Health Technology Assessment

Laura Sampietro-Colom, MD, MscPH, PhD

HTAi President

Review of Tools, Guidelines, and Procedures to

Promote Safe, Affordable, Quality Medical Device Use

WHO First Global Forum on Medical Devices

Bangkok, 9-11 September 2010

Outline

• Health Technologies and global health care context

• Health Technology Assessment (HTA): a tool to

improve decisions in health care policy and practice

• Global available resources in HTA

• Final thoughts

Context: From ancient times … to XX century

Innovation and medicine go together!

Digital

Nano/BIO/Regenerative

Convergent

Burrill S, may 2009

Personal and Informational

Burrill S, may 2009

Context: The XXI century ... Medicine goes

• Innovation in HTs do not always answers health needs

• Needed HTs are not distributed fairly

Nocturnal picture of our world

Equity in Healthcare remains a big issue !

Global Context

Global Context

“ Both politically, in terms of being

accountable to those who fund the

system, and also ethically, in

terms of making sure that you

make the best use possible of available resources, evaluation

is absolutely critical”

Julio Frenk, Minister of Health,

Mexico 2005

Lancet www.thelancet.com, 2010

“Because professionals sometimes do more harm than good

when they intervene in the lives of other people, their policies

and practices should be informed by rigorous, transparent,

up-to-date evaluations”

Ian Chalmers ,Editor, The James Lind Library, 2003

Context: Needs

Context: questions faced by decision

makers

� Is this new HT necessary for my country?

� Is the new HT justified sufficiently by the overall

benefits achieved in terms of safety, health outcomes,

and costs in my country?

�Which patients can benefit the most from this new

HT in my country?

� Among the big number of choices of HTs, which are

the most appropriate for a specific health problem in

my country?

Regu

lation

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Can it work Can it work Can it work Can it work here?here?here?here?

Can it work?Can it work?Can it work?Can it work?PerformancePerformancePerformancePerformance

ImplementationImplementationImplementationImplementation

Effectiveness Effectiveness Effectiveness Effectiveness (relative/comparative)(relative/comparative)(relative/comparative)(relative/comparative)

Safety & Absolute EfficacySafety & Absolute EfficacySafety & Absolute EfficacySafety & Absolute Efficacy

ContextContextContextContextShould we do it Should we do it Should we do it Should we do it

here?here?here?here?

How should we How should we How should we How should we do it here?do it here?do it here?do it here?

Technical tests and

clinical evidence:

explanatory (RCT)

Global evidence:

MegaTrials, non-

experimental

Local evidence:

Pragmatic Trials

Country info &

Registries

Economic evaluati

Budget impact

Ethical, Legal

appraisal

Organizational

analysis

Social analysis

(values and needs)

Policy appraisal

What Health Technology Assessment is?

MACRO

To Inform Coverage

Distribution and allocation resource

Design of payment systems

Entry Schemes mechanism

To guide disinvestments decisions

To guide Scientific and Industrial Policy

Identification of research gaps.

Info valorization & transfer

MESO

To Inform Investments (innovation “in”)

Research

To support Valorization & transfer (own innovat)

Assessment “in-time”

To teach Decision makers

MICRO

To Feed CPG development

To Support Adequate use oh Health Technol

To Teach Professionals & citizens

To disseminate Mas-media, users associati

Possibilities of HTA & Health Systems

HTAi: The Scientific & Professional Society

Western Europe 572

Central/Eastern Europe 67

North America 167

South America 76

Asia/Middle East 78

Australia/NZ 50

Africa 16

Global resources on HTA

• 1062 members

• 48 Non-for-Profit

organizational members

• 16 for-profit

organizational members

n = 1062

HTAi: The Scientific & Professional Society

Memorandum of

Understanding

Which are the main HTAi Activities ?

1. Annual Meetings

2. Interest Subgroups

• Conditional coverage/access with evidence 159 members

• HTA in developing countries 66 members

• Disinvestment of obsolete or low added value 52 members

technologies (launched 2010)

• Ethics in HTA 40 members

• Hospital-based HTA 81 members

• Information resources 163 members

• Patient and citizen involvement in HTA 139 members

Which are the main HTAi Activities ?

3. The HTAi Policy Forum

4. The Journal

INAHTA: the Global Forum for HTA Agencies

Global resources on HTA

46 members

26 countries

EUnetHTA

• 53 Organizations

• 23 EU countries + 2 EEA/EFTA countries

Funded by EU

• EUnetHTA (2006-2008): Tools development

• EUnetHTA Joint Action (2010-2012)

Global resources on HTA

The international information network on new

and emerging health technologies

“A collaborative network of member agencies (n=20) for the

exchange of information on important emerging new drugs,

devices, procedures, processes, and settings in health care”

WHO

Other Global Information Resources

1. Strong and sustainable health care systems

should promote value-based models for the

introduction of HTs

2. HTA is the tool, is used, it works, and it is helpful

to make sound health policy and clinical practice

decisions

3. The more countries that use HTA in a systematic

way, the better the use of global and local health

care resources.

Final thoughts

Thank you for your attention !!