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HTA in the Czech Republic: Still Behind

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  • Institute of Health Economics and Technology Assessment (iHETA)
Conference Paper

HTA in the Czech Republic: Still Behind

Abstract

The paper analyses the current state of HTA implementation and organisational initiatives in the Czech Republic. Although there have been some substantial ele-ments of HTA applied in the decision process of pharmaceutical reimbursement since 2008, HTA methods are rather disregarded in other technologies. Since there is practically no demand for HTA studies from payers and state representa-tives, HTA has been cultivated above all by interested individuals and small aca-demic research groups around them. These groups have succeeded in keeping pace with the global development both in theoretical and practical issues (among others in HTA methods for medical devices), however, the practical production of country specific HTA studies is rather rare. The main problem is non-existence of a national commonly accepted methodology and a legal framework. At least two attempts to establish a regular HTA process initiated by the Ministry of Health were destined to fail due to frequent personal changes in the Ministry. We discuss topical issues to be solved on the way to a national HTA system, and present our vision of a possible solution.
HTA in the Czech Republic: Still Behind
Vladimír Rogalewicz, Ivana Kubátová, Gleb Donin, TomášDoležal,
Klára Lamblová, Jana Bartáková, and Peter Kneppo
Abstract
The paper analyses the current state of HTA implemen-
tation and organisational initiatives in the Czech Repub-
lic. Although there have been some substantial elements
of HTA applied in the decision process of pharmaceutical
reimbursement since 2008, HTA methods are rather
disregarded in other technologies. Since there is practi-
cally no demand for HTA studies from payers and state
representatives, HTA has been cultivated above all by
interested individuals and small academic research groups
around them. These groups have succeeded in keeping
pace with the global development both in theoretical and
practical issues (among others in HTA methods for
medical devices), however, the practical production of
country specic HTA studies is rather rare. The main
problem is non-existence of a national commonly
accepted methodology and a legal framework. At least
two attempts to establish a regular HTA process initiated
by the Ministry of Health were destined to fail due to
frequent personal changes in the Ministry. We discuss
topical issues to be solved on the way to a national HTA
system, and present our vision of a possible solution.
Keywords
HTA Czech Republic Current state
1 Introduction
Health Technology Assessment (HTA) was suggested in
1970s to cope with the problem of a conict between sources
and demands in healthcare. It comprises a number of
methods for assessing safety, effectiveness, appropriateness
and costs of health technologies, i.e. pharmaceuticals,
devices, materials, diagnostic and therapeutic procedures,
preventive measures, and/or organizational and managerial
measures. Next to that, it addresses also unintended conse-
quences of technologies on social, ethical, legal, political
and organizational issues. Latest since the 1990s, HTA has
been used as a decision-supporting tool in most of the
developed countries.
In the Czech environment, rst information about HTA
appeared relatively late. Two articles in the journal Praktický
lékařin 2002 and 2003 [1,2] were probably the rst
information about HTA in the Czech Republic, while the
paper by Žaloudník et al. [3] can be considered the rst
serious attempt to introduce HTA to the country. In 2008,
Dlouhýet al. published a review paper [4] expressing their
opinion that The neglect of HTA in the past might be
excused by the fact that the main issue was a jump to catch
up with the West in the elds we had been lagging behind.
() At present, many national [healthcare] facilities are top
level. () Hence, the slow development of HTA in the
Czech Republic cannot be excused any more.Ten years
later the situation does not seem to have changed much. The
only exception is the drug reimbursement regulation. This
paper will address the current state of HTA in the Czech
Republic and try to name the reasons for its unsatisfactory
situation, giving some accent to medical devices.
2 Drug Pricing and Reimbursement
A concentrated effort of some HTA popularizers including
one of the authors (T.D.) mirrored in the 2008 amendment to
the Act No. 48/1997 Coll. on Public Health Insurance that
prescribes some fragments of HTA for drug pricing and
reimbursement proceedings. In order a (new) drug was listed
for reimbursement from the public health insurance (that
covers about 80% of all healthcare payments in the country),
the applicant (typically a pharma company) has to present a
V. Rogalewicz (&)I. KubátováG. Donin P. Kneppo
CzechHTA, Faculty of Biomedical Engineering, Czech Technical
University in Prague, Prague, Czech Republic
e-mail: rogalewicz@fbmi.cvut.cz
T. Doležal K. LamblováJ. Bartáková
iHETA, Prague, Czech Republic
©Springer Nature Singapore Pte Ltd. 2019
L. Lhotska et al. (eds.), World Congress on Medical Physics and Biomedical Engineering 2018,
IFMBE Proceedings 68/2, https://doi.org/10.1007/978-981-10-9038-7_18
101
cost utility analysis and a budget impact analysis to the State
Institute of Drug Control (SÚKL) that is the responsible state
authority. However, at the beginning there was no generally
accepted methodology for preparation of these analyses as
well as for their content.
The situation was reected by the Czech Pharmacoeco-
nomic Society that drafted and published guidelines for
health-economic evaluations [5]. However, the Society does
not represent the whole Czech HTA community, and their
guidelines serve as an optional tool. Despite of some effort to
cover all technologies, it is modeled above all for pharma-
ceuticals. The SÚKL also produced their recommendations
for cost-effectiveness analyses (published in 2013 and
amended in 2017) [6]. The rules implemented by the SÚKL
have been changing over the years; at present, the required
documents and the transparency of the procedure approach a
true HTA process, at least as concerns its economic side.
