Content uploaded by Lorenzo Giovanni Mantovani
Author content
All content in this area was uploaded by Lorenzo Giovanni Mantovani on Oct 29, 2015
Content may be subject to copyright.
Health technology assessment: what is it?
Current status and perspectives in the field of
electrophysiology
Giovanni Fattore1*, Nikos Maniadakis 2, Lorenzo G. Mantovani 3, and
Giuseppe Boriani4
1
Department of Institutional Analysis and Public Management, Centre for Research in Healthcare Management (CERGAS), Universita
`Bocconi, Via Roentgen 1, Milano 20136, Italy;
2
Department of Health Services Management, National School of Public Health, Athens, Greece;
3
CIRFF/Center of Pharmacoeconomics, Faculty of Pharmacy, University of Naples
Federico II, Naples, Italy; and
4
Institute of Cardiology, University of Bologna, Bologna, Italy
Health technology assessment (HTA) is the multidisciplinary field of policy analysis that studies medical, social, ethical, and economic impli-
cations of the development, diffusion, and use of health technologies. Its worldwide diffusion needs to be understood in the context of
evidence-based healthcare delivery policy, and it is strongly driven by the search for new cost-containment policies by the governments
of universal healthcare systems. This article presents the three main pillars of HTA: evaluating comparative effectiveness, cost-effectiveness,
and organizational impact. While comparative analysis is more familiar to cardiologists, cost-effectiveness and organizational studies are less
widely known because they expand the perspective of the evaluation to institutional settings and society at large and require significant inter-
disciplinary work. Sound economic and organizational studies that extend comparative effectiveness studies may facilitate dialogue between
medical science and policymaking.
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Keywords Comparative effectiveness †Cost effectiveness †Defibrillators †Health economics †Health technology
assessment †Policy
Introduction
Healthcare is a major distinctive element of European values and
traditions. In our continent the culture of compassion and
cooperation has made the system substantially universal, equitable,
and effective for using knowledge and resources to improve human
health. The 2000 World Health Report clearly highlighted the
superior performance of European systems with 7 countries
ranking in the best 10 in the world and 17 ranking in the best
20.
1
Nevertheless, the poor economic performance of European
economies compared with those of other continents and the
necessary major role of government funding required for maintain-
ing equitable and effective systems call for radical action to assure
that resources are used more effectively and efficiently. This is the
background in which to explore the field of health technology
assessment (HTA), a term that describes using problem-focused
scientific evidence to make policy and organizational decisions.
In this introductory article, we sketch the content and the devel-
opment of HTA in the broader context of a general cultural move-
ment seeking to shorten the gap between science and practice by
making research more appropriate for decision making and making
decisions more consistent with scientific evidence. The core of the
article presents the three main pillars of HTA: evaluating compara-
tive effectiveness, cost-effectiveness, and organizational impact.
While comparative analysis is more familiar to cardiologists, cost-
effectiveness and organizational studies cover more unexplored
scientific territories, expand the perspective of the evaluation to
society at large, and require significant inter-disciplinary work. In
particular, they extend the scope of evaluation to the use of
resources according to the well being of a defined community. In
the conclusion section, we highlight the potential and the risks of
HTA and recommend that cardiologists and electrophysiologists
will be primary actors in this emerging field.
Health technology assessment and its
allies
There is consensus about a general definition of HTA. It is ‘the
multidisciplinary field of policy analysis that studies medical,
social, ethical and economic implications of development, diffusion
and the use of health technology’.
2
Therefore, HTA is defined by
its aim: to offer guidance to policymaking.
3
In this respect, the
*Corresponding author. Tel:+39 (0)2 58362581; fax: +39 (0)2 58362593, Email: giovanni.fattore@unibocconi.it
Published on behalf of the European Society of Cardiology. All rights reserved. &The Author 2011. For permissions please email: journals.permissions@oup.com.
Europace (2011) 13, ii49–ii53
doi:10.1093/europace/eur083
by guest on October 18, 2015Downloaded from
metaphor of a bridge is often presented to explain the pragmatic
and translational features of HTA: it is the bridge between the
community of scientists who produce valid evidence of the
impact of technology and policymakers who make decisions that
govern healthcare systems and organizations about topics such
as funding, incorporating new products into national or local for-
mularies, and defining rules for the use of specific technologies.
