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Incorporating 
HTA into 
Health 
Systems 
Reiner Banken M.D. M. SC. 
Advisor to the CEO, Alliances and Networks 
reiner.banken@inesss.qc.ca 
Cape Town, Oct 4, 2014 
HTA in Sub-Saharan 
Africa meeting: Use of 
HTA in Health Systems 
strengthening
2 
Objectives of the presentation 
• Understanding 
– the objectives for introducing HTA 
– the evolution of HTA in Health Systems 
– the human resources and instutional arrangements 
necessary for effective HTA
3 
Outline 
• Why should Health Systems use HTA ? 
• Messages from high income countries 
• From HTA to action: Context, policy tools and 
governance 
• Resources needed 
• Conclusion
4 
Why should Health Systems 
use HTA ? 
 Improve the quest for clinical excellence 
 Support the efficient use of health technologies 
 Inform the formulation of safe, effective, sustainable 
decision-making in health systems that is patient-focused and 
seeks to achieve best value 
 Favor consensus between clinicians and managers 
 Define benefit packages for health care 
 Provide evidence for the development of clinical practice 
guidelines 
Increase the transparency of decision-making 
All of the above and more
Evidence for informing decision-making 
+Evidence 
Intuitive 
Decision-making 
Technological, 
Organisational, 
Ethical, 
Legislative 
Conditions 
Political, Social, 
Economic 
Conditions
6 
Why should you support the 
development of HTA? 
Decision-makers in all Health Systems are being 
held accountable for not meeting the rising 
expectations of patients, clinicians and the public. 
HTA can partially solve this 
unsolvable problem. 
HTA makes your life easier
7 
The price to be paid…. 
HTA as a service for the health system 
cannot work without rigor, independence 
and transparency.
8 
The “natural history” of health 
technology assessment: emergence, 
consolidation, and expansion. 
• Emergence: need expressed by decision-makers in a context 
of depoliticizing allocation decisions in times of increasing 
resource constraints, importance of leaders, development of 
the scientific know-how, high cost medical device focused, 
little stakeholder involvement, 
• Consolidation: more structured organizational HTA systems, 
priority setting, enlargement of scope of technologies, 
increased stakeholder involvement 
• Expansion: multiple disciplines, multiple products, political 
recognition, HTA system, strong stakeholder involvement, 
investment into Knowledge translation 
Battista RN, Hodge MJ . Int J Technol Assess Health Care. 
2009 Jul;25 Suppl 1:281-4.
9 
INESSS – 40 years of science 
advice for decision-making 
1972 1991 
1996 
Conseil d’évaluation des 
technologies de la santé 
(1988) 
Réseau de revue 
d’utilisation des 
médicaments 
January, 19, 
Agences d’évaluation 
des technologies et 
des modes d’intervention 
en santé 
Comité de revue 
de l’utilisation des 
médicaments 
2000 
Conseil consultatif 
de pharmacologie 
Conseil du 
médicament 
2003 
2003 
Institut national 
d’excellence 
en santé et en 
services sociaux 
Social Services 
Clinical Practice 
Guidelines 
2009 
2011 
1988 
2011 
Medical Biology 
Lab tests
10 
HTA in the 21 century – A 
perspective from Political Science 
• HTA has developed in a relatively depoliticized environment … buffered 
from the capricious impacts of electoral politics. 
• HTA in all the countries began with relatively politically innocuous studies 
of technologies recognized to be of major import to national health 
systems or researcher-initiated studies. 
• However, with increased focus in health systems on explicit determination 
of health benefits baskets, the role of HTA has become more high profile. 
This means that political accountability for the entire HTA process will 
increase. 
• The implication is that future management of HTA programs will require 
self-conscious attention to the building of institutions capable of handling 
the delicate process of integrating science and politics in health policy. 
Citation from the abstract of Chinitz. Health technology 
assessment in four countries: response from political science. 
IJTAHC 20:1 (2004), 55–60
11 
Messages from the evolution of 
HTA 
1. The use of HTA in Health Systems is evolving over time. 
2. Institutions (rules, organisations, legal frameworks) are 
important and should enable HTA to evolve. 
3. Mature HTA systems include a wide range of health 
technologies and interventions to be assessed, strong 
stakeholder involvement and knowledge mobilisation 
activities. 
4. The development of HTA takes place in a political arena; the 
objectives and processes have to clear from the start.
12 
Reasoning in HTA 
Implementation 
Appropriateness 
Effectiveness 
and safeness 
How should we do 
it here? 
