Health Care Technology Assessment (HTA): Developing &
Using the Evidence in Health Care Decisions
(The following were presented during the Second Plenary Session at the
ISPOR 1st Latin America Conference, 9, 10, 11 September 2007, Cartagena,
What Is Health Technology
Assessment - And How Is
European Network For HTA
This article will address: 1) Health Technology Assessment (HTA); 2) the relationship
between HTA and policy processes; 3) the need for transnational collaboration
in HTA in Europe; and 4) the European collaborative project -
Health Technology Assessment
Health technology refers to the practical application of scientific knowledge in
health care: All the kinds of interventions that we can do in relation to patients
and to health of the population. Health technology is much more than devices
and machines, it is more than pharmaceuticals, it is also e.g. cognitive interventions
in the area of psychiatry, and it is diagnostic procedures, not necessarily
using a lot of technical equipment. Technology assessment in health care
is a multidisciplinary field of policy analysis. It studies the medical, social, ethical,
and economic implications of development, diffusion, and use of health
HTA is multidisciplinary; you cannot really do a full HTA without having clinical
researchers from health care practice involved together with researchers from
other areas, such as health economics, epidemiology, organization research,
and perhaps social scientists to cover patient and citizen aspects.
HTA is a kind of policy analysis. Policy analysis means analysis of different
ways of implementing alternatives, say, a new technology, and seeing the consequences
of different options -and HTA falls into this broad area. HTA does
not just address the medical implications but also the broader societal implications,
the implication for the patient, as well as the economic implications.
HTA may very well inform regulatory processes. In fact, increasingly HTA has
a defined role in the development of the basis for regulatory decisions - but it
is not regulation itself. It provides information that helps pointing to different
options and consequences, but does not give one direct answer (“yes / no”).
In other words, it is important for understanding the concept and practice of
HTA that HTA is not mandating policies: The resulting report is not the decision
on a policy.
It is fundamentally important that HTA is firmly rooted in research and research
methods. However, this aspect will not be developed further in the article.
In the Danish HTA model we say that we will address the technology, the
patient, the economy, and the organization . “Organization” is organization
of health care, use of human resources, use of doctor time / nurse time and other issues related to the application of the technology. “Patient” does not
refer to the direct clinical outcomes etc. of the technology or the side-effects
(which would fall under the headline “technology”) but the patient as a whole
individual, the patient as a member of society. Questions here might be: 'will it
improve the possibility for the patient to get back to work quicker?' “Economy”
covers health economic issues as applied in e.g. pharmacoeconomics. The
work is multidisciplinary using rigorous methods. It should be transparent, and
it should be synthesized into a report. It is very important to ensure that this
process is as transparent as possible for the user to know how the HTA came
from these questions to the synthesis to the report.
The Relationship between HTA and Policy Processes
Ideally HTA is linking - and in practice HTA is increasingly linked - into policymaking
and decision-making. The role of HTA has been compared with that of
a bridge between research and decision-making . The Figure illustrates the
close relation between HTA and policy-making and depicts the interdependence,
yet division of work, between research-based assessment and decisionmaking.
A successful process from policy question(s) to an HTA report that
informs policy spans across paradigms in a conscious and transparent way.
When preparing a decision you have one or more policy questions on ways of
implementing policy options, say, in the area of diabetes or rheumatology, or a
new vaccine. A “translation process” produces a number of HTA questions -
these are more specific questions that are formulated in a way that is actually
answerable. One question might be: 'what is actually the size of this health
problem?' leading to: “how big is the population that is going to be targeted
with the potential intervention?” and “which negative health consequences can
be avoided?' etc.
Figure 1. From policy questions to HTA reports that inform policy
Figure 1 illustrates that the process of doing HTA moves across domains. To
the left is a decision-making domain, and regulation is included in that. In this
domain people are developing the policies for decision-makers politicians to
decide; it can also be clinical policies at the clinical level. To the right is the
research domain. People in academia work in the research domain and do not
see them as having anything directly to do with the decision-making domain.