From the ‘policymaker’ perspective, HTA is a vital support for
making rational and credible decisions and requires that the
inputs fit with the general framework according to which decisions
are made (e.g. timing and underlying values). From the scientific
community perspective, the bridge is a strong call for focusing
evaluation research on salient issues that can be governed by
decision makers; ‘building the bridge’ requires scientists to serve
the needs of policymakers with good science.
It is fundamental to provide a definition of technology to under-
stand the meaning and scope of HTA. While in the past the term
has been often limited to ‘hard’ medical technologies, such as CT
scanners or robots, with time, HTA has increasingly made refer-
ence to health technologies as ‘applied knowledge’ used in the
healthcare sector or to improve health.
4
This definition identifies
a vast territory of evaluation that comprises pharmaceuticals,
medical devices, screening programmes, organizational interven-
tions (e.g. intensive coronary units and telemedicine), and health
promotion initiatives. This rather wide definition of health technol-
ogies is fully consistent with the mandates of several European
HTA institutions.
5,6
A major feature of HTA is its multidisciplinary content. Policy-
making requires an overall assessment of the main aspects that
may be impacted by technologies. While efficacy measurements
require medical and clinical epidemiologic expertise, the evaluation
of other dimensions requires a different type of expertise. For
example, for implantable medical devices, engineering and infor-
mation technology expertise may be important to make an
overall safety assessment. Moreover, genetic technologies and
other interventions may raise ethical concerns and thus may
require a specific assessment according to ethical standards. In
addition, technologies may have an impact on models of care
(e.g. they may favour home care) or may influence personal beha-
viours (e.g. contraceptive devices) and thus need to be investigated
from sociological perspectives. Furthermore, as European health-
care systems generally provide free access to care, there is a
clear need for decisions about the introduction and use of technol-
ogies to be compatible with financial and economic constraints in
addition to assessments of the value obtained; thus, input about
the best use of resources is typically the domain of economic
analysis. Finally, effectiveness and cost of technology crucially
depend on local contexts; local decision making (e.g. at the hospital
level) needs to be guided to make appropriate decisions about the
conditions required for an efficient and effective use of technol-
ogies. This is the domain of organizational studies and encom-
passes what has been called ‘hospital-based HTA’.
Health technology assessment needs to be understood in the
context of evidence-based health delivery and policy, which calls
for decision making in the healthcare sector and beyond to be
based on a systematic analysis of scientific evidence of the effects
of interventions. Health technology assessment parallels and
overlaps with evidence-based medicine (EBM). While EBM tries
to integrate individual clinical expertise with the best available
external clinical evidence from systematic research,
7
HTA incor-
porates the aims of EBM and makes reference to systematic
research with broader goals: to offer guidance to decision
making at all levels (including health policies at a macro level)
and to assess interventions from a larger societal perspective to
include economic, social, ethical, and organizational impacts.
Health technology assessment is also indebted to the Cochrane
Collaboration (CC) and the development of methods to summar-
ize scientific evidence. The CC is a large international network of
scientists who critically review health intervention literature with
the goal of improving health policy and practice. CC can be con-
sidered a main facilitator to bridge scientific evidence with decision
makers.
It is clear that ‘HTA, EBM, and the CC are natural allies, albeit
with somewhat different foci’.
4
The CC works to summarize evi-
dence, the EBM movement works to use scientific evidence to
improve medical and healthcare practice, and HTA encompasses
the scope of the analysis to offer guidance for health policy.
Despite these different foci, there is an overlap between the
three. ‘Together, they are beginning to lead to significant changes
in how policy and practice decisions are made.’
4
The rise and rise of health technology
assessment
European healthcare systems absorb 8–9% of national GDP and
are primarily funded with public resources (taxation or social
insurance).
