SFEE Key Messages October - PowerPoint Presentation

Slide1

SFEE Key Messages

October

6

th

,

2016

Slide2

Contents

HC

Systems Challenges

Contribution

of Pharma

Industry

Health Expenditure

Pharma Expenditure

Health Effects of Crisis

Clinical Trials

Evolution of Innovation

Value of Innovation

Future: Focus on

Outcomes

SFEE’s Role in the New Era of Medical Product Development

Slide3

Healthcare

systems face significant challenges in expanding access to healthcare while managing constrained budgets

AGING POPULATION

GROWING

CHRONIC DISEASE

BURDEN

INCREASING SOCIAL/POLITICAL PRESSURES

CONSTRAINED BUDGETS

PERSISTENCE OF RISK FACTORS

LACK OF DATA FOR INFORMED DECISION-MAKING

Slide4

Contribution of Pharma Industry

Slide5

The value of medicines to patients, healthcare systems and society

PATIENTS

Patients

live longer

, healthier, more productive lives

HEALTHCARE SYSTEMS

HEALTHCARE SYSTEMS

I

nnovative medicines can put healthcare systems on a more sustainable path by reducing costs in other parts of the healthcare system such as hospitalizationsSOCIETYSociety benefits from health and wellness as individuals are able to continue being productive members of the communityECONOMIESThe biopharmaceutical industry generates essential economic value in terms of job creation, R&D investment, and medications that improve patient productivity

Slide6

Investment in R & D and manufacturing are key elements of economic value offered by Pharmaceuticals

Manufacturing is a key driver for economic success

Pharma has highest R & D intensity

Up to 91% of new medicines have been developed by the private sector and research-based pharmaceutical companies

Source

: New

England Journal of Medicine (NEJM), “The Role of Public-Sector Research in the Discovery of Drugs and Vaccines”

Slide7

The biopharmaceutical industry

invests more of its revenue in generating new knowledge through research and

development than other

sectors

Note: data relate to the top 2,500 companies with registered offices in the EU (608), Japan (360), the USA (829) and the Rest of the World (703), ranked by total worldwide R&D investment (with R&D investment above €17.9M)

Source

: The 2015 EU industrial R&D investment scoreboard, European Commission, JRC, DG RTD.

14.4%: Pharmaceuticals and biotechnology

10.1%

: Software and computer services8%: Technology hardware and equipment 4.5%: Aerospace & defense

4.4%: Automobiles & parts2.6%: ChemicalsR&D spending as a percentage of net sales, 2014

Slide8

The biopharmaceutical sector adds the

most value to the economy per employee

Gross Value Added per Employee, 2012, 000’s Euros

Note: Europe is defined here as the EU-28 plus Norway;

Gross

value added for each industry is defined as the gross income from operating activities per employee. Source: Health Advances analysis; Eurostat Database (accessed February 2016). Pharmaceutical employees in Europe are generating

80% more value per employee than other industries

Slide9

Sectoral

c

omparison

between major industries in Europe

Slide10

The value of the industry for the National Economy

Slide11

11

Employment in the industry shows a tendency to stabilize

(Direct) employment in the production and marketing of medicinal products in Greece in 2014 reached

26

.

1

thousand jobs This figure is by 3.2 thousand or 11% lower than in 2010. However, since 2011 the change has been small.Source: The economic footprint of the production and distribution of pharmaceuticals in the Greek economy, October 2015, FEIR/IOBE

.

Slide12

Strong decline in employment if indirect and induced effects are also included

The industry’s total impact on employment declined to about 87 thousand jobs in 2014 from

148

thousand in

2010 (

down by 60.9 thousand jobs or 41%). The share of the pharmaceutical production and marketing sector in total employment in Greece declined to 2.5% in 2014 from 3.4% in 2010.

Source:

The economic footprint of the production and distribution of pharmaceuticals in the Greek economy, October 2015, FEIR/IOBE.

Slide13

The pharmaceutical sector significantly contributes to Greek Employment & Economy

Source

: IOBE report 2015, Health Advances Analysis: Eurostat Database (Feb. 2016).

The pharmaceutical industry is responsible for >87,000 jobs in Greece

Contributing

€6.2 billion or

3.5% of GDPDirect impact Employment related to production and marketing of medicines in Greece 26,100Total ImpactTotal jobs due

to pharma industry operations in Greece

87,400€1.1Direct impact Impact from the production and marketing of medicines in Greece Total Impact3.5% of GDP €6.2

Slide14

Health Expenditure

Slide15

Greece ranks second to last

in

government health expenditure

Note: Data refer to total health expenditure (current health expenditure +capital formation) as a share of total government expenditure (2013, or nearest year)

Source:

OECD Health Statistics 2015; OECD National Accounts; Eurostat Statistics Database; IMF World Economic Outlook Database

Slide16

Evolution of health expenditure in Greece

(2003-2015

,

in EUR billions

)

Note:

2013, 2014: estimates; 2015: forecasts.Sources: OECD (2015) and National School of Public Health, Department of Health Economics.