They're doing research. The paradigm of policy-making is the theoretical basis
of those who are supporting the decision-makers. Policy-makers are increasingly
people who have an academic background from university in political science,
economics, public health etc. They are developing policies for the decision-
makers, and learned about research in their studies. Most of the HTA parSeptember/
October 2008 ISPOR CONNECTIONS 15
adigm is actually in the research domain but it extends into the decision-making
domain: HTA should be practical in the sense that it should be useful for
planning and decision-making.
Figure 1 depicts from left to right the process from policy questions leading into
more specific HTA questions which are handled in the research domain, reported
- and then fed back to the decision-making domain. Currently the ways of
reporting and feeding back into the system are developed in various countries.
It is important to ensure clarity on who is doing what from HTA to decision.
HTA and decision-making is not the same.
In England and Wales the National Institute for Health and Clinical Excellence
(NICE) do appraisals using the evidence coming from HTA in a process that
leads to guidance . This is policy-making beyond HTA, and even involves a
decision. HTA is building on robust methods coming from research. Decisions
involve other important criteria as well - this is where the appraisal comes in.
Currently there is discussion in Europe about: 'where does the assessment
(policy analysis) stop' and 'where does “appraisal” (policy-making) start'?
There is not one answer; it varies from country to country setting.
The Need for Transnational Collaboration in HTA in
Researchers from academic groups in UK did a study of HTA that took a fresh
look at the use of HTA and the potentials of HTA in Europe . These are some
of the conclusions from that report: HTA can play a valuable role but it has to
be transparent, timely, relevant, in-depth and usable. This is very much asking
for practical implementation of scientific methods. This assumes that HTA is
built on sound methods. It has to be available when the decision-makers need
this kind of information, and not after the decision was made. It has to use
robust methods, and be supplemented by other important criteria. The authors
conclude that if you maximize the potential of HTA the decision-makers will
actually be helped.
So what kind of challenges does this raise? One challenge is about avoiding
unnecessary duplication when several health systems express a need for HTA.
Take an example like PET scanning. A lot of parallel reports have come out and
differed in terms of their conclusions. It was raised as a problem for international
HTA that reports were rather different - also in terms of the kind of advice
one could derive from them.
In the area of HPV vaccination against cervical cancer we tried to coordinate in
Europe, about 8 countries did HTAs on the same topic - in most cases using
the same evidence. We need to use best practice, share what can be shared,
and find out how to produce information in a shared way, that can then be
adapted into national or regional versions, taking into account that the regions
differ, even within the same country, or at least across Europe.
International collaboration in the area of HTA has been there for more than 20
years. There is an international organization called INAHTA which is an association
for agencies. It has more than 40 members from the Americas, Europe
and Austral-Asia. It's been very useful for agencies to participate in this organization,
especially during establishment. There's also an international society
for HTA, HTAi, which has an international journal and annual meetings.
The European Collaborative Project - EUnetHTA
The European Network for HTA is a response to an express need that came
from the member states in the European Union and the European Commission.
They asked for a sustainable network for HTA Europe. EUnetHTA is a 3-year
project from 2006-08, and it is big - it has 34 Associated Partners who contribute
financially and receive a grant from the EU (BOX 1). There are also 29
Collaborating Partners including international organizations. Partners are from
nearly all of the EU countries. There are also a few institutions from other
countries like the AHRQ in the USA and CADTH in Canada.
The objective of the project is to establish an effective and sustainable network.
It shall help informing policy decisions. That said, research and academic
work is absolutely necessary for progress, again taking into account that HTA
is practically oriented. It should be useful for decision-makers. The project
intends to bring agencies together with research institutions, and have links to
health ministries that do the policy-making. This will promote effective support
to policy decisions in the member states.
Health care policy is a national issue in the EU. Coordination of methods is an
EU issue with the member states. EUnetHTA partners want effective use of
their national resources, and there are many examples, where we could do better
in terms of reducing duplication of efforts. This does not mean that there
should be one HTA for the whole of Europe on e.g. HPV vaccination or the treatment
of Alzheimer's disease, but there might be components of the work that
can be shared. Through transnational work partners will be able to increase
the output from the often relatively small agencies that are doing HTA in the
countries. The vision is that we can share some work between counties thus
avoiding parallel work from scratch on the same topic at the same time and be
able to have more output.
