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4th Interna*onal MS Pa*ent Summit
‘Societal and Health Challenges in Europe -‐
Influencing the direc*on of healthcare decision-‐making’
Dr Mary Baker MBE, BA, Hon DSc European Brain Council
Rome 21st – 22nd May, 2015
88
Costs of disorders of the brain
• €798 billion across 30 countries and 19 groups of disorders
• Has increased from €386 billion in 2004
In Europe 2010:
European Neuropsychopharmacology (2011) 21, 718-‐779
Distribu*on of costs Total disorders of the brain
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Indirect costs 40%
Direct healthcare costs 37%
Direct non medical costs
23%
European Neuropsychopharmacology (2011) 21, 718-‐779
The world is living longer
90
A baby girl born in Japan has a 50/50 chance of living 100 years
Global ageing in the 21st century
91
‘The world stands on the threshold of a social transformaCon -‐ even a revoluCon -‐ with few parallels in humanity's past.... Perhaps two-‐thirds of all people who have ever reached the age of 65 are alive today’
Peter G. Peterson
The changing role of women
92
In the 1920’s, a couple in their 80’s had 44 female rela*ves -‐ 14 of these did not work outside the home environment In the year 2000, a couple in their mid 70’s had 13 female rela*ves -‐ 3 of these did not work outside the home environment
Dependency ra*o
1960 1990 2009/10 Australia 6.4 5.2 4.4 Canada 6.8 5.4 4.5 France 4.8 4.1 3.5 Germany 5.2 4.2 3.0 Italy 6.1 4.0 3.0 Spain 6.9 4.3 3.7 UK 5.0 3.7 3.6 Poland 9.4 5.7 4.9 Average 6.3 4.6 3.8
Dr Panos Kanavos London School of Economics
Fewer to care for more: a declining dependency ra*o
93
MS Pa,ent Summit -‐ Rome
94
How familiar are you with Health Economists?
1. I know all about them and what they do. 2. I know a li@le bit about their role. 3. I have heard of them, but don’t know what they do. 4. I have never heard of them and don’t know what they do.
0 10 20 30 40%
20%
36%
20%
24%
1. I know all about them and what they do.
2. I know a little bit about their role.
3. I have heard of them, but don’t know what they do.
4. I have never heard of them and don’t know what they do.
How familiar are you with health economists?
Polypharmacy and co-‐morbidity
96
Provision of culturally relevant care
97
The challenge of migra*on
Time with the doctor
98 .....12 minutes
Access to medica*on
99
A very uneven playing field
Counterfeit medicines (CMs)
100
• 2011: in EU CMs risen to over • 27million
• WHO es*mate CMs sales in developed countries is 1% and
• 10% in developing countries
• GMP Colombian style; ingredients include: Ø Boric acid Ø Lead-‐based road paint Ø Shoe polish Ø Brick dust
Profit before pa*ents!
Way forward
101
Partnership
Communica*on Innova*on
Trust
Europe 2020 for a Healthier EU
102
Innova*on Union To find innova,ve ways to promote ac,ve and healthy ageing Digital agenda for Europe Focuses on developing and using digital applica,ons to address social challenges
Agenda for new skills and jobs Will help to highlight the economic role of mental health and the health of the workforce
European plaiorm against poverty Boost efforts on health promo,on and preven,on with a focus on reducing health inequality
MS Pa,ent Summit -‐ Rome
103
What do you know about the European Semester?
1. I have heard of it and know what it is. 2. I have heard of it but can’t remember the details. 3. I have heard of it, but don’t know what it is. 4. I have never heard of it!
0 20 40 60 80%
9%
8%
5%
78%
1. I have of it and know what it is
2. I have heard of it but can't remember the details.
3. I have heard of it, but don't know what it is .
4. I have never heard of it!
European Semester?What do you know about the
Making it Happen: The European Semester
105
The European Union has set up a yearly cycle of economic policy coordina,on called the European Semester
Excellent Science Innova*on Societal Impact
Outcome Measures
Funding
106
FP5 (pre EBC) Total in FP6 FP7 2007 -‐ 2013
Brain 115m 431m 2b (June ‘13)
Cancer 235m 914m 1,716b
Cardiovascular 54m 232m 554m
EBC con*nues to push for beker funding of brain research
Innova*ve Medicines Ini*a*ve: Joining forces in the Healthcare Sector
107
108
IMI poriolio: budget breakdown up to call 11
109
0,0 1,0 2,0 3,0 4,0 5,0
Rheumatology Pharmacology & Pharmacy
Endocrinology & Metabolism Neurosciences
Clinical Neurology Biochemistry & Molecular Biology
Psychiatry Genetics & Heredity
Research & Experimental Medicine Immunology
Overall
IMI papers EU papers average 2.04 average 1.13
Cita*on impact 2010-‐1012 19% of IMI publica*ons are highly cited
110
§ 28 countries working together to tackle neurodegenerative diseases
§ €100 milllion made available since 2011
§ New partnership with European Commission § €30 million call on:
§ Longitudinal cohorts § Animal and Cell Models § Risk and Protective Factors
Opportuni*es for research -‐ JPND
A quick fix ...
