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Decision on the benefit of innovative medical
procedures and products in Europe – an Overview
Serge Bernasconi
CEO European Medical Technology Industry Association
www.medtecheurope.org
Medical Technology ….
MedTech - A Diverse Sector
• There are more than 500,000 medical technologies registered ,
ranging from syringes and bandages to orthopaedic implants and
pacemakers, Da Vinci Robots (20,000 generic groups)
Source: Global Medical Devices Nomenclature (GMDN) Agency, 2010 www.medtecheurope.org
Innovative Industry
www.medtecheurope.org 4
Analysis based on European patent applications filed with the EPO in 2012 (Direct European applications filed in 2012 and
international (PCT) applications entering the European phase in 2012), including divisional applications filed during the year.
Based on the WIPO IPC-Technology concordance as revised in August 2012.
Source: European Patent Office
Proxy - number of patent applications filed, by field, 2012
10.412
9.799
9.592
8.288
6.633
6.428
6.002
5.668
5.364
5.309
Medical technology
Electrical machinery, apparatus, energy
Digital communication
Computer technology
Transport
Measurement
Organic fine chemistry
Engines, pumps, turbines
Pharmaceuticals
Biotechnology
Innovative Industry
2002-2012
www.medtecheurope.org 5
0
2000
4000
6000
8000
10000
12000
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Num
ber
of
pate
nt
applic
ations
file
d w
ith E
PO
Medical Technology
Pharmaceuticals
Biotechnology
Analysis based on European patent applications filed with the EPO in 2012 (Direct European applications filed in 2012 and
international (PCT) applications entering the European phase in 2012), including divisional applications filed during the year.
Based on the WIPO IPC-Technology concordance as revised in August 2012.
Source: European Patent Office
MedTech Companies in Europe
almost 25,000 medical technology companies
www.medtecheurope.org 6
Europe refers to EU + Norway, Switzerland. An enterprise is considered to be an SME if it employs fewer than 250 persons and has an annual turnover not
exceeding €50 million.
Source: Eucomed calculations based on the data obtained from National Associations of 15 countries for the latest year available. Countries with (partially)
provided data: Belgium, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden, UK, Switzerland.
95% SMEs
< 250 person & < €50 million
HEALTH CARE
Western medical practice has been guided by Experience,
Pathophysiologic Mechanisms, and Unproven Theories
Mid-to-late 1700s. Dr. Benjamin Rush, a “founding father” of
American medicine, believed in direct, drastic intervention.
“Do everything you can, anything is possible.”
Mid-to-late 1800s, early 1900s. a more nihilistic philosophy:
“Do nothing because doctors do more harm than good.”
Circa World War II, therapeutic explosion erases notion of physician as
passive observer. We return to Rush’s view:
“Do everything you can, anything is possible.”
1980s. Dr. David L. Sackett:
Do everything that does more good than harm (based on critical
appraisal of research evidence) :.
“Evidence based medicine”.
Good Medical Practice
Individual characterization
of patient
Best available evidence
Treatment decision for an individual patient
Optimal health for all people
A changing environment ….
www.medtecheurope.org 12
Source: European Chronic Disease Alliance
From Communicable to Chronic Disease
Ageing
13
AWG - Ageing Working Group of Economic Policy Committee
Source: European Commission, The 2012 Ageing Report Economic and budgetary projections for the 27 EU Member States (2010-2060)
www.medtecheurope.org
Patient Expectations
14
AWG - Ageing Working Group of Economic Policy Committee
Source: European Commission, The 2012 Ageing Report Economic and budgetary projections for the 27 EU Member States (2010-2060)
www.medtecheurope.org
Economic Crisis
Evolution of GDP vs. HC expenditure - EU28, 1995-2011
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Source: WHO Global Health Expenditure Database, Eurostat, Eucomed calculations
1,0
1,2
1,4
1,6
1,8
2,0
2,2
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
index
Healthcareexpenditure
GDP
8.8%
10.4%
% - the percentage of
GDP spent on healthcare
?
5,4 6,0
7,3
2,4
6,0
4,9
1,8
4,1
3,3
4,1 3,9 3,5
4,7
2,2
7,1
2,0
4,0
1,5
6,9
2,1
3,4 4,0
5,6
11,2
7,3
3,3
8,6
7,4
3,4
-11,6
-4,4
-6,5
-2,8
-4,6
-0,8
1,0
-0,1
-2,3
-0,6
-2,3
-1,0 -0,5
0,5 0,4
2,4
0,1
2,1
-3,7
0,7 1,3
0,5
2,6 2,4
-5,0
2,9
4,5
5,9
4,8
-11,0
-0,6
1,7
-1,4
0,9
-2,7
-4,1
-1,5
0,8
-0,7
1,3 0,6
0,1
-0,7 -0,4
-1,3
1,3
-0,6
5,2
0,9 0,5
1,4
-0,6
0,2
8,1
2,0
0,6 0,2
4,0
-12,0
-10,0
-8,0
-6,0
-4,0
-2,0
0,0
2,0
4,0
6,0
8,0
10,0
12,0
2000-2009 2010 2011
Austerity
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Annual average growth rate in health expenditure per capita, in real terms, 2000 to 2011
Source: WHO Global Health Expenditure Database, Eurostat, Eucomed calculations.
