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2015 EUROPEAN MEETING OF ISMPP 1
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
MEDICAL PUBLICATIONS FOR
BETTER PATIENT CARE:
INTEGRITY, INNOVATION,AND IMPACT
20-21 January, 2015
etc.venues, St. Paul’s - 200 Aldersgate London, UK
2015 EUROPEAN MEETING OF ISMPP 2
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
INFORMING HEALTHCARE AUDIENCES
ACROSS EUROPE FOR OPTIMAL PATIENT
CARE
Moderator:
Susan Scott, Director, Scott Pharma Solutions Ltd
2015 EUROPEAN MEETING OF ISMPP 3
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
NOTE! GRAB YOUR TECHNOLOGY!
This presentation contains polling questions you can access through the 2015 European Meeting App.
Open up the App and click on the ‘Polls,’ icon; Then look for this presentation,
[Informing healthcare audiences across Europe for optimal patient care]
2015 EUROPEAN MEETING OF ISMPP 4
Audience question
Thinking of your professional remit, which
geographical area(s) do you consider that you are
representing at this ISMPP meeting? You can select
more than one.
1. Global
2. Europe-wide
3. Western Europe
4. Eastern Europe
5. Southern Europe
6. Nordics & Northern Europe 7. Individual country
8. Other
2015 EUROPEAN MEETING OF ISMPP 5
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
INTRODUCTION
Diversity • Healthcare systems and regulations • Healthcare reimbursement • Attitudes and behaviours
2015 EUROPEAN MEETING OF ISMPP 6
Life expectancy across Europe
France
Spain
Italy
Sw eden
Finland
Cyprus
Austria
Luxembourg
Malta
Germany
Netherlands
Slovenia
Belgium
Ireland
Greece
Portugal
United Kingdom
EU-27
Denmark
Czech Republic
Poland
Estonia
Slovak Republic
Hungary
Lithuania
Latvia
Romania
Bulgaria
Sw itzerland
Iceland
Norw ay
Croatia
Turkey
Montenegro
FYR of Macedonia
Serbia
Females Males
85.0
84.9
84.6
83.5
83.4
83.4
83.3
83.3
82.9
82.8
82.8
82.8
82.8
82.7
82.6
82.6
82.3
81.7
81.2
80.6
80.3
80.2
79.1
78.4
78.4
78.1
77.3
77.3
84.7
83.7
83.2
79.9
78.8
78.0
76.8
76.8
30405060708090
Years
HLY LE with activity limitation
78.0
78.7
79.3
79.4
76.7
78.6
77.8
78.0
78.1
77.8
78.7
75.9
77.3
78.0
78.0
76.5
78.2
75.3
76.9
74.3
71.6
69.7
71.3
70.3
67.3
67.9
69.8
70.1
80.0
79.9
78.7
73.5
73.3
73.1
72.5
71.5
30 40 50 60 70 80 90
Years
HLY LE with activity limitation
Source: Eurostat
Statistics Database;
Joint Action: EHLEIS
(2012).
2015 EUROPEAN MEETING OF ISMPP 7
Healthcare spend across Europe
0
1 000
2 000
3 000
4 000
5 000
6 000
7 000
Healthcare spend (US$) per capita in 2012
From OECD (2014) DOI: 10.1787/hlthxp-cap-table-2014-1-en
2015 EUROPEAN MEETING OF ISMPP 8
Learning objectives
• Gain insights into the diverse health care
systems, market access and attitudes across
Europe
• Understand how considerations such as
language, audience identification and author
relationships affect the role of medical
publication professionals
• Appreciate the importance of
communicating the right information to the
right audience for the benefit of patients in
Europe
2015 EUROPEAN MEETING OF ISMPP 9
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
FACULTY Richard Lawson, Director, Health Economics & Payer Analytics, AstraZeneca, UK
Reinhard Griebenow, Professor, Kliniken der Stadt Koln, Germany
Farah Dunlop, Global Publications Manager, Sirtex, UK
2015 EUROPEAN MEETING OF ISMPP 10
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
MEDICAL PUBLICATIONS FOR
BETTER PATIENT CARE:
INTEGRITY, INNOVATION,AND IMPACT
20-21 January, 2015
St. Paul’s - 200 Aldersgate London, UK
2015 EUROPEAN MEETING OF ISMPP 11
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
Accessing healthcare in Europe:
Publication needs of European payers
Richard Lawson
Director of Health Economics and Payer Analytics,
AstraZeneca
2015 EUROPEAN MEETING OF ISMPP 12
Achieving reimbursement and access
Health technology assessment (HTA) refers to
the systematic evaluation of properties, effects,
and/or impacts of health technology.
European countries are undertaking
increasingly formal, rigorous and transparent
assessments.
A consensus of key evidence is required across
countries with key supplementary analyses
required depending on country archetype.
