Health 2007–2013. Various factors influence the availability for drugs against breast cancer, such as the selection of medicines on the market, focus areas of pharmaceutical research, supply systems, financing mechanisms, pricing, reimbursement and cost-containment policies of individual countries, as well as rigid patenting rules. All these factors should be properly analysed with the aim of finding ways of overcoming obstacles and reducing inequalities in access to medicines and treatments for patients with breast cancer. This is a priority for the Group of the Progressive Alliance of Socialists & Democrats in the European Parliament.

In conclusion, putting health literacy at the

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Uniting Against Breast Cancer

ECIBC’s new screening recommendations seek to reduce the breast cancer burden in Europe Aiming to reduce the burden of breast cancer and improve diagnosis and care of breast cancer in Europe, the European Commission Intiative on Breast Cancer (ECIBC) recently launched its first four recommendations for breast cancer screening. D onata L erda , ECIBC Group Leader, spells out the scope of the European initiative and reveals future plans for the evidence-based guidelines for screening and diagnosis

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he European Commission Initiative on Breast Cancer (ECIBC) is the European response to societal challenges and concerns of the citizens. It aims to empower women, patients and their families by offering transparent information on how and where to find evidence-based quality healthcare. The aim of ECIBC is to ensure and harmonise quality of breast cancer services across European countries. The launch of the ECIBC originates from a strong common will of member states and EU institutions to reduce the burden of breast cancer. This sustainable initiative

promoting effective treatment and care of breast cancer, collaborates with nearly thirty five European countries including 28 EU member states, plus Iceland, the former Yugoslav Republic of Macedonia, Montenegro, Norway, Serbia, Switzerland and Turkey. The goals of the ECIBC are also endorsed and promoted by the European Parliament, patient organisations and stakeholders, who partake in the initiative. Supported by nearly 70 European experts, including doctors and nurses coming from different specialities, patients and patients’ advocates, quality managers and methodologists, the ECIBC is a person-

centered initiative, managed by the European Commission’s Joint Research Centre (JRC), under the auspices of the Directorate General for Health and Food Safety (DG SANTE). The JRC is independent of all national, private and commercial interests and the ECIBC transparently communicates the involvement of all parties, processes and decisions along its entire evolution. The ECIBC was also born from the need to counteract the currently fragmented approaches to healthcare quality in breast cancer treatment in Europe. According to recent surveys conducted by the JRC, several existing quality assurance schemes are applied across Europe and are not always adaptable to local contexts. Furthermore, the past European breast cancer guidelines (2006) did not foresee monitoring and impact assessment. Evidence-based guidelines for screening and diagnosis In response to the Council of the European Union’s conclusions on reducing the burden of cancer, the ECIBC initiated a groundbreaking project to develop a European quality assurance scheme for breast cancer services underpinned by accreditation and referring to high quality, evidence-based guidelines. The ECIBC published its first four recommendations on screening in November 2016. Tailored to the needs of citizens and patients, health professionals, and policy makers, they provide guidance on the appropriate age ranges (between 40 and 74)

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Breast Cancer Health Report

The ECIBC guidelines will be updated in real-time as evidence becomes available.Over the next two years, many more recommendations on screening and diagnosis will follow. In 2017, ECIBC will release a guidelines platform, including evidence-based recommendations

for breast cancer screening. This impacts a situation that has remained static for the last ten years. Four guidelines available currentlu: For women between 40 and 44 The ECIBC guidelines suggests not providing mammography screening to women between 40 and 44 years old who are at average risk of breast cancer and do not have symptoms. For women between 45 and 49 For asymptomatic women aged 45 to 49 with an average risk of breast cancer, the ECIBC’s Guideline Development Group (GDG) suggests mammography screening over no mammography screening, in the context of an organised screening programme (conditional recommendation, moderate certainty in the evidence). For women between 50 and 69 For asymptomatic women aged 50 to 69 with an average risk of breast cancer, the ECIBC’s Guideline Development Group (GDG) recommends mammography screening over no mammography screening, in the context of an organised screening programme (strong recommendation, moderate certainty in the evidence). For women between 70 and 74 For asymptomatic women aged 70 to 74

with an average risk of breast cancer, the ECIBC’s Guideline Development Group (GDG) suggests mammography screening over no mammography screening, in the context of an organised screening programme (conditional recommendation, high certainty in the evidence). These recommendations will be updated in real-time as evidence becomes available. Over the next two years, many more recommendations on screening and diagnosis will follow. A platform of guidelines covering the whole care pathway In 2017, ECIBC will release a guidelines platform, including evidence-based recommendations reviewed and assessed using the Appraisal of Guidelines for Research & Evaluation (AGREE II) Instrument in collaboration with one of the international centres of the Cochrane Collaboration, the Iberoamerican Cochrane Centre. The European Breast Guidelines Platform will provide the evidence-base to develop the requirements and indicators of the European Quality Assurance scheme for Breast Cancer Services (European QA scheme). The European QA scheme will be adaptable to the varying national contexts, enabling comparison of services and continuous measurements and improvements when local

implementation adheres to the evidencebased care standards. Its implementation will guarantee that compliant breast cancer services will offer users (women, patients and carers) high quality and the most updated procedures for breast cancer screening and care. The European QA scheme will address the needs of the breast cancer services, the quality dimensions and its implementation will be in compliance with the European legislation for accreditation. Before its piloting, the JRC will contact all countries to have a dialogue on possible barriers and incentives to implementing the QA scheme and the guidelines. Towards the end of the pilot mission in 2018, the European QA scheme will be made available globally to all interested breast cancer services, such as hospitals, clinics and diagnostic centres. Finally, a training template for digital breast screening will be developed. It will contain minimum training requirements for radiologists and radiographers providing digital breast screening in services adhering to the European QA scheme. For more information and details on the methodology and outcomes, visit: ecibc.jrc.ec.europa.eu

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Translating Knowledge To Action

A manifesto for consistent, superior and multidisciplinary breast cancer care While Europe boasts of many good breast cancer services, wide inequality exists in quality of treatment across EU countries. Some member states continue to lack access to specialist units. Fatima Cardoso et al., call on policymakers to ensure high-quality breast cancer care throughout Europe

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he 2016 deadline for all patients in EU member states to access specialist, multidisciplinary breast cancer units or centres, was missed by most countries, despite numerous resolutions and declarations issued since the year 2000 that called for universal specialist services. This means that many women and some men, do not receive optimal breast cancer care in Europe. In the year 2000, the European Society of Mastology (EUSOMA), published a position paper ent itled ‘The requirements of a specialist breast unit’, which set out the standards for establishing high-quality breast cancer centres, or units, across Europe. (1) The paper followed a consensus statement drawn up at the first European Breast Cancer Conference in Florence in 1998. (2) The conference had set up a working group tasked with ‘forging the way ahead for more research and better care in breast cancer’, and highlighted the pivotal role of the dedicated breast cancer unit. The conference demanded that those responsible for organising and funding breast cancer care ensure that all women have access to fully equipped multidisciplinary and multiprofessional breast clinics. EUSOMA’s definition of a breast unit or centre is worth quoting in full: ‘The place where breast cancer is diagnosed and treated. It has to provide all the

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services necessary, from genetics and prevention, through the treatment of the primary tumour, to care of advanced disease, palliation and survivorship. The breast centre is generally made up by a cohesive group of dedicated breast cancer specialists working together as a multidisciplinary team with access to all the facilities required to deliver high quality care throughout the breast cancer pathway.’ Further, the guidelines list no fewer than 16 types of professionals that should make up a team, including radiologists, radiographers, pathologists, surgeons, reconstructive surgeons, medical oncologists, radiation oncologists, breast nurses, data managers, geneticists, psychologists and physiotherapists. Note that it is recommended that mammography screening services should be part of or closely located with breast units, partly because of the pivotal role that radiologists play in screening and symptomatic imaging, and also because of the convenience for women of a seamless service. A key factor for most specialist cancer work is a minimum number of cases needed to ensure that all team members maintain expertise. It is recommended that at least

150 newly diagnosed cases of primary breast cancer are seen each year from a population of about 250,000. All breast centres must achieve minimum standards for the mandatory quality indicators (3), which are used for benchmarking and certification/ accreditation of the breast centres. By the late 1990s, there was evidence that for optimal care, patients with breast cancer must be treated and cared for by specialist, multidisciplinary teams in dedicated breast units. Reports from the United Kingdom (UK), in particular, and guidelines from the European Society of Surgical Oncology and from the European Union on mammography screening, built on this evidence in recommending specialist units as a priority for breast cancer, as it is a major cancer with many and rapidly changing treatment options, has screening standards, and a wide range of psychosocial impacts. For this reason, policymakers, advocates and breast cancer professionals have had to make repeated calls for universal implementation. In particular, European Parliament resolutions of 2003 (4) and 2006 (5) included calls on the member states to ‘establish a network of multidisciplinary breast centres’ and to ‘ensure nationwide


Breast Cancer Health Report

provision of interdisciplinary breast centres in accordance with EU [European Union] guidelines by 2016’. Written declarations on breast cancer in the EU of 2010 (6) and 2015 (7) called on member states to ensure that all women and men in the European Union have access to treatment in units set up in accordance with the ‘European guidelines for quality assurance in breast cancer screening and diagnosis’, by 2016, including those with advanced breast cancer. International consensus conferences for early stage (St Gallen Conference) and metastatic (ABC Conference) breast cancer stress multidisciplinary team working as critical to outcomes. The ‘European guidelines for quality assurance in breast cancer and diagnosis’, currently in a fourth edition (8), included a revision of the EUSOMA paper on the requirements of a specialist breast unit, and in 2013, the EUSOMA updated these guidelines. (9) The European Commission Initiative on Breast Cancer (ECIBC) is currently developing a comprehensive quality assurance scheme for breast cancer services underpinned by accreditation. (10) The Florence statement of 1998 was direct in demanding, not requesting, that patients with breast cancer must have care in specialist breast units. This manifesto is a repeat of that demand in the light of more evidence for the superiority of such specialist care and the failure over the past 15 years or so to deliver it to all breast cancer patients in Europe. There are many good breast cancer services, but there is a wide variation of breast cancer care among and within European countries, and in particular still a lack of access to specialist units as set out in the EUSOMA guidelines.

Across Europe, many women are not offered breast conserving surgery despite being good candidates for that procedure, partly due to lack of radiotherapy equipment, and also because of lack of multidisciplinary expertise and adherence to guidelines

there can be a lack of integrated care for often-complex advanced breast cancer, and lack of ancillary services that add much to quality of life such as specialist breast nurses, psycho-oncologists, patient support groups, physiotherapists, among others. The wide range of shortcomings for care of metastatic breast cancer patients is detailed in the largest report so far on this growing number of patients, ‘Global status of advanced/metastatic breast cancer: 2005 e 2015 decade report’ (11), which includes several European countries in its surveys. We call on policymakers and politicians to ensure, as soon as possible, that all women and men with breast cancer in Europe are treated in a specialist breast unit. To do this, we ask that policymakers and politicians, together with healthcare professionals and patient advocates: - Promote, in public and professional settings, the evidence that breast units staffed with specialist multidisciplinary teams deliver superior care and quality of life to women and men with breast cancer. - Acknowledge the evidence that treatment in multidisciplinary units lead to overall cost savings as well as higher quality of care. - Audit the current national provision of breast cancer care using accredited auditors. - Implement mandatory reimbursement and care models that mean treatment can only be carried out in specialist breast units.

Some countries do not yet have national cancer plans and networking of cancer units, or may have only recently introduced these.

- Introduce a breast unit quality certification scheme that is accredited by an accreditation body.

Wide variations in healthcare systems and professional working can mean that many patients are not treated according to multidisciplinary guidelines, even in highresource countries that have cancer plans, and even in cancer departments, as there can be national and institutional variability.

- Join European-wide scientific societies and groups that promote the availability and quality of breast units, and together commit to providing access to such units for all patients.

In particular, many women are not offered breast conserving surgery despite being good candidates for that procedure, partly due to lack of radiotherapy equipment, and also because of lack of multidisciplinary expertise and adherence to guidelines. There are also variations in the use of adjuvant chemotherapy, hormone therapy and targeted therapy. Apart from a lack of vital therapy, in particular radiotherapy and certain drugs,

We hope this manifesto and supporting evidence will encourage policymakers, health professionals and advocates to investigate their own national and local provision of specialist breast units and the tools and criteria currently in use for developing consistent, high-quality breast cancer care.

services in each country so that better comparisons of health systems policy can be made, and more examples of best practice generated. This article is a shorten revised version of the position paper “European Breast Cancer Conference manifesto on breast centres/ units” (EJC 721 (2017) 244-250 Elsevier has approved the preparation of this article. The article was co-authored by Luigi Cataliotti, Alberto Costa, Susan Knox, Lorenza Marotti, Emiel Rutgers, Marc Beishon.

References: 1. EUSOMA. The requirements of a specialist breast unit. Eur JCancer 2000;36:2288e93. http:// bit.ly/21sjm33. 2. EUSOMA. Florence statement on breast cancer: forging the way ahead for more research on and better care in breast cancer. 1998.http://bit. ly/1oQhrUI. 3. Rosselli Del Turco M, Ponti A, Bick U, Biganzoli L, Cserni G,Cutuli B, et al. Quality indicators in breast cancer care. Eur J Cancer 2010;46(13):2344e56. 4. European Parliament resolution on breast cancer in the European Union. Text adopted 5 June 2003. http://bit.ly/1QEU860. 5. European Parliament resolution on breast cancer in the enlarged European Union. 18 October 2006. http://bit.ly/1XT0WTu. 6. Declaration of the European Parliament of 5 May 2010 on the fight against breast cancer in the European Union. http://bit.ly/1OFqKva. 7. Written declaration submitted under rule 136 of the rules of procedure on the fight against breast cancer in the European Union. 27 April 2015. http://bit.ly/1zS6aHB. 8. European Commission. European guidelines for quality assurance in breast cancer screening and diagnosis. 2006. http://www.euref.org/europeanguidelines. 9. Wilson ARM, Marotti L, Bianchi S, Biganzoli L, Claassen S, Decker T, et al. The requirements of a specialist breast centre. Eur J Cancer 2013;49(17):3579e87. http://bit.ly/1KUKGQ4. 10. See http://ecibc.jrc.ec.europa.eu. 11. Global status of advanced/metastatic breast cancer: 2005-2015 decade report. http://www. breastcancervision.com.

Apart from the imperative to care for all breast cancer patients in specialist units, according to our call to action, it is important that thorough European-wide research is carried out to quantify and qualify the exact provision of breast cancer

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Translating Knowledge To Action

Will access to innovative cancer drugs bankrupt European healthcare? Dr Martine J Piccart and Dr Noam Ponde from Institut Jules Bordet make

an extensive study of the European drug scenario and note that a major reform in drug development is necessary, with “risk sharing” by governments If Europe is to fight cancer efficiently while retaining its current health care systems

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ublic healthcare is a core characteristic of European society, guaranteeing universal access to affordable healthcare to the citizens of European Union (EU) member states. EU citizens live longer and consequently cancer becomes an increasing public health concern. (1) Decades of research to understand the molecular and genetic underpinnings of cancer have led to new kinds of treatment, namely molecularly-targeted therapy and immunotherapy. These innovative drugs attack specific molecules that drive the malignant behaviour of cancer cells or “weaken” the patient’s immune system and their use has been associated with marked clinical benefits, including improved survival. However, these drugs are expensive, leading many public officials, health care policy experts and oncologists to worry about whether granting access to these drugs will not bankrupt European healthcare. Yet as critical as this concern may be, a fundamental question must be answered first: Why are these drugs so expensive? The skyrocketing cost of new cancer drugs has multiple causes. However, at its core is a shift in the nature of cancer research from being mostly an academic endeavour funded by governments and universities to a largely commercial one funded and conducted by pharmaceutical companies. The reasons for this shift relate ultimately to the complexity and huge cost of conducting cancer research. (2) From a scientific standpoint, genomic studies have revealed that cancer originating in one organ such as the lungs or the breast is not one disease, but multiple diseases that differ genetically and biologically from one another. Furthermore, a single tumour

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carries various cancer cell populations; therefore, in any given patient, a drug that kills half of a tumour might do nothing for the rest. Drug candidates must undergo lengthy study before being registered for use, from cell lines and animal models to multiple phases of study in humans. This means that most drug candidates fail before reaching the market, and that successful drugs need to pay for those that fail. Moreover, the complexity of cancer often precludes clear-cut study objectives such as “cure”, and forces the cancer community to choose less ambitious ones, such as temporarily halting progression of disease, or improving symptoms and quality of life. In designing trials to register new drugs, these objectives translate into needing to study hundreds or even thousands of patients for years before concluding whether a drug is effective. The regulatory burden has also increased expenses in a significant manner, as it demands close patient and hospital monitoring in order to maximize patient safety and minimize fraud. While this is important, it renders modern clinical research too expensive for any one hospital or one country to bear alone, leaving only one stakeholder able to invest the necessary billions: pharmaceutical companies (Pharma). Pharma has thus become the inescapable partner for the conduct of “practicechanging” clinical trials. Being privately owned, Pharma has a justifiable financial responsibility towards its shareholders, and this impacts drug development in meaningful ways. Two notable consequences are conservative trial designs and a profusion of “me too” drugs. In the past, when there was little

understanding of cancer heterogeneity, designing trials to answer a very basic question (does the drug work for the average patient?) was scientifically acceptable. Since we now know that any drug given to cancer patients will help only some of them, modern clinical trials should always include a clear strategy to identify those patients. However, this has the inherent problem of diminishing the number of potential consumers. Pharma therefore often (though not always) opts for conservative designs that stack the odds in favour of the new drug “succeeding” for the largest possible number of patients and being prescribed for long durations with little scientific rationale. This leads to significant costs for health care systems and subjects many patients to unnecessary drug exposure – and associated side effects. Additionally, the discovery of a new means to attack cancer cells – a therapeutic target – often leads to a “gold rush” as companies look to develop drugs that exploit it. Similar drugs end up being tested in similar settings – in essence the same study is run repeatedly, using up financial resources that could be put to better use, and reducing the likelihood that clinically useful biomarkers of drug response will be discovered. If Europe is to both fight cancer efficiently and retain its current health care systems, a major reform in drug development is necessary, with “risk sharing” by governments. This is the conclusion drawn by the Breast International Group (BIG) after twenty years of experience in partnering with Pharma for new drug development in breast cancer.