It is also a EUnetHTA objective to strengthen the link between HTA and health
care policy-making. In the HTA environment there are still some people who
really prefer not to have anything to do with policy- and decision-making at all.
They want to stay in their academic setting and the research domain only. This
can work well provided that such contributors to HTA work closely together
with e.g. HTA agency people who ensure the policy relevance of the reporting.
It has proven helpful that the work in the EUnetHTA project was organized in
several work packages with objectives, milestones and deliverables described
in a protocol (See www.eunethta.net for more information).
Examples of EUnetHTA Work
It has already been mentioned that HTA is implemented differently, and it is difficult
to extract data from existing reports because the structure of the reports
and the methods are not sufficiently clearly described in the reports coming out
of HTA agencies. In parallel two work packages either de novo address a technology
with HTA, or adapt existing HTA reporting, leading into reporting and
One Work Package is about trying to define common core information that can
be shared when doing HTA. The project is testing the possibility of producing
core information on a certain technology that can be shared across national
reporting. Not least data on efficacy data and clinical effectiveness data may
be shareable. The project develops two models - one model for therapeutic
interventions, and one model for diagnostic interventions. Two examples of
“HTA core information” will be produced in the project; the first core HTA,
which is drug-eluting stents, the second on multislice CT of coronary arteries.
EUnetHTA use 9 domains that were defined in the previous EU project' EURASSESS):
- Current use of the technology (implementation level);
- Description and technical characteristics of technology;
- Costs, economic evaluation;
- Ethical aspects;
- Organizational aspects; and
- Social aspects
The domains define the landscapes of HTA that you should consider when you
plan a concrete HTA. You don't necessarily have to address them all. In certain
technologies it may be useful to look at legal aspects while in most cases it
may be completely irrelevant. One would expect domains like effectiveness and
safety, issues of cost and economic evaluation, etc. to be covered in an HTA.
The work is centered round defining a common core of information. In the
domain of ethics, is there a big or a small part of the whole of ethical issues >
16 September/October 2008 ISPOR CONNECTIONS
that can be defined as a common core? Probably not very much will be shareable
because in Europe we have people with e.g. different religious and moral
approaches to the individual and society. So probably in ethics it is quite difficult
to share a lot of the ethical discourse.
In the domains of efficacy and effectiveness the common core may extend
quite a bit into national reporting with shareable information from published
reports and systematic reviews like Cochrane Systematic Reviews. Under each
domain there are a number of topics - topics in the domain of clinical effectiveness
could be e.g. influence on mortality, survival. Those outcomes could be
defined into more specific issues. It's analytic work; you divide things into the
smallest bit that is necessary to have a genuine element of information that
may be shared.
Another Work Package is about adapting existing HTA reports into new settings..
This work is trying to dig into existing reports and trying to take out the
things that might be transferable. Currently, agencies (especially in smaller
countries) sometimes take existing reports from another country, if practicable
for language and other reasons, and make a national version, to be able to
deliver HTA reporting sufficiently quickly. There are problems with getting information
out of existing reports in the right way. There is now an “Adaptation
Toolkit” which is being tested for usefulness.
These examples illustrate what should be in place if we want to have real
transnational collaboration. We need to have a common taxonomy and a common
framework - and we need to find out to what extent there is a common
core of information that can be shared irrespective of health system.
In summary, transnational HTA collaboration does not interfere with maintaining
national governance in healthcare. EUnetHTA is doing practical, methodological
work to share information. We are not taking the decision power out of
the hands those who make decisions in the area of the use of health technology.
There is a lot of enthusiasm in EUnetHTA and time will show how far we
- 59 partners
- 34 Associated Partners (national/regional HTA agencies,
- MoH, research institutions, international organisations (Cochrane Collaboration)
- 25 Collaborating Partners (e.g. WHO, OECD, CoE)
- 24 EU countries ( ÷ Slovakia)
- 2 EEA (Norway, Iceland)
- 4 institutions in countries outside Europe (Israel, Australia,
- Canada, USA)
Box 1: EUnetHTA Partners
- International Network of Agencies for Health Technology Assessment. About HTA.
http://www.inahta.org/HTA/ (accessed 25 February 2008)
- Kristensen FB, Sigmund H (eds.). Health Technology Assessment Handbook. 2nd Ed.