Should we 
do it here? 
Can it 
work 
here? 
(here=context 
of decision-making) 
Theoretical 
safety and 
Can it work? efficacy 
Research 
Translational research 
Adapted from Health technology assessment of medical devices. WHO Medical device technical series, 
2011. Available at: http://whqlibdoc.who.int/publications/2011/9789241501361_eng.pdf
13 
Context is essential for evidence-informed 
decision making 
There are decisions that… 
take good 
evidence … 
… and use it 
well 
in context 
w i t h o u t c o n t e x t 
i n c o n t e x t 
poor evidence … and use it poorly 
… 
without context 
Adapted from Shaxson, L 2004: Evidence-based policy making: if it exists 
what makes it robust? Available at http://bit.ly/hIsNC
14 
On Context 
1. Stakeholder involvement is an important element 
of scoping and contextualizing HTA. 
2. Health Service Research and Implementation 
Science are important for providing a perspective of 
health systems context. 
3. The capacity of health information systems to 
provide contextual data is very useful for 
supporting the context aspect of the HTA 
knowledge synthesis
15 
Health Technology Assessment for 
Improving Health Systems and 
Health 
Governance 
Health Technology 
Efficient Health Systems 
Improving population 
health 
Appropriate 
Use 
Decisions 
Policy Tools 
HTA
16 
Science, decisions and policy 
tools for pharmaceuticals 
Governance Current tools in Québec 
Knowledge 
Uncertainties 
Drug 
Reimbursement 
Decision 
Policy 
Tool 
•Regular list 
•« Médicament d’exception » 
•Refusal 
Other possible tools, 
currently not available 
•CED 
•Risk sharing 
•Limited to specific 
settings 
•…
17 
Impact of HTA depends on links to 
policy instruments 
In some countries there are specific mechanisms that lead to the 
incorporation into policy instruments of research such as Health 
Technology Assessments (HTAs) ….no direct link between the 
amount of money spent on HTA and its impact on the decision-making 
process. Indeed, they suggest that small programmes 
can be involved in the core of the policy-making structure whilst 
larger HTA programmes have difficulty in demonstrating 
impact….It seems clear that HTAs have had most impact in 
those situations where there are specific mechanisms in place 
that require research evidence to support well-defined policy 
decisions on provision, coverage or reimbursement. 
Citation from Hanney et al. The utilisation of health research in policy-making: 
concepts, examples and methods of assessment. Health 
Research Policy and Systems 2003, 1:2
18 
How to start the process and 
make it last? 
“Start small, have a clear 
audience and scope, and address 
important questions” 
(Lavis et al 2008, Synthesis of findings from a 
multi-method study of organizations that 
support the use of research evidence)
19 
Dedicated resources for HTA 
1-2 persons 
HTA Knowledge 
Mobilizer 
Putting HTA 
into Context 
HTA Unit/ 
Agency 
4-5 persons 
>9 persons 
Dedicated 
Resources 
HTA 
Committee 
HTA 
System
20 
Human resources and objectives 
1-2 persons 
4-5 persons 
>9 persons 
Team with health 
economist, librarian and 
social scientist. 
Translation of HTA 
knowledge produced 
elsewhere into the local 
decision-making context. 
Clinician champion with 
scientific background in 
knowledge synthesis. Receptor 
for HTA knowledge produced 
elsewhere. Second person could 
act as an HTA Knowledge 
mobilizer and support an HTA 
Committee. 
Multidisciplinary team 
for HTA Knowledge 
Synthesis and Knowledge 
Mobilisation
21 
Guiding principles 
• If you do not have the human resources to do scientific 
knowledge synthesis, you cannot do HTA. 
• If you do not have good links to decision-making, you 
can do HTA, but it will not be effective. 
• If you do not have strong stakeholder participation and 
health systems governance, HTA will not be effective 
for Universal Health Coverage.
22 
Spectrum of HTA implementations 
• Level of governance: HTA for hospital based decision-making, 
for health system level decision-making, for decision-making 
by health insurances Multi-jurisdictional HTA, HTA for 
international decision-making ??? (WHO, World Bank, 
international development, …) 
• Objects and objectives: selected non pharmaceutical 
technologies, wide range of technologies including care 
processes, health care delivery models, health benefit 
baskets, Universal Health Coverage. 
• Dedicated resources: HTA receptor, small unit, full blown 
HTA agency, networked HTA (crowdsourcing ?)