Breast Cancer Health Report

While achieving a number of successes, such as the HERA study results leading to the European registration of the life-saving drug trastuzumab in 2005 (3) – BIG’s attempts, as an academic research network to better select the patients most likely to benefit from new drugs or to investigate shorter treatment exposures, have largely failed, as they are viewed as too “risky” by Pharma. How to address this? Governments can play a decisive role by increasing funding for academic initiatives that could ultimately reduce drug costs and unnecessary exposure of patients to drugs and their side effects. Reducing the regulatory burden by streamlining processes and harmonising them at the EU level is another step in the right direction. Finally, new anticancer drugs are not all created “equal,” and the European Society of Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale is a useful instrument that serves three purposes (4): 1) It provides a ranking of new anticancer drugs in relation to their “value” for patients, with the highest scores allocated to drugs that prolong cancer patients’ lives and/ or significantly improve their quality of life (even if the latter is often difficult to measure);

Governments can play a decisive role by increasing funding for academic initiatives that could ultimately reduce drug costs and unnecessary exposure of patients to drugs and their side effects, reducing regulatory burden by harmonising the process and streamlining the process of delivering anticancer drugs

2) It should impact the design of future clinical trials and, in particular, promote patient-reported outcomes as well as the selection of more meaningful hazard ratios and absolute gains (in overall survival); and 3) It facilitates the dialogue between physicians and their patients, so that the latter will no longer have unrealistic expectations about the treatment being discussed. 4) Last, but not least, new standards for pricing that take into account the degree of benefit of the drug should be put in place. References 1. Ferlay J, Steliarova-Foucher E, LortetTieulent J, et al. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012. Eur J Cancer

2013;49(6):1374–403. 2. Piccart-Gebhart MJ. The 41st David A. Karnofsky Memorial Award Lecture: Academic Research Worldwide--Quo Vadis? J Clin Oncol 2014;32(4):347–54. 3. Piccart-Gebhart MJ, Procter M, LeylandJones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005;353(16):1659– 72. 4. Cherny NI, Sullivan R, Dafni U, et al. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Ann Oncol 2015;26(8):1547–73.

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Translating Knowledge To Action

‘Harmonised reimbursement approach key to reducing treatment inequalities’

Personalised breast cancer treatment for patients in Europe should be a priority, however a discordant reimbursement process means that many cannot access vital tests to prevent under or over treatment. Dr Marjolaine Baldo, EMEA Commercial Vice President, Agendia discusses the main issues within the process

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reast cancer is the most common cancer for women in Europe. With the help of national screening programmes that can detect and diagnose breast cancer early, survival is improving. However, current approaches for determining the chance of a patient’s cancer recurring postsurgery and how they should be further treated do not take into account the genes of the tumour itself, therefore a more individualised approach is urgently needed. Gene expression-based tests are available, but patients are routinely prevented from accessing them due to discordant reimbursement policies across Europe. Policy makers and payers must address this to help spare patients from unnecessary treatment, and reduce the financial burden of treatment of supportive care. Accurate assessment of cancer recurrence risk can spare patients from unnecessary treatment Typically, early-stage breast cancer patients have surgery to remove their tumour, followed by any subsequent treatment to reduce the risk of the cancer returning. Traditionally, this post-surgery decision is based on clinico-pathological risk factors such as the patient’s age, tumour size, number of lymph nodes affected and hormone receptor status. Whilst useful, this does not take into account the tumour biology. Consequently, this can mean that a patient is classified at high risk of their cancer returning and advised to undergo chemotherapy, but when taking into account genomic data from their tumour, they are actually found to be low risk, needlessly suffering the arduous side effects

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Policy makers and payers must spare patients from unnecessary treatment, and reduce the financial burden of treatment of supportive care

of chemotherapy without any additional benefit. The findings of the landmark MINDACT trial of almost 7,000 European breast cancer patients, which were published earlier this year, show that 46% of patients originally classified as high risk of their cancer returning according to clinico-pathological factors alone were reclassified by the MammaPrint® breast cancer recurrence assay to low risk. MammaPrint looks at the expression levels of the 70 genes most associated with cancer recurrence to provide a definite low or high risk result. A disconnected approach to reimbursement across Europe Tests like MammaPrint can benefit patients and their physicians by providing objective, quantitative data to clearly identify whether chemotherapy is needed or can be safely omitted from a treatment programme. However, many patients cannot access these tests unless through private health insurers due to a discordant approach to reimbursement in Europe. Currently, each country can determine the price of tests and decide what to reimburse. These systems are usually complex and adapted to the country’s health and economic needs, therefore, the route to reimbursement varies dramatically. For example, MammaPrint is reimbursed in the Netherlands, Spain, Switzerland and Ireland. Patients in France can benefit from conditional reimbursement of the test for three years, but in Germany, reimbursement is still being assessed. Other European

countries still have a long way to go. Although many pan-European policies and treatment guidelines endorse these tests and encourage physicians to adopt them, I believe the lack of harmonisation or having a centralised procedure to obtain reimbursement is a substantial roadblock to universal introduction in standard practice. Another issue is the lack of clear guidance on the essential requirements that test developers must meet to achieve reimbursement. There is also uncertainty amongst policy makers and payers of the level and extent of clinical evidence required for approval and reimbursement. Each country has its own reimbursement body, informed by national experts who evaluate the clinical utility of tests and make recommendations accordingly. However, what may be considered a satisfactory level of evidence in Spain, in the Netherlands, in Switzerland or in Ireland may not be acceptable in Germany. A critical need to harmonise reimbursement to benefit patients Fundamentally, there needs to be an aligned, Europe-wide and patient-oriented review and approval process. Transparency of the requirements for test developers to meet, and a roadmap for approval across Europe will also ensure that policy makers and payers from individual countries are empowered to make these decisions to the benefit of patients. To achieve this, support is needed from the European Parliament, who could centrally


Breast Cancer Health Report define the essential requirements for reimbursement in Europe. The European Parliament has recently taken a first step by releasing new policies to recommend best practice breast cancer treatment, and is enhancing pan-European training programmes for gynaecologists and oncologists to ensure consistent knowledge and management of the disease, and optimised early diagnosis across the member states. I believe that harmonisation of reimbursement is key to ensuring that breast cancer patients are not discriminated against in accessing a beneficial prognostic and predictive test simply due to their geographical location. With physicians and patients across Europe aligned in support for gene expressionbased breast cancer recurrence tests, it’s time that the policy makers and payers recognise how beneficial these tests can be in improving and personalising how early-stage breast cancer is treated.

How should the EU act differently in tackling the burden of breast cancer? There is no better time than now to reflect on what individual member states could change in diagnosis and treatment of breast cancer. F rancesca C olombo, Head of the OECD’s Health Division, and Rie Fujisawa, OECD Health Statistician present four major objectives for change

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The burden of breast cancer varies across European countries, but countries with high incidence rates do not necessarily have high mortality rates. To change this, patients across Europe should be able to access evidence-based, high-quality care quickly, with minimal waiting times to see specialists

disease in terms of premature deaths and lost earnings is much higher.

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reast cancer imposes a large health and financial burden on individuals and societies in Europe. It is the most common form of cancer among women in all European countries and on average, one in nine women will develop breast cancer at some point in their life. It is also the leading cause of death from cancer among women, followed by lung cancer and colorectal cancer, and one in thirty will die from the disease. Spending on breast cancer care accounts for up to 1% of total expenditure on health while the economic impact of the

The burden of breast cancer varies across European countries. In 2013, incidence rates were highest in Belgium, Denmark and France, with rates 40% or more than the EU average, while Greece has the lowest rate, followed by Lithuania and Romania. But countries with high incidence rates do not necessarily have high mortality rates and mortality from breast cancer was highest in Croatia, Ireland and the Slovak Republic, and lowest in Spain, Portugal and Estonia. These cross-country variations can be partly explained by the differences in how well countries deal with preventing, diagnosing and treating breast cancer. Although average screening rates for women aged 50-69 across the European Union has risen and the gap in screening rates has narrowed across countries in the past decade, breast cancer screening rates still range widely from 23% in the Slovak Republic to over 80% in Portugal,

Denmark, Finland and Slovenia in 2014. There is also significant international variation in when and how breast cancer is treated. The waiting time between diagnosis and initial treatment for breast cancer varies from a few days in Iceland and Luxembourg to a few months in countries such as Poland and Slovenia. Conservative, breast-sparing surgery is the norm in most countries, but in a few countries, such as Finland, Luxembourg and Poland, more aggressive treatment of mastectomy is more common than other countries. Even after taking into account differences in the nature of the disease, this may suggest cross-country differences in the application of evidence-based cancer care. Across countries, survival after the diagnosis of breast cancer, which reflects quality of care based on early diagnosis and timely and adequate treatment, still varies, although it is improving over time. While five-year relative breast cancer survival is above 80% in most EU countries, it is lower than 75%

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Translating Knowledge To Action

in Estonia and Poland. Poland also shows the lowest relative survival for other cancers such as cervical and colorectal cancers and these low rates appear to be related with limited care access and relatively fewer numbers of cancer care centres and radiotherapy facilities. However, over the last decade, breast cancer survival has improved across all EU countries, and this increase has been particularly noticeable in Estonia, the Czech Republic and Latvia. This reflects advances in improved treatments as well as public health interventions to detect the disease early and greater awareness of the disease. Nonetheless, countries can do more in the ongoing fight against breast cancer by pursuing the following four objectives: • Put adequate resources into breast cancer care - Expensive healthcare is not necessarily the best care: countries need the right policies in place to use resources such as workforce or equipment to diagnose and treat breast cancer effectively and fairly. • Ensure that breast cancer care is both rapidly accessible and high quality – early diagnosis and treatment is key in the fight against breast cancer. Patients should be able to access evidence-based, high-quality care quickly, with minimal waiting times to see specialists. Ensuring that care is multidisciplinary and delivered in specialist cancer units while putting patients at the centre of care is increasingly being used to improve the quality of cancer care. • Continuously improve services by strengthening the governance of cancer care - the bedrock of governance is an effective national cancer control plan. These help focus political and public attention on the performance of cancer care systems, attract new resources, and drive debate on difficult topics such as resource allocation. They also offer opportunities to reinforce the common goals and approaches shared by patients,

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health care providers, researchers and other stakeholders.

Cycle, OECD Publishing, Paris; http:// dx.doi.org/10.1787/9789264265592-en

• Monitor and benchmark performance through better data - countries need to build rich information systems to monitor outcomes, costs and quality of cancer care. Public dissemination and benchmarking of performance, as well as incentives set adequately around quality improvement can help to reduce variations in breast cancer care and ensure continuously improving quality.

2. OECD (2016), Health Statistics, OECD Publishing, Paris.

A pre-requisite, however, is a rich and detailed information system which can track patients’ diagnoses, treatment and outcomes of breast cancer care. References: 1. OECD/EU (2016), Health at a Glance: Europe 2016 – State of Health in the EU

3. OECD (2014), OECD Reviews of Health Care Quality: Czech Republic 2014 – Raising Standards, OECD Publishing, Paris, http://dx.doi.org/10.1787/9789264208605en 4. OECD (2013) Cancer Care: Assuring Quality to Improve Survival, OECD Health Policy Studies 5. OECD Publishing, Paris, http://dx.doi. org/10.1787/9789264181052-en


Breast Cancer Health Report

Elderly women with breast cancer have worse outcomes Though almost half of women dying from breast cancer are aged 75 or above, the screening upper age in Europe never exceeds 75. C arole Mathelin, Vice President for Europe, International Society of Senology, et al, recommend that information campaigns on breast screening and examination must be strengthened to change the state of breast cancer care for the elderly

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reast cancer is the most common malignancy among women worldwide, particularly in developed countries. In 2012 in the European Union, it represented 30% of the newly diagnosed cancers and was responsible for 16% of the cancer mortality. While it is well known that age is the largest risk factor of breast cancer - incidence grows with age, and the over-mortality among elderly women due to breast cancer is largely unknown. Indeed, the specific mortality associated with breast cancer increases with ageing. Almost half (45%) of the women who die from breast cancer are aged 75 or over. Moreover, the difference between young and older women is spreading and epidemiological estimations show that after 65, both mortality and breast cancer incidence are constantly up, whereas before 65 they are starting to decrease. In this context, it is well known that Europe’s population is getting older. It is estimated that, between now and 2050, its population of over 65 is set to increase from about 19% to about 28%. It seems therefore clear that breast cancer, which right now is already a major public health concern, will become more important in the future and will therefore become more central in the medical practice of the future. Yet an analysis of the international scientific literature reveals facts that are somewhat paradoxical. On the one hand, ageing

appears to be associated with increased favorable biological and histological characteristics. On the other hand, the clinical data show that the disease is more advanced: tumors are larger in size, lymph nodes are more often affected and metastases are more frequently diagnosed. How can this apparent contradiction be explained? It is well known that ageing leads to a decreased protection against cancer. Indeed, age is associated with a decreased immunological response - not only to infections but to cancers too - and this is called immunosenescence. The body’s tissues are more exposed to environmental carcinogens and the DNA reparation systems are less effective. In addition to these general physiological modifications, with ageing some breastspecific modifications are observed. While older age is associated with lower levels of circulating estrogens, in the elderly breast epithelial cells become more sensitive to estrogens. Furthermore, with advancing age the mammary gland becomes “fattier” - i.e. breast tissue is progressively replaced with adipose and conjunctive tissue - leading to increased intra-mammary estrogens production. Such “fatty” transformation of the breast allows for easier clinical and radiological examination. In addition, with advancing age the breast cancer micro-environment changes, which could also explain why less aggressive breast carcinomas spread more easily. The biological mechanisms essential for understanding this apparent paradox are

at the moment the object of fundamental and translational research. However, societyrelated mechanisms also exist. Today, the general population of most European countries undergoes screening for breast cancer as an established practice. The screening upper age varies in the different countries, however it never exceeds 75. Hence, none of the E.U. member states’ breast cancer screening programme includes elderly women. Moreover, participation rates in such programmes - be them national or at the individual level - are heterogeneous, sometimes insufficient and decrease with advancing age. This leads to a huge discrepancy between breast cancer screening and the high incidence among elderly women. Some - including health professionals - may mistakenly interpret the exclusion of the elderly from the screening as justified by a lower-risk situation, which is not. Similarly, clinical breast monitoring in elderly women is not performed sufficently. For example, only about half of physicians perform breast clinical examination on elderly women. This omission may lead to late diagnosis with more advanced local lesions and more likely tumour extension to lymph node or metastasis. Furthermore, the common thinking can also be misleading; it is not uncommon to hear that in older patients “cancer progresses slowly” and “does not kill”. Such lingering dogmas contribute to aggravating

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Uniting Against Breast Cancer

the problem as they delay provision of the necessary medical care. These ill-conceived assertions are easily contradicted by the documented scientific evidence. In addition, up until 85 years, the leading cause of mortality in elderly women with breast cancer is the cancer itself and not co-morbidity. In this respect it can be affirmed that a part of the medical community, patients and the society are generally either badly or not informed at all. Epidemiological and societal data indicate that in most European countries breast cancer in elderly women is not always properly managed. Ideally, the physiological age should be considered rather than chronological age. We suggest that information campaigns should be held and training on breast clinical examination for physicians and caregivers in general be strengthened. Also, women over the upper age limit for screening programmes should be not only allowed but also encouraged to undergo individual screening, both clinical and mammographic, if they so wish. This article was co-authored by Massimo Lodi, Louise Scheer and Andrea Lodi.

The Big Data revolution in breast cancer The prevention, treatment and care of breast cancer in Europe have rapidly evolved during the past two decades. Part of this evolution is due to individual or organised breast screening programs, while the rest is due to the evolution of medical techniques. Carole Mathelin, Vice President for Europe, International Society of Senology, et al, note that massive investments are required to develop a truly European vision of the future of breast cancer care

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ecently, the advent of Big Data technologies has generated a lot of interest among the medical community. Indeed, the available storage capacities increased exponentially during the last three decades, thus leading to bigger volumes and variety of stored medical data (X-ray, MRI, genomic data). These data are generally exploited at an individual level during a specific period of time, to establish a diagnosis, a therapeutic protocol, to follow the disease evolution and to estimate a prognosis for a specific patient. However, only structured data, which represents a small fraction of accessible and interesting information sources, can be readily exploited on a statistical scale. The rest is stored in data graveyards that the medical staff barely sees. The big promise of Big Data is to leverage all data sources, including unstructured ones such as textual patients reports or images, thus impacting medical research, and ultimately patient care. To understand more precisely how Big Data may revolutionise healthcare, one has to understand its two pillars. First, the software landscape that emerged in the past decade, which implements predefined operations on huge volumes and different varieties of data. Second, machine learning algorithms and their practical implementations in programming languages, which can learn

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from data in order to extract patterns and correlations, and ultimately produce valuable insights. The so-called data scientists are the experts in juggling these sets of techniques. Various medical projects based on Big Data techniques were launched in the past few years, with many implications on the understanding of prognosis and on decision making. One of these projects, named Senometry, consists in analysing 10,000 textual records of patients suffering from breast cancer. The analysis is performed using machine learning algorithms that extract and structure a wide variety of information, including medical history, risk factors, size of tumours, lymph node involvement, presence of specific biomarkers, use of different treatments or patients’ evolution. Once this information is structured, a second iteration of statistical modelling is performed, with many interesting insights on specific subpopulations, the importance of certain biomarkers for prognosis, or the adequacy of the decision criteria used by the medical staff in breast cancer treatment. Other projects, such as an ongoing research on type II diabetes, focus on cancer risk factors. Their results will enhance our understanding of the many intricate mechanisms underlying cancer development, as nearly 75% of breast cancer occurrences have no known cause.