% GDP on HealthCare - Public 1995-2011
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4%
5%
6%
7%
8%
9%
10%
11%
% o
f G
DP
EU total HC expenditure
EU public HC expenditure
Weighted EU28 average. Source: WHO Global Health Expenditure Database, Eurostat, Eucomed calculations
Public
Others
Public vs. private HC expenditure in EU
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Expenditure as a share of GDP, 2011
Unweighted EU28 average.
Source: WHO Global Health Expenditure Database, Eucomed calculations.
12,0
11,6
11,2
11,1
10,6
10,6
10,4
9,5
9,4
9,4
9,4
9,3
9,1
9,0
8,9
8,8
8,7
8,7
7,8
7,8
7,7
7,4
7,4
7,3
6,7
6,6
6,2
6,0
5,8
0
2
4
6
8
10
12
14
Private Public
% o
f G
DP
New Era … VALUE BASED
20
Society
Socio-Economic benefit
Patients & Carers
Health Care System
MEDTECH – COMMITTED TO VALUE
www.medtecheurope.org
21
MEDTECH – COMMITTED TO VALUE
PATIENTS
www.medtecheurope.org
Patient Value (1) Clinical
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Mortality
Morbidity
Symptoms
Quality of Life
Cost-Effective ?
CLINICAL OUTCOME
Personalized
- Risk / Benefit assessment with technical (in-vitro, animal) and clinical (human) performance
testing
conformity assessment
- Post market surveillance (PMS) – permanent monitoring serious adverse events
- Clinician & Hospital gatekeeper
- Professional Societies – Evidence Based
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CE Marking
Clinical Guidelines
Patient Access to Lifesaving Tx
Population – Standard of Care
Patient Value (2) Clinical
New Tools: Clinical - Patient Value (3)
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Patient Reported Outcomes
Coverage with Evidence Development – Conditional Financing (new)
Health Technology Assessment*
Interventional Procedural Recommendation (IPG, ..)
Sub-group of Patient to Benefit
* On selected technologies, with real life experience
Cost-Effectiveness
Comprehensive validated questionnaire
New access scheme eg Netherlands, Germany, France, UK, Switzerland
Need Fit to MedTech !
Health Technology Assessment
25 www.medtecheurope.org
• European HTA projects:
Cross-Border Directive on Patient Rights
• HTA Network
• JA-1, JA-2
• FP-7 Research
Europe Member States
• Heterogeneous in purpose & use
Need Fit to Purpose ! Need Fit to Purpose !
HTA - Fit for Purpose – For what used ?
Formal HTA process
Clear link to reimbursement
Impact on diffusion
Some kind of a HTA process
No clear link to reimbursement
No impact on diffusion
Sporadic or no HTA
Formal HTA process
No clear link to reimbursement
Impact on diffusion
Heterogenous use reimbursement-diffusion
27
MEDTECH – COMMITTED TO VALUE
HOSPITALS
A System Under pressure
28
Source: OECD Health at glance 2011: Health expenditure data 2009, Eucomed calculations. 1 Refers to curative -rehabilitative care in
in-patient and day-care settings, 2 Includes home-care and ancillary services, EU * - Belgium, Czech R., Denmark, Estonia, Finland,
France, Germany, Hungary, Luxembourg, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden
0
1419
1207
786
1274
996
0
208 236 137
212 218
0
626 627
529 289
533
0
200
400
600
800
1000
1200
1400
1600
. France Germany Spain Denmark EU*
US
D P
PP
Expenditure on pharmaceuticals
Medical goods excluding Pharmaceuticals
Inpatient care
21 20 22
12
22
36 29 26
29
29
23
29 38
31
32
12 12
9
25
10
9 9 6 3
7
0
10
20
30
40
50
60
70
80
90
100
France Germany Spain Denmark EU*
%
Medical goods Inpatient care¹ Outpatient care²
Long-term care Collective services
29
Novel Procedures & Quality of Care
Avoid Healthcare Acquired Infection Optimal Efficiency- Avoid
Complications
Personalized – Optimal Outcome
Selective Population Point of Care Diagnosis
VALUE to HOSPITAL
Quality of Care and Economic Value
www.medtecheurope.org 30
Hospital
Manufacturer
Value - Hospital
Innovation
Value based
Hospital based HTA ?