Slide17

Greece shows the largest drop in

per capita

health spending among OECD countries in 2009-2013

Source

: OECD Health Statistics 2015.

Slide18

Pharma Expenditure

Slide19

Sources

:

IOBE, EOPPYY and National School of Public Health.

Evolution of Net Public Pharmaceutical Expenditure

2000-2014 and pharmaceutical policy measures (EUR billions)

Slide20

Pharmaceutical consumption: imports, production, packaging 1990-2014

Slide21

2016 Public Outpatient Pharma Expenditure has

been reduced back to

2003 levels. During the same period many innovative treatments

– targeting unmet

medical needs - have been

launched

(in EUR billions)1 in 4 medicines are provided free of charge by Pharmaceutical Industry

Slide22

Evolution of Public Outpatient Pharmaceutical Expenditure

(

EUR

m

illions

)

Source: Introductory Reports on the Budgets for years 2013 and 2014; EOPYY data 2012-2015, clawback notices; System of Health Accounts 2013

. SFEE calculations.

New treatments, Hep. C, RA, Oncologicals…

Slide23

Evolution of Public Outpatient Pharmaceutical Expenditure

and corresponding

clawback

& rebates

2016

: annualized figure based on available data for the first half of the year Source: EOPYY data on clawback & rebates 2012-2015; State Budgets 2012-2016. SFEE calculations. Data for 2016 H1 are based on EOPYY

estimates – final figures are not available yet.

Slide24

Industry contribution to outpatient pharmaceutical expenditure

Source

:

EOPYY

data on

clawback & rebates 2012-2015; State Budgets 2012-2016. SFEE calculations. Data for 2016 H1 are based on EOPYY estimates – final figures are not available yet.

Slide25

Slide26

Social security

contributions (main and supplementary insurance)

)

-

114

Labour income tax revenue

-

57VAT revenue -30Corporate income tax revenue

-207-46Cost of unemployment benefits

-454EUR millionsTotal public revenues lost as a result of pharmaceutical expenditure cuts (2009-2013)Source: Souliotis K. (2014), The impact of pharmaceutical expenditure cuts on public revenue, Institute of Social and Preventive Medicine (ISPM).

Slide27

Source

:

Souliotis

K. (2014), The impact of pharmaceutical expenditure

cuts

on public revenue, Institute of Social and Preventive Medicine (ISPM).

The highest loss in public revenue is seen between 2012-2013 (

about €188 million)

, suggesting a relevant multiplier of 0.47. This means that for every €100 million cut from pharmaceutical expenditure, public revenue losses are close to €47 million (

maximum). € 100m.

€ 47mκ.Total public revenues lost as a result of pharmaceutical expenditure reductions (2009-2013)Beyond a certain level, any further contraction of the pharmaceutical market causes greater loss in total public revenue than the direct fiscal gains from the expenditure cuts

€ 188mκ.

Slide28

Source

:

Souliotis

K. (2014), The impact of pharmaceutical expenditure

cuts

on public revenue,

Institute of Social and Preventive Medicine (ISPM).€5,000 income tax

€9,

000 social security contributions€2,500 VAT* annually2009-2013-30%9.600 εργαζόμενοι

€ 1m.For every cut of=jobs are lost

CONTRIBUTIONS PER PERSON EMPLOYED2009-2013-30%9,600 jobs

Total public revenues lost as a result of pharmaceutical expenditure cuts(2009-2013)

Slide29

Source: SFEE calculations based on EOPYY and BI health data.

1.25bil

1.08bil

830mil

760mil

752mil

742mil726mil490 milIncl.1ADispensed through EOPYY

Hospital Budget Evolution

Slide30

Divesting or Devaluing Pharma Innovation is bad for

Business

and Health

in Greece

Pharma jobs, manufacturing & tax contributions have all declined over the past 5 years

Patients have reduced their spending on H.C.

30% 30% reduction of HCPs visits60% patients face compliance challenges

% change 2010 - 2014

Importantly, we are also seeing signs of decline in patient healthPharma jobs, manufacturing & tax contributions have all declined over the past 5 years

Slide31

Greece’s pricing policy affects several countries in the EU and beyond

Directly

Indirectly

Slide32

6.75

SK

4.7

PL

2.9

HU

3.7

CZ

4.0SE4.7

NO6.8FI7.2UK4.2

NL6.9DE7.6FR9.0

BE7.6AT7.0On-patentvolume m.s.(% SUs)

8.6PT8.2ITES

IE7.1GR10.77.5AverageOn-patent:volume m.s.8.3%

On-patent:volume m.s.6.8%On-patent:volume m.s.5.9%On-patent:volume m.s.