8,9
Public funding aims at providing universal protection
to citizens by eliminating financial barriers to access to care. This
means that in European countries the allocation of resources to
health providers and interventions is not driven by the market,
consumer choice, or market competition among providers, but
rather by policy decisions concerning the total amount of
resources attributed to healthcare, the set of interventions
covered by the statutory systems, the way healthcare providers
are paid, and other measures to govern the systems.
The availability of new and expensive technologies, the effects of
ageing on the demand for care, and the increase in patients’ expec-
tations increasingly strain European health systems. Moreover, the
gap between supply and demand has been recently exacerbated by
the financial crisis and the more competitive global economic
environment: they are both forcing European states to adopt con-
servative fiscal policies and new measures for reducing costs.
In this scenario, HTA is appealing to policymakers. The call for
delivering services only if supported by scientific evidence is pala-
table to politicians eager to adopt and sell cost-containment strat-
egies. Who should be against saving public money by denying
services for which there is no available scientific evidence of
efficacy?
Clearly, the use of economic analyses is less palatable to both
the general public and medical professionals. According to econ-
omic thinking, effectiveness does not justify the use of a technology
because costs may exceed benefits so much that, if resources are
truly constrained, the use of the technology ultimately drains
resources from other areas of care that may provide greater
G. Fattore et al.ii50
by guest on October 18, 2015Downloaded from
benefits to the population. While we have evidence that doctors
are increasingly familiar with this principle and use economic cri-
teria in decision making,
10 –12
it is challenging for policymakers to
explicitly deny access to effective services. Despite these difficul-
ties, the use of economic arguments to filter the introduction of
new interventions is gaining ground.
13
In summary, having tighter
control over the introduction and diffusion of technologies is per-
ceived to be useful by politicians striving to contain healthcare
costs.
Health technology assessment is also popular due to its refer-
ence to scientific evidence to inform policymaking. During the
last 20 years, evidence-based approaches have become prominent
for health policy in several countries.
13
Not only does HTA offer
actionable tools for policymaking, but it also provides the rationale
for their use. Scientific evidence justifies political decisions on a
more neutral and non-ideological ground; evidence takes centre
stage in the decision-making process and creates an easy-to-sell
basis for collective action.
14,15
To manage economic and social
affairs ‘rationally’ in an apolitical, scientific manner is very appealing
to policymakers because it transfers the costs of unpopular choices
beyond the political domain. Also, HTA favours the incorporation
of new scientists (e.g. clinical epidemiologists and health econom-
ists) into policy circles.
The pillars of health technology
assessment
Although a description of the main tools of HTA is beyond the
scope of this article, an overview of the elements of HTA is essen-
tial for understanding its nature. The pivotal question for scientific
evidence is effectiveness: does the intervention work? A major
review of the evidence available for the technology is often the
most relevant undertaking. Typically, HTA scientists work with
secondary data and either produce systematic reviews or use exist-
ing ones. High-quality summaries of available evidence for the
effectiveness of the technology are thus crucial and often go
beyond regulatory files. While Food and Drug Administration
(FDA) and European Medicines Agency (EMA) aim at obtaining
evidence about safety and efficacy, HTA requires additional evi-
dence to evaluate comparative effectiveness: whether the technol-
ogy works in routine conditions (not only in clinical trials) and
compared with other active treatments.
16
Effectiveness evidence
concerns the actual net benefits produced by interventions in
normal settings and under normal practices, which may radically
differ from those of most clinical trials. Evidence about efficacy is
generally evaluated using well-consolidated approaches to
reviews and meta-analysis, often with scores to weigh the quality
of the studies.
17
The question ‘does the technology work in
routine settings?’ requires an extension of the knowledge pro-
duced by randomized clinical trials and is mainly derived from prag-
matic clinical trials,
18
indirect comparisons,
19
and network
meta-analyses.
20
Comparative effectiveness needs actionable evi-
dence to improve actual care; the choice of the appropriate com-
parator for the evaluation of the intervention is thus very critical
and is generally determined on the basis of usual care.
The second pillar of HTA is economic evaluation. The basic idea
of the contribution of economic analysis is that resources should
be used for the most beneficial interventions by taking into
account their overall costs, including the costs and savings attribu-
table to the effects of the intervention. Three main techniques
consistent with this approach have been suggested and piloted in
the last 30 years: cost-effectiveness analysis (CEA), cost-utility
analysis (CUA), and cost-benefit analysis (CBA).