Agenda setting- the policy context in Colombia 
Problem 
stream 
Policy 
stream 
Politics 
stream 
Policy 
window of 
opportunity 
2 
2004 inflationary costs 
and raising exceptions, 
government starts 
considering HTA 
processes 
2008 Constitutional 
court´s mandate to 
amend structural 
factors 
2008 National 
methods 
guidelines 
Early 2009 crisis 
within the health 
system threatening 
sustainability 
Policy 
window of 
opportunity 
Mid 2009 
increased 
interest in NICE 
methods and 
processes, 
government´s 
official request 
for technical 
advice 
Late 2009 
controversial 
law of social 
emergency by 
former 
president 
1 
2007 Decision 
making body 
created not an 
HTA agency 
2011 HTA 
agency 
(IETS) 
enacted by 
law 
2012 HTA 
agency 
(IETS) starts 
operations 
Late 2010 
New 
government 
Early 2010 law of 
social emergency 
declared 
unenforceable 
04 05 06 07 2008 2009 2010 11 
Source: Based on Kingdon model- 1984 by Castro HE, 2013 work in progress 
12 
2012 Decision 
making body 
abolished lack of 
legitimacy 
2013 POS 
content 
updated 
using HTA by 
IETS 
13 
Hector Castro, IETS, Columbia. From presentation at EMRO First Intercountry HTA Meeting, 
November 2013, used with permission.
24 
HTA as a service for the health system 
cannot work without rigor, 
independence and transparency 
The strategies of influence entail a number of risks that may undermine the 
scientific evaluation of drugs. Some outcomes of drug evaluation may favour 
the interests of multinational drug companies over those of the public payer. 
We suggest that the risks involved in drug evaluation might be mitigated 
through (1) professionalization of health technology assessment; (2) 
restriction of job seeking and post public-payer employment; (3) disclosure 
and management of experts’ conflicts of interest; (4) institutionalisation 
of patient and public involvement; and (5) increased institutional 
separation of the AHTAPol from political elites. 
Citation from the abstract of Ozieranski et al. The politics of health 
technology assessment in Poland. Health Policy 108 (2012) 178–193
25 
Strategies for Africa 
• Developping scientific capacity for knowledge synthesis in 
collaboration with universities, the Cochrane Collaboration, 
EVIPNet Africa, and other Health Systems Research initiatives. 
• Capacity building with existing HTA networks, such as 
INAHTA. 
• Using country or region specific Policy Windows. 
• Regional communities of practice in HTA. 
• Promoting the need for HTA with policy makers and funding 
agencies , but also the necessary conditions of rigor, 
independence and transparency 
• Linking HTA to collaborations in regulation for 
pharmaceuticals and devices (NEPAD ?, ECOWAS ?,…)
26 
Conclusion 
• HTA as a service for the health system cannot work 
without rigor, independence and transparency. 
• HTA should be implemented gradually, starting with 
scientific human resources. 
• HTA Systems need institutions (organisations, legal 
frameworks, dedicated resources) 
• HTA relies on strong stakeholder participation and 
health systems governance in order to contribute 
significantly to Universal Health Coverage.

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2014 09-04 hta afrique banken final

  • 1. Incorporating HTA into Health Systems Reiner Banken M.D. M. SC. Advisor to the CEO, Alliances and Networks reiner.banken@inesss.qc.ca Cape Town, Oct 4, 2014 HTA in Sub-Saharan Africa meeting: Use of HTA in Health Systems strengthening
  • 2. 2 Objectives of the presentation • Understanding – the objectives for introducing HTA – the evolution of HTA in Health Systems – the human resources and instutional arrangements necessary for effective HTA
  • 3. 3 Outline • Why should Health Systems use HTA ? • Messages from high income countries • From HTA to action: Context, policy tools and governance • Resources needed • Conclusion
  • 4. 4 Why should Health Systems use HTA ?  Improve the quest for clinical excellence  Support the efficient use of health technologies  Inform the formulation of safe, effective, sustainable decision-making in health systems that is patient-focused and seeks to achieve best value  Favor consensus between clinicians and managers  Define benefit packages for health care  Provide evidence for the development of clinical practice guidelines Increase the transparency of decision-making All of the above and more
  • 5. Evidence for informing decision-making +Evidence Intuitive Decision-making Technological, Organisational, Ethical, Legislative Conditions Political, Social, Economic Conditions
  • 6. 6 Why should you support the development of HTA? Decision-makers in all Health Systems are being held accountable for not meeting the rising expectations of patients, clinicians and the public. HTA can partially solve this unsolvable problem. HTA makes your life easier
  • 7. 7 The price to be paid…. HTA as a service for the health system cannot work without rigor, independence and transparency.