3.4%PIIGS

ΕU CoreNordicsEastern EuropeOn-patent products in Greece have the highest volume(in SUs) market share in EU (MAT/02/2016)

Note : Figures for all countries refer to the retail channel only.Source: IMS data (MAT/02/16), IMS Health Consulting analysis

Slide33

Note :

Figures for all countries refer to the retail channel only.

Source

: IMS data (MAT/02/16), IMS Health Consulting analysis

On-patent products in Greece have the third lowest average price

(in €/SU) in Europe (MAT/02/2016)

Average

Price per SU(€/SU)1.840.68

IE2.72GR0.86

SK2.50PL0.99HU

1.65CZ0.99

SE3.84NO1.69

FI1.99UK1.25NL

1.74DE3.82PT

1.97BE2.24ATFR

ES1.060.80IT

2.65On-patent:Price per SU0.936€On-patent:Price per SU2.435€

On-patent:Price per SU2.621€On-patent:Price per SU1.312€

PIIGS

Ε

U Core

Nordics

Eastern Europe

Slide34

Note :

Figures for all countries refer to the retail channel only.

Source

: IMS data (MAT/02/16), IMS Health Consulting analysis

Off-patent products penetration, in Greece, in volume (in SUs) is higher than EU average (MAT/02/

20

16)

7.8

HU18.7CZ

13.0SE19.4

NOUKNL26.032.4

22.2FI11.7DE

11.3FR27.0BE

43.8AT34.8ES26.8

PT23.722.029.9

IE25.8GRITSK

Off-patentvolume m.s.(% SUs)11.8

PL33.9Off-patent:volume m.s.28.3%Off-patent:volume m.s.21.0

%Off-patent:volume m.s.24.3%Off-patent:volume m.s.10.9%

PIIGS

Ε

U Core

Nordics

Eastern Europe

Average

Slide35

Note :

Figures for all countries refer to the retail channel only.

Source

: IMS data (MAT/02/16), IMS Health Consulting analysis

0.0

1.0

0.8

0.6

0.4

0.2

Price per SU

(€/SU)0.31SK0.33

PL0.21HU0.18CZ

0.17SE0.31NO0.23FI0.31

UK0.29NL0.45DE

0.63FR0.30BE0.27AT0.33

ES0.23PT0.22IT

0.30IE0.40GR0.27The prices of the off-patent drugs (in €/SU) in Greece are close to EU-average (MAT/02/2016)

PIIGSΕ

U CoreNordicsEastern EuropeOff-patent:Price per SU0.268€Off-patent:Price per SU

0.351€

Off-patent:Price per SU

0.283€

Off-patent:

Price per SU

0.204

€

Average

Slide36

Note :

Figures for all countries refer to the retail channel only.

Source

: IMS data (MAT/02/16), IMS Health Consulting analysis

Gx

in Greece have the lowest penetration in Europe

(in SUs, (MAT/02/2016) )

31.5

52.6GR

FI48.857.3UK

45.9Gx volume m.s.(% SUs)59.1SK

PL70.1HU56.4

CZ60.8SE57.3

NO69.2NLDE75.3

FR55.9BE

40.6AT39.3ES50.7

PT50.3IT42.7

IE68.3Generics:volume m.s.45.9%Generics:volume m.s.

65.3%Generics:volume m.s.52.2%Generics:volume m.s.65.9%

PIIGS

Ε

U Core

Nordics

Eastern Europe

Average

Slide37

Note :

Figures for all countries refer to the retail channel

only. Prices rounded to 2 decimal places.

Source

: IMS data (MAT/02/16), IMS Health Consulting analysis

0.0

0.2

0.4

0.13

SK0.09

HU0.10CZ0.09SE0.10NO

0.09FI0.15UK0.11

NL0.08DE0.15FR

0.16BE0.17AT0.200.120.12

PT0.13IT0.14ES

0.15GR0.20PLPrice per SU(€/SU)IEGx

in Greece have the highest average price (in €/SU) in the EU, being 58% higher vs. EU average (MAT/02/2016)

PIIGSΕU CoreNordicsEastern EuropeGenerics:

Price per SU0.137€Generics:Price per SU0.135€Generics:Price per SU0.111€Generics:Price per SU0.096€Average