21,22
All three
techniques assess the impact of the intervention on the use of
resources in a similar way. Typically, the analysis of costs concerns
all the resources whose use is affected by the technology. For
example, a cost analysis of the implant of a defibrillator includes
the cost of the device and the medical services required for the
implantation, the cost to treat adverse events (e.g. infections)
due to the device and its implantation procedure, the monitoring
of its functioning, and, inversely, the cost of care of all the events
prevented by the technology. If a broad societal perspective is
used in addition to direct healthcare costs, the analysis includes
social services, formal and informal custodial care, and productivity
losses. These resources may be very relevant when interventions
prevent the disability of people of working age and/or when
helping individuals maintain their daily living capabilities.
The three economic techniques mostly used are different in
respect to the measurement of the effects of the intervention on
the well being of patients. Cost-effectiveness analysis is based on
only one measure, typically years of life saved, and thus does not
capture the impact on quality of life. Cost-utility analysis, to
address the limitation of CEA, is based on measures combining
quantity and quality-of-life effects in a single index that can be
used across different medical conditions and interventions.
Quality-adjusted life years (QALYs) is the most frequently used
measure in this category, and it is recommended by HTA insti-
tutions such as NICE in England and Wales and CADTH in
Canada.
23,24
Cost-benefit analysis aims at providing monetary
measures of both costs and outcomes of interventions and is
less frequently used because of methodological uncertainties and
a reluctance to monetize health effects.
In CUA, interventions are evaluated against the most relevant
alternative to calculate the ratio between the incremental costs
and the incremental QALYs. This ratio signals how cost effective
the intervention is. The higher the incremental cost-effectiveness
ratio, the higher the cost of producing health effects with the inter-
vention and, in turn, the lower its priority. Logically, beyond a
certain threshold, the ratio is so high that the delivery of the inter-
vention would utilize too many resources. The basic idea of CEA
and CUA is that systems have a limited amount of resources and
thus services need to be prioritized to maximize the health of
the population. Interventions that are too costly may reduce the
health of the population because they would take away resources
from more cost-effective interventions.
The third pillar of HTA is the investigation of the organizational
conditions required to use technologies effectively and efficiently.
25
Here, the focus is shifted from whether the technology should be
adopted to identifying how to appropriately change the delivery
system. Evidence is searched in order to identify the set of
actions required to get the best results from the introduction of
the technologies. These actions may include training initiatives,
changes in routines and procedures, new organizational tasks and
roles, new mechanisms of coordination, and the introduction of
Health technology assessment ii51
by guest on October 18, 2015Downloaded from
complementary technologies. Given the strong focus of HTA
activities in Europe regarding reimbursement issues, organizational
analysis of the introduction of new technologies is often over-
looked. Nevertheless, it may be very beneficial for helping organ-
izations to obtain the best results from new innovations.
As mentioned earlier, ethical and sociological evaluations may
be important additions to these three main types of evaluation.
While in some areas they are often required (e.g. assisted repro-
duction), they still play a minor role in cardiology HTA initiatives.
Health technology assessment and
electrophysiology
Cardiology is one of the medical specialties that has been most influ-
enced by EBM, and technologies used for the prevention and treat-
ment of cardiovascular diseases have been largely investigated by
HTA agencies. As a subfield of cardiology, electrophysiology is par-
ticularly exposed to HTA studies and presents many subtleties,
mainly attributable to medical devices that are an increasingly promi-
nent and vital component of its medical armamentarium.
Traditionally, medical devices have been less regulated than
pharmaceuticals,
26 –28
and the amount of evidence collected for
licensing medical devices is traditionally lower than that required
for drugs.
27
However, for high-risk devices or new devices for
which there is no comparative product currently available (class
III devices), the requirements of the FDA imply submission of a
pre-market approval application in order to assess if there is suffi-
cient evidence for safety and effectiveness.