Value Innovation - Hospital
Hospital based HTA - Mini HTA to assess impact and prioritize (Y/N in package)
• Providing hospital decision-makers with contextualized assistance to make sound investment
decisions on innovations, to ensure that good-value innovative health technologies (HTs) reach
clinical practice*.
• Tailoring HTA to specific hospital circumstances (comparators, how care is organized in the hospital,
BIA,…) *
• Hospital own data collection – analysis
• Challenging Industry !
• EU Research a solution ?
www.medtecheurope.org
31
HTAi-Hospital ISG, 2007 * Laura Sampietro-Colon coordinator AdHopHTA
www.medtecheurope.org 32
Hospital
Reimbursement
Funding
DRG-FFS -
Global
Budget
Innovation, Innovation ?
What is Value of innovation, for whom, hospital, society ?
What incentives in place to obtain reimbursement, funding for
innovation?
This process is not systematic, not same across Europe, limited consideration of value
Payer
Insurer / NHS
Reimbursement & Funding - Hospital
Special
Payment/
Update
DRG
Results :
A process in place & successful used in some countries
New DRG Group
Introduced
Special (Innovation)
Payment Made
Drug-Eluting Stents AUT, CAN, POR, SPA,
USA
AUS, ENG, FRA, GER,
IRE, ITA
Transcatheter Heart Valve
(TAVI) AUT, FIN, FRA, GER, NOR AUS, ENG, FRA
Neuromodulation Implants AUT, FIN, GER, NOR ENG, FRA, NOR, POR,
ITA
Ambulatory Volumetric Pumps ENG, GER FRA
Gastric Bands AUT, NOR ENG, FRA, POR, SPA
Cochlear Implants AUT, CAN, ENG, GER,
NOR
AUS, FRA, IRE, NOR,
POR, SPA, ITA
Hip Prosthesis AUT, FIN, GER,NOR, POR,
SPA AUS, FRA, SPA
Knee Prosthesis AUT, FIN, GER, NOR,
POR, SPA AUS, FRA, SPA
Bladder Band AUT FRA
Little consideration of Value
Lengthy and country specific, requiring high
local expertise
0
2
4
6
8
10
12
14
Use of Evidence of Value
Nu
mb
er
of
Co
un
trie
s
Yes
No
Uncertain
0
2
4
6
8
10
12
14
Use of Evidence of Value
Nu
mb
er
of
Co
un
trie
s
Yes
No
When determining new or updated DRG rates/tariffs When Special Innovation Payment
In 14 countries examined
www.medtecheurope.org 35
Hospital
Manufacturer
Procurement
Value based procurement ?
Innovation
Innovation, Innovation ?
What is Value of innovation, for whom - hospital, society, ?
What incentives in place
(Public) Procurement
In the new Public Procurement Directive MEAT shall be the default award criterion (Article 66 of the proposal).
MOST ECONONOMICALLY ADVANTAGEOUS TENDER (MEAT) CRITERION
www.medtecheurope.org 36
CRITERIA MUST BE DEFINED BY EXPERT TEAM INCLUDING
CLINICIANS AND PURCHASING MANAGERS.
MEAT shall be assessed on the basis of the price or cost, using a cost-effectiveness approach:
- life-cycle costing;
- best price-quality (qualitative criteria). Possible sub-criteria:
Quality, technical merit, aesthetic, accessibility, social, environmental and innovative
characteristics.
After-sales service and technical assistance.
Award criterion specifications must be sound, clear and transparent
SUPPLIERS opportunity to show the added value of their offering.
Funding Reimbursement - Innovation
www.medtecheurope.org 37
Joint EHTI-HOPE initial debate
Hospital based Financing for MedTech Innovation Ensuring sustainable access to innovation
4 December 2013, 10.30 - 16.00 Brussels
Linking Hospital Payments to
Innovation and Value
.
www.medtecheurope.org 38
More sustainable health system
Health as human capital
Reducing Inequalities
EU Public Health Strategy :”Investing in health”
Health for Well-Being
Health a pre-requisite for economic growth
Improving cost efficiency and reconciling fiscal consolidation targets with
the continued provision of sufficient levels of public services
improving the health of the population in general and reinforcing
employability, thus making active employment policies more effective,
helping to secure adequate livelihoods and contributing to growth.
contributing to social cohesion and breaking the vicious spiral of
poor health contributing to, and resulting from, poverty and
exclusion.
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