Slide38

Austria

Belgium

Czech Republic

Finland

France

Germany

Greece

Hungary

IrelandItaly

NetherlandsNorwayPolandPortugalSpain

SwedenSlovakiaUnited KingdomGx value m.s.(% €

)Gx volume m.s.(% SUs)Average Gx value m.s.(€)25.6%

PIIGSAverage Gx volume m.s.(SUs)59.1%Eastern Europe

NordicsΕU Core

Greece have below average Gx m.s. both in terms of value and volumeSource: IMS data (MAT/02/16), IMS Health Consulting analysis

1Based on Pharmacy-Purchase-Prices (PPPs); 2. Figures for all countries refer to the retail channel only.;3. Prescription-bound drugs included only.Value1 (PPP) and volume (in SUs) m.s. for Gx products2,3 (MAT/02/2016)

Slide39

0.28

0.24

0.12

0.20

0.16

0.08

0.04

Price per SU

(€/

SU

)Gx volume m.s.(% SUs)Price per SU (in €/SU) and volume (in SUs) m.s.

for Gx products1,2 (MAT/02/2016)Average Gx volume m.s.(SUs)59.1%High price per SU and Low volume m.s. (in SUs)Low price per SU and High volume m.s. (in SUs)

PIIGSΕU CoreNordics

Austria

BelgiumCzech RepublicFinlandFrance

GermanyGreeceHungaryIrelandItalyNetherlandsNorway

PolandPortugalSpainSwedenSlovakiaUnited Kingdom

The high price of Generics in Greece may partly explain their low market shareEastern EuropeSource: IMS data (MAT/02/16), IMS Health Consulting analysis

1. Figures for all countries refer to the retail channel only. 2. Prescription-bound drugs included onlyAverage price per SU 0.13 €MAT/03/2016MAT/08/2015Greece with no significant changes vs. MAT/08/15

Slide40

4.0

2.0

3.5

3.0

2.5

1.5

1.0

0.5

0.0

On patent volume m.s.

(%

SUs)Price per SU(€/SU)

Price per SU (in €/SU) and volume (in SUs) m.s. for On patent products 1,2 (MAT/02/2016)High price per SU and Low volume m.s. (in SUs)Low price per SU and High volume m.s. (in SUs)Average price per SU 1.84 €The low price of On patent in Greece may partly explain their high market share

Source: IMS data (MAT/02/16); IMS Health Consulting analysis1. Figures for all countries refer to the retail channel only.;. Prescription-bound drugs included only

ΕU CoreNordicsEastern EuropePIIGS

Austria

BelgiumCzech RepublicFinlandFranceGermanyGreeceHungaryIrelandItalyNetherlandsNorway

PolandPortugalSpainSwedenSlovakiaUnited KingdomAverage On patent volume m.s.(SUs)6.75%

Slide41

Volume

91.0

ΔSales

85.4

Price

-42.3

134.1

Slide42

Health Effects of the Crisis

Slide43

Greece is the European country with the

highest rise in the suicide rate

!

Source

:

OECD

Factbook, Economic, Environmental and Social Statistics, 2015-2016

Slide44

Source

:

OECD

Factbook

, Economic, Environmental and Social Statistics, 2015-2016

Greece has the

third highest elderly population ratio and the fourth lowest fertility rate in Europe

Slide45

Greece ranks first

in adult population smoking

…

Source

:

OECD

Factbook, Economic, Environmental and Social Statistics, 2015-2016

Slide46

First in overweight and obese children

…

Source

:

OECD

Health at a Glance, 2015

Slide47

First in unmet medical and dental care needs

Source

:

OECD

Health at a Glance, 2015

Slide48

Social impacts of

the crisis on health

Increase

in depression rates from

3.3% to 8.2%

between 2008 and 2011

(Economou et al,. 2012).Suicides rose by 45% between 2007 and 2011 (Kentikenelis et al., 2013).

(2010: 377 deaths vs 2013: 533 – up by 41%).Surge in epidemics since 2010,

including malaria, Η1Ν1, West Nile virus, but also Hepatitis C and HIV (Bonovas & Nikolopoulos, 2012).Increase in HIV infections among intravenous drug users by a factor of 33.5, from 15 in 2010 to 522 in 2013

(Paraskevis et al, 2013).Deterioration of infant mortality, with 3.8 deaths/1,000 live births in 2010 compared with 2.7 in 2008 (Eurostat)

The stillbirth rate rose by 32%, from 3.31/1,000 births in 2008 to 4.36 in 2010 (Vlachadis & Kornarou

, 2013).

Slide49

Patients are forced to prioritize their needs

Source

:

ELSTAT data

2015

, IOBE-SFEE calculations.