Breast Cancer Health Report

These achievements highlight the considerable potential of Big Data techniques in breast cancer care, but also for other pathologies for which a simple duplication of the previous works is practicable. Consequently, medical time is progressively changing: whilst up to 30 years were necessary to gather data using cohorts to answer a specific question, such as the impact of night work on breast cancer development, Big Data technologies now allow to analyse all sorts of existing data to isolate the relevant information for answering the medical staff questions. More generally, the medical research paradigm is slowly shifting from the logic of hypothesis verification on ad hoc constructed populations, to the discovery of interesting correlations after the data collection phase. Transdisciplinarity is central to the success of these innovative studies. Learning a shared semantics between the medical staff and data scientists takes time, and the breast disease units’ experience in transversal organizations will be very helpful in defining a frame for these collaborations. In addition to the medical staff and data scientists, Big Data projects should involve patients, and more generally civil society, since only a strict compliance with privacy rules can ensure their success and viability. In the light of the evidence presented in this article, massive investments are necessary to develop a truly European vision of the future of breast cancer care, and more generally of how data exploitation can be at the service of public health policies. We recommend that young doctors get involved early in their training in the Big Data research thematic. Indeed, in a very near future, it will be up to them to define the interesting questions that need to be answered, the data sources where to look for answers, the data that need to be collected, and the ethical frames for Big Data projects. More generally, all medical staff should progressively learn how to incorporate the new possibilities offered by the Big Data revolution to the day-to-day practice with patients. The article was co-authored by Issam Ibnouhsein, Nicolas Thiébaut and Karl Neuberger.

Tackling breast cancer: Prevention, diagnosis, treatment and collaboration Despite several medical advancements in the last decade, the mortality rate of breast cancer remains high across Europe. Alexander Roediger, Policy Lead - Oncology for Europe, Middle East, Africa and Canada (EMEAC) and Dr Christian Hosius, Regional Director Medical Affairs, Oncology, Europe and Canada (EuCan) from MSD, detail the role of collaboration in tackling the disease

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reast cancer is the most commonly diagnosed cancer in women and the most likely reason for cancerassociated death in women (1) With nearly 400 clinical trials underway in more than 30 tumor types, MSD is investing significant resources to develop innovative oncology medicines to help people living with cancer worldwide. (2) Cancer remains one of the most devastating diseases, with 2.6 million people diagnosed with the disease across Europe in 1995, rising to 3.4 million people in 2012 – a staggering increase of 30%, mainly driven by demographic change. (3). What is more, cancer incidence is expected to continue its upward trajectory, rising again by over a third, by 2030. But, there is hope. Over the same period, cancer mortality decreased in nearly every single country. The central factors that drove a wedge between the trends in incidence and mortality are advances in diagnostics, medical treatment, and screening. (4). Despite these improvements over the last decades in the field of breast cancer the mortality rate

Dr Christian Hosius

associated with this tumor type remains very high in Europe. In 2012 the incidence of breast cancer was 71.1 and the mortality rate 16.1. (5) Screening and Diagnostic Tools – for better outcomes and better use of healthcare resources Breast cancer can be divided into 3 main subtypes (although recent work suggests that these categories can be further subdivided): Hormone receptor positive (HR+, which may include estrogen and/or progesterone), HER2 positive (presence of the human epidermal growth factor receptor2 gene) and triple negative (absence of aforementioned receptors/gene). The disease is heterogeneous. Of equal importance as new treatments is also the improvement of the diagnostic tools and screening methods to identify patients at an earlier stage of the disease. Screening and diagnosis should be at the forefront of breast cancer management. Screening of high-risk patients could include younger women based on their family history, BRCA mutation status and other genetic alterations. (6) Individual European member states have local guidelines which are not necessarily identical and therefore the standard screening may differ across Europe. As part of this commitment, MSD is striving to determine biomarker relevance for immunotherapies in breast cancer, as well as other tumor types by including prospective biomarker testing in our clinical program. The study of biomarkers will help develop a better understanding of the biology of the individual tumour. This knowledge may allow for better selection of treatment and a more accurate understanding of the potential for response. Targeted or personalised healthcare may lead not only to better outcomes but also more efficient health

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Breast Cancer Health Report

resources use. (7) We must work together

Alexander Roediger

2. See http://www.merck.com/index. html (11/12/2016)

Finally, the role of prevention is also very important: better education is needed to support the individuals in making well informed choices about lifestyle and health. Patients with higher health literacy levels manage better to navigate and access the health system, understand the importance of cancer prevention, and seek earlier diagnosis or adhere better to treatment. (8) Patient empowerment and education are key to achieve this. The cancer challenge cannot be tackled by a single stakeholder nor resolved by simple solutions. Dialogue is critical to understanding the priorities and needs of each partner in the access equation, physicians, nurses, patients, payers and governments, in order to support and drive the rapidly advancing science and deliver access to innovative medicines across Europe. About MSD For 125 years, MSD has been a global health care leader working to help the world be well. MSD is known as Merck in the United States and Canada. Through our

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burden of cancer in the European Union 1995-2014; European Journal of Cancer 66: 162-170

3. Jönsson B et al. (2016), The cost and burden of cancer in the European Union 1995-2014; European Journal of Cancer 66: 162-170 4. Jönsson B et al. (2016), Comparator Report on Patient Access to Cancer Medicines in Europe Revisited; IHE Report 2016:4; http://www.ihe.se/accessto-cancer-medicines-in-europe.aspx 5. Zagouri et al. (2014) Breast cancer in Europe; J Thorac Dis 2014;6(6):589-590

prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. 1. Jönsson B et al. (2016), The cost and

6. http://www.cancer.org/cancer/ breastcancer/moreinformation/ breastcancerearlydetection/breast-cancerearly-detection-acs-recs 7. Godman B et al. (2014), Personalizing health care: feasibility and future implications; BMC Medicine 11: 179 8. WHO Europe (2013), Health Literacy. The solid facts; edited by Ilona Kickbusch, Jürgen M. Pelikan, Franklin Apfel and Agis D. Tsouros


Lung Cancer - Policy Update

Recent advances in personalised medicine in lung cancer – how can the benefits be leveraged throughout Europe? Michael Koehler, Commercial Portfolio Lead and Jason Almond, Brand Director, Oncology International Developed Markets at Pfizer discuss why it is imperative to support routine biomarker testing for lung cancer in Europe

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espite the highest mortality rates worldwide amongst all types of cancer, (1) significant progress has been made over the last decade in the classification and subsequent treatment of patients with advanced nonsmall cell lung cancer (NSCLC). In patients whose average life expectancy traditionally ranged around one year, survival of more than 4 years has now been described for patients with NSCLC that bears one of the so-called driver mutations named EGFR, ROS1, or ALK. (2) This much more favourable outcome is achieved through specific targeting of these drivers with EGFR, ROS1 and ALK inhibitors. A patient population of up to 20% of those with advanced NSCLC can potentially benefit from these recent breakthrough therapies. (3) Such tremendous advances in patients’ outcome can only be achieved with the accurate identification of these oncogenic drivers through biomarker testing at the time of initial diagnosis of lung cancer.

Healthcare systems in Europe are still facing numerous challenges with the introduction of routine biomarker testing in lung cancer. (4) Systemic hurdles are spanning technical issues, process-related gaps, insufficient education and funding issues. Numerous efforts were undertaken by medical societies, healthcare funds, patient advocacy groups and industry to establish a proficient and well-functioning testing landscape. However, there remains a huge discrepancy in the percentage of NSCLC patients tested for biomarkers across the European Union, varying from far less than 50% up to 90% in different countries. (5) The result of this shortfall in testing is that a large number of patients are not benefitting from the most efficacious, proven treatment options for their lung cancer. To allow lung cancer patients access to the most appropriate treatments for their individual disease, it is imperative that the European and national health care policies support routine biomarker testing.

establishing routine testing by incentivising cancer centres, supporting the establishment of multi-disciplinary teams, and providing appropriate funding. The authors are employees of Pfizer, Oncology International Developed Markets and in their roles are responsible for the commercial development of medicines in lung cancer. References: 1. Int. J. Cancer: 136, E359–E386 (2015) CV 2014 UICC 2. Clin Cancer Res; 21 (12); 2745-52. 2015 AACR 3. J Thorac Oncol. 2016 May;11(5)613-38. doi 10.1016j.jtho.2016.03.012. 4. J Thorac Oncol. 2016 Jul;11(7)1040-50. doi 10.1016j.jtho.2016.03.010. 5. Ipsos Oncology Monitor (Q2 2016 Moving Annual Totals) – Projected Data (data on file)

National cancer plans as cornerstones for the continuous development of innovative healthcare systems can play a crucial role in

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Government Gazette

Health REport Recommendations to reshape policy making

The recipe to beat prostate cancer

Featuring

Academics and healthcare professionals discuss what the EU should do differently with prostate cancer

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What’s inside A radical vision to beat prostate cancer in Europe 33 An overview of the ICPS Prostate Cancer Europe Roundtable 2017

Call to action

35 White Paper Launch by Prof Dr Hein Van Poppel - Professional bodies

call for action to lower risk and mortality rates in prostate cancer 37 Dr Lydia Makaroff from European Cancer Patient Coalition on why patients should be partners in their treatments 38 Prof Dr Hein Van Poppel from the European Association of Urology on latest twists in diagnosis and treatment 39 Dr Marisca Marian from Bayer offers suggestions for timely drug appraisal and patient access to treatments 40 Dr Bradley Pieters, Head - Brachytherapy Department, University of Amsterdam on the need to improve access to brachytherapy 42 Claire Takizawa and Juliette Plun-Favreau from Genomic Health reiterate the need to reduce health inequalities 44 Prof Giuseppe Morgia, Urology Section, Department of Surgery, University of Catania on the need to centralise patients 45 Dr Brian Wodlinger from Exact Imaging on the role of microultrasound imaging in PCa screening 46 Chris Booth from CHAPS Men’s Health Charity on the latest information on PSA testing 48 Dr Tit Albreht, Head of Centre, National Institute of Public Health addresses future challenges in treatment 49 Dr Ben Pais from Elekta writes about usefulness of Image Guided Adaptive Radiotherapy (IGART) 50 Dr Arnulf Stenzl, Chairman, Eberhard Karls University discusses the role of immunologic prevention


Call For Action

A radical vision to beat prostate cancer in Europe

By Diane Rolland, International Program Manager, International Centre for Parliamentary Studies

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n increasing trend in the incidence of prostate cancer (PCa) has been observed in almost all European countries over the last few decades. There are no population-based, organised programmes for PCa in Europe as existing detection tests do not meet the criteria for screening. Men with suspected low-grade disease are often offered Active Surveillance (AS), however progress to treatment happens only when their biopsy results show the cancer has become more aggressive. There’s new evidence every day of next-generation cancer drugs extending survival while maintaining the quality of life of cancer survivors. Promising new therapies have arrived at the market, yet what explains the gaps in patient access? There are several important points to be raised concerning prostate cancer management and control for the future. Addressing some of these pressing gaps within prostate cancer policy making in Europe, the International Centre for Parliamentary Studies (ICPS) convened the 7th edition of the EU Prostate Cancer Roundtable in Brussels in January 2017. Chaired by John Bowis OBE, Former Member of Parliament and Minister of Health (United Kingdom), it brought together Members of the European Parliament, Representatives from the European Commission, top medical and

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clinical professionals in the fields of urology, oncology and radiology, academic experts and patient groups. The objective of this meeting was to examine current policy guidelines and strategies on managing more effectively prostate cancer within the European member states and to arrive at a shared set of policy priorities that affect the prevention, detection of risk, diagnosis, and management of prostate cancer – the most common cancer in men. The informal group of healthcare policy makers and stakeholders from the industry developed a series of proposed changes in prostate cancer policy making to be considered by the decision makers in Brussels. While not thoroughly exhaustive, they are key orientations to support policy making. Followed by a re-cap of the key policy recommendations presented during an earlier chapter of the EU Prostate Cancer Roundtable and the consequential changes over the year, this year’s discussion was commenced with a launch of the European Association of Urology’s White Paper on Prostate Cancer. Translated in 50 languages, the 22-page White Paper is a set of recommendations and evidence-based guidelines for urological specialists, creating support for patient advocates and facilitating active collaboration with other medical disciplines to lower the risk and mortality rate of this most frequent cancer in men.

What should the EU do differently with prostate cancer? Besides discussing the need for EU-wide screening, improved accuracy, the rate of awareness of existing treatment guidelines, treatment inequalities, the policy makers present at the roundtable discussed the role of personalised medicine, the use of intelligent surgical assistance systems and the need for technologies to support patients and reduce appointments through e-health and m-health. Discussing the value of robotic surgery in prostate cancer treatment, surgeons agreed that it helped in improving recovery and the quality of lives, however they raised an issue relating to costs and treatment disparities. An issue was raised about the costs involved and again, the disparities between health insurances and reimbursement and accessibility between countries. While surgeons started using machines only in 2000, there is still no evidence whether robotic assisted surgery is better than other types of surgery, whether it is cost effective or if it is making the surgeon better. At the moment, the European Commission is funding a trial aiming for patients to use their mobile phone to receive information about their treatments. Though significant advances have been made in the EU fight against cancer, more remains to be done. In December 2003,


Prostate Cancer Health Report

health ministers collectively adopted the European Council Recommendation on cancer screening to implement a national population-based screening for different types of cancers including breast and colorectal. Participants in this year’s roundtable unanimously agreed that such similarities with other cancers should be used in discovering how we can broaden it to PCa screenings. In the same vein as other cancers, national screening programmes should be implemented with suitable standards for prostate cancer. Prostate cancer is a considerable healthcare problem that would benefit from a uniform EU-wide risk adapted early detection programme. Current estimates show that 1 in 7 men in Europe will develop detectable prostate cancer before the age of 85. Incidence rates across European countries vary in unexpected rates, with the variation attributed to an unequally implemented detection programme. There was also a general agreement that eradicating the stigma surrounding prostate cancer could play an integral role in reducing the number of men who are killed by the disease. Delegates agreed that we should help them identify symptoms, speak about the health of their prostate, and eventually help them take control of their health. Key recommendations for better policy making: At a time when cancer survival, including that of prostate cancer, is increasing, it is important to recalibrate our goals and develop a strategy that leads to the cure of prostate cancer. The recommendations listed below have been arrived at through focused discussions and proposals from all stakeholders present at the 7th edition of the EU Prostate Cancer Roundtable: • The EU needs to support initiatives to tackle prostate cancer in the same way as it does with other cancers; • Better assessment of other therapies: robotics, radiotherapy, brachytherapy, surgical techniques should be made; • There is a need for a more objective look at the cost of the diverse treatments for prostate cancer and reflection of cost-

address the late effects of therapy, second disorders and psychological effects before discharge;

effectiveness when comparing the accessible modalities; • Brachytherapy facilities should be provided in a uniform manner across Europe so that all potential patients can have access to it; • We have to bridge the training and guideline gap between experts and primary physicians; • Timely treatment access: It is crucial to treat the patient according to their individual health status and not according to their numerical age; • The EU should implement appropriate pricing and reimbursement across the continent; • Reference centres are vital from a treatment and diagnostic perspective and must have sufficient clinical capacity in experts; • Advanced and metastatic disease and treatments: multidisciplinary approach is required to improve the patient’s quality of life; • PSA tests should be reimbursed for patients across Europe and we should encourage GPs to learn how to interpret them; • There has to be a more efficient use of palliative care to improve the quality of life of patients and families; • There has to be a uniformity in manpower and infrastructure in all areas of the diagnostic pathway across Europe; • Pharmaceuticals should better identify sub sets of patients for each treatment modality, and not market it to everyone at great expense to public purse. There needs to be better agreement between them and clinicians; • The research on eHealth possibilities should be increased in order to create more economic means of diagnosis; • Practitioners should discuss how to

less will become vital.

• Prostate cancer treatments cannot be viewed in isolation from healthcare systems. As demand on the latter is likely to go up considerably faster than the level of investment into healthcare systems, getting more for

Participants at the Roundtable included: Associate Professor, Physician, Aalborg University Hospital, Radiation Oncologist, Academic Medical Center, Vice Chairman, Association Nationale des Malades du Cancer de la Prostate (ANAMACaP), Bayer, Regional Market Access, Secretary General and Head Of The Department - Uro Oncology, Oncology, Belgian Association of Urology, Chief Executive Officer, Chronix Biomedical, Chief Medical Officer, Chronix Biomedical, MD Professor, Copenhagen University Hospital, Chairman, Eberhard Karls University, Vice-President Medical Affairs, Elekta, Radiologist, Erasmus University Medical Center Rotterdam, Chairman, Europa Uomo, President, Europa Uomo Switzerland, Director, European Cancer Patient Coalition, Policy Officer, European Parliament, Scientific and Policy Officer in charge of cancer research, European Commission, Executive Vice President, Exact Imaging, Business Lead, Ireland & EMEA Prostate Marketing Manager, Genomic Health, International Reimbursement and Market Access Manager, Genomic Health, Government Affairs, Janssen, Clinical Oncology, Janssen, Urologist, St. AntoniusHospital, Medical Researcher, Kom op tegen Kanker - Fight against Cancer, Radiation Oncologist, Mater Private Hospital of Dublin, Director, National Cancer Institute Vilnius, Head of Centre, Coordinator of JA Cancon, National Institute of Public Health, Director, NHS European Office, PhD Student, Norwegian University of Science and Technology – NTNU, Oslo University Hospital, Member of the Executive Committee, Società Italiana di Urologia – SIU, EAU Adjunct Secretary General – Education, University Hospitals of the KU Leuven, Medical Professor, University of Bonn (UKB), Consultant, Wales Cancer Network, Technical Officer, World Health Organisation. The next edition of the Prostate Cancer Roundtable will be taking place in 2018. If you wish to attend, please contact information@parlicentre.org

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Call For Action

Professional groups call for action to lower the risk and mortality rate of prostate cancer Implementing prostate cancer awareness campaigns and corresponding survivorship plans, at both European and national levels, are key elements in effective healthcare strategies, but these moves have to be underpinned by a dynamic research environment and efficient collaborative work between professional and patient advocacy groups. Prof Dr Hein Van Poppel, Adjunct Secretary General Education, European Association for Urology, briefly presents the main findings of the White Paper on Prostate Cancer, launched at the PCa Europe Roundtable 2017 organised by the International Centre for Parliamentary Studies at Brussels in February 2017

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n conjunction with a recent Roundtable organised by the International Centre of Parliamentary Studies, where EU policymakers, medical professionals, academic experts, healthcare payers and patient groups explored practical solutions to reach an EUwide consensus on the management of the prostate cancer, the European Association of Urology (EAU) announced the launch of a new White Paper discussing how we can lower the risk and reduce the mortality rate of this deadly cancer. Prostate cancer (PCa) affects one in seven men in Europe and accounts for more than 417,000 new cases and 92,000 deaths recorded annually in the region. In comparison, breast cancer, the most common cancer in European women, recorded an estimated incidence of 458,337

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in 2012. One in eight women in the EU-28 will develop breast cancer before the age of 85. Although the statistics are quite similar, the public awareness for breast cancer is much higher. This White Paper on PCa was prepared in close connection with medical experts, representatives from related medical societies and patient advocacy group and covered key topics such as risk factors and prevention, diagnosis, treatment, living with prostate cancer, the role of the EAU and the current activities initiated by the European Union (EU) regarding cancer control. Prevention Besides established risk factors like increasing age, ethnic origin and family history, the White Paper states that obesity has an important impact on the progression of the disease. Underscoring that there is

limited, conflicting or low-level evidence to directly link PCa to obesity, poor diet and lack of exercise, among other factors, the White Paper still recommends the importance of early detection to remain ahead of the disease’s metastatic spread. Early detection reduces PCa-related mortality and reduces the risk of being diagnosed with and developing advanced and metastatic PCa, especially when conducted in combination with guideline-based treatment. The EAU widely disseminates a set of guidelines on prostate cancer treatment which are officially endorsed by the national urological societies of all 28 EU member states and 27 countries outside Europe. One of the main recommendations of the White Paper is that “future updates of the EAU guidelines should take into consideration the recommendations made by

The EU research and innovation programme, Horizon 2020, and its successor can support an environment conducive to translational research in key areas for PCa, such as personalized medicine, in vitro diagnostics (IVDs) and the socio-economic impact of cancer, in order to support three main areas where research gaps are still wide.


