European challenges and the way forward” Medicine into the EU Strategy EMA Human Scientific Committees’: Brussels - 09th & 10th September 2014 (PCWP) and (HCPWP) Joint meeting September 20th, 2016 Denis H Horga n , EA EAPM PM Ex Executive D i rector
Technology Advancement 2005 2015 $100 million Cost of Sequencing a ~$1000 Human Genome 14 Personalized Medicine >160 Products on the Market 1 13 Personalized Medicine U.S. Drug approvals that year 26 years 4 years Example of Time (EGFR cetuximab) Elapsed from Discovery (ALK crizotinib) to Market 73% of Oncology Drugs in 42% of All Drugs in Development Development Are Personalized Are Personalized Medicines Medicines Personalized Medicines 2
Emerging Molecular Taxonomy Prevalence of Phenotypes Biankin and Hudson 2011
The Perfect Storm? Shifting Increasing Changing Regulatory Reimbursement Data Volume, Variety Initiatives Science Landscape & Velocity $ : Traditional Approaches are Limited Established Solutions Homegrown Tools Point Applications • Often not open platforms • Challenge keeping pace with • Limited to single use case • Incomplete Electronic Data industry best practices • Not highly scalable Warehouse models • High operational and • Reinforces silos • Inflexible approaches opportunity costs
Healthcare System Bringing healthcare to the next level requires that we move out of our castles and work together
Personalised Medicine • Is it not just a natural evolution ? • We understand more about disease; so shouldn’t our treatment approaches be more complex? • Where are we? • What are the barriers ?
Personalised Medicine • Science has evolved but health systems lag behind • We understand more about disease; so shouldn’t our treatment approaches be more complex? • Challenges for society
We Are Getting Faster!!! KRAS Slebos 1990 EGFR Many 1990s EML4-ALK Kwak 2010 ROS-1 Bergathon 2012
• www ... : What? – Why RAPM? - Why now? What? • pan-EU network on personalised medicine and personalised healthcare (1) capacity-building (connecting existing initiatives) (2) coordination (contributing to policy roadmap based on needs) (3) open platform (sharing best practices and giving policy advice) (4) networking opportunities Why IAPM? • fragmented picture in Europeanand Polish landscape: need for overarching initiative Why now? • expressed need for timely guidance for implementation on European level (good governance = branding/trust developed by with all stakeholders) 10
11 Different Legislative Issues Addressed by EAPM Informed Consent Clincal Evidence Registeries Treatment decision-making considerations Collaborating with your Patient empowerment healthcare team Value/Cost Rubicon Ensuring access for tests Research in Personalised AND treatment Medicine Bio - banking Public Private Partnerships Expanding organizational reach to G enetic, genomic and NGS untapped patients Definitions testing Role of Ethics Committee Educating policymakers Establishing Big Data & Research consistent language
Chair: Queen ’ s University Belfast There are four thematic focuses in this Working Group: Key Policy Ask : For the EU to commit to the development of a European Translational Research Platform that enables the Stream 1: Clinical Trials efficient translation of research discoveries to innovative Policy Ask: To ensure a diagnostics, therapeutics, products and processes that will responsive regulatory benefit European patients, industries and societies. “ Chair: INTEL environment that responds to the needs of all stakeholders Policy Ask : “ By 2020, the whilst ensuring patient safety, EU should endeavour to with the end result of ensuring achieve widespread benefits development of treatments for for patients and citizens from patients personalised healthcare by defining in 2015, and Stream 2: Data Protection subsequently executing a Policy Ask: easier circulation Data Strategy for and sharing of personal data, Personalised Medicine. EAPM appropriately balanced with personal privacy for the Chair: European Workin benefit of patients Haematalogy Association g Stream 3: In-Vitro Diagnostics Key Policy Ask: “ By 2020, Policy Ask: greater attention the EU should support the Groups to the role of diagnostics and development of a Europe- imaging in personalised wide education and training medicine. of Chair: ROCHE & European healthcare professionals ’ Patient Forum curriculum for the personalised medicine era, Key Policy Asks: to ensure: by