Decision on the benefit of innovative medical procedures ... · Decision on the benefit of innovative medical ... Impact on diffusion Some kind of a HTA process No clear link to reimbursement

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


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


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 ….


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)


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)


Economic Crisis

Evolution of GDP vs. HC expenditure - EU28, 1995-2011


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


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


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


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


21


PATIENTS


Patient Value (1) Clinical


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


CE Marking

Clinical Guidelines

Patient Access to Lifesaving Tx

Population – Standard of Care

Patient Value (2) Clinical

New Tools: Clinical - Patient Value (3)


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


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


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 ?


31

HTAi-Hospital ISG, 2007 * Laura Sampietro-Colon coordinator AdHopHTA


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


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


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


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

http://www.google.be/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=vNVCikoP6a1c_M&tbnid=18d8YoJRCbQhQM:&ved=0CAUQjRw&url=http://www.skeelercup.nl/index.php/Seizoen-2013/verwarring.html&ei=9b5aUsndLcO80QW-yIDwAg&bvm=bv.53899372,d.Yms&psig=AFQjCNFRHR6_UuF_byiT37UlXBoSgjWLtw&ust=1381765229975943

.


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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Decision on the benefit of innovative medical procedures ... · Decision on the benefit of innovative medical ... Impact on diffusion Some kind of a HTA process No clear link to reimbursement