Prostate Cancer Health Report

The EAU widely disseminates a set of guidelines on prostate cancer treatment which are officially endorsed by the European Society for Radiotherapy and Oncology (ESTRO) and the International Society of Geriatric Oncology (SIOG). The same EAU guidelines on PCa have been endorsed by all 28 EU member states and 27 countries outside Europe

the European Commission’s Joint Action on Cancer Control (CanCon) in relation to the creation of survivorship cancer plans, to be provided by the urologist to the patients as a guide to facilitate the return of the patient to a normal life.” Future prospects Regarding future prospects, the White Paper stressed the importance of creating a favourable environment for translational research on prostate cancer. Boosting research studies that examine new biomarkers and gene mutations linked to inherited and aggressive types of prostate disease may lead to the development of diagnostic and prognostic markers, risk stratification and more effective drugs. These new personalised treatments may further improve clinical effectiveness and may have fewer side effects,” the paper noted. However, research outcomes have to be conveyed to patient groups and their usefulness placed within the context of individual treatment plans. To achieve this goal, the EAU stresses increased awareness on the potential of personalised medicine to both European and national decision-makers. The current collaborations between the EAU, the European Cancer Patient Coalition (ECPC) and the European Prostate Cancer Coalition (Europa Uomo) will be extended to ensure that patients and policymakers are aware of the need to facilitate research into personalised medicines for PCa. “The role of PCa patient advocacy groups is also extremely important to sustain awareness campaigns, both at the European and national level and to help achieve the main goals set out in this paper,” the

EAU said as it reiterated to continue actively engaging EU institutions. Role of the European Union The White Paper also highlighted the EU’s central role in bringing together various sectors as reflected by the European Commission creating in 2014 the Expert Group on Cancer Control, and followed in the same year with the establishment of CanCon aiming to create a European Guide on Quality Improvement in Comprehensive Cancer Control, which is intended for governments, parliamentarians, health care providers and funders and cancer care professionals at every level. “Given the EU competence in public health and prevention, the EU could certainly do more to help raise awareness of medical practitioners and citizens on PCa. Programmes such as the EU Health Programme could provide support to a pan-European awareness raising campaign on PCa, either through a specific call for proposals for projects on this topic, or through making cancer a priority for framework partnership agreements with European non-governmental organisations,”

the White Paper noted. In its call for all stakeholders to consolidate their efforts and benefit from synergies, the White Paper underscored that equitable healthcare access and effective awareness campaigns and survivorship plans are equally vital. All contributors agree on the fact that PCa is a considerable healthcare problem that would benefit from a uniform EU-wide risk adapted early detection programme for PCa. The EU should increase funding to improve both the diagnosis and treatment of men with PCa. It needs to fund work to better understand the association between potential risk factors and lethal PCa. Together with the EAU, research organisations and patients groups, the European Union should start acting by raising men’s awareness of PCa and consistent EU actions in this area. About the European Association of Urology The EAU represents the leading authority within Europe on urological practice, research and education. Over 15,000 medical professionals have joined its ranks and contribute to their mission: To raise the level of urological care throughout Europe and beyond. For over 40 years the EAU has addressed the most pressing issues of urological care in Europe and stimulates scientific and educational initiatives. Prostate Cancer is one of those pressing issues. The White Paper Prostate Cancer, recommendations to lower risk and mortality rate of the most frequent cancer in men, is one of many initiatives the EAU takes in this field. For more information see uroweb.org.

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Treatment Modalities

Integrating patient preference into treatment decisions prove crucial Director of the European Cancer Patient Coalition, Dr Lydia Makaroff, writes that patients should be partners in their own treatments, as well as empowered to offer insights and practical recommendations to improve policy

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he rates of prostate cancer have increased substantially over the last two decades. While effective treatments exist if the cancer is detected early, outcomes are worsened by delays in diagnosis and treatment. Outcomes can be improved by effective screening programmes, treatment in line with current guidelines, as well as faster authorisation, pricing and reimbursement decisions. Effective action for people with prostate cancer depends on a coherent multistakeholder European strategy, with a united approach to marshalling and integrating limited resources. Patients and patient organisations must be involved in developing policies that result in improved survival and quality of life for people with prostate cancer (2). The complexity of selecting treatment options can lead to people with cancer feeling uncertain about which option to choose, especially when each option has different risks and benefits. Treatment discussions and decisions should be patientcentred, based on the needs and preferences of the person diagnosed with cancer. However, many people with prostate cancer report that they lack information, and are unable to communicate what is important to them during discussions with health professionals. Improving patient-clinician engagement through tools such as webbased decision support technology can help patients to become better informed, resulting in higher levels of patient satisfaction (1). To ensure a truly patient-centred approach, people with prostate cancer should be provided with information on multidisciplinary treatment plans, to allow

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them to make an informed decision, based on their individual profile. A strong collaboration of health professionals is needed, including urologists, nurses, oncologists, psychologists, nutritionists, sexual therapists, physiotherapists, and experts in supportive care. Patients, patient representatives, and patient organisations are also important resources for both people with cancer and their informal carers (2). There is also a need to increase the awareness of the potential of personalized medicine and support research into this area. To work towards this objective, the European Cancer Patient Coalition is partnering with the European Association of Urology, the European Prostate Cancer Coalition (Europa Uomo), and the European Alliance for Personalised Medicine to ensure that policymakers are aware of the need to continue to invest into research in personalised medicines. For many cancer survivors, prostate cancer becomes a chronic disease, with late effects that cause many emotional and social problems. These effects may have a substantial impact on everyday life, work, social life, and sexuality. Proper followup should be included in a personalized cancer survivorship plan, to empower individuals and ensure that each person has as much control as possible over their life. For example, prostate cancer survivors should be encouraged to engage in walking and other forms of non-vigorous physical activity to improve their quality of life (3). Furthermore, as secondary and tertiary prevention are essential for all cancer survivors, necessary measures should be addressed in the cancer survivorship plan. The European Cancer Patient Coalition was involved in the production of the European Association of Urology’s White Paper on Prostate Cancer (2). This white paper has six main policy recommendations: 1. European institutions and member states should ensure that people with prostate

cancer receive high quality, standardized, and integrated care with a focus on a patientcentred multidisciplinary approach. 2. The EU and its member states should also guarantee equitable access to novel technological tools that enable better diagnosis, treatment and research. 3. Access to innovative treatments and personalised medicines should be made fast and equitable for all people with prostate cancer who can benefit from them. 4. Prompt and consistent Health Technology Assessment should be performed on all new screening, diagnostic, therapeutic and rehabilitation technologies in order to provide the base for effective and efficient, targeted and optimised allocation of resources in urology and specific prostate cancer services. 5. Awareness campaigns should be sustained at both European and national level 6. The EU and its member states should promote the implementation of survivorship cancer plans, to facilitate the return to a normal life for all European cancer patients. Implementing these policies at a European and national level will result in earlier diagnosis, more equitable care, and improved quality of life for people diagnosed with prostate cancer. References: 1. Davison J, Szafron M, Gutwin C, and Visvanathan K. 2014. Using a web-based decision support intervention to facilitate patient-physician communication at prostate cancer treatment discussions. Canadian Oncology Nursing Journal. 24(4): 241-247 2. European Association of Urology. 2017. Prostate cancer: Recommendations to lower the risk and mortality rate of the most frequent cancer in men. Arnhem: European Association of Urology 3. Phillips SM, Stampfer MJ, Chan JM, Giovannucci EL, and Kenfield SA. 2015. Physical Activity, Sedentary Behavior and Health Related Quality of Life in Prostate Cancer Survivors in the Health Professionals Follow-up Study. Journal of Cancer Survivorship. 9(3): 500–511


Prostate Cancer Health Report

Latest twists in PCa diagnosis and treatment Prof Dr Hein Van Poppel, Adjunct Secretary General - Education, European

Association for Urology, provides an overview of the latest in the fast moving field of prostate cancer diagnosis and management

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opulation based PSA screening has remained contentious over the last 20 years. Today, with longer follow up in the European randomized prostate cancer screening study (ERSPC) it is clearly shown that screening decreases prostate cancer mortality while the numbers to test and the numbers to treat to avoid one prostate cancer death continue to decrease, and get close to the figures known for breast cancer screening. Therefore, the EAU today clearly states that men should not be subjected to PSA testing without counselling them on the potential risks and benefits, but one should offer an individualised risk adapted strategy for early detection to the well informed man with good performance status and a life expectancy of at least 15 years. The guidelines of the EAU, also reported in the “White Paper on Prostate Cancer”, specify the modalities of PSA screening. To avoid over-diagnosis, the use of multiparametric MRI has shown to become instrumental. MRI ignores low grade insignificant cancers, does avoid biopsy and its complications and at the same time decreases overtreatment of low risk cancer. MRI is becoming the key examination, even the first examination to be done in a men who are at risk of having prostate cancer. While still some Gleason 3 + 3 are found either with systematic biopsies or at TURP, oncologic urologists know that the vast majority of these cancers can be managed with active surveillance, including repeated PSA testing, repeated mpMRI and eventually re-biopsy. Not only in elderly patients but also in younger patients active surveillance will become widely applied. Further research on biomarkers should further help the urologists to better distinguish between

insignificant and aggressive cancers. By doing so, one will be able to also safely surveil a number of Gleason 3 + 4 cancers. The best local treatment for aggressive prostate cancer remains surgery as shown by long term follow up studies and registries. Since they showed that at 15 years follow up, the prostate cancer mortality can be twice as high after primary treatment with radiotherapy, there is today a trend of offering surgery to the most aggressive and high risk prostate cancers. The surgery, performed open or laparoscopically (eventually robot assisted) is complemented with extensive lymph node dissection. Multidisciplinary tumour boards can after the surgery, looking at the definitive pathology, the postoperative PSA, the wishes of the patient, … decide on when and where radiotherapy can be used in an adjuvant or salvage setting and when hormonal treatment is mandatory. Another newcomer in the staging and follow up of prostate cancer is the Choline- or even better the PSMA-PET-CT. Its use is rapidly increasing in patients that had earlier surgical or radiation treatment for presumably localised disease and that present with PSA relapse after one or two local treatments. With the nuclear imaging we are now faced with a new disease, the oligometastatic hormone naïve prostate cancer, an entity that we didn’t know or recognize years ago. Instead of treating those patients with hormones, nowadays many high volume centres deliver metastasis directed therapies (MDT) (surgical

removal of lymph nodes, radiotherapy to lymph nodes or to solitary bone metastases) but it is obvious that randomized trials will need to position this MDT. The last important newcomer follows after three randomised clinical trials showing that the early administration of six times Docetaxel together with conventional hormonal manipulation improves survival in the newly diagnosed metastatic prostate cancer patient. The beneficial effect is more pronounced in more advanced metastatic disease but the combination of chemotherapy plus hormonal therapy should be discussed in all new metastatic prostate cancer patients. With an increasing complexity of the management of prostate cancer today, the patients need to be involved and correctly informed. The patient information leaflets prepared by the EAU and translated in many European languages are an excellent starting point to empower the patient to discuss his situation with his caregiver.

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Treatment Modalities

Ensure patient access to nextgeneration cancer treatments

There have been several new promising therapies for prostate cancer, but many patients across Europe are not yet getting equal access to treatment. Dr Marisca Marian from Bayer calls on policy makers, researchers and key stakeholders to work together to ensure drug-appraisal ensures timely patient access to new medicines

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normous progress has been made in cancer treatment during the last 20 years. As researchers have learned more about the mechanisms of cancer drug resistance, they’ve developed a number of next-generation therapies that markedly delay the progression of disease, allowing patients to live longer. Cancers that would have been fatal a decade ago are now being managed with treatment, while patients are able to conduct their daily lives. Prostate cancer is a case in point. Most men will be diagnosed early and their cancer can be controlled for years; however, there are times when it becomes life threatening. Clinical practice guidelines issued by the European Society for Medical Oncology (ESMO) and the European Association of Urology (EAU) offer a comprehensive overview of recommended treatments, ranging from active surveillance in early-stage disease to more aggressive approaches as it advances. However, the pattern of progression is rarely linear, and patients often have different and highly individualised treatment goals that may not

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always align exactly with the guidelines. Especially for men with late-stage cancer and rapidly spreading bone metastases, treatment is challenging. (3)

the trademark symptomatic skeletal events that result in costly hospital stays. (8) As a result, only a fraction of patients are seeing the benefits of scientific progress.

Thankfully, the past decade has ushered in several promising treatments for advanced prostate cancer. From 2004 to 2013, four new therapies have been approved. (3, 4, 5, 6) However, even with these and other, newer life-extending prostate cancer therapies, many patients across Europe are still not getting equal and timely access to treatment. The clinical burden of prostate cancer in Europe remains substantial.

Advanced patients don’t have time to wait. It is critical that independent value assessments keep pace with advances in clinical evidence, which accumulates over time and takes into consideration input from all key stakeholders. In recent years, steps have been taken to streamline HTAs across the EU’s 28 member states. Collaborations like the European Network for Health Technology Assessment (EUnetHTA) have formed to improve the process for granting patient access through joint approaches on scientific advice, mutual input on clinical guidelines and debate surrounding evidence requirements, like relative efficacy.

What explains the gaps in patient access? According to a recent Value in Health study, fragmented and outdated practices among health technology assessment (HTA) bodies delayed or even prevented patient access to 10 cancer drugs approved by the European Medicines Agency (EMA) from 2010 to 2012. (7) In other instances, HTAs discounted the merits of attributes like delaying time to bone metastasis or maintaining quality of life when assessing drug value, or discounted the economic burden associated with bone metastases and

We manufacturers can also do our part to assist HTAs. We can provide real-world evidence demonstrating the benefits of alternating treatments and employing multiple lines of therapy in resistant or hard-to-treat cancers. We can define new, patient-focused endpoints that measure the value of quality-of-life (QoL), as well as


Prostate Cancer Health Report

surrogate endpoints beyond Overall Survival (OS). And we can ensure a closer dialogue with HTAs from early in drug development and along the life-cycle of products to better identify regulatory requirements and reduce duplication. Evidence accumulates every day of nextgeneration cancer drugs extending survival while maintaining QoL. A few cancers are even becoming chronic diseases that can be controlled for long periods by a succession of different treatments. Nevertheless, the development of new therapies is meaningless when the very mechanisms for evaluating them are stalling their delivery to those who need them most. All healthcare stakeholders – industry, researchers, policy-makers, payers, and regulators – need to work together to ensure drug-appraisal ensures timely patient access to new medicines. HTAs differ from country to country, but all share the same commitment to ensuring patient access to safe, quality treatments.

Improve access to brachytherapy for all patients across Europe Despite brachytherapy being highly effective among prostate cancer patients, availability of facilities differs across Europe and several countries are still under-equipped. Dr Bradley Pieters, Head - Brachytherapy Department, University of Amsterdam, calls for a uniform spread of brachytherapy facilities among all European countries and reiterates the need for raising awareness about its applications in treating prostate cancer

low-dose rate (LDR) isotope (iodine-125) is used. The sources are placed directly in the prostate gland using needles passed through the skin of the perineum under anesthetic guided by ultrasound. This treatment can be delivered as a daytime admission or at most onenight hospital admittance. Because of the low source activity used, the sources remain for a lifetime in the human body and decay over several months to negligible radiation activity.

We’re hopeful the information sharing and progress being made to fill knowledge gaps, improve standards in methodology and assessment, and factor real-world evidence and other sources of data into decision-making will soon result in a more streamlined healthcare system that expands cancer treatment options for patients and physicians. References: 1. Parker C, Gillessen S, Heidenreich A, Horwich A, on behalf of the ESMO Guidelines Committee. Cancer of the prostate: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 26 (Supplement 5): v69–v77, 2015/ doi:10.1093/annonc/mdv222. Published online 22 July 2015. 2. Mottet M et al. EAU-ESTRO-SIOG guidelines on prostate cancer. Eur Urol. 2017;71:618-629. 3. de Bono JS, et al. Lancet. 2010;376:11471154. 4. de Bono JS, et al. N Engl J Med. 2011;364:1995-2005. 5. Scher HI, et al. N Engl J Med. 2012;367(13):1187-1197. 6. Parker C, et al. N Engl J Med. 2013;369(3):213-223. 7. Akehurst, Ronald L et al. Variation in Health Technology Assessment and Reimbursement Processes in Europe 8. Value in Health. 2017;20 (1): 67-76. 9. Jayasekera J, et al. PharmacoEconomics. 2014;32 (2): 173-191.

