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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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