2015 EUROPEAN MEETING OF ISMPP 13
What do payers want to know?
• Payers, broadly, want the following questions
answered to support reimbursement
Why do patients need this drug?
Does this drug represent
good value?
Do you have
evidence of the drug working in the real world setting?
Is your drug better than comparative drugs in
this population?
What are the patient outcomes associated
with this drug?
What is the unmet
need for me and my patients?
What are the
consequences of not funding?
2015 EUROPEAN MEETING OF ISMPP 14
European payer landscape
• A consensus of evidence is required across
countries but there are different mechanisms
on how an assessment around a technology is
reached.
– Cost effectiveness
– Comparative clinical effectiveness
– Patient led purchase
– Budget optimizing
2015 EUROPEAN MEETING OF ISMPP 15
Payer archetypes across Europe
Archetype Description Countries which
adopt this process
Cost
effectiveness
Undertaking an economic
evaluation to assess value
Comparative
clinical
effectiveness
Translating the efficacy
shown in the RCT to
effectiveness against key
comparators
Patient led
purchase
Patients have choice over
which drug to be treated
with
Budget
optimizing
Measuring the budget
impact of reimbursing the
drug
Most countries will
require this,
especially at a local
level
2015 EUROPEAN MEETING OF ISMPP 16
Cost effectiveness requirements
Bodies which consider cost effectiveness as a
primary requirement include:
• England and Wales – NICE
• Sweden – TLV
• The Netherlands – Zorginstituut
• Belgium – KCE
These bodies require data around costs,
resource utilization and health state utility as
well as efficacy and safety data.
Reimbursement dossiers are typically submitted
using a structured template.
2015 EUROPEAN MEETING OF ISMPP 17
Accessing healthcare in comparative
clinical effectiveness markets
• Many markets are becoming more stringent in
their requirements.
• A mandatory benefit assessment process was
introduced in Germany four years ago. This
assessment impacts drug pricing in Germany.
More stringency to gain
reimbursement
What this means
Compare with SoC Head to head data is required for +ve assessment
Requirement of longer
term data
In a chronic condition a minimum of 24 week
efficacy data is mandated
Focus on patient relevant
endpoints
Don’t just focus on your regulatory endpoints. How
does your trial relate to clinical care?
Patient segmentation Which population gives greatest additional
benefit?
2015 EUROPEAN MEETING OF ISMPP 18
European payer requirements
Different healthcare systems
Specific evidence requirements to support local
market access and reimbursement
Unmet need and
burden of illness
Budget
impact
Resource utilization
Patient reported endpoints
Indirect
comparisons
Payer analyses of
clinical trials Cost
effectiveness
2015 EUROPEAN MEETING OF ISMPP 19
Create a payer story to demonstrate
the value of the drug
•Burden of illness and prevalence of a disease Why do patients need this drug?
•Is the population adequately covered with the current treatment options
What is the unmet need for me and my patients?
•Consider relevant patient and payer endpoints, including PROs and resource use
What are the patient outcomes associated with this drug?
•Conduct head to head or indirect comparison to evaluate effectiveness vs. the local SoC
How does your drug compare to others in the population?
•Is the RCT generalizable – do we need RWE studies to support ?
Do you have evidence of the drug working in the real world setting?
•Economic evaluation of the drug Does this drug represent good value?
•An evidence based summary to justify the use of the drug as an intervention
What are the consequences of not funding?
2015 EUROPEAN MEETING OF ISMPP 20
Communicating to payers
• The payer story is an intrinsic element of the
value message of the drug.
