2014 09-04 hta afrique banken final

Incorporating HTA into Health Systems

Reiner Banken M.D. M. SC.

Advisor to the CEO, Alliances and Networks

[email protected]

Cape Town, Oct 4, 2014HTA in Sub-Saharan Africa meeting: Use of HTA in Health Systems strengthening

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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

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Outline

• Why should Health Systems use HTA ?

• Messages from high income countries

• From HTA to action: Context, policy tools and governance

• Resources needed

• Conclusion

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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

IntuitiveDecision-making

+Evidence

Political, Social, EconomicConditions

Technological, Organisational,

Ethical, LegislativeConditions

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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

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The price to be paid….

HTA as a service for the health system cannot work without rigor, independence and transparency.

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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.

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INESSS – 40 years of science advice for decision-making

Conseil d’évaluation des technologies de la santé

(1988)

Agences d’évaluationdes technologies et

des modes d’intervention en santé

Comité de revue de l’utilisation des médicaments

2000

Réseau de revue d’utilisation desmédicaments

Conseil consultatifde pharmacologie

Conseil du médicament

2003

2003

Social ServicesClinical Practice Guidelines

Institut nationald’excellence

en santé et enservices sociaux

2009

January, 19, 2011

1988

1996

1972 1991

2011

Medical BiologyLab tests

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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

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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.

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Reasoning in HTA

Effectiveness and safeness

Can it work here?

(here=context of decision-

making)Theoretical safety and

efficacyCan it work?

AppropriatenessShould we do it here?

ImplementationHow should we do

it here?

Research

Tra

nsla

tion

al r

esea

rch

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

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Context is essential for evidence-informed decision making

There are decisions that…

take good evidence …

… and use it well

… and use it poorly poor evidence …

Adapted from Shaxson, L 2004: Evidence-based policy making: if it exists what makes it robust? Available at http://bit.ly/hIsNC

in context

in context

without context

without context

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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

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Health Technology Assessment for Improving Health Systems and Health

Health Technology

Appropriate Use

Efficient Health SystemsImproving population health

DecisionsPolicy Tools

Governance

HTA

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Science, decisions and policy tools for pharmaceuticals

KnowledgeUncertainties

DrugReimbursement

Decision

Policy Tool

Governance Current tools in Québec•Regular list•« Médicament d’exception »•Refusal

Other possible tools, currently not available•CED•Risk sharing•Limited to specific settings•…

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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

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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)

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Dedicated resources for HTA

HTA Knowledge Mobilizer

1-2 persons

Putting HTA into Context

HTA Unit/ Agency

4-5 persons

>9 persons

DedicatedResources

HTA Committee

HTA System

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Human resources and objectives

1-2 persons

4-5 persons

>9 persons

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.

Team with health economist, librarian and social scientist. Translation of HTA knowledge produced elsewhere into the local decision-making context.

Multidisciplinary team for HTA Knowledge Synthesis and Knowledge Mobilisation

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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.

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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 ?)

Problem streamPolicy streamPolitics 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

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

Policy window of

opportunity 1

2007 Decision making body

created not an HTA agency

2011 HTA agency (IETS)

enacted by law

Late 2010 New

government

2010 11070604 05 20092008

Early 2010 law of social emergency

declared unenforceable

Source: Based on Kingdon model- 1984 by Castro HE, 2013 work in progress

Agenda setting- the policy context in Colombia

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2012 Decision making body

abolished lack of legitimacy

2013 POS content updated

using HTA by IETS

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2012 HTA agency

(IETS) starts operations

Hector Castro, IETS, Columbia. From presentation at EMRO First Intercountry HTA Meeting, November 2013, used with permission.

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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

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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 ?,…)

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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.