29
The studies requested
for this approval can be non-randomized, and long-term efficacy
data are not required, thus reducing the knowledge basis for
HTA activities. In addition, while in many countries prescriptions
are systematically recorded in large administrative databases, the
recording of implanted medical devices (e.g. stents, defibrillators,
and devices for resynchronization therapy) is not systematic in
most European countries.
Also, it is claimed that the economic evaluation of devices raises
special challenges.
30
Given the intrinsic differences between drugs
and devices, guidelines for conducting studies are not always ade-
quate for evaluating devices because they have been generally
written with reference to pharmaceuticals. Two major salient
peculiarities of devices deserve special attention: (i) the device–
operator interaction that can generate learning curve effects and
thus the risk of underestimating the size of the benefits and (ii)
the incremental nature of innovation (e.g. longer battery life,
improvement of the software systems, and smaller size) that
needs to be addressed by adequate and reasonable licensing pro-
cedures, but also by careful identification of the alternatives for
comparative and incremental CEA. Whether methods of evalu-
ation for devices and drugs are substantially different is debatable.
Nevertheless, it is certain that more knowledge would be valuable
to offer guidance about decision-making policy, management, and
professionals in the field of electrophysiology.
Conclusions
The rise of HTA in the policy agenda of several European health-
care systems is consistent with the promotion of rational and
scientific bases for decision making. In this respect, HTA owes
much to the EBM movement and to a general desire to use
science to govern the delivery of healthcare. At the same time,
the proliferation of HTA agencies and activities is driven by an
attempt to institutionalize the production and use of evidence
into policy frameworks. While EBM is a cultural movement
expression of the emergence of a new paradigm in the medical
community, HTA regards policy measures such as reimbursement,
pricing, and the appropriateness of rules in an environment with
limited resources.
We note that HTA raises both risks and opportunities for the
medical scientific communities. The logic of politics and policy pro-
cesses may clash with the logic of scientific evidence. Using evi-
dence restricts space of policymaking and may be problematic in
systems that are governed by political and social accountability.
Scientific evidence calls for transparency, consistency and del-
egation of power, but the exertion of political power is often
dominated by limited rationality and much less linear processes
than science suggests. For example, the need to compromise
between stakeholders of different strengths may result in decisions
that are inconsistent with scientific evidence. While promoting
HTA may be seen as step forward for the inclusion of evidence-
based criteria in policy decision making, there is the risk of
mimetic behaviours: scientific evidence collected to legitimize
decisions that are only marginally influenced by the products of
good research. At the same time, the institutionalization of EBM,
comparative effectiveness research, and CEA is an opportunity
to bridge science with practice and create a genuine grounding
in decision making into the culture of ‘what matters is what
works’ and ‘value for money’. Whether the risks will be minimized
and whether the opportunities for more effectively including sound
scientific evidence in policymaking will greatly depend on the atti-
tude of professionals and their scientific communities. In this
respect, the role of economics may be vital as it brings a societal
perspective in the world of medicine that has been traditionally
dominated by the centrality of the doctor– patient relationship.
Sound health economics evidence, as an extension of clinical evi-
dence, may facilitate the dialogue between medical science and
policymaking.
Acknowledgements
The authors wish to thank Professor Rod S Taylor, Peninsula
Medical School, University of Exeter, UK, for useful suggestions
during manuscript preparation.
Conflict of interest: none declared.
References
1. WHO. The World Health Report 2000: Health Systems: Improving Performance.
Geneva: WHO; 2000.
2. International Network of Agencies for Health Technology Assessment. HTA
Resources 2009; http://www.inhata.org/HTA.
3. EUR-AsSESS. Introduction to the EU-ASSESS project. Int J Health Technol Assess
Health Care 1997;13:133 –43.
4. Banta D. The development of health technology assessment. Health Policy 2003;
63:121– 32.
5. Schwarzerer R, Siebert U. Methods, procedures, and contextual characteristics of
health technology assessment and health policy decision making: comparison of
health technology assessment agencies in Germany, United Kingdom, France
and Sweden. Int J Health Technol Assess Health Care 2009;25:305 – 14.