• It needs to focus on evidence and outcomes
pertinent to the payer:
– Value
– Budget impact
– Relevant comparator and population
– Consider a PICO approach for each market
• These need to be communicated in the most
appropriate way to the payer:
– Local publication or conference
– Technical journals
– Payer submission
2015 EUROPEAN MEETING OF ISMPP 22
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
MEDICAL PUBLICATIONS FOR
BETTER PATIENT CARE:
INTEGRITY, INNOVATION,AND IMPACT
20-21 January, 2015
etc.venues, St. Paul’s - 200 Aldersgate London, UK
2015 EUROPEAN MEETING OF ISMPP 23
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
Healthcare systems across Europe: similarities ‒ differences ‒
challenges
Prof. Reinhard Griebenow, MD
EBAC, Cologne, Germany
2015 EUROPEAN MEETING OF ISMPP 24
Conflict of interest
• Prof. Reinhard Griebenow, MD
– President, UEMS Cardiology Section
– Chairman of the Board, ECSF
– Chairman, EBAC Advisory Committee
– Member, EACCME Taskforce
– Head, Academy for Training and Education, Chamber of
Physicians Northrhine
– Member of the Board, Chamber of Physicians Northrhine
– Member, German Senate for CME, German Medical
Association
– Member, Education Committee, German Cardiac Society
– Member, Editorial Board, JECME
2015 EUROPEAN MEETING OF ISMPP 25
2015 EUROPEAN MEETING OF ISMPP 26
0
20
40
60
80
100
120
140
160
180
200198
128 127
112 110
99 93
85 80
74 71
68 65
60 56
53 48 47 46 44 43
40 39 36 36
26 20
15 11
FIG 1. No of cardiologists per million inhabitants in 2006
Manpower survey
67/million
2015 EUROPEAN MEETING OF ISMPP 27
2015 EUROPEAN MEETING OF ISMPP 28
Germany (2010 - )
Ct, 3y Cardio, 3y
Ct, 3y Cardio, 3y
5y, Internal medicine 3y Cardiology
2015 EUROPEAN MEETING OF ISMPP 29
UK
3y 2y 2y 2y 5y
Internal
medicine
Foundation
training Cardiology
Core
cardiology Subspecialty
2015 EUROPEAN MEETING OF ISMPP 30
• strict gate keeping (GP): e.g. NL
• free choice: e.g. DE
Access to specialist care
2015 EUROPEAN MEETING OF ISMPP 31
• strictly separate: e.g. DE
• not separated: e.g. UK
Ambulatory vs. hospital care
2015 EUROPEAN MEETING OF ISMPP 32
Funding of health-care
• 100% government: e.g. UK
• statutory health insurance: e.g. DE
• private insurance
2015 EUROPEAN MEETING OF ISMPP 33
Reimbursement of drugs, devices etc.:
• indication regulated (e.g. by NICE/GBA): e.g.
UK, DE
• quantity regulated
2015 EUROPEAN MEETING OF ISMPP 34
•For laypersons, but also for an
increasing number of experts, press has
become the gatekeeper to information
felt to be relevant
2015 EUROPEAN MEETING OF ISMPP 35
•Standards
•Reliability
•Sustainability
2015 EUROPEAN MEETING OF ISMPP 36
Conclusion
•Standards for reporting should be the
same for scientific journals as for press
media.
2015 EUROPEAN MEETING OF ISMPP 37
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
THANK YOU FOR YOUR ATTENTION
2015 EUROPEAN MEETING OF ISMPP 38
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
MEDICAL PUBLICATIONS FOR
BETTER PATIENT CARE:
INTEGRITY, INNOVATION,AND IMPACT
20-21 January, 2015
etc.venues, St. Paul’s - 200 Aldersgate London, UK
2015 EUROPEAN MEETING OF ISMPP 39
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
UNDERSTANDING THE CHALLENGES FOR
MEDICAL PUBLICATION PROFESSIONALS IN
EUROPE
Farah Dunlop
Global Publications Manager, Sirtex Medical Ltd.
21/01/15
2015 EUROPEAN MEETING OF ISMPP 40
Disclaimer
Any opinions expressed are those of the presenter and not
necessarily those of Sirtex Medical Ltd.
2015 EUROPEAN MEETING OF ISMPP 41
Agenda
• Recent EMA policies and their implication on
publication planning
• Challenges facing publication professionals in Europe
– Attitudes to authorship in different countries & regions
– Financial disclosures & conflict of interest in Europe
– Language barriers
• Recommendations for when to select European vs
National publications and congresses
2015 EUROPEAN MEETING OF ISMPP 42
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
RECENT POLICIES
2015 EUROPEAN MEETING OF ISMPP 43
European Medicines Agency
2 policies summer 2014
• June 2014: Mandatory posting of clinical trial summary results in EudraCT
– Interventional clinical trials ending after July 21st 2014 must be posted on
EudraCT within 12 months (adult) or 6 months (paediatric) of study
completion using a defined data set
– Interventional Clinical trials ended before July 21st 2014 must be posted
retrospectively by 2016 using a defined data set and/or summary
• October 2014: Publication of clinical data
– Clinical study reports, overviews & summaries all need to be made
publically available with redaction of personal identifying and
commercially confidential information (CCI)
– Include protocols & amendments, sample case report form,
documentation of statistical methods and individual patient data (IPD)
– Effective from 1 January 2015
2015 EUROPEAN MEETING OF ISMPP 44
FDA Nov 2014: FDA proposed rule
making
Two proposals have been released for comment to
increase the transparency of clinical trials via information
submitted to ClinicalTrials.gov
• Notice of Proposed Rulemaking (NPRM)
• Draft National Institute of Health (NIH) policy
– To register all trials whether drug approved or not
– First steps towards new law
The complete NPRM will be available in docket number NIH-2011-0003 atwww.regulations.gov .
The proposed NIH Policy will be published in the NIH Guide for Grants and Contracts
at: http://grants.nih.gov/grants/guide.