36.7%62.6%

Slide50

Clinical Trials

Slide51

At least

10-15

years of research are required, and

only one in

10

,

000 potential molecules are ultimately brought to patients

Slide52

Industry-sponsored clinical trials contribute tangible economic activity to the communities in which they are located

In 2015, the biopharmaceutical industry sponsored

9,059 clinical trials

of medicines around the world, supporting tangible economic activity in the countries in which they are located.

Note: The graph represents all clinical trials Phase 0 through Phase 4 that registered with Clinicaltrials.gov in 2015.

Source

:

Health Advances analysis; Clinicaltrials.gov (accessed February 2016).

Number of

Industry-Sponsored Clinical

Trials in Selected Countries, 2015

500+

400-499

300-399

200-299

Number of Clinical Trials

100-199

0-99

Slide53

Pharma investment in

similar-sized

countries

Population

10,992,589

11,203,992

4,604,029

Source

: EFPIA , The Pharmaceutical Industry in Figures , 2015 report (2013 data)

Slide54

If Ireland and Belgium

can,

why not Greece?

Skilled workforce

Medical / Manufacturing Expertise

Access of

patients

Predictable environment

Regular payments

Tax breaks & Incentives for investment

Adoption of innovation & fair

pricing

Public -Private partnership

Slide55

Development of Clinical Trials

Possesses

the expertise and human capital to create high added value in biotechnology and biomedical science

Can participate in transnational networks of research

centres

from around the world used by international pharmaceutical companies to develop and test their products

Can become

a research and development

centre for diagnostic technologies, given its large number of diagnostic centres with high–quality facilities and a large pool of highly qualified healthcare professionals

Can develop entrepreneurship and participate effectively in research into new molecules and development of innovative medicinesGreeceClinical Research can ensure rapid patient access to new treatments, hence better healthcare, while benefiting the national economy in the form of significant foreign capital inflows and job creation, leading to higher productivity

Slide56

Designing a framework of growth-inducing tax incentives

%

Can help to:

enhance extroversion

and competitiveness of companies in the sector

increase research spending in companies (for every 1% increase in R&D spending (about €4 million in the past two years) GDP grows by an estimated 0.07%

(i.e., about €140

million)Support domestic employment and create new jobs. Source: 2015 Global Survey of R&D Tax Incentives

Slide57

Linking research to production

Improving the competitiveness

of companies operating in the country

.

Developing new high value-added products

.

Employing large numbers of high-skilled professionals and combating the brain drain/personal Grexits (over 130,000 tertiary education graduates have left the country

)

Slide58

Evolution of Innovation

Slide59

Advances in pharmaceutical innovation have helped to address unmet care needs

Slide60

With over 7000 medicines in development, the exciting new wave of medical innovation will play a key role in

addressing the challenges faced by patients and healthcare systems

Source

: Health Advances analysis;

Adis R&D Insight Database

. March 2015, compiled by PhRMA

Slide61

Today more than 7000 medicines

are

in

development around

the

world targeting areas

of high unmet needMedicines in Development WorldwideNote: Defined as single products which are counted exactly once regardless of the number of indications pursued.Source: Health

Advances analysis; Adis R&D Insight Database

.Biopharmaceutical companies are focusing on areas of high unmet needBiopharmaceutical companies have made significant gains in key disease areasHIV/AIDS is now a manageable, chronic disease, thanks to prior advances in biopharmaceutical research

Slide62

Value of Innovation

Slide63

Source

: F

. R.

Lichtenberg, The impact of pharmaceutical innovation on

longevity and hospitalization in Greece, 1995-2010;

Presentation at the 9th Pan-Hellenic Congress on Management, Economics and Health Policy, Athens, December 2013. Pharmaceutical innovation increases longevity: During the period 1995-2010, mean age at death in Greece increased by 0.87 years

Slide64

For

many

patients and

their

families

, medicines have significantly increased chances of survival

Cancer

New therapies

have contributed to

significant declines

in

cancer

death

rates around the world since its peak in 1991. Today,

2 out of 3 people

diagnosed with cancer survive at least 5 years

1

.

Percent Decline in Cancer

Mortality

Rates Since 1991

1991 to

2011 - All

Cancers

2

Source

: Health

Advances analysis;

1

PhRMA 2016 Prescription Medicines: Costs in Context;

2

WHO Mortality Database (accessed February 2016).