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rostate cancer is by now the most common cancer among males in Europe. For localised low-risk prostate cancer, an active surveillance policy can be followed. However, patients at aggressive stages of the disease are commonly treated by surgery or radiation therapy. When radiation treatment is considered, several options are available including brachytherapy, intensity modulated radiotherapy (IMRT), and proton therapy. Based on the stage of the disease, radiation therapy may be combined with hormonal therapy. Choice of treatment should be according to patient preference and based on expected outcome, considering both cancer control and side effects. However, the choice of therapy for individual patients, particularly the choice for brachytherapy, can be influenced by the availability of resources. Brachytherapy The techniques of brachytherapy can be divided in permanent and temporary implants. For permanent implants a

Temporary implants are performed by placing needle or catheters in the prostate using the same ultrasound guided technique. In this case a high-dose rate (HDR) source (iridium-192) is used that is passed through the needles or catheters by a brachytherapy afterloader. This is a machine that enables safe application of high dose rate radiation using remotely controlled transmission and withdrawal of the source along guide tubes into the patient. For HDR brachytherapy, several radiation exposures (fractions) may be necessary; although there are several promising studies showing that a single dose will result in a satisfactory outcome. Advantages The major advantage of brachytherapy is that the radiation dose distribution can be planned and delivered in a very conformal way, adapted to the prostate shape of the individual patient. In this way, the dose is concentrated in the prostate gland, where the tumor is, and the neighbouring organs receive only a very small dose, an important consideration in minimising side effects. Another not unimportant aspect of brachytherapy is the cost of treatment. Brachytherapy equipment is the least expensive of all available radiation therapy

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Optimising Treatment

equipment and because treatment is performed in one or two days the total cost of treatment is limited particularly when compared to surgery or a prolonged course of external beam radiotherapy. The cost of installation of a brachytherapy unit is in the order of €400-600K, whereas for an IMRT linear accelerator is €2-3M and a proton center €100-300M. Labour costs are another expense that determines the overall cost of treatment. When comparing a 1-2 day brachytherapy treatment to a 4-7 weeks EBRT treatment the cost differences can be by a factor 2 to 4.

France, Spain, and Italy availability offer brachytherapy. Whereas 60% of radiotherapy departments in northern, eastern and southeastern European countries have such facilities. (5) Where brachytherapy cannot be offered to patients, they will be offered surgery or radiation treatment provided by IMRT and in certain cases even by the more expensive proton therapy.

Threats Despite the favourable treatment outcome with brachytherapy and the lower costs, not all patients in Europe can be offered this treatment modality because of restricted availability. About 52% of all radiotherapy departments in Europe have brachytherapy facilities. The availability of brachytherapy facilities differs among European countries. 40% of all radiotherapy departments in

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5. There is a need for a more balanced look at the cost of the different treatments for prostate cancer and consideration of cost-effectiveness in comparing the available modalities. 1. Shah C, Lanni TB, Jr., Ghilezan MI, Gustafson GS, Marvin KS, Ye H, et al. Brachytherapy provides comparable outcomes and improved cost-effectiveness in the treatment of low/intermediate prostate cancer. Brachytherapy. 2012;11:441-5.

Efficacy

Image showing an LDR prostate implant with sparing of the urethra (indicated by an arrow) and rectum (bottom of the picture). Circles are the positions of the radioactive sources. Coloured lines indicate the dose distribution within and around the prostate, which is outlined in red.

4. Expansion of brachytherapy facilities should be planned to enable access and delivery of treatment without unacceptable waiting lists developing.

References:

As an example, published data from the United States, facing the same issues as in Europe, shows the large differences in cost of prostate cancer treatment estimated to be $2395, $5467, and $23,665 for LDR, HDR and IMRT, respectively. (1) Brachytherapy has been shown to be an efficient treatment modality to treat prostate cancer. In a comprehensive literature review tumor a control probability of 82-96% at 10-12 years was found. (2) As expected by the favourable dose distribution the toxicity rates were low. (3) In the recent randomized ASCENDE-RT trial a better disease-free survival was found for patients for who brachytherapy was given compared to IMRT alone. (4)

3. The option for brachytherapy needs to be discussed with every single candidate patient in order that they are able to choose among all potential treatments.

The reason why brachytherapy is not offered or not discussed with patients is often because of the restricted availability of brachytherapy and a lack of education and training in brachytherapy to develop new teams comprising brachytherapists (medical doctors), clinical physicists and radiation technologists. Urgent measures In order to maintain and increase the use of brachytherapy for the treatment of prostate cancer some measures need to be taken by policymakers, governments, stakeholders, national cancer societies, oncology and radiotherapy departments, and professionals in the field. 1. There is a need for the uniform spread of brachytherapy facilities among all European countries so that all potential patients can have access. 2. Education of residents and young specialists needs to be developed to include knowledge of brachytherapy and its applications in prostate cancer.

2. Crook J. Long-term oncologic outcomes of radical prostatectomy compared with brachytherapy-based approaches for intermediate- and high-risk prostate cancer. Brachytherapy. 2015;14:142-7. 3. Budaus L, Bolla M, Bossi A, Cozzarini C, Crook J, Widmark A, et al. Functional outcomes and complications following radiation therapy for prostate cancer: a critical analysis of the literature. Eur Urol. 2012;61:112-27. 4. Morris WJ, Spandinger I, Halperin R. Low-Dose-Rate Brachytherapy for Low- and Intermediate-Risk Prostate Cancer: A DoseResponse Analysis for 3392 Consecutive 125-Iodine Monotherapy Patients. Radiother Oncol. 2015;115:S239. 5. Rosenblatt E, Izewska J, Anacak Y, Pynda Y, Scalliet P, Boniol M, et al. Radiotherapy capacity in European countries: an analysis of the Directory of Radiotherapy Centres (DIRAC) database. The Lancet Oncology. 2013;14:e79-e86.


Prostate Cancer Health Report

Optimising prostate cancer care, providing patients with best outcomes Innovative genomic-based diagnostic technologies can help patients and healthcare professionals to assess risk and personalise treatment. Claire Takizawa and Juliette Plun-Favreau from Genomic Health explain why barriers to equal access should be urgently addressed

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rostate cancer (PCa) is the most common cancer diagnosed in men, with 417,000 new cases every year in Europe (1), because of an ageing population and also the wide presence of screening programmes in developed countries. Compared to the high incidence rate, PCa has a low mortality. Most men diagnosed with low and intermediate-risk prostate cancer will not die of PCa. Nonetheless, in Europe, the majority of these patients are treated with radical therapy, despite the small chance of their disease progressing. In addition to being costly, over-diagnosis of disease and overtreatment of non-clinically-meaningful tumours may result in lasting side effects such as urinal

dysfunction, sexual dysfunction, bowel problems, pain, fatigue and disturbed sleep. (2) Recent studies have demonstrated that more men with low risk disease can be managed safely with active surveillance (3), avoiding negative side effects and saving costs related to overtreatment. Assessing risk and guiding treatment decisions - traditional tests Traditionally, physicians have used PCa characteristics such as tumour stage, prostate specific antigen level, Gleason score and imaging to estimate the aggressiveness of PCa and to help guide treatment decisions. These traditional characteristics and new imaging techniques (MRI) are helpful, but cannot fully determine whether a man has low-risk PCa that can be safely managed

with active surveillance, or whether he has aggressive PCa that will benefit from more radical therapies. The need for better tools - The Oncotype DX® Genomic Prostate Score™ There is a strong need for better tools to stratify newly diagnosed PCa patients and the aggressiveness of their tumour. In this respect, genomic testing is increasingly being used by physicians to determine the risk of the patient’s PCa. The Oncotype DX® test improves risk stratification by incorporating individual underlying tumour biology that can help patients and physicians decide on the best treatment option. The Genomic Prostate Score™ is a biopsybased genomic test that looks at 17 genes

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Improving Outcomes

Prof. Roger Kirby, The Prostate Cancer Center, London, UK: “New genomicbased diagnostic technologies such as the Oncotype DX® Genomic Prostate Score™ are very valuable tools to personalise and optimise prostate cancer care, enabling physicians and patients to confidently decide on the best treatment option, leading to better outcomes. Unfortunately access for patients to the Oncotype DX assay and other genomic-based technologies is limited and unequal across Europe. This needs to be addressed.”

across four distinct biological pathways to predict prostate cancer aggressiveness. The test is used in conjunction with the Gleason grading system, imaging (e.g. MRI) and conventional parameters to personalise prostate cancer treatment. It adds independent predictive information beyond standard clinical and pathological measures, meaningfully impacting patient treatment decisions. The development and validation of the Oncotype DX assay included over 1,500 patients. (1, 2, 3) Additional information is available on: http://prostatecancer.oncotypedx.com/en-US/Professional. Prof. Roger Kirby, The Prostate Cancer Center, London, UK: “New genomicbased diagnostic technologies such as the Oncotype DX® Genomic Prostate Score™ are very valuable tools to personalise and optimise prostate cancer care, enabling physicians and patients to confidently decide on the best treatment option, leading to better outcomes. Unfortunately access for patients to the Oncotype DX assay and other genomic-based technologies is limited and unequal across Europe. This needs to be addressed.” Urgent action required to improve patients’ access Despite the fact that genomic-based diagnostic tests offer important benefits to patients and healthcare professionals, access to these innovative technologies remains unequal across Europe, with reimbursement and value assessment constituting the main barriers. (1) Current European healthcare

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systems are not designed to support innovative genomic-based technologies which can optimise PCa care, leading to better outcomes for patients. (2) Unclear or non-existent reimbursement pathways, together with the lack of clear evidence requirements, have led to significant delays in the assessment of these new technologies in different countries or regions. (6) Clarification and reform of such pathways, is urgently needed. Clear value-based funding and reimbursement systems and rewarding outcomes should be developed and implemented at relevant levels (national or regional), together with adapted Health Technology Assessment (HTA) processes including clear evidence requirements and value recognition. In addition, EU research and innovation programmes, should support research advancing the use of precision medicine in prostate cancer care, including genomic-based diagnostic tools and their impact on clinical practice.

for Research on Cancer; 2013.

EU initiatives in the areas of research, cancer and HTA (strengthening EU cooperation to clarify and harmonise evidence requirements) are an important opportunity to support PCa patients across Europe in accessing new tools, like the Oncotype DX test, that provide them with the best possible health and quality of life outcomes.

6. Klein et al. A 17-gene Assay to Predict Prostate Cancer Aggressiveness in the context of Gleason Score heterogeneity, tumor focality and biopsy undersampling. Eur Urol. 2014.

References: 1. Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11. Lyon, France: International Agency

2. Cooperberg MR, Broering JM, Carroll PR. Time trends and local variation in primary treatment of localized prostate cancer. J Clin Oncol. 2010;28(7):1117-23. 
 3. Glass AS, Cooperberg MR, Meng MV, Carroll PR. Role of active surveillance in the 
management of localized prostate cancer. J Natl Cancer Inst Monogr. 2012;2012(45):202-6 4. Cooperberg et al. Development and validation of the biopsy‐based genomic prostate score (GPS) as a predictor of high grade or extracapsular prostate cancer to improve patient selection for active surveillance. AUA 2013 5. Cullen J et al. A biopsy-based 17 gene genomic prostate score predicts recurrence after radical prostatectomy and adverse surgical pathology in men with Prostate Cancer. Eur Urol 2014

7. Plun-Favreau J, et al. Enabling Equal Access to Molecular Diagnostics: What Are the Implications for Policy and Health Technology Assessment? Public Health Genomics; 2016; 19:144–152 8. Miller I, et al. Market access challenges in the EU for high medical value diagnostic tests. Pers Med 2011;8:137–148. 



Prostate Cancer Health Report

Need for a multidisciplinary approach to PCa By Prof Giuseppe Morgia, Urology Section, Department of Surgery, University of Catania

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rostate cancer (PCa) represents the most common cancer in men in developed countries in 2013. Incident cases increased more for prostate cancer than any other malignancy globally, irrespective of development status. In fact, incidence and death rates have risen considerably between 1990 and 2013, with the steepest rise in agestandardized incidence rates of all cancers in men, and a higher percent change in developing versus developed countries (1) With the worldwide diffusion of PCa screening, the number of prostate biopsy due to elevated prostate specific antigen (PSA) has increased over the years. Although the PSA test lead to an increased risk of PCa at an early stage of the disease, it has limited specificity for detecting clinically significant tumours leading to unnecessary biopsies and detection and treatment of some indolent tumours. (2) For these reasons PSA screening is still controversial due to some limitations of the test and it is one of the most debated matters. (3) As a consequence, active surveillance (AS) has gained popularity with the aims to mitigate the overtreatment of indolent disease and potentially harmful side effects of active treatments, retaining the option of definitive therapy for patients who are reclassified over time as high risk. (4) Despite its several benefits, AS has been

underutilised for men with localised prostate cancer for some reasons. One of these may be attributable to cancer-related anxiety on the follow-up management. In fact, the severity of distress may vary with perceptions of health and overall psychological adjustment. (5) Distress of patients may be related to the uncertainty of the results of the visit, PSA and biopsy diagnosis during the followup that perpetuate anxiety, especially in predisposed men. It is in fact known that as people wait, they increase in distress and other events during this time like experiencing negative emotions with anxiety and worry. In fact, it has been proposed that men who choose AS may be at greater risk of psychological distress because of the passive nature of the strategy. Unfortunately, up to now it is not clear how to identify demographic predictors for these conditions. Some previous studies have identified that some variables like impaired mental health and patient’s perceived importance of the physician in the treatment decision making process appear to be associated with poorer quality of life among AS patients. Based on all these premises how can we centralise patients’ emotions and take care of their distress? First of all, it is now evident that physicians cannot work alone. In this context, the professional figure of psychologist should be more involved

In the present context, it is evident that physicians cannot work alone anymore. Particularly, a psychologist should be more involved during the treatment decision making and counselling, as men who choose Active Surveillance may be at greater risk of psychological distress because of the passive nature of the strategy

during the treatment decision making and counselling. Moreover, academic institutions of urologists (such as the European Association of Urology) and health organisations should strength their communication system in order to educate patients about PCa diagnosis and treatment strategy. A multidisciplinary team should be present at every atage of care, starting from screening, treatment and especially in AS protocols in order to provide an effective management of the disease. References: 1. Dy, G. W., Gore, J. L., Forouzanfar, M. H. et al.: Global Burden of Urologic Cancers, 1990-2013. Eur Urol, 2016 2. Roobol, M. J., Steyerberg, E. W., Kranse, R. et al.: A risk-based strategy improves prostate-specific antigen-driven detection of prostate cancer. Eur Urol, 57: 79, 2010 3. Loeb, S.: Guideline of guidelines: prostate cancer screening. BJU Int, 114: 323, 2014 4. Cantiello, F., Russo, G. I., Cicione, A. et al.: PHI and PCA3 improve the prognostic performance of PRIAS and Epstein criteria in predicting insignificant prostate cancer in men eligible for active surveillance. World J Urol, 34: 485, 2016 5. Tan, H. J., Marks, L. S., Hoyt, M. A. et al.: The Relationship between Intolerance of Uncertainty and Anxiety in Men on Active Surveillance for Prostate Cancer. J Urol, 195: 1724, 2016

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Screening For Prostate Cancer

The role of micro-ultrasound imaging in PCa screening and management By Dr Brian Wodlinger, Manager, Advanced Development and Clinical Research, Exact Imaging High Resolution Micro-Ultrasound Exact Imaging has developed a highresolution (<100 micron) micro-ultrasound system for urology that addresses the clinical need for more accurate screening without significantly changing the pathway or increasing costs from the current standard of care. The ExactVu™ micro-ultrasound system provides a 300% improvement in resolution compared to conventional ultrasound, and recent data show dramatic improvements in the ability to detect prostate cancer. (9,10) The microultrasound scan is a direct replacement for conventional ultrasound, has better resolution than MRI and can be performed in real time in the urology office for both targeted and systematic biopsy guidance.

ExactVu™ micro-ultrasound offers a 300% improvement in resolution over conventional ultrasound, and is proving highly sensitive to prostate cancer, providing a powerful new tool to improve patient care

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rostate cancer is the most common cancer in the western world, and the inefficacy of current screening practices are leading health care systems to explore new technologies. Current screening using systematic biopsy guided by conventional ultrasound is cost effective and has a well established patient flow centered around the urologist, who is best positioned to manage and treat the patient. Unfortunately, conventional ultrasound lacks the resolution required to target biopsies effectively and thus fails to find cancer in an estimated 30-40% of men with the disease. (1–3) Failing to identify cancer on first biopsy results in repeated procedures which are costly and increase risk to the patient. Further, the delay in detection causes patients with aggressive disease to be identified later, resulting in lower rates of curative treatment, reduced quality of life, and higher healthcare costs. Multi-parametric MRI Using multi-parametric MRI as a screening tool has become a topic of debate within the urology community. Some large academic centers have achieved good results performing MRI-based targeted

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biopsies, recently demonstrating a 12% (4) missed cancer rate, and in certain cases an ability to postpone biopsy in men who have no targets identified by MRI. Similar results (5) merited changes to the EAU recommendations (6), which now suggest that MRI be used on men with prior negative biopsy and persistent clinical indications. Unfortunately, these lower false negative rates have been inconsistent, especially at lower volume centers, and there is significant variability even between expert readers. (7,8) Further, within this highly complex procedure, there are significant economic concerns due to the high cost of MRI, expert radiologist review, and specialized MRI/US fusion system required, especially compared to traditional in-office ultrasound costs. If this technology is to expand from the niche identified in the EAU recommendation, costs must drop significantly and a unified education and quality plan will be required to ensure consistency between readers. Even then, this technology has been shown to be less sensitive to low-grade cancer. While this is often discussed as a positive for MRI, it may require tighter screening intervals since it is unable to separate men with benign prostates from those with low-grade cancer who require more frequent follow-up.

