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EARIP – Work package7 – How best to establish a European Innovative Partnership for
the Management of Asthma
Date: 5pm-7pm, Tuesday 9th September 2014
Venue: Room 2.160, Second Floor, ERS International Congress, Internationales Congress
Center Munich, Germany
Agenda
04:50-05:00 Arrival
05:00-05:10 Welcome and Introduction
Nikos Papadopoulos (UoA, EAACI)
05:10-05:20 Overview of European Innovation Partnership in asthma
Samantha Walker (Asthma UK)
05:20-05:30 The Vision of EIP in AHA
Jean Bousquet (INSERM, University of Montpellier)
05:30-05:40 The Vision for an EIP in asthma: The patient perspective
Susanna Palkonen (EFA)
05:40-05:50 The Vision for an EIP in asthma: The needs and expectations of industry
David Myles (GSK) / Thomas Martin (Novartis)
05:50-06:00 Achievements though International Collaboration
Mark Fitzgerald (GINA)
06:00-06:10 Asthma as a societal problem - Political solutions
Piotr Kuna (Medical University of Lodz)
06:10-07:00 Discussion
All
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Attendees:
First Name
Surname
Organisation
Nikos
Papadopoulos
EAACI, UoA
Aggeliki
Androutsopoulou UoA
Jean
Bousquet
ARIA, INSERM
Jessica
Edwards
Asthma UK
Mark
Fitzgerald
GINA
Emily
Humphries
Asthma UK
Piotr
Kuna
UMED
Thomas
Martin
Novartis
Dan
Murphy
Asthma UK
David
Myles
GSK
Susanna
Palkonen
EFA
Samantha
Walker
Asthma UK
Leif
Bjermer
EAACI
Sebastian
Johnston
Imperial College London
Martine
Puhl
Patient Representative
Purpose of the meeting (Nikos Papadopoulos)
NP outlined that what it is aimed to achieve from the meeting was to develop the first
draft of the vision for the EIP on Asthma. The meeting would also discuss the activities
that lead towards the vision, and the stakeholders who should be involved in developing
the final version. The intention would be to draft some text based on the first set of ideas
that will be discussed during this workshop and circulated it “transparently” to the
different stakeholders in order to provide their input. A dynamic process will follow
requiring involvement of other groups.
Introduction to EIPs
European Innovation Partnerships are a new approach to research and innovation.
Enhancing Europe’s competitiveness is an important component. They pool all relevant
actors at EU, national and regional level and coordinate different actions to ensure rapid
uptake of breakthroughs in the market.
Currently there exist five EIPs:
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Active and Healthy Ageing
Agricultural Sustainability and Productivity
Smart Cities
Water
Raw Materials
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Vision
Current EIPs are very wide, and their visions have very different styles. For instance AHA’s
vision being strong, measurable and specific, while in the Water and Agri -EIP are more
general. We have had no specific direction on whether we should set a target on deaths
and hospital admissions, or perhaps suggest something wider on the contribution to
European economy and competitiveness, but the recent report evaluating the current EIPs
suggests:
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Include a societal headline objective
Engage stakeholders
Have an objectively measurable target
Keep relevant to member states
Link to current policy initiatives
The starting point from the EARIP proposal is reducing the annual level of asthma deaths
by 25% within 10 years and 50% in 20 years, and hospitalisations by 50%. To date the bid
has been framed as 30 million people; 4 million hospitalisations, 20 billion of treatment
costs; and significant lost productivity costs, with no effective treatments for 5% of people
with asthma.
There was some discussion about the need to redefine the objectives of the EIP to look at
disease burden and prevalence.
-JB observed that asthma only accounts for a tiny proportion of deaths. Asthma is not
mentioned in the Nοn Communication Diseases Action plan of the WHO before 2025,
Asthma is not mentioned, maybe people will thought it is not a major problem, because
the number of asthma deaths simply isn’t high enough.
-MF: See the rational paper on hospitalizations by GINA in ERJ. MF said that GINA had has
a very similar discussion and decided to focus on admissions instead of deaths; there is an
ERJ paper on the rationale for this from approximately two years ago.
- JB: The major target of the EIP should be on asthma prevalence (both deaths and
hospitalisations should be secondary targets). For example, 20% reduction of Asthma
prevalence is a very clear objective. You can get a lot of impact in the reduction of
Asthma prevalence and the outcome of this in decrease of asthma deaths and
hospitalizations. You need to give number. EIP are supposed to be on big problems,
you have to show something big “you have X million people affected now; you will
have Y million in 20 years” and we should be setting out to reduce this by, say 20%.