Copenhagen: Danish Centre for Health Technology Assessment, National Board of Health, 2007.
- Battista RN, Hodge NJ. The development of health care technology assessment. An international
perspective. Int J Technol Assess Health Care 1995;11:287-300.
- Walley T. Health technology assessment in England: assessment and appraisal. MJA
- Sorenson S, Kanavos P, Drummond M. Ensuring Value for Money in Healthcare - the Role of
HTA in the European Union. In: Financing Sustainable Healthcare in Europe (Cox Report), 2007
- Banta HD et al. (eds.). Introduction to the EUR-ASSESS Project. Int J Technol Assess Health
Results of The NEVALAT ProjectResults of The NEVALAT Project
This article presents the results of the NEVALAT (Network for the Economic
Evaluation of Health in Latin America) Project. This project was a follow-up of
a previous initiative, called the REDEFS, Red de Economía y Financiamiento de
la Salud [Financing and Health Economy Network] that was promoted in the
early 90's by the World Bank, PAHO and the IDB. By the mid 90's, these institutions
discontinued the sponsorship of the REDEFS and so those who had
participated - researchers in Latin America and some researchers in Europe -
saw the need to get organized in order to maintain the collaboration. They prepared
a project and applied for a grant to the DG XII (Directorate for Research)
of the European Commission (EC) and began working on this project from
2000 to 2004. There were teams from the following countries: Argentina,
Brazil, Colombia, Cuba, Mexico, Nicaragua, Peru and Uruguay in Latin America
and from Spain and the UK in Europe. The overall outcome of the NEVALAT
project is an informal open network of contacts between professionals and a
set of virtual information assets and analytical tools that are publicly available
but quickly becoming out-dated.
The NEVALAT activities were organized into several modules or work packages.
One of the most important parts of the project was the Work Package
aimed at assessing how far economic evaluation had already been implemented
for decision making purposes, as well as the identification of the relevant
decision-makers and of future opportunities for using economic assessment in
the region. The current situation was analyzed by means of a survey aimed at
eliciting 1) the mechanisms actually used to allocate health resources in the
countries of the region (there were 10 countries surveyed at that point in time);
2) how resources were being allocated; and 3) whether it was any evidence
that economic assessment was being used for decision-making regarding priority
setting, resource allocation, pricing and financing health services and
technologies, etc. The results of the survey are available at Iglesias,
Drummond and Rovira . At the time the survey was done (2002) the scenario
was quite discouraging and disappointing, as it became evident that,
although a certain number of good quality studies had been produced, economic
evaluation was practically not used for any policy and management purposes
in the region. As has been evidenced recently by the presentations given
at the ISPOR 1st Latin America Conference, the situation seems to be improving
in many countries, especially in Brazil, where some regulations requiring
the presentation of economic evaluations have been introduced, but also in
Mexico and Argentina. The situation has moved forward and there is an explicit
and growing interest on the part of decision-makers on this approach.
A second Work Package was aimed at eliciting the knowledge, actual use and
attitudes towards economic evaluation in health care among decision makers
in each country. The main purpose was to assess whether the limited use of
economic evaluation was out of ignorance, or because of other reasons: e.g.
they believed that it is not ethical to base clinical and health policy decisions on
money and cost considerations, or they did not trust the results of the studies.
Information on the attitudes of several groups of health professionals and decision-
makers was collected using a combination of techniques - focus groups,
personal interviews and postal surveys -in some countries of the project, especially
in Argentina and Cuba. The answer to the question “Why is economic
evaluation not much used in Latin America?” is an important one for professionals
and organizations committed to the diffusion of this approach in the
region. In Europe and in other countries with a longer tradition in economic
evaluation, those who sponsor and do the studies are often surprised to know
that most decision-makers are not making a regular use of economic assessment
tools, and the reaction is often one of blaming those decision-makers and
assuming that they either do not want to do it for some hidden reasons, or
because they do not know or understand the techniques. Critics seldom realize
that decision-makers might have very rational and legitimate reasons for not
using economic evaluations, such as, the lack of transparency, of the method-
• 59 partners
• 34 Associated Partners (national/regional HTA agencies,
MoH, research institutions, international organisations
• 25 Collaborating Partners (e.g. WHO, OECD, CoE)
• 24 EU countries ( ÷ Slovakia)
• 2 EEA (Norway, Iceland)
•4 institutions in countries outside Europe (Israel, Australia,
September/October 2008 ISPOR CONNECTIONS 17
ology, the validity of the studies or the relevance of the results for the actual situations.