The ExactVu™ system recently received regulatory approval for sale in both Europe and North America, and is now available commercially. Like MRI’s PI-RADS, a standardized risk identification and reporting protocol is available for microultrasound as well. PRI-MUS™, or “Prostate Risk Identification using Micro Ultrasound”, has undergone retrospective and forthcoming prospective validation studies to demonstrate its performance. (10) Also like MRI, initial results suggest that micro-ultrasound with PRI-MUS may be useful in safely avoiding biopsy in some men with low risk factors and no targets identified on imaging. (11) Micro-Ultrasound Imaging for Active Surveillance Prostate cancer is the most common cancer among men in the western world, however it is only the 3rd leading cause of cancerspecific mortality in Europe. (12,13) This is because many prostate cancers progress too slowly to be a danger. Men with suspected low-grade disease are offered Active Surveillance where they are re-biopsied, often annually, and progress to treatment only when their biopsy results show the cancer has spread or become more aggressive. One of the promises of imaging-based technologies is to allow comparison of images between follow-up intervals, with biopsy only required if the imaging results show a change. For this to be safe and effective a high sensitivity is required, ensuring that the rate of missed cancer is very low. Preliminary results show this may be possible with micro-ultrasound. A similar technique could be considered for low-risk screening patients, where imaging


Prostate Cancer Health Report

PSA testing: A more informed approach By Chris Booth, Trustee, CHAPS Men’s Health Charity is used first and the patient only biopsied if a change is seen compared to the baseline scan, or high risk features are seen. Recommendation The high false negative rate of prostate biopsy is a significant burden on European health care systems and patients. Recent advances in MRI and micro-ultrasound present an opportunity to find cancer sooner, and be more confident in classifying low- and high-grade disease. Unlike MRI, micro-ultrasound is a direct upgrade for the current standard of care, with far lower procedural costs, time, and unique imaging expertise required. Adoption of the microultrasound technology has the significant potential to improve patient outcomes while simultaneously reducing health care costs. References: 1. Jain S, Loblaw A, Vesprini D, et al. Gleason Upgrading with Time in a Large Prostate Cancer Active Surveillance Cohort. J Urol. 2015;194(1):79-84. doi:10.1016/j.juro.2015.01.102. 2. Otaibi M Al, Ross P, Jeyaganth S, et al. Role of Repeated Biopsy of the Prostate in Predicting Disease Progression in Patients With Prostate Cancer on Active Surveillance. 2008;(May):286-292. doi:10.1002/cncr.23575. 3. Berglund RK, Masterson TA, Vora KC, Eggener SE, Eastham JA, Guillonneau BD. Repeat Biopsy in Patients Eligible for Active Surveillance. 2008;180(November):1964-1968. doi:10.1016/j. juro.2008.07.051. 4. Rosenkrantz AB, Verma S, Choyke P, et al. Prostate MRI and MRI-Targeted Biopsy in Patients with Prior Negative Biopsy.; 2016. 5. Fütterer JJ, Briganti A, De Visschere P, et al. Can Clinically Significant Prostate Cancer Be Detected with Multiparametric Magnetic Resonance Imaging? A Systematic Review of the Literature. Eur Urol. 2015;68(6):1045-1053. doi:10.1016/j. eururo.2015.01.013. 6. Mottet N, Bellmunt J, Representative EBP, et al. Guidelines on Prostate Cancer. 2016. 7. Vargas HA, Akin O, Afaq A, et al. Magnetic Resonance Imaging for Predicting Prostate Biopsy Findings in Patients Considered for Active Surveillance of Clinically Low Risk Prostate Cancer. J Urol. 2012;188(5):1732-1738. doi:10.1016/j.juro.2012.07.024. 8. Branger N, Maubon T, Traumann M, et al. Is negative multiparametric magnetic resonance imaging really able to exclude significant prostate cancer? The real-life experience. BJU Int. 2016. doi:10.1111/bju.13657. 9. Pavlovich CP, Cornish TC, Mullins JK, et al. High-resolution transrectal ultrasound: Pilot study of a novel technique for imaging clinically localized prostate cancer. Urol Oncol. April 2013. doi:10.1016/j.urolonc.2013.01.006. 10. Ghai S, Eure G, Fradet V, et al. Assessing Cancer Risk on Novel 29 MHz Micro-Ultrasound Images of the Prostate: Creation of the Micro-Ultrasound Protocol for Prostate Risk Identification. J Urol. 2016;196(2):562-569. doi:10.1016/j.juro.2015.12.093. 11. Wodlinger B, Ghai S, Eure G, et al. Micro-ultrasound of the prostate, PRI-MUSTM protocol guidance along with clinical variables: Combined approach for reducing unnecessary biopsies. In: ESUI. Milan, Italy; 2016. 12. Ferlay J, Parkin DM, Steliarova-Foucher E. Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer. 2010;46(4):765-781. doi:10.1016/j.ejca.2009.12.014. 13. Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013;132(5):1133-1145. doi:10.1002/ijc.27711.

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espite continuing controversy, (1) for the foreseeable future the blood test Prostate Specific Antigen (PSA) remains the only initial, simple, cheap option available to screen for Prostate Cancer (PCa) in asymptomatic men to detect PCa at an early, curable stage. Nearly all western national and international urological guidelines recommend PSA-based screening for appropriately selected, counselled men who can then make an informed decision. (2, 3, 4) In summary, the majority of international expert panels recommend or propose: • Screening from age 45 for men with a family history of an immediate male relative with PCa and black African or African Caribbean men (risk 1 in 4). • Obtain a baseline PSA in a man’s forties to predict future risk. • Link PSA to a “risk calculator” to assess need and frequency of future PSA testing. • Do not screen men below 40 or with less than 10 years’ life expectancy. The most reliable clinical trial evidence in support of these recommendations comes from Europe where reductions in PCa mortality of up to 51% have been demonstrated. (5, 6) Despite this a number of national agencies continue to advise

against PSA screening. (7, 8) on the basis that the “harms” of “over-diagnosis” and “over-treatment” of non-aggressive PCa outweigh its benefits in terms of lives saved. In addition to this European screening evidence, two very important UK trials were published in 2016 that go a considerable way to answering the problems of over-diagnosis and over-treatment of screen-detected, nonaggressive PCa. The PROMIS Trial This trial (9) of multiparametric MRI (mpMRI) showed that only prostate glands with lesions demonstrable on mpMRI needed biopsy. If no lesion was visible, it could be safely assumed that any underlying PCa present would be non-aggressive.

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Improving Outcomes

mpMRI should therefore be performed before biopsy.

TRUS biopsies during the trial period 19992009.

The ProtecT Trial

In conclusion, we now have emerging evidence that appears to support PSA-based testing for appropriately informed men backed up by further evidence that shows how we can now avoid the pitfalls of overdiagnosis and over-treatment. It is therefore essential that this positive information is disseminated as widely as possible and especially to those countries where men are discouraged from PSA-based screening and PCa death rates lag behind the best in Europe.

This reports the 10 year clinical outcome of 1643 men with apparent, non-aggressive, PSA screen-detected PCa randomised to receive radical treatment or active surveillance. (10) After 10 yearsâ&#x20AC;&#x2122; follow-up, the death rate was only 1% whether treated initially or followed on active monitoring, though in the latter group over half the men on surveillance developed progression and changed to active treatment. Presumably, without screening in the first place, these men would have presented with late stage, incurable disease and most likely added to our PCa death toll. This progression rate is not surprising given the limitations on the accuracy of standard

3. AUA: AUA Guideline: http://www. aua.net.org/education guidelines/prostatecancer-detection. Accessed 2/11/16 4. Melbourne Consensus: BJU Int 2014; 113: 186-8 5. Lancet Oncol, 2010, 1: 725-732 6. European Urol 2014; 65: 329-36 7. UKNSC: Screening for Prostate Cancer Review 2015 update 8. US Preventive Services Task Force. Accessed Jan 2017

References:

9. PROMIS Trial: J Clin Oncol 2016; 34 (suppl; abstr 5000). ASCO 2016

1. Academy of Medical Royal Colleges; Choosing Wisely UK, Oct2016

10. ProtecT Trial: NEJM 2016; 375: 14151424

2. EAU: European Urol 2013; 64: 347-54

What is my risk of prostate cancer? 1 in 8

In the UK, about one in eight men will get prostate cancer at some point in their lives.

Prostate cancer is the most common cancer in men in the UK.

Over 50 years old Prostate cancer mainly affects men over 50 and your risk increases with age. The average age for men to be diagnosed with prostate cancer is between 65 and 69 years.

You are two and a half times more likely to get prostate cancer if your father or brother has been diagnosed with it, compared with a man who has no affected relatives.

Your risk of prostate cancer might be higher if your mother or sister has had breast cancer, particularly if it was linked to faults in the genes BRCA1 or BRCA2.

Ethnicity 47

Black men are more likely to get prostate

Š Prostate Cancer UK

Family history and genetics


Prostate Cancer Health Report

Future challenges for better control of prostate cancer Reducing over-diagnosis and the resulting overtreatment through refined and improved early detection is crucial in improving the quality of life and survival of prostate cancer patients. Dr Tit Albreht, Head of Centre, National Institute of Public Health raises a few key challenges

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here are several important points to be raised concerning prostate cancer management and control for the future. The first one is related to refining the possibilities and the means of early detection. Prostate Specific Antigen (PSA) does not prove to be an adequate and efficient tool for population-based screening and its controversies continue raising many concerns. More importantly, it is becoming increasingly important to better identify the subpopulation of men at high risk for the development of invasive disease. Methods to move in this direction have already been improved but too many patients still remain immersed in the masses of PSA-positive cases, which require additional diagnostic workup. Moreover, further work should be undertaken to assess the combination of different methods, especially including the new technological opportunities of the multi-parametric MRI. Obviously, these exert additional financial challenges where objectives and cost-benefits of raising such complex and technologically intense options need to be assessed very precisely. National Institute of Public Health as a public health institute, dealing with health promotion, screening and early detection of non-communicable diseases (NCDs), will be available to work on fine tuning all screening

and early detection methods that could help in reducing the burden of NCDs, in particular, the burden of cancer. As cancer has already become the number one group of causes of death in men in most highly developed countries, it is clear that we need to address this challenge in a clear and resolute action. Secondly, it is important to further explore and research the area of â&#x20AC;&#x2DC;watchful waitingâ&#x20AC;&#x2122;, which through delaying the initial treatment clarifies an important number of cases as not invasive or not as invasive as to require an immediate treatment. This might be beneficial both for patients (who will be thus less exposed to side effects of treatment) as well as for health professionals as the workload of new cases would be gradually reduced without any harm in performance. Another aspect in this sense is the consideration of patientâ&#x20AC;&#x2122;s age at the initiation of aggressive treatment. This needs to be assessed in view of the comorbidities these patients may have (especially taking into account their age). Thirdly, it is important to work on all aspects of after-care and survivorship issues. Given the advances in treatment, survival in prostate cancer has improved greatly, which means that there are increasing numbers of

patients who require follow-up. This further raises the importance of putting more stress on the quality of life, both of patients as well as that of survivors. Because of the implications of side effects of treatment, patients and survivors need to receive an adequate level of psycho-oncological care available to them in a prolonged period of time and not only during active treatment. Other important aspects of survivorship such as rehabilitation and full return to pre-morbid life are of essence to cancer survivors, not the least to prostate cancer survivors.

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Improving Outcomes

Image Guided Adaptive Radiotherapy Image Guided Adaptive Radiotherapy combines state of the art imaging and radiotherapy techniques. Dr Ben Pais, Vice President Medical Affairs, Elekta, says it will contribute to better, more efficient and cost-effective treatment of patients with prostate cancer

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adiotherapy is one of the cornerstones in the treatment of men with prostate cancer, but also of many other patients. It can be used as monotherapy or together with surgery, chemotherapy, hormone therapy or any combination of these therapies. Interestingly the clinical outcomes do not vary a lot for any type of prostate cancer patient for either therapy. And patients with “low risk” prostate cancer are usually not actively treated anymore but monitored over time in “Watchful Waiting” or “Active Surveillance” programs. The development of radiotherapy techniques in combination with the improvement of imaging techniques has substantially contributed to improved treatment results which is the basis for the inclusion of radiotherapy in all international treatment guidelines for prostate cancer. In the past two decades the use of imaging has become instrumental and has resulted in Image Guided RT (IGRT) becoming the standard of care whereby the accuracy of the radiation is optimised. Initially IGRT has been done with CT (Computed Tomography) but more and more CT is replaced by MRI (Magnetic Resonance Imaging) because of its advantages over CT. Soft tissue visualisation is much better with MRI. Many anatomic structures can be better visualised with MRI than with CT which enables the radiation being delivered more precisely and accurately. Also, the generation of CT images needs a bit of radiation which makes it less suitable for frequent use. MRI does not need radiation for image generation. And, finally, CTs cannot provide anatomical data during radiation delivery which makes it impossible to use CT for real-time imaging when the patient is irradiated. MRI can be used in real-time procedures. Image Guided Adaptive Radiotherapy (IGART), especially with MRI, has a number of advantages. The most important advantage is that it allows for real-time

49

target visualisation during radiation. The target represents the tumour and the area around the tumour that is supposed to be irradiated. As a result the irradiation can be interrupted when the target moves outside the treatment field. Without the possibility to visualise the target radiation would continue and healthy tissue would be irradiated. But there are more advantages. In RT there are always margins around the tumours that must be irradiated and these margins also include healthy tissue. IGART allows to reduce the margins and thereby reduce the volume of healthy tissue that is exposed to radiation. As a result the toxicity of the treatment is being reduced. At the same time it is anticipated that using IGART allows an increase of the dose to the target and higher doses are associated to better local (tumour) control, i.e. higher efficacy. This combination of higher efficacy and lower toxicity implies that the overall benefit-risk ratio of radiotherapy will improve. Another aspect is the number fractions of a treatment. Radiotherapy is applied in a number of fractions, each used to administer a sub-dose of the overall, planned treatment dose. In the past two decades new RTtechniques have made it already possible to substantially reduce the number fractions from roughly over 30 fractions to around 20 or less fractions per treatment. IGART will most likely allow to further reduce the number of fractions. This process is referred to as hypofractionation. It is generally known that in the upcoming decade the total number of patients with cancer will substantially increase which implies also a need for more radiotherapy treatments. In an era with limited growth possibilities for healthcare budgets this trend will demand more efficient treatment possibilities. Stereotactic Body Radiation Therapy (SBRT) is a form of RT

combining a limited number of fractions (maximum 5 per treatment) with higher doses per fraction. SBRT reduces the overall treatment time of a patient without compromising the quality of the treatment. IGART makes it possible to treat more and more patients with SBRT so that more patients can be treated on one RT system, i.e. increase the efficiency of the treatment. Prostate and thus its cancers typically move. IGART will help increasing the benefit-risk ratio of RT in the treatment of prostate cancer. There are potentially even further advantages. RT of prostate cancer currently irradiates the glad, mainly because it is difficult to precisely identify the tumour in the prostate. With the latest MRI innovations it is already possible to better diagnose the actual tumour in the prostate and it is likely that in the nearby future with real-time use of this type of MRI will allow to only that part of the prostate that contains the tumour. Of course this require a state-of-the-art MRI with diagnostic quality combined a state-of-the-art linear accelerator, a so called “MR-Linac.”


Prostate Cancer Health Report

Role of immunologic prevention and therapy for prostate cancer Analysing several forms of immune modulation for prostate cancer and cases of early detection, Dr Arnulf Stenzl, Chairman, Eberhard Karls University, explains why early treatment using a form of vaccination might treat the disease better

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rostate cancer is the second most common cancer in the European Union and still the 4th most frequent cause of cancer death. What does this tell us? Like breast cancer, prostate cancer – despite 76.000 men dying from it every year – does not lead to death in all cases. Genetic constellations, environmental factors, and an increasing life expectancy will all lead to a further increase in the number of prostate cancer patients throughout Europe in the next decade. The European randomised study on prostate cancer – the largest randomised screening study in the world – has shown that screening will reduce mortality, however, at the prize of overtreatment. Prostate cancer is known to be an

immunogenic tumor, which means it can be influenced by modulation of the immune system. Several forms of immune modulation have been tested and an approval has been either given or is under consideration at the European Medical Association and FDA respectively. In several research projects, we and others have been able to demonstrate the possibility of changing the immune system so that it can recognise (again) tumor cells which then will be destroyed by the body`s own surveillance system. However, immunotherapy should not be applied predominantly at the end of an advanced stage of the disease, but should be included in the armamentarium of treatment modalities at the earliest stage possible. Vaccination prior to a curative removal of the prostate (prostatectomy) is one of

the possible strategies which should be elucidated in the future by research calls. (Fig. 1). Furthermore current knowledge of the interaction between the immune system and the development of clinical prostate cancer also leads to the assumption that men at risk due to their family history of cancer of prostate cancer (or even a broader population of men) might benefit from a protective immunomodulation preventing the clinical outbreak of prostate cancer (Fig. 2). In the future, early detection of this disease may help some men, however a better solution may be prevention or early treatment that uses some form of vaccination as a booster of a standard treatment and has minimum side effects.