2015 EUROPEAN MEETING OF ISMPP 45
Implications on publication planning
• Data/results communicated should be
consistent across
– CSR’s/protocols*
– Trial registries
– Results databases
– Congresses
– Publications
*Redacted for confidentiality of subjects & sensitive commercial information
2015 EUROPEAN MEETING OF ISMPP 46
Achieving consistency across all
communications
Plan
Communicate
Formalise
Train
2015 EUROPEAN MEETING OF ISMPP 47
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
CHALLENGES FOR THE
PUBLICATION MANAGER
European Authors
2015 EUROPEAN MEETING OF ISMPP 48
Attitudes to authorship
Increasing awareness of
guidelines: GPP2/ICMJE
Variations in policies
Expectations of authorship
2015 EUROPEAN MEETING OF ISMPP 49
Challenges relating to financial disclosure and
conflict of interest in Europe
Employment
Consultancy
Stock ownership or options
Honoraria
Patents
Paid expert testimony
2015 EUROPEAN MEETING OF ISMPP 50
Language barriers and (lack of)
common terminology
• Unless top KOLs, most still speak national language
• Overcome by using regional head of regions or local key account
managers to facilitate
– Often have a “relationship”
– Able to converse in local language to lessen margin for
misunderstandings
• Reliant on an “intermediator” to facilitate the process
• More complicated process for manuscripts than abstracts
• For congress posters or oral presentation then English language
capability must be considered if regional congress
2015 EUROPEAN MEETING OF ISMPP 51
Who is best placed to coordinate National
publications; regional or national leads?
• Company set up
– Smaller companies have pub managers who overlook all
national/regional and global congresses
– Larger companies may have a tiered structure with specific publication
managers for regions as well as therapeutic areas
• Need national as well as regional input
– logistics and nuances
• Take advantage of the relationships national leads may have with
local KOLs and local cultural knowledge
• Local language capabilities
2015 EUROPEAN MEETING OF ISMPP 52
Recommendations for when to select European
vs National publications and congresses
Audience/Attendance
Maximum exposure of data
Likelihood of acceptance
Advice from KOL
Both? Regional congress followed by national?
2015 EUROPEAN MEETING OF ISMPP 53
Summary
• Recent EMA policies
– Plan SOPs/CWIs & communication across groups in
future to ensure that the content presented
publicly in all these channels is consistent and
aligned.
•Challenges for the Publication Manager – Cultural difference make it hard to work
consistently across the different regions in Europe
– Challenges still exist in conforming to guidelines
and recommendations
2015 EUROPEAN MEETING OF ISMPP 54
Thank you
2015 EUROPEAN MEETING OF ISMPP 55
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
MEDICAL PUBLICATIONS FOR
BETTER PATIENT CARE:
INTEGRITY, INNOVATION,AND IMPACT
20-21 January, 2015
St. Paul’s - 200 Aldersgate London, UK
2015 EUROPEAN MEETING OF ISMPP 56
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
Panel discussion
Susan Scott, Scott Pharma Solutions Ltd, UK
Richard Lawson, HEOR Senior Scientist, AstraZeneca, UK
Reinhard Griebenow, Kliniken der Stadt Koln, Germany
Farah Dunlop, Global Publications Manager, Sirtex, UK
2015 EUROPEAN MEETING OF ISMPP 57
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
NOTE! GRAB YOUR TECHNOLOGY!
This presentation contains polling questions you can access through the 2015 European Meeting App.
Open up the App and click on the ‘Polls,’ icon; Then look for this presentation,
[Informing healthcare audiences across Europe for optimal patient care]
2015 EUROPEAN MEETING OF ISMPP 58
Audience question
Does your company/ do your client(s) prepare one
publication plan with clinical and HE publications,
or separate publication clinical and HE plans?
1. One integrated publication plan
2. Separate clinical and HE publication plans
3. One clinical publication plan PLUS a separate HE plan for
each major market
4. Something else
5. Don’t know
2015 EUROPEAN MEETING OF ISMPP 59
Audience question
Have your company/ your client(s) introduced
processes to address consistency between clinical
trial registry postings and clinical publications?
1. Yes, fully
2. Yes, started but not complete yet
3. No, but starting to plan
4. No, not at all
5. Don’t know
2015 EUROPEAN MEETING OF ISMPP 60
Audience question
Where should congress presentations of clinical
trials conducted in Europe and sponsored by the
pharmaceutical & medical device industries be
presented?
1. Internationally focused conferences
2. European focused conferences
3. National conferences
4. Mix of these
5. Depends on relevance of information
2015 EUROPEAN MEETING OF ISMPP 61
Audience question
Where should results of clinical trials conducted in
Europe and sponsored by the pharmaceutical &
medical device industries be published?
1. Internationally focused journals
2. European focused journals 3. National journals
4. Depends on relevance of information