EU5

Australia

South Korea

Japan

Canada

Mexico

-21%

-8%

-21%

-22%

-17%

-15%

USA

-24%

Slide65

Innovative

new therapies have enabled patients to continue contributing to society

Cancer

The

overall rate of returning to work following a cancer diagnosis has

grown to over 75%

due to innovative

therapies

2

In France,

82.1% of working women diagnosed with breast cancer returned to work

after

a median sick leave of 10.8

months

4

Note: In all three studies, return to work includes full-time and part-time work. Source: Health Advances analysis; 2Amir Z 2009 Cancer Survivorship and employment Occup Med; 3Endo 2015 Returning to work after sick leave due to cancer: a 365-day cohort study of Japanese cancer survivors J Cancer Surv; 4Fantoni 2010 Factors related to return to work by women with breast cancer in Northern France J Occup Rehab; 5Verdonck-de Leeuw 2010 Employment and return to work in head and neck cancer survivors Oral Oncol.

In the Netherlands, 83% of working individuals diagnosed with head and neck cancer returned to work, and most often within 6 months after treatment5

In

Japan,

81% of patients diagnosed with cancer returned to work

within 12 months of their initial sick leave

3

Slide66

Medicines

are

some

of the

most

powerful tools in treating and curing deadly

diseases

Hepatitis C Virus (HCV) HCV, which is the leading cause of liver transplants and the reason liver cancer is on the rise, is now curable in more than 90% of treated patients with only 8-12 weeks of treatment duration.Note: EMA approval dates. Cure rates are based on the results of clinical trials reported by the US Food and Drug Administration (FDA) for different drugs against Hepatitis C. Source: Health Advances analysis; 1Hope 2014 Prevalence and estimation of hepatitis B and C infections in

the WHO European region Epidemiol Infect; European Medicines Agency (EMA) website; 2EFPIA 2015 Health & Growth Evidence Compendia analysis of PhRMA 2014 25 Years of Progress Against Hepatitis C and PhRMA 2015 Pharma Profile.41%cure rate63-80%cure rate90%

cure rate95-96%cure rate+133% cure rate increase for patients2

48 Weeks

24-48 Weeks

12 Weeks

8-12 Weeks

1st generation

(1999-2010)

Interferon and Ribavarin (IFN-R) Injection

2nd generation

(2011-2013)

Protease Inhibitors w/ IFN Injection

3rd generation

(2013-2014)

Polymerase Inhibitors w/ IFN Injection

4th generation

(2014-2015)

Oral

Combination Therapies

15 million

people

are living with Hepatitis C in Europe

1

Slide67

Medicines

are

transforming

outcomes

for patients living

with chronic disease

Cardiovascular Disease

In Europe, biopharmaceutical companies are currently developing 172 medicines (Phase I through III ) to treat heart disease, stroke and other cardiovascular diseases.1 Between 2000 and 2012, the death rate from cardiovascular disease fell 37% in the EU5, 27% in Japan, and 5% in Mexico.2

DiabetesBetween 2000 and 2012, new therapies contributed to a 48% and 31% decline in the diabetes death rate in Korea and Canada, respectively.2Rheumatoid Arthritis The recent introduction of disease-modifying therapies has dramatically improved the lives of patients and caregivers by slowing and sometimes even reversing negative physical symptoms of the disease.3

Note: The 4 main types of non-communicable diseases defined by WHO are cardiovascular diseases, cancers, chronic respiratory diseases and diabetes. Source: Health Advances analysis

; 1PharmaProjects (accessed February 2016); 2WHO Mortality Database (accessed February 2016); 3PhRMA 2015 Pharma Profile.

Death rates for

non-communicable diseases

declined nearly 20%

in the EU5, Australia, Canada, and Japan from 2000 to 2012

2

Slide68

Biopharmaceutical companies have made continued advances against rare diseases

Source

: Health

Advances

analysis

; 1PhRMA 2013 Rare Diseases

ReportSource: Alexis Schimmings

, New active substances launch plummet , Scrip Intelligence Unit. available at : http://www.scripintelligence.com/home/New-Active-Substance-Launches-Plummet-363577There are approximately 7,000 different rare diseases worldwideRare DiseaseBig Impact

1 in 10 individuals in the USA and Europe are living with a rare disease1

Percentage of New Active Substances launched with

orphan drug

status 2012-2015

Source: Scrip Intelligence, Citeline’s

Pharmaprojects

Slide69

The use of pharmaceutical treatment can save significant costs from other forms of care in the health system

Countries

included:

EU5,

Australia, Austria, Belgium, Canada, Czech Republic, Finland, Hungary, Japan, Korea, New Zealand, Norway, Poland, Slovak Republic, Spain, Switzerland, Turkey, USA

. Source: Health Advances analysis; 1Preaud 2014 Annual public health and economic benefits of seasonal influenza vaccination;