The results of that part of the project have clear implications for sponsors
and analysts of economic evaluation studies in the region: before involving
themselves in financing and producing economic assessment it would be
advisable for them to learn more about the users' needs and perceptions and
to ensure that the studies they produce are reliable and relevant to the target
The Work Package on Standardization of the Methodology tried to promote
standardization as it is already done in some countries. But no progress was
attained along these lines except for Cuba. A possible explanation for this is
that at the time the project was conducted, no agencies in the region were
using economic evaluation for financing, pricing or regulatory purposes and
they consequently felt no need for, nor were they receptive to proposals of
standardization. As part of the process of standardization NEVALAT promoted,
among other tools, the development of national unit costs databases, and
PREVE, a software program for carrying out cost-effectiveness analyses, so as
to facilitate the implementation and transference of the results of studies
across countries. It also produced a web page (www.nevalat.org) with an
inventory of the economic assessments carried out in the region in Spanish,
Portuguese and English and a directory of researchers and centers involved in
economic evaluation in health.
LITERATURE REVIEW OF ECONOMIC EVALUATION
STUDIES IN LATIN AMERICA
The review of economic assessment studies done in the region was done by
means of a common form for summarizing the studies, which was as simplified
version of the one used by the Office of Health Economics, Health
Economics Evaluations Database (OHE-HEED). The OHE had developed a
database that included more than 25,000 references of economic assessment
papers and studies. The use of a compatible form was aimed at allowing the
comparison of what was being done in Latin America vis-à-vis the rest of the
world. The review started with a series of electronic searches on the internet
and at the OHE-HEED, but it was complemented with manual searches of grey
literature at national level by the researchers of the participating countries.
The first compilation was carried out by Jerry Crosby, of the Health Economic
Office, which conducted a study of 115 papers identified in the OHE-HEED as
full economic evaluation studies performed in all Latin American countries,
published in the period 1992-2002. He did a descriptive analysis according to
several variables. Most of the studies - 50 out of the 115 - were drug assessments.
The data showed a large proportion of studies that involved infectious
diseases when compared to the aggregate results for all countries. In relation
to the studies' sponsorship, the results show that the pharmaceutical industry
did not have a majority role in financing these studies, although this information
was only available in roughly half of the studies. Most studies had been
financed by government or by public agencies. These results were presented
at the ISPOR 9th Annual International Meeting .
A second analysis was published by Rovira and Sanabria . It comprised
about 300 economic studies including economic assessments of health technologies,
but also costs and cost of disease studies. It covered the period 1960
and 2003, and included both published and unpublished studies, but only from
the countries that were members of the NEVALAT project. The review did not
make a quality assessment of the papers, but is only a descriptive bibliometric
analysis aimed at finding some general trends in the literature.
Iglesias, Drummond and Rovira  also included a list of references of full economic
evaluation studies found in the OHE-HEED database and in the NHS
Economic Evaluation Database at the University of York.
It is worth mentioning, as well, the review published in 2006 by Machado,
Iskedjian and Einarson . They carried out a search in MEDLINE, EMBASE,
LILACS and SIETES using the following key words: cost-effectiveness, costutility,
cost reduction, cost-benefit, and all the names of all South American
countries. They selected studies that had considered both costs and outcomes of a technology. The papers were rated for quality according to a list of 12 criteria.
The quality of most studies was evaluated as “poor” or “acceptable” and
the overall level was considered relatively low in comparison to the results of
similar exercises done in other countries.
