MEDICAL PUBLICATIONS FOR BETTER PATIENT CARE: …...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:

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



INFORMING HEALTHCARE AUDIENCES

ACROSS EUROPE FOR OPTIMAL PATIENT

CARE

Moderator:

Susan Scott, Director, Scott Pharma Solutions Ltd



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Open up the App and click on the ‘Polls,’ icon; Then look for this presentation,

[Informing healthcare audiences across Europe for optimal patient care]


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



INTRODUCTION

Diversity • Healthcare systems and regulations • Healthcare reimbursement • Attitudes and behaviours


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).


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


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



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






20-21 January, 2015

St. Paul’s - 200 Aldersgate London, UK



Accessing healthcare in Europe:

Publication needs of European payers

Richard Lawson

Director of Health Economics and Payer Analytics,

AstraZeneca


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.


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?


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


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


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.


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?


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


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?


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


Many thanks for your time

• Any questions?

[email protected]






20-21 January, 2015




Healthcare systems across Europe: similarities ‒ differences ‒

challenges

Prof. Reinhard Griebenow, MD

EBAC, Cologne, Germany


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



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



Germany (2010 - )

Ct, 3y Cardio, 3y

Ct, 3y Cardio, 3y

5y, Internal medicine 3y Cardiology


UK

3y 2y 2y 2y 5y

Internal

medicine

Foundation

training Cardiology

Core

cardiology Subspecialty


• strict gate keeping (GP): e.g. NL

• free choice: e.g. DE

Access to specialist care


• strictly separate: e.g. DE

• not separated: e.g. UK

Ambulatory vs. hospital care


Funding of health-care

• 100% government: e.g. UK

• statutory health insurance: e.g. DE

• private insurance


Reimbursement of drugs, devices etc.:

• indication regulated (e.g. by NICE/GBA): e.g.

UK, DE

• quantity regulated


•For laypersons, but also for an

increasing number of experts, press has

become the gatekeeper to information

felt to be relevant


•Standards

•Reliability

•Sustainability


Conclusion

•Standards for reporting should be the

same for scientific journals as for press

media.



THANK YOU FOR YOUR ATTENTION






20-21 January, 2015




UNDERSTANDING THE CHALLENGES FOR

MEDICAL PUBLICATION PROFESSIONALS IN

EUROPE

Farah Dunlop

Global Publications Manager, Sirtex Medical Ltd.

21/01/15


Disclaimer

Any opinions expressed are those of the presenter and not

necessarily those of Sirtex Medical Ltd.


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



RECENT POLICIES


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


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.

http://www.regulations.gov/

http://www.nih.gov/exitdisclaimer.html

http://grants.nih.gov/grants/guide


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


Achieving consistency across all

communications

Plan

Communicate

Formalise

Train



CHALLENGES FOR THE

PUBLICATION MANAGER

European Authors


Attitudes to authorship

Increasing awareness of

guidelines: GPP2/ICMJE

Variations in policies

Expectations of authorship


Challenges relating to financial disclosure and

conflict of interest in Europe

Employment

Consultancy

Stock ownership or options

Honoraria

Patents

Paid expert testimony


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


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


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?


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


Thank you






20-21 January, 2015

St. Paul’s - 200 Aldersgate London, UK



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



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]


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


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


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


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

Documents

MEDICAL PUBLICATIONS FOR BETTER PATIENT CARE: …...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: