From Strasbourg 2003 to Bucharest 2009 – the impact of the MS Resolution of the

European ParliamentChristoph Thalheim

Secretary General

European MS Platform

Structure of this presentation

• Introduction EMSP

• Multiple Sclerosis – the disease & its therapies

• EP Report & Resolution on MS

• The “Code of Good Practice in MS”

• …and its related “European Consensus Papers”

• Costs of the disease versus budgetary issues

• Summary

• … is the umbrella organization of the predominant national MS-Societies in currently 33 European countries and represents almost half a million people affected by MS

• and here are our members:

Austria

Spain

Port

ugal

Iceland

Ireland UK

France

Belgium

Netherlands

Lux

GermanyPoland

Italy

Estonia

Latvia

Lithuania

FinlandSweden

Norway

Russia

Belarus

Switzerland

SlovakiaCzech R.

Greece

Malta

RomaniaBosnia-

Herzegovi

na

SerbiaHungary

Croatia

Slovenia

Austria

Spain

Port

ugal

Iceland

Ireland UK

France

Belgium

Netherlands

Lux

GermanyPoland

Italy

Estonia

Latvia

Lithuania

FinlandSweden

Norway

Russia

Belarus

Switzerland

SlovakiaCzech R.

Greece

Malta

RomaniaBosnia-

Herzegovi

na

SerbiaHungary

Croatia

Slovenia

• Austria• Belarus• Belgium• Bosnia-Herzegovina• Croatia• Czech Republic• Denmark• Estonia• Finland• France• Germany• Greece• Hungary• Iceland• Ireland• Italy• Latvia• Lithuania• Luxembourg• Malta• Netherlands• Norway• Poland• Portugal• Romania• Russia• Serbia• Slovakia• Slovenia• Spain• Sweden• Switzerland• UK

EMSP Members

6

Globally, at any point in time, around 30 people in

100,000 have been diagnosed with MS = 1.3 million *

MS symptoms mostly start between 25 and 31 years of age - Lost production due to decreased work capacity is one of the biggest cost driver of MS

Among chronic diseases, MS has one of the worst utility (quality of life) scores, similar to that of rheumatoid arthritis * *

-------------------------------------------------------------------------- * Atlas of MS – WHO / MSIF 2008 * * Dr. G. Kobelt ea, “The Burden of Rheumatoid Arthritis (RA) and Patient Access to Treatment”, 2007

The burden of Multiple Sclerosis

• beta interferon [IFN] 1b FDA:1993 EU: 1997

• beta IFN 1a-intramuscular [im] FDA: 1996 EU: 1997

• glatiramer acetate FDA:1996 EU: 2002

• mitoxantrone FDA: 2000 - not approved for MS in EU

• beta IFN 1a-subcutaneous [sc] FDA: 2002 EU: 1998

• natalizumab FDA: 2004 FDA & EU:2006

7

List of currently approved DMTs for MS

Phase I

Biosimilars Injectables Orals Other

MLN3697 Millennium/sanofi

-aventis

CDP-323 Celltech Group

Dronabinol Unimed Pharma

AVE 9897sanofi-aventis

AlemtuzumabILEX Pharma

LaquinimodTeva

BG-12 Fumapharm

/Biogen

BX-471 Berlex Biosciences/ Schering AG

ZK-117137 Schering AG

C-6448 Merck & Co

GSK-683699GSK

CCI-779Wyeth

Interferon t,Pepgen

Phase II

Daclizumab, Biogen Idec

NBI-5788 Neurocrine BioSci Inc.

Abatacept Bristol-Myers

ATL-1102 Antisense

ABT-874 Abbots Lab

ISIS-107248 Antisense

MBP8298 Lilly/BioMS

Cpn 10 Cbio Ltd

EMZ 701 Transition

CNTO1275 Centocor

TV-5010 Teva

Tovaxin, OpexaPharmaFrontier

s

IFN beta 1A Vakzine

IFN beta 1A Synovex

Teriflunomide sanofi aventis

Cladribine Merck Serono

Fingolimod Novartis/

Mitsubishi

E-2007Eisai Co. Ltd

Fampridine Accorda/Elan

Rituximab

Biogen

IFN beta 1A Biopartners

Phase III

Courtesy Merck Serono

Therapies in MS: the pipeline

1. Early detection / confirmed diagnosis

2. Immediate start of appropriate treatment

3. Continued access & adherence to treatment

9

Key to successfull delay of disabling symptoms/ same for all existing and coming therapies

Presentation: Uma Aaltonen, MEP

Discussion with MEP‘s

Approval of the MS Report by 240 MEP‘s in the European Parliament (Petition 842/2001) concerning the effects of discriminatory treatment towards persons with MS, within the European Union (2003/2173 (INI))

…persons with Multiple Sclerosis, and many other chronic long-term illnesses, are subject to varying levels of medical and therapeutic care depending on their place of residence and …insufficient priority has been accorded by Member States of the Union…to remedying this fact;