The last updating of the literature that has been done for the present paper took
into account the previous reviews quoted above. It is worth noting the limited
level of overlapping across the groups of papers selected in each review. For
instance, the NEVALAT review  (93 papers) and the Machado et al (2005)
review (24 papers) have only 12 papers in common in the period 1984-2002.
Similarly, Machado and Iglesias have only 5 common papers in the same period.
Out of the 93 papers selected in the NEVALAT review, only 33 were in the
York database. These findings highlight how much searches on a given topic
can yield widely different results according to the methodology, keywords,
databases and selection criteria applied.
The updating of the inventory of economic evaluation studies in Latin America
tried to be consistent with the previous studies on the topic. Table 1 summarizes
the search strategy. Table 2 displays the number and time distribution of
the studies found in the various reviews mentioned in the paper. Our last search
in Pubmed (last column) identified 143 out of the 174 studies found by all
searches combined (first column). This updating exercise added 18 studies
from the period covered by the NEVALAT review  that had been missed for
some reason in the previous search. For the period posterior to the NEVALAT
search, 2003-2007, 65 papers were added from the York University database,
5 from Machado et al.  and 25 from the additional PubMed search done by
the authors of this paper.
Table 1. Summary description and results of the search by source
Table 2. Distribution of studies by source and year of publication
To sum up, the search results of the NEVALAT project, up to 2003 (Iglesias et
al) included 93 references, but the present review raises this number to 174 as
of August 2007. The distribution of studies by year of publication suggests a
real leap between 1995 and 1998 and an apparent stabilization in the number
of publications thereafter (Graph 1). In other words the number of published
studies rose from 2 or 4 studies per year to about 14 or 15 per year on average.
The distribution by country shows a high concentration in a few countries:
the six countries with the higher number of studies Brazil, Mexico, Argentina,
Colombia, Chile and Peru account for over 90% of the total number of studies
(Graph 2). It is also worth mentioning that most of the studies are single country
studies: only 12 (14%) of the studies are multi-country. Multi-country studies
involve usually (10 studies) Brazil and Argentina. NEVALAT tried to promote
cross-national studies assuming this would improve the quality and efficiency
and the possibility of comparing results across countries.
Graph 1. Evolution of the number of published studies
Graph 2. Distribution of studies by country (only countries with three or more studies)
The NEVALAT project was aimed at supporting the production and use of economic
evaluation studies by building a network of researchers, decision-makers
and institutions interested in the topic and facilitating some key elements,
such as general information, databases on researchers, studies, standard tools
such as software programs and unit cost databases and other analytical tools.
The use of economic evaluation for decision-making purposes is still limited in
Latin America, but its role is rapidly growing.
According to the literature searches done in the context of the NEVALAT project
and by other researchers, there are a considerable number of studies on
economic assessment in health. The quality may not be optimal, according to
the sample analyzed by Machado et al, but the skills for improvement seem to
be available in the region.
The NEVALAT initiative needs new inputs or continuity somewhere else. ISPOR might provide the appropriate environment for providing a new momentum to
the evolution of economic evaluation in Latin America.
The full report and tools of the NEVALAT Project is available upon request from
Joan Rovira, University of Barcelona, firstname.lastname@example.org.
 Iglesias CP, Drummond MF, Rovira J. NEVALAT Project Group. Health-care decision-making
processes in Latin America: problems and prospects for the use of economic evaluation.
International J Technol Assess Health Care 2005;21:1-14.
 Rovira J, Sanabria C. La evaluación económica en salud y la toma de decisiones en
Iberoamérica. Revista de la Facultad de Ciencias Económicas de la UNMSM 2005;10:27-46.
 Machado M, Iskedjian M, Einarson TR. Quality assessment of published health economic analyses
from South America. Ann Pharmacother 2006;40:943-9.
 Rovira J. Developing strategy for promoting the use of economic evaluation in health care decision
making in Latin America [oral presentation]. ISPOR 9th Annual International Meeting, Arlington,
VA, USA, May 16-19, 2004.
HTA Experiences from the
Many from the pharmaceutical and device industry believe that individuals who
assess medical technologies are evil technology suppressors who don't like
innovation. That is not true. Assessors love medical technology. The only
problem is that people who assess medical technology for a living are the types
who when their wife asks them “does this dress make me look fat?” will think
about it deeply for five seconds and boldly answer “not really.”