The major problem in asthma today is prevalence across the lifecycle. So, the EIP
should have two messages; to decrease the prevalence and secondly to improve the
trajectory of asthma because it is a lifecycle problem, which is connected with
productivity. Later it was concluded to focus on burden, i.e. “Reduce the burden by
40% within 10 years and then define the burden, to have indicators that we are going
to use to assess the burden (e.g. prevalence, hospitalisatons, deaths, costs).
-JB: Prevalence is a measurable target using epidemiologic studies
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-SP added that prevention is an important word for EU, so the EIP should frame the
problem in asthma as a lack of innovation in asthma medications, which is important for
prevention (even if secondary prevention). There are huge disparities and health
inequalities in Europe and that is key for the patient community, so there could also be a
target there. For example, “Each asthma patient in Europe will receive the care that they
need by XYZ”.
ACTION: Circulate ideas to different stakeholders for input (NP).
ACTION: Input to stakeholder list (all).
ACTION: Join and disseminate LinkedIn group (all)
Introduction to EARIP (Samantha Walker)
An overview of the project was given by Samanhta Walker. EARIP was funded as part of
the EU’s Framework Package 7 programme, led by Asthma UK with 12 partners from across
Europe. It needs to do some big things – change how Europe thinks about and organises
asthma research mapping on H2020 priorities. EARIP’s work package 7 is intended to
identify what is needed for a European Innovation Partnership (EIP) in asthma.
-SW: The vision has to move away from deaths, since it is much less comparing to other
diseases. Treatment and loss productivity costs is very important to be reduced. We need
to make a composite case under a big ambition.
-MF: The case for productivity losses can be made based on a recent paper, which MF has
published in Chest on presenteeism – productivity losses have been underestimated. It’s
also important to note that productivity losses for asthma are throughout the lifecycle
and impacts parents and young workers unlike a lot of other long-term conditions, which
are predominantly in older people and productivity loses occur in the end of lifetime. A
productivity case can be made to employers if 10% of their workforce has asthma (GSK has
recently shown the benefits of workplace education as being cost-effective for
employers). Modelling practices should be involved in cost effectiveness.
-JB: You need to shock people to read your EIP. If you will say that you will reduce
prevalence you need to decrease everything, you need to understand why the disease is
occurring. But what EARIP should not focus only on understanding, but through the EIP it
is should be going into practice, policies and economy development.
ACTION: SW reminded the group of the need to get the EC on board, to talk to all
different stakeholder groups, to get some high level influence and take advise from
people. It is also important to discuss the impact on competitiveness and involve SMEs
(where innovation lies, e.g. startups) and industry and engaging them with clear targets.
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Lessons from the Active and Health Ageing EIP (Jean Bousquet)
JB has been leading the care pathway area of the AHA EIP and has tried to divert it
towards chronic respiratory. He has set up the Airways ICPs (as chair of action group B3 on
care pathways); this has meant chronic respiratory diseases has been accepted as the
model. He has also been to the WHO to convince them it should also be on their
programme and to have a consultation on how the Airways ICP are going to impact NCD
action plan. The next step is to contact Ministries of Health of various European countries
will, including Portugal, Poland, Italy, Finland, Norway and France to convince them of
the need to get involved. Next meeting on October is in the Health Ministry of Italy, due
to the Italian presidency.
JB suggestions on important aspects:
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Challenge driven
o Asthma is 30 million people across the lifecycle
o How asthma is occurring?
o Why asthma is persisting?
o Why asthma is becoming severe?
Social benefits
o Gender issues
Rapid modernisation of associated sectors and markets
o It is not for health, it is for growth and economy. It can affect an enormous
market, by reducing costs and making innovation and business for EU.
The EIP should change the mind of people about non-communicable diseases and
position respiratory disease as leading the way, reverting investors to fund NCD.
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Research and development
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Regulation and Environment (existing regulations are not being enforced).
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Public procurement; bring a new vision (not just treating people the old way)
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ACTION: List existing instruments and initiatives (FP7 and others), start with a
summary of these and a SWOT analysis and proposal to bring them together (eg
supporting the cohort studies so they don’t decline which DG Health and
Consumers/SANCO would be interested in).
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Prevention and Environmental actions (Important for DG SANCO)
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DG connect should be also involved (it is responsible for 50% of the active ageing
partnership)
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Show that asthma is increasing and will continue increasing if nothing is done.
JB showcased the major problems related with AHA.The AHA-EIP has various different
streams. For asthma, we should do the same thing by outlining the major challenges we
want to tackle, and find 5 or 6 key areas where we are going to improve the life of EU
citizens, e.g. better treatment, understanding severe asthma, prevention and so on.