G. Fattore et al.ii52
by guest on October 18, 2015Downloaded from
6. Organization for Economic Co-operation and Development. The OECD Health
Project, Health Technology and Decision Making. Paris: OECD; 2005.
7. Gray J. Evidence Based Health Care. New York: Churchill Livingston; 1997.
8. Mossialos E, Dixon A, Figueras J, Kutzin J. Funding Health Care: Options for Europe.
Buckingham: Open University Press; 2002.
9. OECD. Health at a Glance: Europe 2010. Paris: OECD Publishing; 2010. http://dx.
doi.org/10.1787/health_glance-2010-en.
10. Fattore G, Torbica A. Economic evaluation in health care: the point of view of
informed physicians. Value Health 2006;9:157 –67.
11. Torbica A, Fattore G. Understanding the impact of economic evidence on clinical
decision making: a discrete choice experiment in cardiology. Soc Sci Med 2010;70:
1536– 43.
12. Hoffmann C, Graf von Schulemburg MJ, on behalf of the Euromet group. The
influence of economic evaluation studies on decision making: a European
survey. Health Policy 2000;51:179– 92.
13. Niessen LW, Grijseels EWM, Rutten FFH. The evidence-based approach in health
policy and health care delivery. Social Science & Medicine 2000;51:859 –69.
14. Davies HTP, Nutley SM, Smith PC. Editorial: what works? The role of evidence in
public sector policy and practice. Public Money Manag 1999;19:3 – 5.
15. Sanderson I. Evaluation, policy learning and evidence-based policy making. Public
Admin 2002;80:1– 22.
16. Final Conclusions and Recommendations of the High Level Pharmaceutical
Forum. http://ec.europa.eu/pharmaforum/docs/final:conclusion_en.pdf (12
November 2010, date last accessed).
17. Higgins JPT, Green S (eds). Cochrane Handbook for Systematic Reviews of Interven-
tions Version 5.0.2 [Updated September 2009]. The Cochrane Collaboration,
2009. www.cochrane-handbook.org.
18. Tunis SR, Stryer DB, Clancy CM. Practical clincal trials. Increasing the value of
clinical research for decision making in clinical health policy. JAMA 2003;290:
1624– 32.
19. Glenny AM, Altman DG, Song F, Sakarovitch C, Deeks JJ, D’Amico R et al. Indirect
comparisons of competing interventions. Health Technol Assess 2005;9.
20. Lumley T. Network meta-analysis for indirect treatment comparisons. Stat Med
2002;21:2313–24.
21. Weinstein MC, Stason WB. Foundations of cost-effectiveness analysis for health
and medical practices. N Engl J Med 1977;296:716 –21.
22. Drummond MF, Schulpher MJ, Torrance GW, O’Brien BJ, Stoddart GL. Methods
for the Economic Evaluation of Health Care Programmes. Oxford: Oxford University
Press; 2005.
23. National Institute for Health and Clinical Excellence (January 2009). The
Guidelines Manual. London: National Institute for Health and Clinical Excellence;
2009.
24. Canadian Agency for Drugs and Technologies in Health. Guidelines for the Econ-
omic Evaluation of Health Technologies: Canada. 3rd ed. Ottawa: Canadian Agency
for Drugs and Technologies in Health; 2006.
25. Fulop N, Allen P, Clarke A, Black N. From health technology assessment to
research on the organization and delivery of health services: addressing the
balance. Health Policy 2003;63:155–65.
26. Avorn J. Regulation of devices. Lessons can be learnt from drug regulation. Br Med
J2010;341:947–8.
27. Taylor RS, Iglesias CP. Assessing clinical and cost-effectiveness of medical devices
and drugs: are they that different. Value Health 2009;12:404 – 6.
28. Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by
the FDA in premarket approval of cardiovascular devices. JAMA 2009;302:
2679– 85.
29. Maisel WH. Medical device regulation: an introduction for the practicing phys-
ician. Ann Intern Med 2004;140:296 –302.
30. Drummond MF, Griffin A, Tarricone R. Economic evaluation for devices and
drugs – same or different? Value Health 2009;12:402– 6.
Health technology assessment ii53
by guest on October 18, 2015Downloaded from