committing to this in 2015. a) health care resources The EU should subsequently allocated to development Stream 4: Medical Adaptive Pathways facilitate the development of and utilisation of Key Policy Asks : an Education and Training personalised medicine, A)There is a need for a better understanding of Strategy for HCP in through acceptance of its patients ’ and payers ’ willingness to operate Personalised Medicine. ” long-term cost-effective with greater uncertainty driven by the release of benefits and needed therapies with less evidence at the initial b) to effect a paradigm shift in launch; pricing and reimbursement B)There is a need to facilitate the IT to recognise the societal infrastructure and processes to provide the value of a medicine necessary evidence base using real-world data
Three dimensions • Increase in the incidence of chronic disease • Change in demographics and epidemiology • Non Compliance • Patient and citizen needs and involvement in the healthcare ecosystem How does this European impact R&D? healthcare What solutions challenges can be drive through R&D? Research and Regulatory/ Development healthcare (technological/ delivery How does this impact Scientific) healthcare delivery? challenges challenges What research is required to provide solutions? 13
DEFINTION OF PERSONALISED MEDICINE N o commonly agreed definition of the term “ personalised medicine ” . W idely understood that personalised medicine refers to a : • medical model using characterisation of individuals' phenotypes and genotypes (e.g. molecular profiling, medical imaging, lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time, and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention. • Personalised medicine relates to the broader concept of patient- centred care, which takes into account that, in general, healthcare systems need to better respond to patient needs;
Growing divide across Europe
“An imbalance between rich and poor is the oldest and most fatal ailment of all republics” Disparities in male life expectancy between East and West Europe have grown in the last 40 years Public health efforts are at risk due to poor European and National legislation Health services for children are not keeping pace Migration of health workers is a major threat to many European countries Economic policy has major effects on health Prince M, Sullivan R et al . The burden of disease in older people: implications for health policy and practice Lancet Series on Ageing Nov 6 th 2014
Economic disparities are a balance between what we spend on cancer care and what cancer ‘costs’ economies Fernandez-Luengo R, Leal J, Gray A, Sullivan R. Economic burden of cancer in Europe . Lancet Oncology 2013: 14(12): 1165-1174.
Massive variation in direct spend on cancer care across Europe: major differences in where money is spent Lithuania € 8,421 Portugal € 9,002 Primary Hungary € 9,177 Outpatient Sweden € 9,325 Bulgaria € 9,600 A&E Denmark € 9,891 Inpatient Cyprus € 10,081 Medicine Romania € 11,140 Latvia € 11,314 Belgium € 11,410 Slovenia € 12,215 Italy € 12,526 Malta € 13,642 France € 14,459 Spain € 14,623 United Kingdom € 15,955 EU-27 € 16,243 Slovakia € 16,478 Czech Republic € 17,175 Ireland € 18,072 Estonia € 21,036 Netherlands € 21,301 Poland € 21,475 Germany € 22,887 Austria € 23,476 Luxembourg € 24,381 Finland € 24,646 Greece € 26,215 € 0 € 5,000 € 10,000 € 15,000 € 20,000 € 25,000 € 30,000 € 35,000 € 40,000 Healthcare costs per incident COLORECTAL cancer, adjusted for price diferentials
Medicines have contributed to 15% of increased health costs in Europe – with hospitalizations and elderly care being the key drivers Share of Growth per healthcare category (2004 – 2010, 15 EU OECD Countries, population-weighted, current prices, PPP, $) 54% 16% 14% 5% 4% 4% 3% 0% 100% Note: Countries included: Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden Source: OECD Health Statistics Database (accessed 2013); Eurostat Database (accessed 2013)
Total cost 2 billion euro The bridge over öresund between Sweden and denmark
Personalised and Precision Politics • President Obama’s Precision Medicine Initiative • European Commissions Work Programme for Health, Demographic Change and Wellbeing • Genomics England 100,000 Genomes Project • MRC Stratified Medicine Initiative • Vice President Biden’s Cancer Moonshot • Innovative Medicine Initative II
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