  • 8. 8 The “natural history” of health technology assessment: emergence, consolidation, and expansion. • Emergence: need expressed by decision-makers in a context of depoliticizing allocation decisions in times of increasing resource constraints, importance of leaders, development of the scientific know-how, high cost medical device focused, little stakeholder involvement, • Consolidation: more structured organizational HTA systems, priority setting, enlargement of scope of technologies, increased stakeholder involvement • Expansion: multiple disciplines, multiple products, political recognition, HTA system, strong stakeholder involvement, investment into Knowledge translation Battista RN, Hodge MJ . Int J Technol Assess Health Care. 2009 Jul;25 Suppl 1:281-4.
  • 9. 9 INESSS – 40 years of science advice for decision-making 1972 1991 1996 Conseil d’évaluation des technologies de la santé (1988) Réseau de revue d’utilisation des médicaments January, 19, Agences d’évaluation des technologies et des modes d’intervention en santé Comité de revue de l’utilisation des médicaments 2000 Conseil consultatif de pharmacologie Conseil du médicament 2003 2003 Institut national d’excellence en santé et en services sociaux Social Services Clinical Practice Guidelines 2009 2011 1988 2011 Medical Biology Lab tests
  • 10. 10 HTA in the 21 century – A perspective from Political Science • HTA has developed in a relatively depoliticized environment … buffered from the capricious impacts of electoral politics. • HTA in all the countries began with relatively politically innocuous studies of technologies recognized to be of major import to national health systems or researcher-initiated studies. • However, with increased focus in health systems on explicit determination of health benefits baskets, the role of HTA has become more high profile. This means that political accountability for the entire HTA process will increase. • The implication is that future management of HTA programs will require self-conscious attention to the building of institutions capable of handling the delicate process of integrating science and politics in health policy. Citation from the abstract of Chinitz. Health technology assessment in four countries: response from political science. IJTAHC 20:1 (2004), 55–60
  • 11. 11 Messages from the evolution of HTA 1. The use of HTA in Health Systems is evolving over time. 2. Institutions (rules, organisations, legal frameworks) are important and should enable HTA to evolve. 3. Mature HTA systems include a wide range of health technologies and interventions to be assessed, strong stakeholder involvement and knowledge mobilisation activities. 4. The development of HTA takes place in a political arena; the objectives and processes have to clear from the start.
  • 12. 12 Reasoning in HTA Implementation Appropriateness Effectiveness and safeness How should we do it here? Should we do it here? Can it work here? (here=context of decision-making) Theoretical safety and Can it work? efficacy Research Translational research Adapted from Health technology assessment of medical devices. WHO Medical device technical series, 2011. Available at: http://whqlibdoc.who.int/publications/2011/9789241501361_eng.pdf
  • 13. 13 Context is essential for evidence-informed decision making There are decisions that… take good evidence … … and use it well in context w i t h o u t c o n t e x t i n c o n t e x t poor evidence … and use it poorly … without context Adapted from Shaxson, L 2004: Evidence-based policy making: if it exists what makes it robust? Available at http://bit.ly/hIsNC
  • 14. 14 On Context 1. Stakeholder involvement is an important element of scoping and contextualizing HTA. 2. Health Service Research and Implementation Science are important for providing a perspective of health systems context. 3. The capacity of health information systems to provide contextual data is very useful for supporting the context aspect of the HTA knowledge synthesis
  • 15. 15 Health Technology Assessment for Improving Health Systems and Health Governance Health Technology Efficient Health Systems Improving population health Appropriate Use Decisions Policy Tools HTA
  • 16. 16 Science, decisions and policy tools for pharmaceuticals Governance Current tools in Québec Knowledge Uncertainties Drug Reimbursement Decision Policy Tool •Regular list •« Médicament d’exception » •Refusal Other possible tools, currently not available •CED •Risk sharing •Limited to specific settings •…
  • 17. 17 Impact of HTA depends on links to policy instruments In some countries there are specific mechanisms that lead to the incorporation into policy instruments of research such as Health Technology Assessments (HTAs) ….no direct link between the amount of money spent on HTA and its impact on the decision-making process. Indeed, they suggest that small programmes can be involved in the core of the policy-making structure whilst larger HTA programmes have difficulty in demonstrating impact….It seems clear that HTAs have had most impact in those situations where there are specific mechanisms in place that require research evidence to support well-defined policy decisions on provision, coverage or reimbursement. Citation from Hanney et al. The utilisation of health research in policy-making: concepts, examples and methods of assessment. Health Research Policy and Systems 2003, 1:2