111
Lifestyle choices
112
• Ageing • Infer*lity
60% of NHS budget is spent on lifestyle issues:
• Alcohol • Obesity
• Sexual health • Smoking
• Drug Addic*on
........
113
‘The doctor of the future will give no medicine, but will interest his pa*ents in the care of the human frame, in diet, and in the cause and preven*on of disease’
Thomas A Edison 1847 -‐ 1931
The Pa*ent’s Voice
114
The Regulator and the Payer
115
Professor Guido Rasi Chief Execu*ve Officer
European Medicines Agency (EMA)
Professor David Haslam Chairman
Na*onal Ins*tute of Health & Clinical Excellence (NICE)
New approach to clinical trials
116
Clinical trials – the facts
117
• 30% of all clinical trials fail to recruit a single person
• 85% of clinical trials face delays due to limited par*cipa*on
• Fewer than 10% of Parkinson's pa*ents ever take part in trials, despite overwhelming interest in working with scien*sts to help speed treatment breakthroughs
Harveian Ora*on 2008 Professor Sir Michael Rawlins
118
“Randomised controlled trials (RCTs), long regarded as the 'gold standard' of evidence, have been put on an undeserved pedestal. Their appearance at the top of "hierarchies" of evidence is inappropriate; and hierarchies, themselves, are illusory tools for assessing evidence.”
"Hierarchies akempt to replace judgement with an oversimplis*c, pseudo-‐quanta*ve, assessment of the quality of the available evidence."
........
119
Arguments about the rela*ve importance of different kinds of evidence are an unnecessary kind of distrac*on.
What is needed instead is:
• for inves*gators to con*nue to develop and improve their methodologies • for decision-‐makers to avoid adop*ng entrenched posi*ons about the nature
of evidence • for both to accept that the interpreta*on of evidence requires judgement
Future challenge for society
120
• The need for both the Regulators and the Payers to have a collec*ve impact on trial design, conduct and data interpreta*on is becoming more obvious to all stakeholders
• But nothing much is happening – the divide remains
• What happens if this con*nues for another 10 years?
Pa*ent reported outcomes
121
MS Pa,ent Summit -‐ Rome
122
Have you worked on projects with Universi*es?
1. OYen. 2. Occasionally. 3. Rarely. 4. Never.
0 10 20 30 40 50%
21%
19%
19%
41%
1. Often.
2. Occasionally.
3. Rarely.
4. Never.
Have you worked on projects with Universities?
Pa*ent reported outcomes
124
Develop a measurement acceptable to European Medicines Agency (EMA) and Food & Drug Administra*on (FDA) in partnership with: • Academia (University of Oxford -‐ Ox-‐PAQ
project)
• Regulatory, payers, pa*ents and their families
• Clinicians • Industry
Distress is not enough
125
• Establish credibility • Collect evidence • Contribute to discussions • Understand health technology assessments
Pa*ent advocacy groups need to:
HTA Summer School for Pa*ent Groups
126
Working for people living with brain disorders
Collabora*on between EFNA and London School of Economics:
Ini*ated in September 2009 – ongoing, twice yearly
The Pa*ent’s journey
127
Informa*on is needed from:
• Clinician -‐ about the disease • Industry -‐ about the medica*on • Pa*ent non-‐governmental organisa*ons -‐ about the fellow travellers
A major challenge – societal engagement
128
• How do we involve pa*ents/carers in research?