There are a number of examples of very good medical technologies that many
health technology assessment (HTA) agencies have looked at - lung transplants,
liposomal amphotericin, implantable cardioverters and defibrillators - all
great technologies, not likely to be misused. Clinicians are knowledgeable and
do good patient screening when using these technologies. Then there are categories
of medical technologies that are good, but often misused, such as
antibiotics, bariatric surgery, pulmonary artery catheters, and red blood cell
transfusions. When a clinician is faced with a parent whose child has an ear
infection, it is (at least in the United States) very easy to prescribe an antibiotic
while knowing in all reality that the infection is probably of viral origin and the
antibiotic is doing no good. Finally, to compile a list of technologies that are
truly bad, you have to go into the distant past for blood-letting and lobotomies.
There have been some recent examples, such as intraoptic nerve decompression
and aprotinin, although in many cases over-aggressive marketing and
inappropriate clinical use may be the culprit.
HTA is of great interest to government agencies and insurance companies that
pay for a substantial portion of health care. But, it should also be of interest to
academic medical centers (AMCs) because of the tremendous amount of new
medical technology introduced into the market every year. About 20-30 new
molecular entities are approved annually in the US by the FDA, as well as thousands
of medical devices via the 510(k) process demonstrating substantial
equivalence to existing devices, or via pre-market authorization (PMA) requiring
some level of clinical evidence. AMCs purchase these products and often
hope that some level of reimbursement will be forthcoming.
The US health care system is complex and confusing, with numerous payers,
such as Medicare, Medicaid, and thousands of commercial insurers administering
policies for services at over 4,000 hospitals. These institutions often
function as independent entities, with little or no collaboration or coordination
of services. Dilemmas exist with one payer paying for a specific medical techSeptember/
October 2008 ISPOR CONNECTIONS 19
nology and another not paying. This 'schizophrenic environment' would seem
to be a reasonable call for sophisticated assessment by hospital for incorporating
any new technologies into routine practice.
Unfortunately, the state of formal HTA in US hospitals is dismal. Probably less
than 25% have any sort of technology assessment infrastructure and process,
excluding the P&T committee and formularies that evaluate a new drug's addition
to the clinical armamentarium. New devices and medical/surgical procedures
are rarely evaluated. There is usually limited discussion about clinical
evidence, safety, and all the issues that formal technology assessment
reviews. Many promote quality of care as the number one goal for American
hospitals - it is often in our mission statements - but financial viability will be
equally vital in the coming years. AMCs are beginning to recognize that they
can no longer be “the best at everything.” Training health care professionals
and conducting biomedical research while caring for patients is an enormous
task. Perhaps the era of a single regional institution being a center of excellence
in oncology, neurology, cardiology and all the “-ologies” in medicine has
passed. Greater coordination and communication between all health service
providers in an area will be required.
There are several sources of technology assessment information available to
hospitals. Some payers, such as the Blue Cross and Blue Shield Association,
have sophisticated in-house HTA capabilities. They make their assessments
available to the public on their website. Other payers are not as transparent,
and often the first time a hospital finds out about a policy decision is when a
clinician uses the technology and the claim is denied. HTA in this case is rarely
a prospective process - it is often a retrospective and mysterious process,
which US health providers find very frustrating. Another source of HTA information
is the Agency for Healthcare Research and Quality (AHRQ), a US governmental
agency that contracts with designated evidence practice centers to
create public technology assessments. Several US organizations (e.g., ECRI,
Hayes, Inc., Health Technology Center, Health Care Advisory Board) provide
HTA services for a fee.
The University HealthSystem Consortium (UHC), formed in 1984, is an alliance
of 102 academic medical centers and 184 of their affiliated hospitals representing
approximately 90% of the nation's non-profit academic medical centers.
UHC offers its members specific programs and services to improve clinical,
operational and patient safety performance. UHC's mission is to advance
knowledge, foster collaboration, and promote change to help members succeed
in their respective markets. UHC's vision is to be a catalyst for change,
accelerating the achievement of clinical and operational excellence.