  • 18. 18 How to start the process and make it last? “Start small, have a clear audience and scope, and address important questions” (Lavis et al 2008, Synthesis of findings from a multi-method study of organizations that support the use of research evidence)
  • 19. 19 Dedicated resources for HTA 1-2 persons HTA Knowledge Mobilizer Putting HTA into Context HTA Unit/ Agency 4-5 persons >9 persons Dedicated Resources HTA Committee HTA System
  • 20. 20 Human resources and objectives 1-2 persons 4-5 persons >9 persons Team with health economist, librarian and social scientist. Translation of HTA knowledge produced elsewhere into the local decision-making context. Clinician champion with scientific background in knowledge synthesis. Receptor for HTA knowledge produced elsewhere. Second person could act as an HTA Knowledge mobilizer and support an HTA Committee. Multidisciplinary team for HTA Knowledge Synthesis and Knowledge Mobilisation
  • 21. 21 Guiding principles • If you do not have the human resources to do scientific knowledge synthesis, you cannot do HTA. • If you do not have good links to decision-making, you can do HTA, but it will not be effective. • If you do not have strong stakeholder participation and health systems governance, HTA will not be effective for Universal Health Coverage.
  • 22. 22 Spectrum of HTA implementations • Level of governance: HTA for hospital based decision-making, for health system level decision-making, for decision-making by health insurances Multi-jurisdictional HTA, HTA for international decision-making ??? (WHO, World Bank, international development, …) • Objects and objectives: selected non pharmaceutical technologies, wide range of technologies including care processes, health care delivery models, health benefit baskets, Universal Health Coverage. • Dedicated resources: HTA receptor, small unit, full blown HTA agency, networked HTA (crowdsourcing ?)
  • 23. Agenda setting- the policy context in Colombia Problem stream Policy stream Politics stream Policy window of opportunity 2 2004 inflationary costs and raising exceptions, government starts considering HTA processes 2008 Constitutional court´s mandate to amend structural factors 2008 National methods guidelines Early 2009 crisis within the health system threatening sustainability Policy window of opportunity Mid 2009 increased interest in NICE methods and processes, government´s official request for technical advice Late 2009 controversial law of social emergency by former president 1 2007 Decision making body created not an HTA agency 2011 HTA agency (IETS) enacted by law 2012 HTA agency (IETS) starts operations Late 2010 New government Early 2010 law of social emergency declared unenforceable 04 05 06 07 2008 2009 2010 11 Source: Based on Kingdon model- 1984 by Castro HE, 2013 work in progress 12 2012 Decision making body abolished lack of legitimacy 2013 POS content updated using HTA by IETS 13 Hector Castro, IETS, Columbia. From presentation at EMRO First Intercountry HTA Meeting, November 2013, used with permission.
  • 24. 24 HTA as a service for the health system cannot work without rigor, independence and transparency The strategies of influence entail a number of risks that may undermine the scientific evaluation of drugs. Some outcomes of drug evaluation may favour the interests of multinational drug companies over those of the public payer. We suggest that the risks involved in drug evaluation might be mitigated through (1) professionalization of health technology assessment; (2) restriction of job seeking and post public-payer employment; (3) disclosure and management of experts’ conflicts of interest; (4) institutionalisation of patient and public involvement; and (5) increased institutional separation of the AHTAPol from political elites. Citation from the abstract of Ozieranski et al. The politics of health technology assessment in Poland. Health Policy 108 (2012) 178–193
  • 25. 25 Strategies for Africa • Developping scientific capacity for knowledge synthesis in collaboration with universities, the Cochrane Collaboration, EVIPNet Africa, and other Health Systems Research initiatives. • Capacity building with existing HTA networks, such as INAHTA. • Using country or region specific Policy Windows. • Regional communities of practice in HTA. • Promoting the need for HTA with policy makers and funding agencies , but also the necessary conditions of rigor, independence and transparency • Linking HTA to collaborations in regulation for pharmaceuticals and devices (NEPAD ?, ECOWAS ?,…)
  • 26. 26 Conclusion • HTA as a service for the health system cannot work without rigor, independence and transparency. • HTA should be implemented gradually, starting with scientific human resources. • HTA Systems need institutions (organisations, legal frameworks, dedicated resources) • HTA relies on strong stakeholder participation and health systems governance in order to contribute significantly to Universal Health Coverage.