• An informed pa*ent is a cost effec*ve pa*ent (Wanless)
Good Prac*ce
129
Beker Outcomes with Beker Data
130
Allows data sharing at a European Level and addresses a widely recognised gap in data on:
-‐ age and gender -‐ causes and triggers -‐ availability, access and effec,veness of drugs -‐ costs and resources
European Network of MS Registries
131
EUReMS project co-‐funded by the Health Programme 2011-‐2014 (European Commission, DG Sanco)
Collabora*ve approach to MS data: pa*ents’ representa*ves, Clinicians and academics
11 Project partners incl. 5 MS Registers par*cipa*ng In 2011
The future of medicine
132
Today Future
Today we diagnose and treat based on symptoms and a subjec*ve interpreta*on of
symptoms
In the future we diagnose and treat based
on biology and select medica*on based on an objec*ve evalua*on
of the benefit/risk for the individual pa*ent
Personalised Medicine
133
P4 Medicine:
Personalised, Predic*ve, Preven*ve, Par*cipatory
mHealth and Personalised Medicine
134
e-‐Health and emerging technologies
135
e-‐Health and emerging technologies • improve quality of care
• increase pa*ent autonomy, mobility and safety • help clinical decisions based on computer modelling of diseases
Priori*es in e-‐Health : Research FP7 2007-‐2013 DG Connect Goals to offer e-‐Health solu*ons to:
e-‐Health and emerging technologies
136
ICT Solu*ons for e-‐Health and e-‐Inclusion: • home monitoring systems • health alert systems
• molecular diagnos*c systems at point of care • home rehabilita*on • risk assessment • electronic health records • computer models of diseases and decisional systems based
on models for selec*ng treatments and performing earlier diagnosis -‐ VPH (virtual physiological human)
Priori*es in Health : Research FP7 2007-‐2013 DG Connect
The Future of the Mind
137
“We've learned more about our brains in the last 15 years than in the whole of human history and new technologies like MRI means we're entering a golden age of neuroscience”
The renowned physicist Michio Kaku, author of "The Future of the Mind”
Balance
138
PHYSICAL &
BIOTECHNICAL
SCIENCE
ETHICS
SOCIAL
ENVIRONMENT
& POLICY
SOCIAL
SCIENCE
& HUMANITIES
“Sciences are the ‘how’. Humani*es are the ‘why’. I don’t think you can have the ‘how’ without the ‘why’,”
George Lucas, Producer, Screenwriter and Director
From the bench to the bedside
139
Rx
HTA review ~ 2 years
New drug applica*on & review ~ 2 years
Preclinical & clinical development ~ 8 years
From the bench to the bedside
140
Rx
HTA review ~ 2 years
New drug applica*on & review ~ 2 years
Preclinical & clinical development ~ 8 years
HTA review ~ 2 years
New drug applica*on & review ~ 2 years
Preclinical & clinical development ~ 8 years
Rx
HTA review ~ 2 years
New drug applica*on & review ~ 2 years
Preclinical & clinical development ~ 8 years
HTA review ~ 2 years
New drug applica*on & review ~ 2 years
Preclinical & clinical development ~ 8 years
From the bench to the bedside
141
Rx
HTA review ~ 2 years
New drug applica*on & review ~ 2 years
Preclinical & clinical development ~ 8 years
From the bench to the bedside
142
Rx
HTA review ~ 2 years
New drug applica*on & review ~ 2 years
Preclinical & clinical development ~ 8 years
From the bench to the bedside
143
Rx
HTA review ~ 2 years
New drug applica*on & review ~ 2 years
Preclinical & clinical development ~ 8 years
Management of long term chronic illness
144
• The ability to adapt and self manage
• To be able to par*cipate in social ac*vity despite all limita*ons
Year of the Brain
145
Protect, preserve, develop and nurture
our most vital asset: the brain
In Europe – 2014/2015 An exci*ng programme to influence and improve the lives, the health and the future for many millions of people
Year of the Brain Our vision and overall objec*ves
Improve the care of those affected by brain disease today
and Ensure that treatments are available to them
as quickly as possible
• Encouraging higher prioritisation of brain disease in the EU and national health systems
• Promoting earlier diagnosis and more equitable access to adequate treatment and care
YOtB vision ‘To protect, preserve, develop and nurture our most vital asset: The Brain'
Increase investment in research for future generations
• Securing increased funding for basic research into the brain
• Strive after optimising regulatory conditions to incentivise innovation from research to patient
Educate society about how to nurture and protect the brain
• Raising awareness of the human and economic burden of brain disease
• Communicating personal and societal strategies for preventing brain illness and brain disability
Securing early and adequate treatment for the patients affected today
Raising awareness of the challenges with brain illness
Driving improvements in treatment for the generations to come
Focu
sing
on
the
need
s of
so
ciet
y
Music and the Brain
147
Olga Bobrovnikova – A piano diva living with MS
148
What makers most ... ‘It is not the strongest of the species that survives nor the most intelligent that survives. It is the one that is most adaptable to change.’
A quote oVen aWributed to Charles Darwin!
Health is Wealth
149
Health should be viewed as an investment rather than a cost
A Healthy Na*on is a Wealthy Na*on
MS Pa,ent Summit -‐ Rome
150
Friday, May 22nd, 2015 Summit Moderator: Kaz Aston (UK) 08:30
08:40
09:20
10:00
10.40
Welcome & Introduction - Antonella Moretti (AISM, It) & Anna Chiara Rossi (Novartis, It)
Plenary session
• Patient rights in research and treatment - Dr Vittorio Martinelli (It), Aliki Vrienniou (Gr)
• Influencing the direction of healthcare decision-making - Mary Baker (UK)
• The ‘Expert’ Patient - Jean Hardiman-Smith (UK)
Panel discussion
11.15 Break 11.30 Breakout sessions
• Patient rights in research and treatment (co-facilitator - Michele Messmer (It))
• Influencing the direction of healthcare decision-making (co-facilitator - Silvia Traversa (It))
• The ‘Expert’ Patient (co-facilitator - Federica Balzani (It)) 12.30 MS World Café
Best Practice Sharing Fair for Patient Advocates
13.00 Buffet Lunch 14:00 Breakout sessions (continued) 15:00 Breakout group feedback to plenary 15:55 Closing Remarks – Antonella Moretti (AISM, It) & Anna Chiara Rossi (Novartis, It) 16.00 Meeting Close
Raising standards; The voice of people with MS