2Lichtenberg 2009 Have

newer CV drugs reduced hospitalization in 20 OECD countries Health Econ.The number of cases of flu prevented by the use of anti-flu vaccineThe total annual cost saved by avoided doctor visits, hospitalizations and lost work days as a result of seasonal vaccination in EuropePer capita costs of cardiovascular hospitalizations would have been 70% higher in 2014, if new cardiovascular medicines had not been discovered in 1995-2004Direct savings on hospitalization costs in 20 OECD countries, 1995-2004

Slide70

Pressure on healthcare system resources would increase further Without new medicines

€22 billion

savings in Germany by 2040 from the development of new medicine that

halts the progression

of Parkinson’s Disease (PD)

3

savings if medicine

slows progression by 20%

2 Study duration and savings modeled through 2050 for an intervention that would delay the onset of dementia by 5 years and would become available in 2020.Source: Health Advances analysis; 1PhRMA 2016 Prescription Medicines: Costs in Context; 2Alzheimer’s Research UK 2014 Defeat dementia policy report; 3

Johnson 2012 Economic value of slowing Parkinson’s Disease in Germany: Modeling progression through Hoehn and Yahr Stages ISPOR 15th Annual European Congress.In the UK, a treatment delaying the onset of dementia by 5 years would result in* 2:666,000 fewer people with dementia566,000 fewer informal carers required£21.2 billion (36%) reduction in the cost of dementia

€3.9 billion

Slide71

New medicines address healthcare challenges while also support economic growth

Innovative

treatments allow patients to

work

longer and more

productively

2 Conventional therapy in study refers to conventional DMARDs = disease-modifiying anti-r

heumatic drugs. Note:

Presenteeism is the act of attending work while sick.  Source:, 2Halpern 2009 Impact of Adalimumab on work participation in RA Ann Rheum Dis.When comparing worker productivity for European, Australian, and Canadian patients with rheumatoid arthritis (RA), researchers found that patients were able to work longer and earn more money when treated with a novel biologic rather than conventional therapy* over the study period of 2 years.

Ability to remain in employment

31

weeks longer

and

earn €26,000 more

than patient on conventional therapy

RA PatientNovel Biologic

Slide72

Initiatives focusing on health outcomes can Improve quality of care and reduce costs

Total Cost of Healthcare per Patient (Euros)

A recent study in Sweden targeting disease management found that patients enrolled in a heart failure program involving regular follow-up with specialized nurses

led to

improved

outcomes and 30% reduced costs

through fewer hospital admissions and GP visits

Source: BCG based on Agvall 2014, “Resource use and cost implications of implementing a heart failure program for patients with systolic heart failure in Swedish primary health care”, International Journal of Cardiology.

Slide73

Future: Focus on Outcomes

Slide74

Industry is keen to engage in the debate and to partner with payers to deliver

outcomes driven sustainable healthcare systems

The objective of outcomes-focused

healthcare systems

is to deliver

better

patient outcomes at the same or lower cost...

relying on quality outcome data

as starting point to improve care cycle

Feedback

and

learning

Transparent, high-quality

outcomes

data

Analyze

variation

Identify current best practices Change behavior

ValueBenefits of a focus on outcomes: improved patient outcomes, reduced variation, reduced medical cost, continuous improvement

Slide75

Medicines are part of the solution

and more can be done together

FIND SOLUTIONS

PAY FOR VALUE

IMPROVE EFFICIENCY

Look at all

healthcare

costs, reduce administrative costs and waste,

and improve efficiency. Support evidence-based care and empowered patients and providers, backed by sound research and strong quality measures. Avoid blanket policies that chill investment, and collaborate to find new approaches.Governments, Providers, and National PayersBiopharmaceutical CompaniesCONTINUE DEVELOPING INNOVATIVE THERAPIES, PROMOTE MEDICATION ADHERANCE, MAINTAIN EFFORTS TO SUPPORT BROAD PATIENT ACCESS

Look at all healthcare costs, reduce administrative costs and waste, and improve efficiency. Support evidence-based care and empowered patients and providers, backed by sound research and strong quality measures. Avoid blanket policies that chill investment, and collaborate to find new approaches.

Slide76

SFEE’s Role in the New Era of Medical Product Development

Slide77

Paving the Way for Personalized

Medicine

SFEE’s Role in

the New

Era of Medical Product Development

Slide78

Personalized Medicine

Slide79

Successful When it Leads to Innovation and Improves Standard of Care.

Fails When We Settle for “Trial and Error” Medicine

AS

the Standard of Care.