Influencing to get an EIP (Jean Bousquet)
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Italy currently has the EU presidency until December and will issue a handover document
on its conclusion; JB advises that we should try to get an asthma EIP mentioned within this
which will be a good lever. He plans to promote EARIP at an Italian meeting on 14/15
October and hoping so that one of the conclusions could be an EIP on asthma there. He
will also mention this at his forthcoming WHO meetings and perhaps they will also
recommend an asthma EIP. The key point should be that in the official organ of EU there is
the EIP as priority.
-NP: Italian presidency chronic respiratory diseases as one of priorities. Presidencies are a
good way to access the EU legislation.
ACTION: We should try to convince them to propose to the EU that the EIP on asthma is
one of the priorities. Convince the national government to include the priority in the
official document. Mobilize with the Italian, Polish, Portuguese government and so on. If
we have many governments, the WHO consultation next year may also propose the EIP.
ACTION: JB to mention asthma EIP at WHO meetings
ACTION: JB to invite 2/3 people (SW/NP?) from EARIP to attend meeting in Italy
ACTION: Have on board Mike Bewick, NHS Scotland and NHS Ireland, Donald Tusk, the PM
of Poland, president of the European Council from December is critical – but we have only
one opportunity to reach him so the level of aspiration needs to be big enough to impress
people but realistic and concrete enough to be convincing.
The patient perspective (Susana Palkonen)
SP suggested that the scale of ambition could not only come from the target, but from the
way it is linked to the priority agenda of what members states and the commission (and
WHO) want.
The patient should to be central - think about what’s around them, what issues affect
them:
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Treatment
Participation
Environment
Research (or needs that have to do with Research)
This also highlights policy areas that are relevant and not only on the country level, but
also at EU level:
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Agenda on ICT
Treatment as whole package (not only medicines, includes early diagnosis, smoking
cessation, etc.)
For EFA the starting point should be the patients, the vision should formulated with the
direction that “everything who will need will be engaged”.
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EFA’s Vision: Everybody in Europe has the right of high quality of care and safe
environment. The vision has to always have a totally human face, even linked with other
economy and policy issues. For further justifications, EFA can give all the information to
the partnership – medical devices, clinical trials directive, air pollution and so on to link to
policy dossiers.
There was also some discussion of using EARIP to link to the chronic diseases agenda
around the world and at European level. EARIP/asthma can be presented as a pilot or a
flagship/example of how to fix a chronic disease problem. Targeted actions are needed
and EARIP would be an excellent mechanism to bring all stakeholders together to solve
asthma.
-MP suggested creating a visualisation of the project putting the patient at the centre and
covering the whole of Europe by creating an animated image of individual people, which
merges into a map of Europe. This indicates that we start from one person and go to the
mass.
ACTION: advise on relevant current policy dossiers (SP)
GINA update/involvement (Mark Fitzgerald)
A new GINA report has been published this year. It’s a global programme but has some
relevance with EU in providing a management framework. The latest report talks about
framing treatment to individual patient with a prevention and management strategy. It is
a practical approach.
EARIP can gain from the experience of GINA, through frameworks, strategies, innovative
things and educational material. GINA is happy to do what they can to help in terms of
support.
-MF highlighted the importance of “humanomics” issues in the chronic diseases
management.
-SW highlighted the importance for the Commission of the “European under Global
Community” working together.
-NP the whole community should learn what GINA is doing and GINA will part of the
community, we should define how GINA can help.
-DM: We have to think how will bringing in other diseases when speaking on management
asthma.
-SW: There are a lot of other diseases when speaking about asthma.
-NP: We need targeted actions to learn and transmit to other diseases. Focusing on asthma
we will achieve the maximum for other diseases.
The needs and expectations of industry (Tom Martin/David Myles)
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Tom/David are representing a Novartis and GSK perspective. They think a lot about the
science of developing new drugs; past in academia so interested in actual process of
getting drugs to patients
What pharmaceutical industry actually does when they want to develop a new medicine:
The first stage is pre-clinical discovery, then first in human studies, then proof of concept
to show target engagement to show efficacy of a compound, then phase 2 studies to test
the patient population and dosing regimen, then finally large phase 3 studies to show long
term efficacy and safety, then the drug goes for review. Finally, in phase 4 – tests in
50,000 people, looking out for safety signals in larger populations. This is a very long and
costly process.
From an EIP, industry would be looking for synergies with academics, biotechnology groups
in the early stages, then later with patients. A lot of the time, pharmas are getting
involved half way through because they buy a drug at the point where it’s been shown to
be safe in humans.