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Government Gazette

Health REport Recommendations to reshape policy making

Accelerating policy action to end AIDS Key policy experts and healthcare institutions present the fast-track strategy to end AIDS by 2030

Whatâ&#x20AC;&#x2122;s inside The European action plan to end AIDS 52 An overview of the ICPS HIV/ AIDS Europe Roundtable 2017

Call to action

54 Alfred Sant MEP discusses what needs to be done at a policy level to create more awareness 55 Neven Mimica, European Commisssioner for International Cooperation & Development on EU action on HIV/ AIDS 56 European AIDS Treatment Groupâ&#x20AC;&#x2122;s Koen Block calls for a more united approach within Europe 57 A.J. Amato Gauci, et al., from European Centre for Disease Prevention and Control provides a statistical update on current trends in Europe 58 Sini Pasanen from AIDS Action Europe explains how communities can play an active role in fighting AIDS 59 Dr Luiz Loures from UNAIDS says EU leadership and unity gets more important than ever 61 Cecile Vernant from Deutsche Stiftung Weltbevoelkerung on EU research funding for AIDS


Towards Ending AIDS

The European plan of action to end AIDS The threat of HIV/AIDS has receded in several countries across the world. However, eastern Europe and Central Asia are exceptions to this. The number of newly reported HIV cases are increasing ever so fast in Europe. Hopeful of a possibility to eliminate a killer disease that is set to affect more than one billion people by 2030, the International Centre for Parliamentary Studies recently gathered industry leaders, academics and policy makers to examine current policy guidelines and strategies on combating HIV/AIDS in the EU. D iane R olland, International Program Manager at ICPS, discusses the major recommendations presented at the roundtable

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early 30 years since the first cases of HIV were reported; at least 81 new infections are reported every day in the European region. Whilst effectual treatments for HIV are available, neither cure nor preventative vaccine exists. Whatâ&#x20AC;&#x2122;s more worrying is that 1 in 7 people living with HIV within the EU/EEA region do not know they are infected and 1 in 6 people who are diagnosed are not on treatment. Globally, men who have sex with men (MSM) are 19 times more likely to be living with HIV than the general population. This route is the most prevalent in Europe (42%) followed by heterosexuals (32%), others (20%) and injected drug users (4%). There is growing evidence of the value of including pre-exposure prophylaxis (PrEP) in the package of combination HIV prevention interventions offered to men who have sex with men. Yet, what factors put men who have sex with men at risk of HIV? For instance, how progressive are European policies regarding the LGBT community? In contrast with global decline in new infections, why are the number of newly reported HIV cases in Europe on the rise? The World Health Organisation has a vision for zero new infections, zero HIV-related deaths and zero HIV-related discrimination. However, how optimistic is Europe in ending AIDS by 2030? The HIV/ AIDS Europe Roundtable 2017

organised by the International Centre for Parliamentary Studies in March 2017 brought together European policy makers, medical and clinical professionals, academic experts, healthcare players and patient groups, to examine current policy guidelines and strategies on combating HIV/AIDS in the EU. Chaired by John Bowis OBE, Former Member of European Parliament and Minister of Health (United Kingdom), more than 30 participants from across ten European member countries present at the roundtable discussed what works, what does not work and the greatest challenges in the medium and long term. Followed by a series of policy updates from the European Centre for Disease Prevention and Control (ECDC), the Joint United Nations Programme on HIV/AIDS (UNAIDS) and members of the European Commission, the delegates at the roundtable discussed a variety of issues, including surveillance and HIV treatment guidelines within Europe, strategies of intervention, testing and diagnosis, prevention, cost of treatment, antiviral drug resistance, the commissioning and provision of Pre Exposure Prophylaxis (PrEP), the need for providing adequate psychological counselling and the latest developments in HIV science. Evidence-based HIV prevention Addressing the main route of HIV

transmission in Europe, participants at the roundtable agreed that programmes for men who have sex with men should be a cornerstone of HIV prevention in all EU/ EEA countries. Given the high proportion of HIV cases among migrants in many EU/EEA countries, and evidence of postmigration HIV-acquisition, migrant-sensitive prevention services are crucial. While adequate harm reduction levels should continue to prevent HIV among people who inject drugs, expansion of HIV testing and linkage to care should ensure early diagnosis and access to treatment; as this will reduce the number of late presenters and improve treatment outcomes. Critical areas for fast-track action Participants at the roundtable voted for a three-pronged approach to ending AIDS in Europe: 1) Sustain the progress that has been made over the last 20 years in Europe i.e., protect what we have achieved; 2) While scaling up HIV testing and treatment toward achieving the 90-90-90 treatment targets by 2020, Europe should aim for a 95-95-95 target over the long term; and 3) Recognise

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Towards Ending AIDS

that HIV is only one issue and unless you change the broader sociological context the overall benefit will not be met. The overall message of the meeting was to stress the importance of taking stock of the situation at hand, incorporate lessons learnt from different member states and respond to long term needs. Whilst acknowledging that national HIV responses have often failed to focus their intervention strategies on discriminated communities and populations most in need, policymakers agreed that there needs to be a focus in fighting the stigma associated with testing. Leaving it out of the equation might mean battle half lost. Migrating populations in Europe should continue to be high on the agenda. Some of the major recommendations tabled at the roundtable included: 1. We should ensure all people living with HIV know their status: New testing approaches, including home sampling and self-testing should be more democratised and Europe should increasingly invest in observation studies that can guide further policy; 2. Move to a more holistic approach of support for patient, beyond healthcare: Facilitate access to social protection, psychological support, social care, and education for all priority groups and risk populations; 3. There are substantial disparities in access to treatment and care and this gap must be breached. Europe needs to strengthen disease treatment and infection control; 4. The broader context is key: Lessons can be learned both within the EU and from outside. When we identify a solution that works for one particular region or country, we should be able to seek the means of implementation to others; 5. Try to model HIV care: We need to explore beyond the borders and look at different areas in the world, including the most affected ones (e.g. sub-Saharan Africa) and learn from their current studies; 6. Keeping people healthy and alive through holistic care: We should take the person’s psychological status into consideration and invest more in tailored individual programmes; 7. We should invent new models of care suitable for all populations around the globe; 8. Criminalised behaviour against people affected by HIV should be eradicated; 9. We need a better understanding and implementation of current treatment modalities; 10. Europe requires a more coordinated and

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holistic approach, adequately addressing existing research gaps and raising awareness. Delegates at the roundtable included: Regional Director, Government Affairs EMEA, Abbvie, AAE Steering Committee Member, AIDS Action Europe, Medical Doctor, Dept Infectious Diseases AOU Polyclinic, Public Health Analyst, Centre for Disease Prevention and Control, Consultant Physician, Chelsea and Westminster Hospital, Project Officer, European & Developing Countries Clinical Trials Partnership (EDCTP), Director General, European AIDS Treatment Group, Head of Disease Programme HIV, Sexually Transmitted Infections & Viral Hepatitis, European Centre for Disease Prevention and Control (ECDC), Scientific officer for HIV/AIDS research, European Commission - DG Research and Innovation, Policy Officer, European Commission - DG SANTE, Head, Division of Communicable Diseases Federal Office of Public Health, Advocacy Officer, German Foundation for World Population (DSW), Advocacy Officer,

German Foundation for World Population (DSW), Chair, Dutch HIV Association, Secretary General, HIV Norway, Director, Scientific Affairs, Hologic, Senior Director, Infectious Diseases & Vaccines, Janssen Pharmaceuticals, Senior Study Responsible Physician, Janssen Vaccines and Prevention, B.V. Pitié Salpêtrière Hospital, Professor of Infectious Diseases and Head of the HIV Clinical Research Unit, Head, Department of Infectious Diseases Saint-Pierre University Hospital, Fund Portfolio Manager, Eastern Europe & Central Asia Team , The Global Fund to Fight AIDS, Tuberculosis and Malaria, Senior Adviser, Tuberculosis and HIV UNAIDS, Team Lead, Strategy UNITAID, Director of Clinical Infectious & Tropical Diseases, University of Milan, ViiV Healthcare, Senior Advisor, Strategy, Policy & Equity, WHO Department of HIV and Global Hepatitis Programme. The next edition of the HIV/ AIDS Roundtable will be taking place in 2018. If you wish to attend, please contact information@parlicentre.org


HIV / AIDS Health Report

EU institutions should engage more politically to induce change in HIV awareness Nearly 122,000 are unaware of their HIV infection in Europe. To decrease the number of people who are diagnosed late or are unaware of their infection, new strategies are required to expand targeted HIV testing services. Alfred Sant MEP, Head of the Malta S&D Delegation in the European Parliament, lists out what needs to be done to make it easier for the undiagnosed

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uring 2015, almost 30,000 newly diagnosed HIV infections have been reported by the European Union and European Economic Area countries. This is similar to the observed notification trends in the last decade. This high incidence of infection confirms the persistence of the HIV epidemic in our societies. Yet this is not the complete picture. The estimate is that there are some 122, 000 people living with HIV across our region who are unaware of their infection. They continue to transmit it to others. (1) We need to encourage increased testing especially among key populations who are more at risk. We must look at ways of encouraging more people to come forward for testing. It is still not easy for individuals to take the test. There is fear about the result, especially among high risk groups. We have come a long way in the management of HIV. Effective treatment is now available. A positive result is no longer a death sentence but a path to lifelong treatment. In fact, today we talk of people living with HIV just as we talk of people living with diabetes.

However, the stigma still persists. Many believe that HIV infection is a self-inflicted shame. We need to fight that stigma. Testing should be made accessible in various settings. It should come along with professional support before and after testing. The training of health professionals and people working with the youth and key populations should be enhanced. People who test positive require complete support of a professional team including psychological support. We should develop enhanced tests which are fast, reliable and affordable. On the other hand, the high cost of diagnostics remains a barrier to testing. True, the massive expansion of antiretroviral therapies has reduced the global number of people dying from HIV-related causes. Yet, prices continue to remain very high, placing a burden on the health authorities as they strive towards universal treatment and an end to the epidemic. Nevertheless, countries need to live up to their commitment to end the AIDS epidemic as a public health threat by 2030. That target is included in the 2030 Agenda for Sustainable Development adopted by the United Nations General Assembly in September 2015. There is no room for complacency.

Meanwhile, viral hepatitis is not mentioned much. Yet it could be emerging as a larger public health issue than HIV. It remains a silent epidemic. Many living with viral hepatitis do not know that they are infected; placing them at greater risk for severe, even fatal, complications from the disease. The two infectious diseases have many similarities by way of how they affect people, the strategies for control and the challenges faced by public health authorities. All of us should spur the development of further concrete action to tackle the incidence of HIV and hepatitis, which remains a significant threat to the health of our citizens. References: 1. European Centre for Disease Prevention and Control (ECDC). HIV/AIDS surveillance in Europe 2016: ECDC. Available at http://ecdc.europa.eu/en/ publications/Publications/HIV-AIDSsurveillance-Europe-2015.pdf

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Towards Ending AIDS

European Commission’s passionate response to AIDS Thirty years since the first cases of AIDS were reported, the European Commission has been providing funding and support to several developing countries across the globe. Neven Mimica, European Commissioner for International Development and Cooperation writes about the EU’s united and fervent response to the epidemic over the years

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oday nearly 36 million people in the world live with HIV (1), the virus that causes AIDS, according to estimates from the World Health Organisation (WHO). This disease joins deadly forces with one of the world’s oldest diseases, tuberculosis. Of all the people dying from AIDS-related causes, nearly one-third die of Tuberculosis. Since the early days of the epidemic, the European Commission has been providing funding and support for those that suffer and working with developing countries, and global institutions, in particular in Africa over many years. For example back in 1987, the late European Commission Vice-President Lorenzo Natali convinced the signatory states of the Lomé Convention - the agreement setting out the principles and objectives of the European Union cooperation with ACP countries (2) - to join the creation of the “EC-ACP AIDS Control Programme”. This would support the efforts of the Global Programme on AIDS created by the WHO. (3) These early efforts were visionary because alongside an immediate response to a global emergency, they laid the foundations for a long-term structural approach. Based on this vision, close partnerships were built between beneficiary governments, civil society and other international actors. At the turn of the millennium, the European Union realised the battle had to be intensified. Once again, we were at the forefront to promote The Global Fund to fight AIDS, Tuberculosis and Malaria. Over the years, the EU and its Member States consistently contributed to about half of the Global Fund’s funding. (4) We can be proud that today, the Global Fund provides access to life saving antiretroviral treatment to 10 million people worldwide. And last year, the European Commission increased its pledge by 27% to a total of €475 million for the period 2017-19. This supports the Global Fund’s objective to help save eight million lives over the next

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three years and reach the Sustainable Development Goal target of ending the epidemics of HIV, tuberculosis, and malaria by 2030. We don’t just focus on the global level. The European Commission also helps to strengthen country systems for integrated AIDS care. As we celebrate the 60th anniversary of the Rome Treaty, the International Union against Tuberculosis and Lung Diseases provides a good illustration of this. This 100-year-old leading NGO paved the way to tuberculosis control worldwide, confirming that it is only when we are united that we can overcome great challenges. (5) From 2006 to 2012, the European Commission budget funded the Union’s Integrated HIV Care programme in Benin, (6, 7) Democratic Republic of Congo and Zimbabwe to bring national AIDS and tuberculosis programmes together. The strategies that the Integrated HIV Care programme developed were endorsed by national programmes, then further scaled-up with Global Fund support. This also contributed to state building. Under this programme, the European Union also catalysed corporate funding for AIDS care in Myanmar (8) which permitted rapid scale-up through the Three Diseases Fund co-financed by the EU, then by The Global Fund. In war-torn eastern Democratic Republic of Congo, this programme introduced antiretroviral treatment alongside tuberculosis care and successfully maintained patients on treatment over the years. (9) It found how to efficiently monitor the effectiveness of the treatment and resistance to medicines. (10) It did so in the most rural areas in really challenging environments, ensuring that no patient was left behind. It built synergies with the EU bilateral support to health through the European Development Fund that contributes to the SDG target of Universal Health Coverage. As the epidemic shows signs that it could finally start to recede, there is now a place for reasonable optimism in Africa with

reduced rates of new HIV infections and fewer deaths caused by AIDS. This success does not reduce our energy or our vision to make the world free of AIDS by 2030. Confronting human rights breaches, stigma and discrimination must remain part and parcel of the fight. The Ebola epidemic is also a sober reminder that we must continue our common efforts to protect health security, not only to respond to emergencies but also to prepare health systems worldwide to be strong enough to withstand the pressures that may come at any time. References: 1.http://www.who.int/hiv/en/ 2.European Commission – African Caribbean and Pacific Countries 3.http://aei.pitt.edu/33694/1/A227.pdf 4.http://www.theglobalfund.org , consulted March 27, 2017 5.http://www.theunion.org/who-we-are/history 6.http://www.theunion.org/what-we-do/technicalassistance/tb-hiv-and-hiv/integrated-hiv-care-for-tbpatients-living-with-hivAIDS/benin 7.Ferroussier O et al. Results of rapid and successful integration of HIV diagnosis and care into tuberculosis services in Benin. International Journal of Tuberculosis and Lung Disease, 2013, 17(11):1405-1410 8.http://www.theunion.org/what-we-do/technicalassistance/tb-hiv-and-hiv/integrated-hiv-care-for-tbpatients-living-with-hivAIDS/democratic-republicof-congo 9.http://www.theunion.org/what-we-do/technicalassistance/tb-hiv-and-hiv/integrated-hiv-care-for-tbpatients-living-with-hivAIDS/zimbabwe


HIV / AIDS Health Report

EATG calls for a more unified approach The only way to achieve the ambitious 90:90:90 target set by the World Health Organisation is through a unified approach grounded in the principles of human rights and inclusion. Koen Block, Director General, European AIDS Treatment Group (EATG) calls for a unified approach that decreases the barriers of discriminated population groups and increases access to prevention, diagnosis and treatment of HIV/ AIDS

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t a time when the threat of religious fanaticism, populism, extremism, and other isms seem to gain popularity across the world, working on human rights, supporting vulnerable populations and providing healthcare has become more challenging than ever. More than 30 years after the discovery of the HIV virus, there has been incredible progress in HIV science. People can be efficiently treated with several possible combinations that are far less toxic than in the early years. This treatment also allows better protection towards partners of People Living with HIV (PLHIV), as it brings the viral load down to a level that doesn’t allow infection anymore. Even more: treatment seems to be able to prevent the transmission of HIV when taken by HIV negative people via Pre-exposure Prophylaxis (PrEP). On hepatitis C, one of the major coinfections with HIV, the cure has become a feasible reality for those infected by the virus. New treatments have allowed to reduce the time of treatment and increased to rate of success to get cured to a chance of more than 90 percent. These major improvements in treatment however have also highlighted the dramatic differences within Europe between regions and key populations with an evolution that doesn’t always seem to be going into the right direction. In many areas within Europe, access to testing remains low, which in-turn has led to far lower number of people without an awareness of their status. That also doesn’t allow treating

people, which increases the risk of transmitting the virus. The high pricing of drugs creates low access to drugs. Newer drugs are often not available in several European countries, which leaves doctors and patients with limited – and often more toxic – options for treatment. Some regions within Europe have lower access to treatment than some African countries. The epidemic rises faster in several countries within Eastern Europe compared to many other regions within the world. Key populations are being addressed in an even more discriminatory way than before, thus closing doors on proper prevention, testing, treatment, and care services. The 90-90-90 goals from WHO (90% know status; 90% are on treatment and 90% are undetectable) is becoming a realistic goal in certain fast track cities. But the gap between those cities and many countries and regions continues to increase. Prevention is often the first action that is dropped because of austerity or other economic concerns. The risk of such decisions has been already shown when harm reduction programs, services to key populations etc. were stopped. Better education of patients, health care providers and policy makers is needed to inform them about the need for a continued investment at all levels. Information in local languages needs to be provided. Evidence based initiatives should be developed. If not, we will see a world where the 90-90-90

will be successful within a small number of countries, however, an impossible goal for major parts within our region. As a community based organisation, the European AIDS Treatment Group calls for a more united approach within Europe to deal with the challenges faced by many countries and regions: increase testing within key populations that are most at risk (MSM, migrants, IDU, prisoners etc.); decrease the barriers for these populations to access services; decrease the cost for drugs and support solutions for the problems faced by many countries due to the ended support by the Global Fund; increase access to treatment and prevention services; fight against continued stigma, discrimination and criminalization of people living with HIV and other co-morbidities.

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Bending The Trajectory of AIDS

Current HIV trends in Europe Although HIV is preventable through effective public health measures, significant HIV transmission continues in Europe. In 2015, nearly 30,000 people were diagnosed in European Union and European Economic Area member states - a rate of 6.3 cases in every 100 000 people when adjusted for reporting delay. A.J. Amato-Gauci, Anastasia Pharris and Teymur Noori from the European Centre for Disease Prevention and Control discuss the current HIV trends in Europe evidence that migrants are at risk of acquiring HIV after arrival to the EU/EEA . Between 2006 and 2015, the number of reported HIV diagnoses in the EU/EEA acquired through injecting drug use decreased by 44% and in 2015 accounted for only 4% of new reported HIV diagnoses.