UHC's Clinical Knowledge Service has tried to fill the gap for AMC HTA
resources using a variety of formats. It has produced assessments, reports,
bulletins, case studies, and monographs. These resources are available online
to UHC members in “health care topics,” under clinical specialty headings.
Topics of 2005 and 2006 reports included:
- Dual-modality positron emission tomography/computed tomography imaging
- Embol-X aortic embolus protection device;
- Patient-controlled fentanyl transdermal delivery device;
- Transcatheter closure of secundum atrial septal defects;
- Kyphoplasty for vertebral compression fractures;
- Bone morhogenetic proteins in spinal fusion;
- Lumbar total disc replacement;
- Bar-coded medication administration;
- ICU Telemedicine; and
- Ultrafiltration in heart failure
These reports are usually between 30-50 pages, with 50-100 references.
Another UHC offering called TechFlash has been available to UHC members
since 2005. TechFlashes are based on an individual request from a UHC member,
with a response turnaround in 3-4 weeks. They provide a summary review
of a specific medical technology, with over 90 completed since June 2005.
This format is preferred by many health care organizations to aid in decisionmaking.
Topics that have been tech flashes in 2007 are listed below, and the
majority has been on devices:
- Intravenous immunoglobulin off-label use;
- Hemoglobin-based oxygen carriers;
- Perineural pain pumps in ambulatory patients;
- Embolic protection systems;
- CardioMEMS Endosure intraortic pressure sensor;
- ProDisc lumbar disc arthroplasty;
- Barrx HALO endoscopic RF ablation for Barrett's esophagus;
- Arista AH absorbable hemostat;
- Total ankle replacement systems;
- InSpectra StO2 tissue oxygen monitor;
- BrainLab intraoperative MRI;
- US Com ultrasonic cardiac output monitor;
- Orthofix Physio-Stim bone growth stimulator;
- Cardiva Boomerang wire;
- CR Bard Simpulse Varicare wound management system;
- INSORB absorbable subcuticular skin stapler;
- Prestige cervical disc;
- Audiocor for optimizing heart failure treatment; and
- EsophyX transoral fundoplication
AMCs need to build or refine their infrastructure to make greater use of HTA
information. There should be something analogous to the P&T process - a multidisciplinary
committee charged with technology decision-making. Someone
has to be accountable for either right decisions or wrong decisions. Of key
importance is picking the right projects - not doing TA on everything - only the
ones that are going to have a major impact on the organization. Success can
be achieved by holding regular TA meetings, having policies and procedures in
place for this committee, and with ongoing financial and administrative support
for this process.
The era of evidence-based medicine demands that we know which technology
is good, which technology is mediocre and has the potential for misuse, and
which technology is truly no better than the alternative. Rarely is there a single
individual you can go to in an AMC or any hospital and say 'What technologies
do we have?' The pharmacy department could print a list of the formulary, usually
about 2000 drugs, and you could look through that list and know what is
available. In terms of devices and medical/surgical procedures, it would be
rare that a single individual or source would have knowledge of that institution's
capabilities. You would have to go to 20 - 30 different departments and talk to
numerous clinicians before a true picture of the institution's technology inventory
So how do US hospitals evaluate new technology today? Randomly, financially
on a pure return of investment, or is it a political process? Often in AMCs a
new medical technology is used as a recruitment tool, and when the new clinician
decides to leave, the institution is left with a technology that no other clinician
has an interest in using. Surgical robotic systems, specialty transplant
programs, and advanced imaging modalities are examples with high investment
costs with dubious clinical and financial returns.
HTA in the US is a sporadic and uncoordinated activity performed by various
public/private and non-profit/for profit organizations for varying motives. The
complex - and most would say inefficient - nature of the US health system is
only recently embracing HTA concepts of evidence based medicine, comparative
effectiveness, and systematic reviews as a basis for efficient and rational
decision-making. Who will lead and how will the system change is very much
open to debate. Western European countries have a considerable lead on dealing
with the issues of access, quality, and cost of population health, and many
Latin American countries seem to be in a position to reap the benefits of formal
HTA in providing the health services to their populations in an equitable