18th December 2003, EU Parliament Straßbourg

Official presentation of the “First EU Report on MS”

The fight of a courageous British young lady with MS insisting on her right as European citizen for the best possible therapy, found strong support from the EMSP, the Petition Committee of the European Parliament and finally the European Parliament

A CODE driven by a patient plightA true story of success

"There are hundreds of thousands of MS sufferers in the UK and across Europe who are finding life a lot harder than me but I am a strong person and fight hard to get what I should rightfully receive, while others are not in a position to be like this”

Louise McVay before the Committee on Petitions, European ParliamentJuly 2003

A political statement reflecting “state of the art” practice outlined in the following European Guidelines:

Disease modifying therapies (e.g. Interferons)Symptomatic treatments (e.g. against bladder problems)RehabilitationPalliative CarePrinciples of Quality of Life (developed by MSIF)http://ec.europa.eu/health/ph_information/dissemination/diseases/neuro_en.htm#monitoring

Supported by epidemiology facts and figures available on an interactive internet database (www.europeanmapofms.org )

Structure of the “CODE of Good Practice” – requested by the European Parliament

Implementation on the national working level

The method of development of The European Code of Good Practice could serve as a model for other chronic conditions

Model character

Small consensus group develops draft

Repeated consultation with leading European experts

Regular updates

Acknowledgement on political level

Publication of the widely accepted findings

The European Code of Good Practice in Multiple Sclerosis is a political instrument offering help to national responsible authorities

Aiming to raise the standards in the five key areas critical for persons with MS up to the level of the current optimum

As practised in some EU member states and/or demanded by the leading experts in each field in European consensus

Purpose of the CODE

Major MS Conference held by EMSP 29- 30 May 2007

Promoting European Code of Good Practice in MS

“Code” & related European Consensus Papers endorsed by:

– President of the European Parliament, Prof. Dr. Gerd Pöttering,

– the German Health Minister Chairwoman of the EU Health Council Ulla Schmidt

– the European Commission (Commissioner Kyprianou), who confirmed his support again in the European Parliament on June 18, 2007

http://www.ms-in-europe.org/ourevents/index.php?kategorie=events2007&cnr=58&anr=219

16

Total Cost of MS in EuropeHigh cost compared to other disorders of the brain

0

5 000

10 000

15 000

20 000

25 000

30 000

35 000

40 000

Cost per patient (€ 2004)

tumour

multiple

sclerosis stroke

dementia

psychotic disorders

parkinson

epilepsy

affective disoders

trauma

addiction

anxiety disorders

migraine

1) J. Neurology (S) June 2005 (www.ebc-eurobrain.net)2) Sobocki et al, Multiple Sclerosis (in press)

17

Total Cost of MS in EuropeLow prevalence compared to other disorders of the brain

-

5

10

15

20

25

30

35

40

45

Number of cases (million)

Anxiety disorders

Migraine

Affective disorders

Addiction

Dementia

Psychotic disorders

Epilepsy

Parkinson's disease

Stroke

Trauma

Multiple Sclerosis

Brain tumour

1) J. Neurology (S) June 2005 (www.ebc-eurobrain.net)2) Sobocki et al, Multiple Sclerosis (in press)

Prevalence 380’000Slightly over 2% of all brain disorders

“The cost of diagnosis and treatment of MS at the earliest possible stage

(but definitely within the window of the first five years of the disease)

can be offset by the reduction of societal costs in the long term, with considerable gains in the quality of life for PwMS at the same time.”

Dr. Gisela Kobelt at EMSP- MSID Conference Brussels, May 2007

The need of “holistic budgeting” and higher priority of health in national budget decisions

Source: OECD figures for 2006

Healthcare Expenditure as % of GDP

Aging society and the obvious increase of prevalence of chronic diseases require more “holistic budgeting” and higher priority for healthcare budgets, but this will not be enough:

Pharma industry and research bodies need to develop medicines which are more efficient & cheaper than what exists at the moment.

European Guidelines and consensus papers such as the “European Code of Good Practice in MS” – developed in close cooperation by medical experts and patients – are available and should be used on national level as tool to overcome existing inequities in healthcare.

Summary

Innovative medicines might be expensive, but they are a necessary investment into lower societal costs.

The proven considerable inequities in access to those innovative medicines are unacceptable (as pointed out by the European Parliament in 2003) and should be reduced, if not removed by the Member States of the European Union.

A positive development of patient empowerment and involvement in decision making processes over the past years is definitively true for the European Institutions, but not (yet?) for the - for health issues more important- national level

Summary

An aging society and longer life expectancy are requiring wise decisions towards a future European Health Policy.

Allow us patients as end users of new medicines and as experts in our chronic disease to make our contributions to those decisions, but also to take our reasonable share in the responsibility for those decisions.

This is Your challenge, but also Your chance!

An appeal to all Health Policy Decision Makers

Thank you for your attention!

Christoph ThalheimSecretary General

European MS Platform

christoph.thalheim@emsp.orgwww.ms-in-europe.org