Old Paradigm: Trial and Error Medicine

Slide80

New Paradigm: Personalized Medicine

Linking

Tests to Action and Therapy

Observation

Test

Action

Predictable

ResponseBreaking The Cycle of Trial and Error Medicine

Slide81

Traditionally, doctors used:

Family history

Socioeconomic circumstances

Environmental factors

Now:

genomic/genetic testing

proteomic profilingmetabolomic analysis (study metabolites at microcellular level)Personalized medicine takes into account individual genetic differences

Slide82

Pharmacogenetics

Study of genetic variation that gives rise to different responses to drugs

It is estimated that genetics can account for 20 to 95 percent of variability in drug disposition and effects.

Nongenetic

factors include: age, organ function, concomitant therapy, drug interactions, and the nature of the disease

Slide83

Personalized medicine

today

y

esterday

Cytochrome

P450 genotyping test

Enzyme group ‘cytochrome P450’ (CYP450Many types of medications(including antidepressents, anticoagulants, proton pump inhibitors, etc)Determine dosing and effects of these drugs.Thiopurine methyltransferase testThiopurineThiopurine methyltransferase (TPMT)UGT1A1 TA repeat genotype testIrinotecan (Camptosar)UGT1A1 enzymeDihydropyrimidine dehydrogenase test5-flourouracil (5-FU)Dihydropyrimidine dehydrogenase enzymeResponsible for breaking down 5-FU

Slide84

Human Variation

Slide85

Slide86

Why Now?

The Human Genome Project

Slide87

Why Now?

Explosion of the “Omics”

Proteomics

Allergenomics

Bibliomics

Biomics

CardiogenomicsCellomicsChemogenomicsChemoproteomicsChromatinomicsChromonomicsChromosomicsCombinatorial PeptidomicsComputational RNomicsCryobionomicsCrystallomicsCytochromicsCytomicsDegradomicsEcotoxicogenomicsEicosanomicsEmbryogenomicsEnviromicsEpigenomicsEpitomics

ExpressomicsFluxomicsFragmentomicsFragonomicsEtc…

http://www.genomicglossaries.com

Slide88

Diagnosis

Save

Lives

Diagnosis Save MoneyPersonalized Medicine Why is it Important?

Slide89

Personalized Medicine

Slide90

Benefits of Personalized Medicine

Better

matching

patients to drugs instead of “trial and error”

Customized pharmaceuticals may

eliminate

life-threatening reactionsReduce costs of clinical trials by:Quickly identifying total failuresFavorable responses for particular backgroundsImproved efficacy of drugs

Slide91

Industry is keen to engage in the debate and to partner with payers to deliver outcomes driven

sustainable healthcare

systems

The way to personalized medicine requires a holistic patient centric approach

Feedback

and

learning

Transparent, high-quality

outcomes

data

Analyze

variation

Identify

current best

practices

Change

behaviorValue

Slide92

SFEE’s mission is to protect and promote the health of all Greeks

through:

Assuring that the

right prevention and treatment

is provided for

the right patient at the right

time, whilst the pharmaceutical industry is under increasing pressure (ageing population, reduced investment , cuts in healthcare spending, increased participation of patients)Driving a new and integrated approach, with engagement and coordinated co-operation between all key stakeholders in the delivery of healthcare today

Focusing on research and innovation

via defining the research priorities adopting innovative clinical trial design and establishing Greece as a leader in medicines development. These are after all the key elements that support the aim of the European Health 2020: “to improve the health and well-being of populations, reduce health inequalities, and ensure sustainable people-centered health systems”SfEE’s unique role & responsibility in personalized medicine

Slide93

Four major areas have been identified where an integrated approach will have significant impact on increasing the probability of success and reducing the overall cost of new

medicines:

1.

Target identification and biomarker research

(efficacy and safety

)

2. Driving the adoption of innovative clinical trial design, development of new patient focused clinical outcome measures; new clinical trial paradigms to support the evaluation of benefit/risk in small numbers of stratified patient populations; and the development of infrastructures for the collection and sharing of trial data3. Emphasis on Innovative MedicinesPreventive medicineMedicines for areas of high public health concern Patient tailored adherence programs

Focus on vaccinesEnabling Technologies

4. Successful implementation, through operational excellence in all phases of the value chain, from early research up to the regulatory process and the marketFrom discovery to delivery

Slide94

Future Health Care Spending

Years

Health

Care

$

Individual Health Care Spending Curve

Current

Practice

Potential ofPersonalizedMedicineInvestment In DiagnosticsAnd PreventionImproved Quality of Life &Financial SavingsSource: Deloitte Development LLC 2006

Slide95

To conclude with

…

…

It’s far more important to know what person the disease has than what disease the person

has

–

HippocratesPersonalized Medicine Conference 2016October 6th, 2016