Enablers to speed drug development could be (see slide):
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Large patient networks to enable trials and investigations into patient needs (John
Walsh COPD foundation in USA has a vision of 100,000 involved patients)
Standardised intellectual property processes and confidentiality
Validated tools for patient relevant outcomes
Databases - not just for discovery but for safety
Better biomarkers, better tools to understand how patients feel
Current knowledge gaps:
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Clarity about patients’ desires and needs (especially in different parts of Europe as
populations will vary)
Better engagement of patients and patients organisations across Europe
“One company, one drug” paradigm; it’s difficult to work across companies for
drug development
Understanding how to improve compliance and current therapy
Understanding whether there are therapies which could permanently modify the
disease (ie get treated, and prevent asthma from coming back). Novartis are trying
this with a compound (e.g. immunotherapy)
Understand the disease better Various specifics of asthma – how does it start,
progress, sustain, become more severe, disappear (in some cases)?
-JB: Disappearance of the disease to discover the mechanism to treat it
If the objective is improved disease management, can we do more with patients at
home through remote monitoring etc. Need to target the right drugs to the right
patients
Discussion on this session focused on how to expand from the pharmaceutical industry to
consider other types of company (e.g. Generics) to be fit in the EARIP vision. There are
already other interested companies in respiratory, so this will not be an issue. JB
suggested going everywhere outside Pharma companies, to nutrition companies, to big ICT
companies - Google, Microsoft, IBM who may be interested in data and monitoring. He also
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suggested to mobilise other industries e.g. car manufacturers, transportation (FIAT,
Mercedes, cars with air conditions or without pollution) and tourism (make hotels more
allergy friendly), insurance companies (AXA, Allianz). TM observed that big companies
have a stake in reducing the asthma burden as employers – it’s in their interest to catalyse
something that makes their employees feel better. We have to justify the transformation.
SP suggested approaching industry associations to ask them which of their members would
be interested. NP said that to argue that environmentally friendly actions that already
industries do has to do with asthma, to use as their own argument. Another argument is
that asthma is one of the major cause of driver accidents. The project should focus on
everywhere, job loss, health insurance economics (see Health economic studies, involve
economists), educational sector, schools (kids with asthma).
ACTION: consider mapping and approaching industry associations / trade unions
associations in Europe (NP)
Further influencing opportunities (Piotr Kuna)
As President of the Polish Respiratory Society in 2004, PK was successful in convincing the
EU to include respiratory in FP7 (it had been excluded). Political support from a Polish MP
was really important but lack also played an important part.
PK feels that because healthy ageing (already a priority) depends on childhood health,
EARIP should make a case focused on premature death and premature disease across the
spectrum. Respiratory and allergic diseases start in early age and asthma is a complex
issue, since it is not really separate to other respiratory diseases (there are links to
allergic rhinitis, COPD/ACOS). Asthma is the most common chronic disease from early
childhood up to the age of 40 in Poland. For 40 years asthma and other respiratory
diseases are the third major cause of death. In Poland it is the most common reason for
hospital visits and admissions among children. Asthma is also a major risk factor for COPD
(asthma 13-fold higher risk; smoking only threefold higher risk) and cardiovascular disease.
The European Council (in December 2011) has already welcomed existing networks such as
GA2LEN and GARD and invited member states to take national action, exchange good
practice and data and collaborate. This is the political agenda/ behind the EARIP idea.
-JB suggested organising a meeting through the Airways ICP work; he already has a mission
from the Portuguese government to organise something. The priority should be getting
into the official organs of the EU that there should be an EIP in asthma, with the support
of six or seven governments. The Italian presidency report will also be crucial.
EARIP needs to come with a coherent programme by October 2015 – take this as part of
airways ICPs as being what they want.
ACTION: reconvene to discuss further plans (JB/NP/SW)
Publications mentioned in the meeting which may help to make a case (references
needed)
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ERJ paper on GINA’s rationale for focusing on admissions c.2012
Latest GINA report 2014
Position paper in Allergy 2012 (67) - Samolinski
Suissa Am J Med 2003 – there is a fivefold decrease in heart attack rates for those
with asthma who comply with ICS
MF has just published a paper in Chest on presenteeism – productivity losses have
been underestimated. Productivity losses for asthma are throughout the lifecourse
UNLIKE a lot of other LTCS which are predominantly in older people.
GSK has recently shown the benefits of workplace education as being cost-effective
for employers
MF Paper in press in JACI on cost effectiveness of different interventions.
MF Annals of Internal Medicine paper about how HCPs are bad at describing risk.