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THE VALUE OF INNOVATION

The “Patients W.A.I.T.” Indicator

Marie-Claire PICKAERT EFPIA Deputy Director General

Lisbon, 28 June 2013

EFPIA Mission

The aim of the European Federation of Pharmaceutical Industries & Associations, which has no profit-making purpose, is to promote pharmaceutical discovery and development in Europe and to bring to the market medicinal products in order to improve human health worldwide.

EFPIA pursues a mainly scientific aim, ensuring and promoting the technological and economic development of the pharmaceutical industry in Europe.

EFPIA’s represents the pharmaceutical industry operating in Europe. Its direct membership includes 40 national associations and 39 leading companies. Two specialised groups within EFPIA represent vaccine manufacturers – Vaccines Europe (previously EVM), with 9 member companies and emerging bio-pharmaceutical companies – EBE with approx. 60 member companies.

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Our aspiration for EU citizens

Our common goal should be that patients around Europe have equal access to modern healthcare, regardless of medical, social and economic vulnerability

This includes that regulatory processes (pre- and post-MA) should be efficient and streamlined

Patients should not suffer undue delays in accessing new therapies

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The Patients W.A.I.T. Indicator

Patients W.A.I.T. stands for patients waiting to access

innovative treatment

Scope of the Indicator includes medicines with active

substance that has not been approved before

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The EFPIA Database – publicly available information

Information Relating To The Marketing Authorisation Process – source: HCS

• Scope: medicines with an active substance that did not receive an EU MA

(i.e. First MA in Europe) – diagnostics and V-class products are excluded; vaccines are included

• Information for each medicine includes:

Identification – name of product and MAH

Dates – each step in the MA process

Category – legal status and therapeutic class

Label – indications and prescription recommendations

for Europe – taken from EMA and Commission websites

for the US – taken from the FDA website

EFPIA’s database of new medicines includes 169 medicines (from 2004 to 2012-s1) and 15 vaccines

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Country-specific data

Information Relating To The Administrative Processes In The Countries – collected from Member Associations

• Accessibility dates – the first date when doctors can prescribe the medicine to patients, who will be able to benefit from reimbursement conditions applicable in the country

• Access to medicines

Ambulatory or Hospital-only

Ambulatory, but initiated in hospital

Additional conditions, such as: special reimbursement conditions

Any other information, such as: application for reimbursement rejected; pending; etc.

Data taken from official sources, where available; other sources (mostly directly from member companies of the national associations)

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Patient availability depends on different pricing &

reimbursement processes in each country

Date of marketing

authorisation

Date of price

approval

Date of

reimbursement

approval

Date of

publication

Is price approval

required in this

country?

Is reimbursement

approval required in

this country?

Is any form of

publication required in

this country?

Date of

patient access

Pricing & reimbursement approval may take place simultaneously

We have defined availability as

completion of the regulatory

processes required for patient

access at a basic level of

reimbursement

Official publication of the decision may be required

What does the Indicator measure?

The rate of accessibility

measured by the number of medicines available to patients in each country, compared to number of medicines with EU MA granted in the reference period

The average time between MA and patient access

measured by the number of days elapsing from the date of EU MA to the day of completion of post-MA administrative processes (including pricing and reimbursement processes)

These are not the delays as meant in the “Transparency” Directive

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Delays increase

Country % 2011 % 2012

Average

2011

days

Average

2012

days

Increase

days

Portugal 35 20 412 498 86

Spain 38 43 352 463 111

Italy 50 60 347 417 70

Belgium 43 50 371 414 43

Slovenia 30 41 283 382 99

Sweden 71 62 272 318 46

Finland 45 52 248 261 13

Netherlands 61 71 209 239 30

Switzerland 140 190 50

Denmark 77 82 116 153 37

9

Preliminary

Portugal – average delay increasing year-on-year

220

276

349

412

498

0 100 200 300 400 500 600

2005-2007

2006-2008

2007-2009

2008-2010

2009-mid-2012

Average Delay

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Preliminary

Expectations of citizens and patients

Modern medicine shows that prevention, early diagnosis,

and early treatment improves the prognosis

Citizens and patients rely on their governments to ensure

that they have access to the care they need

Governments are under popular pressure to reduce

waiting times and remove obstacles to access healthcare

products and services

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Budgettary Orthodoxy

Source: OECD Economic Outlook 90 database, 2011, Source: Region Europe Pharma,

Global Insight 2011, Deutsche Bank 2011.

12

Demographic pressures on budgets

Source: Global Trends in Public Health Spending and the Outlook ,

International Monetary Fund (IMF), 2011.

13

Exploiting efficiency gains would allow to improve health

outcomes further…

Source: OECD Health Data 2009; OECD calculations. 14

Efficiency in healthcare (1/2)

…and help to contain future health care spending

Source: OECD Health Data 2009; OECD calculations. 15

Efficiency in healthcare (2/2)

Total costs per asthma patient

0 €

500 €

1.000 €

1.500 €

2.000 €

2.500 €

3.000 €

1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Total indirect costs

Other direct costs incurred by society

Mecicines costs

Heath care costs excluding medicines costs

2004 value of money

Source: STAKES statistics and treatment record database, STAKES publications, expert interviews, Statistics Finland, KELA publications and

Statistics, Finnish Centre for Pensions, Finnish publications, NHG calculations

Innovation has delivered value-for-patients

7% 17% 16%

32%

52%

40% 38%

62% 65%

15%

35% 45%

60% 66%

76% 84% 87%

100%

0%

20%

40%

60%

80%

100%

1970-74 2000-04

Men

Wo

men

12% 13% 22%

33% 35% 27%

65% 72%

57%

18%

31% 41%

60% 67% 70%

81% 82% 88%

0%

20%

40%

60%

80%

100%

Lunge Magen Leukämie Darm Niere Harnblase Brust Gebär- mutter

Melanom

1970-74 2000-04

lung gastric leukaemia colon renal bladder melanoma testicular prostate

uterine

lung gastric leukaemia colon renal bladder breast melanoma

Source: VfA; RKI, 2009.

Development of 5 year survival rates in cancer

17

Bridging the gap

Policy makers becoming increasingly concerned about

health expenditure and cost of innovation

Debate too much focused on cost and not on efficiency

Growing concern over possible ineffective (or harmful) use

of untested technology

Need for enlightened tools for assessing value of health

care services

18

1 9

0,0

0,5

1,0

1,5

2,0

2,5

FR DK ES BE IE DE AT SE IT GR SK FI SI UK CZ LU NL HU RO EE PT PL BU LT LV

SALES P

ER 1

00,0

00 (

m€)

Sales of innovative products (launched 2005-2009) per 100,000 inhabitants in 2009 per country

Seminal report from BE Presidency

• SOURCE: IMS MIDAS; analysis for INAMI

19

20

Economic challenges have had a dramatic effect

on the growth of healthcare expenditure

-1%

0%

1%

2%

3%

4%

5%

6%

7%

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Gro

wth

Average OECD health expenditure growth rates in real terms, 2000 to 2010, public and total

Total expenditure on health, growth rates Public expenditure on health, growth rates

SOURCE: OECD health accounts data. June 2012.

21

Recommandations

Focus on value not on cost

Deliver sustainable funding mechanisms

Support science and strengthen the science base

Keep talking, with the determination to address

the issues whatever difficult they are, and aim for

workable solutions

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