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n 2015, 29 747 newly diagnosed HIV infections were reported by 31 EU/EEA countries. The rate of new diagnoses has not declined over the last decade, having levelled out at 6.6 to 6.3 per 100 000 population. The rate of new diagnoses was three times higher among men (9.1 per 100 000) than among women (2.6 per 100 000) . Sexual transmission remains the main mode of transmission in the EU/EEA with 42% of all new cases reported in men who have sex with men (MSM) and 32% attributed to sex between men and women. MSM are the only key population in the EU/EEA that has not seen a decline in the number of new infections reported during the last decade (Figure 1). Migrants, defined as people born outside of the reporting country, continue to be disproportionately affected by HIV and accounted for 37% of all newly diagnosed cases in 2015. HIV in migrants coming from high HIV prevalence countries accounts for around 15% of all newly diagnosed cases. Although the trends of new diagnoses among those born abroad are declining, in part due to changing migration flows to the EU/EEA, there is growing

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The annual number of AIDS cases and deaths continues to fall in the EU/EEA. In 2015, 3 754 people were diagnosed with AIDS compared with 8 465 in 2006. This is understood to be the result of improvements in linkage to quality care, treatment effectiveness and better follow-up of people living with HIV (PLHIV) in the region. HIV prevention, testing and treatment, 2016 monitoring data Most EU/EEA member states report that coverage and uptake of comprehensive prevention interventions (defined as condom promotion and distribution, health promotion and behaviour change interventions, Pre-exposure prophylaxis (PrEP), awareness raising and harm reduction, including needle and syringe programmes (NSP) and opioid substitution treatment (OST)), are not reaching enough people to impact the number of new infections. (Figure 2) This is likely due to the lack of resources dedicated for

contribute to limiting the provision and uptake of HIV prevention services for key populations. About 47% of those diagnosed with HIV in the EU/EEA in 2015 were diagnosed late (CD4 cell count <350/mm3) (3), indicating that testing rates among populations most at risk of HIV remain too low (Table 1) (5). Despite data limitations, me estimate that approximately 15% of PLHIV have not been tested. Finally, the number of member states that have adopted ‘Test and Treat’ policies increased from four in 2014 to 24 in 2016. This has raised the estimated proportion of those people diagnosed with HIV on treatment to 83%. Rising overall costs resulting from growing numbers of people on treatment, people with HIV living longer and the higher price of some of the new/second-line medicines are straining countries’ limited resources for HIV. Of those PLHIV who are on treatment, it is estimated that 89% have achieved viral suppression in the EU/EEA member states. The European Centre for Disease Prevention and Control (ECDC) is a European Union (EU) agency tasked with strengthening Europe’s defences against infectious diseases. It does this primarily by providing the EU Institutions and member states with reliable evidence based on solid data, analysis and expert opinion about infectious diseases and the threats they pose. ECDC coordinates the enhanced surveillance of HIV/ AIDS in Europe, together with the World Health Organization Regional Office for Europe (WHO) and also monitors the implementation of the Dublin Declaration (2) in Europe and Central Asia. The authors are from the Programme on HIV, Sexually Transmitted Infections, and viral Hepatitis, European Centre for Disease Prevention and Control, (ECDC), Stockholm, Sweden.

prevention in the member states, but also to the effect of certain legal and policy barriers, as well as stigma and discrimination, that

The authors would like to acknowledge the support and guidance by members of the Dublin Declaration Advisory Group and country focal points


HIV / AIDS Health Report

as well as the Operational Contact Points for HIV Epidemiology from the EU/EEA Member States participating in the European Network for HIV/ AIDS Surveillance. We would also like to thank the WHO Regional Office for Europe for jointly coordinating HIV surveillance in the WHO European Region.

AIDS in Europe and Central Asia. 2004. Available at: http://ecdc.europa.eu/en/healthtopics/aids/Pages/ monitoring-dublin-declaration.aspx 3.

4. European Centre for Disease Prevention and Control. Migrant health: Sexual transmission of HIV within migrant groups in the EU/EEA and implications for effective interventions. Stockholm: ECDC; 2013. Available at: http://ecdc.europa.eu/ en/publications/publications/migrant-health-sexualtransmission.pdf 5.European Centre for Disease Prevention and Control. The status of the HIV response in the European Union/ European Economic Area, 2016. Stockholm. ECDC. Available at: http://ecdc.europa. eu/en/publications/Publications/Status-of-HIVresponse-in-EU-EEA-2016-30-jan-2017.pdf

References: 1. European Centre for Disease Prevention and Control (ECDC). Monitoring implementation of the Dublin Declaration. Stockholm: ECDC. Available at: http:// ecdc.europa.eu/en/ healthtopics/aids/ Pages/monitoringdublin-declaration.aspx 2. Dublin Declaration on Partnership to Fight HIV/

Control, WHO Regional Office for Europe. HIV/ AIDS surveillance in Europe 2015. Stockholm: ECDC; 2016. Available at: http://ecdc.europa. eu/en/publications/_layouts/forms/Publication_ DispForm.aspx?List=4f55ad51-4aed-4d32-b960af70113dbb90&ID=1607

6. Pharris A, Quinten C, Noori T, AmatoGauci AJ, van Sighem A, the ECDC HIV/AIDS Surveillance and Dublin Declaration Monitoring Networks. Estimating HIV incidence and number of undiagnosed individuals living with HIV in the European Union/European Economic Area, 2015. Euro Surveill. 2016;21(48):pii=30417. DOI: http:// dx.doi.org/10.2807/1560-7917.ES.2016.21.48.30417

European Centre for Disease Prevention and

Communities play a key role in ending AIDS Whilst countries are already challenged by lack of research funding and resources, stigmatisation compounds the challenge. Sini Pasanen, AIDS Action Europe, Steering Committee Member, explains how communities can play a critical role in ending AIDS

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uring recent years, weâ&#x20AC;&#x2122;ve witnessed immense biomedical progression in our fight against HIV and AIDS. Advancements, that are essential in reaching targets like 90-9090: 90% of all people living with HIV will know their HIV status. 90% of all people with diagnosed HIV infection will receive sustained antiretroviral therapy. 90% of all people receiving antiretroviral therapy will have viral suppression. Unfortunately, these targets are not ambitious enough and in reaching the first 90, we have already left several people behind. There is no one-size-fits-all solution in our fight. We are often confronted by the lack of resources, prejudiced and stigmatising attitudes, and sometimes politics. How, then, can decision makers determine the best allocation of scarce HIV prevention and treatment resources for their setting? Every country is different and there are further differences within countries. Decision

makers should know their epidemic, analyse their current response and further tailor their intervention plans utilising the available strategic information. Whatâ&#x20AC;&#x2122;s more, AIDS will not be ended unless key populations are meaningfully involved at all levels of interventions, including prevention, testing, treatment and care. Community based organisations and their services have access to key populations. There is no state actor that can have access to all key populations. Policy makers and scientists should promote community ownership. Solidarity, commitment and respect for differences should be embraced between different stakeholders. Stigma and silence undermine prevention efforts Stigma has a harmful effect on everything, from prevention to diagnosis and treatment. Therefore fighting stigma and discrimination against people living with HIV and key populations remains high on the agenda. We must ensure human rights and end criminalisation, discrimination

and stigmatisation of people living with HIV, men who have sex with men, drugusers, sex workers, people in prison, the LGBT community, migrants and mobile populations. We need to work hard to change harmful and prejudiced attitudes within our societies. Ending AIDS is not possible without the Eastern European and Central Asian countries, where access to medication is worse than in Africa and where human rights of most affected populations are systematically breached. According to the World Health Organisation, Russia alone has 64% of new HIV infections in Europe. Besides prevention, testing and treatment, we need strong and visionary declarations, fully funded NGOs and political will. Stigma, discrimination and denial undermine all efforts and achievements. So governments, speak up!

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Embarking On A Fast-Track Strategy

‘The EU can play a major role in ending AIDS by 2030’ 2017 is a year of great change across Europe, however in this change there is opportunity. Europe has an opportunity to strengthen its role as a leader in ending AIDS by 2030. Dr Luiz Loures, Assistant Secretary General of the United Nations and Deputy Executive Director, UNAIDS, observes current trends across the continent and says EU leadership and unity is more important than ever

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IDS is not over in Europe. At the end of 2015, UNAIDS estimated that 900 000 (810 000 – 990 000) people were living with HIV in the European Union (EU). However, EU member states have made impressive progress in scaling up HIV testing and treatment toward achieving the 90-90-90 treatment targets by 2020. In 2015, an estimated 84% [77-93%] of people living with HIV were aware of their status, 72% [66-80%] of people living with HIV were receiving antiretroviral treatment and 61% [56-68%] of people living with HIV were virally suppressed. (Fig. 1) (1) Despite progress in HIV treatment coverage, UNAIDS estimates that the annual number of new HIV infections in the region has remained stubbornly high at around 32 000 [31 000-34 000] at the end of 2015. Of particular concern is the number of member states reporting rising numbers of new HIV diagnoses among men who have sex with men, especially among north-, central- and south-eastern EU countries. (2)

reduction in new HIV diagnoses. (6, 7). Across the region however, only France (January 2016), Norway (October 2016) and recently Scotland have adopted a national policy of offering PrEP to men who have sex with men within the context of combination HIV prevention. Compared to men who have sex with men, the HIV epidemic among people who inject drugs and their sexual partners is smaller and more focused among fewer countries, mostly in Eastern Europe. The spread of HIV among people who inject drugs has been successfully contained in countries, such as Portugal, the Czech Republic and Belarus, all of whom have implemented evidence-based harm reduction programmes. (8, 9, 10)

There is now strong evidence of the effectiveness of including pre-exposure prophylaxis (PrEP) in the package of combination HIV prevention interventions offered to men who have sex with men. (3, 4, 5). Furthermore, there is optimistic yet anecdotal evidence from a network of London sexual health clinics for men who have sex with men that the introduction of PrEP to existing HIV prevention interventions has resulted in a near 40%

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Fig. 1 – Progress towards the 90-90-90 treatment targets in the European Union (Source: UNAIDS 2016 estimates, special analysis)

It is important to achieve viral load suppression among the remaining one-third of people living with HIV in the EU, in order to reduce HIV transmission and HIV-related morbidity and mortality. However, co-morbidities, such as tuberculosis, viral hepatitis, cancers and other non-communicable diseases continue to affect the health and wellbeing of people living with HIV throughout the EU, despite antiretroviral therapy. HIV treatment and care is further complicated in many instances by the rising threat of antimicrobial resistance. Continued leadership and innovation to ensure rapid and equitable scale up of access to evidence-informed HIV prevention, treatment and care programmes is required in all EU member

states. Improved data and analysis will be required to identify and overcome the age-, sex-, and key population-specific bottlenecks in delivering HIV prevention and treatment services. The 2016 United Nations Political Declaration on Ending AIDS adopted regional Fast-Track targets that need to be achieved by 2020. If these targets are reached in all regions by 2020, the world will be on the Fast-Track to ending AIDS as a public health threat by 2030, within the context of the Sustainable Development Goals. There is much work ahead if the EU Fast-Track target to reduce new HIV infections is to be achieved (Fig. 2). The AIDS epidemic remains a global concern and the biggest threat today is complacency. Ending AIDS by 2030 requires us to end AIDS for everyone, everywhere. More than ever, the EU has a critical leadership role to play. Firstly, in remaining a leading donor to the global AIDS response; secondly, by demonstrating leadership and commitment at home by supporting the development and adoption of the Malta declaration on HIV/AIDS(11), and finally, by demonstrating what can be achieved, with adequate resources, when the evidence is put into practice, such as Sweden, the first country to declare achievement of the 9090-90 targets. (12) There is no room left for complacency and no place for discrimination in the AIDS response. Fear of criminalisation, stigma and discrimination or lack of legal status prevents thousands of people from accessing HIV prevention and treatment services and fuel the continued spread of new HIV infections across the EU. Our unified response must be inclusive and requires sustained effort to reach the


HIV / AIDS Health Report

Continued leadership and innovation to ensure rapid and equitable scale up of access to evidence-informed HIV prevention, treatment and care programmes is required in all EU member states

Fig. 2 – Progress towards the Fast-Track target for reducing new HIV infections in the European Union by 2020 (Source: UNAIDS 2016 estimates, special analysis)

populations currently being left behind, particularly men who have sex with men, migrants and people who inject drugs and their sexual partners. Resources should follow trends in urbanisation and economic migration and focused in the locations where they will have greatest impact. 2017 is a year of great change across Europe but in this change there is opportunity. With intensified commitment, the EU could become the first region to achieve the FastTrack targets, and through leadership in the G20 and across the Sustainable Development Goals, the EU can lead the world to achieve the end of AIDS as a global public health threat by 2030. References: 1. UNAIDS 2016 estimates, special analysis. 2. European Centre for Disease Prevention and Control/WHO Regional Office for Europe. HIV/AIDS surveillance in Europe 2015. Stockholm: ECDC; 2016. 3. Grant RM, Anderson PL, McMahan V, et al. Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study. Lancet Infect Dis. 2014;14(9):820–9. 4. McCormack S, Dunn D. Pragmatic open-label randomised trial of pre-exposure prophylaxis: the PROUD study; Conference on Retroviruses and Opportunistic Infections; Seattle, Washington. 2015. Abstract 22LB 5. Molina J-M, Capitant C, Spire B, et al. On demand PrEP with oral TDFFTC in MSM: results of the ANRS Ipergay trial; Conference on Retroviruses and Opportunistic Infections; Seattle,

Washington. 2015. Abstract 23LB 6. Nwokolo, G Whitlock, A McOwan. Not just PrEP: other reasons for London’s HIV decline. Lancet HIV 2017;4: e153 7. www.aidsmap.com/The-large-fall-in-HIVdiagnoses-in-London-gay-men-is-real-andthanks-to-combination-prevention-notjust-PrEP/page/3129924/, accessed 13 April 2017 8. Domosławski A. Drug policy in Portugal: the benefits of decriminalizing drug use. Warsaw: Open Society Foundations; 2011 (www.opensocietyfoundations.org/ sites/default/files/drug-policy-inportugalenglish-20120814.pdf, accessed 13 April 2017 9. Csete J. A balancing act: policymaking on illicit drugs in the Czech Republic. New York: Open Society Foundations; 2012, www.opensocietyfoundations.org/sites/ default/files/A_Balancing_Act-03-14-2012. pdf, accessed 13 April 2017 10. www.unaids.org/en/resources/ presscentre/featurestories/2017/ april/20170412_belarus, accessed 13 April 2017. 11. Malta declaration on HIV/AIDS: Call for fast tracking actions on HIV towards ending the AIDS epidemic by 2030 in the European Union. www.eu2017.mt/en/PressReleases/Documents/PR200317_EN.pdf accessed 13 April 2017. 12. Gisslén M et al. Sweden, the first country to achieve the Joint United Nations Programme on HIV/AIDS (UNAIDS)/ World Health Organization (WHO) 9090-90 continuum of HIV care targets. HIV Medicine, online edition. DOI: 10.1111/ hiv.12431 (2016)

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Towards Transforming Outcomes

How innovation can help defeat HIV & AIDS The need of the hour is a new, innovative generation of vaccines, treatments and diagnostic tools. Cecile Vernant, Head of EU Advocacy, Deutsche Stiftung Weltbevoelkerung (DSW) explains how EU research funding can act as a catalyst in transforming how we tackle HIV & AIDS

I

n all the gloom surrounding the European Union this year – Brexit, migration, the Trump administration – there is one issue where the EU can stake a claim to global leadership in 2017: global health innovation and the fight against HIV & AIDS. An end to the epidemic of HIV & AIDS by 2030 would be a landmark achievement. It is one which, given the current geopolitical climate, will only be achieved through European leadership. In 2017, by increasing investment in research to overcome HIV & AIDS, and other diseases of poverty, the EU can spur the creation of the new vaccines, and new drugs that are essential to ending HIV & AIDS by 2030. The fight against HIV & AIDS – slow progress Despite huge progress made in the last three decades, HIV & AIDS remains a serious global health challenge. According to the latest WHO statistics, 1.1 million people died from HIV-related causes in 2015; 2.1 million people around the world were newly infected with the diseases, two-thirds of which live in sub-Saharan Africa. This rise is not exclusive to Africa; Europe experienced a 7% annual increase in new HIV infections in 2015. It doesn’t have to be this way. The Millennium Development Goals and the rollout of life-saving medicine have saved millions of lives in the last 20 years. However, these existing treatments are not enough to stem the tide of HIV infections. What’s needed is a new, innovative generation of vaccines, treatments and diagnostic tools. Just look at what could be achieved if we were to introduce a HIV vaccine. A 70%-effective vaccine could prevent the majority of annual new HIV infections by 2050, saving millions more lives in the process and ending the HIV epidemic. But, a new vaccine won’t conjure itself out of thin air – it needs long-term investment to make it a reality. Enter the European Union. American decline, European advance? For the first time since reporting on funding

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levels began, in 2015 the EU overtook the UK as the second largest public funder of global health research. Things are moving at the national level. In 2016, the German government doubled its funding for innovative initiatives working on global health research. Programmes launched by the European Commission in the last decade are beginning to deliver results; half of all new malaria drugs registered since 2000 have received EU funding. However, these European advances are happening against a backdrop of stagnating levels of funding for global health. A report by Policy Cures and DSW found that funding from both the EU and European governments fell in four out of the five years between 2009 and 2014. What’s more, the prospect of huge cuts to US research funding by the Trump administration means that US global health leadership is no longer guaranteed. If Europe is serious about wanting to end HIV & AIDS by 2030, then it needs to address several challenges in 2017. DSW’s Imagine2030 campaign has plotted a course through them. Funding The EU and EU member states should work harder to meet the 0.01% of GDP spending target set out by a WHO body. Research suggests that to achieve our health goals by 2030, we need to double the amount invested in R&D to $6bn by 2020. The EU will have to contribute meaningfully to this. Bureaucracy In the interim, the European Commission can already make its funding for HIV research smarter and more targeted. A key to this is developing a long-term global health strategy that guides EU policy, includes research at its core, and is backed by high-level political support. Parallel to this, the EU can make funding more accessible and more transparent. We need to make sure that EU investment in HIV research gets to the most promising projects, supporting innovative models like product development partnerships (PDPs).

Brexit Brexit could be a major external challenge to EU global health leadership. The UK is a significant contributor to EU research programmes like Horizon2020, and is a centre of research excellence, housing many leading research institutes. If it is not dealt with properly, Brexit will pose a significant threat to the EU’s leadership ambitions. Negotiations therefore have to consider the importance of the continued participation of UK institutions in EU-funded research programmes beyond Brexit. European funding in 2017 – an opportunity not to be missed In 2017, there is an opportunity to make EU research funding a catalyst for a transformation in how we tackle HIV & AIDS. Negotiations have already started on how to re-tool the EU’s multi-year budget to address the big challenges facing Europe and the wider world. We are also about to launch into the debate on the priorities for the next multi-year budget starting in 2020. The EU needs to harness these processes to put global health innovation – and the fight against HIV & AIDS – front and centre. A 2030 without HIV & AIDS might seem ambitious, but it is often easy to forget the staggering progress that has been made in the last 30 years. For Europe, 2017 is a pivotal year for its plan to get us there. Let’s get started.


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Government Gazette Vol 1; 2017  
Government Gazette Vol 1; 2017  
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