However, organizational, social and other issues considered
by multidisciplinary HTA analyses are not taken into
account by the Institute. There is no separation of the
appraisal, approval and decision phases within the SÚKL, at
least in their organizational structure. Since the SÚKL is a
governmental body with decision-making powers, acting as
a HTA agency would bring them into a conict of interests.
While the process is at least partly covered by the SÚKL
for drugs, there is no formal HTA procedure for any other
technologies incl. medical devices, diagnostic and thera-
peutic interventions, preventive measures, or organizational
measures.
3 Attempts to Implement HTA Processes
and Establish an Agency
In the time of the above described legislative activity, there
denitely was a community of experts (above all in the
academic sphere) in the Czech Republic, who had an interest
in promoting and disseminating methods and ndings of
evidence-based medicine and HTA. Such a group and their
common belief is probably the decisive factor in reaching
their political goals [7]. Löblovásuggests that One of the
crucial beliefs of an HTA community would be healthcare
technologies that offer an unfavorable cost-benet ratio
should not be reimbursed (unless there are overriding con-
cerns), and that this ratio should be established by a thor-
ough scientic multidisciplinary analysis[7]. Nobody of
that community expected that the legal requirements incor-
porated in the Act No. 48/1997 Coll. in 2007 would be their
last success for a long time.
It has not been a period without any HTA initiative. The
health ministers Jurásková, Heger, Holcát and Němeček
were interested in HTA and started some initiatives. How-
ever, due to different reasons their time in the ofce was
limited to full the whole process of HTA institutionaliza-
tion, while also each of them had a different inkling of what
HTA is. The most promising project was started by the
Ministry of Health in 2012. EU pressure was one of the
impulses: Article 15 of the EU Cross-Border Healthcare
Directive (2011/24/EU) set up a network of national HTA
bodies, which meant the Czech Republic needed to decide
on an institution to represent it in the new network. Several
organizational setups were considered throughout 20123,
and some formal materials were drafted by an external group
supported by a ministerial grant [810]. However, the gov-
ernment fell in June 2013, no nished materials were pub-
lished, and the successors in the ofce preferred other
solutions. There were two other smaller ministerial initia-
tives in 2010 and 2015. The result of that of 2010 was a
research grant focused on HTA for medical devices [11]. In
2015, a tender for HTA implementation was managed by the
Ministry; although the winning consortium was announced,
the funding was actually never provided. Thus, all attempts
to establish a regular HTA process initiated by the Ministry
of Health were destined to fail due to frequent personal
changes in the Ministry.
4 Medical Devices
Application of HTA methods for medical devices appeared
to be a real challenge. While some therapeutic devices can
be assessed within the whole intervention, diagnostic devi-
ces have posed many problems [1214]. These are usually
relatively expensive technologies with multiple applications,
and thus they require the perspective of a hospital or a region
as a whole. The CzechHTA group backed by biomedical
engineers from the Czech Technical University in Prague
have focused on HTA methods for devices for last 10 years.
The main goal of HTA studies for devices is not to optimize
the cost-effectiveness ratio, but to support the
decision-making process about procurement and/or incor-
poration of the device. The clinical benet is not expressed
in terms of life expectancy and/or quality of life, but rather in
the rate of diagnostic yield. This requires application of
multiple-criteria decision analysis (MCDA), often in a
combination with value engineering methods [11,15,16].
Despite of partial results, some problems have not been
decided yet, including the choice of a suitable MCDA
method [16], or the selection of the expert group [17].
Next to that, the group studied general conditions for
device assessment [13,18], pricing and procurement prob-
lems [11,1820], and assessment of devices in a hospital
[14,21,22]. Thus, the Czech HTA community has suc-
ceeded in keeping pace with the European development in
HTA for medical devices that appeared in the spotlight of
the cost-effectiveness and HTA research [2329].
102 V. Rogalewicz et al.
5 Discussion
Despite of the effort of some individuals, the institutional-
ization of HTA stays behind the global (and European)
development. What is missing is a legal framework and a
generally respected authority that would coordinate activi-
ties, issue guidelines, as well as approve HTA studies so that
they could not be called in question without evidence. The
capacity problem that has been often mentioned in this
context is probably not relevant any more. HTA methods are
taught within study programs at the Faculty of Biomedical
Engineering of Czech Technical University in Kladno
(several hundred master level graduates), and also to some
extent at the Pharmaceutical Faculty of Charles University
and the Medical Faculty of Masaryk University in Brno.
Although requiring some more training and international
experience, these graduates are able to work in the HTA eld
immediately.
Löblová[30] recently studied the history of HTA insti-
tutionalization in the Czech Republic and showed that the
Czech academic (she calls it epistemic) community was
prepared to inuence establishing a HTA agency and pro-
cesses in the same (or even higher) measure as in Poland,
where they were successful. She proposes a hypothesis that
the result was affected above all by external random events
like economic crises, geopolitical developments or political
scandals, in the Czech case primarily by the frequent chan-
ges in the government (government fall, changes in the
position of the minister).
In our opinion, HTA has never been supported enough by
the stakeholders, and the academic community has not been
strong enough to put it through. In another paper, Löblová
[9] studied the roles of individual actors. Even if her results
are interesting, we would like to complete them with our
observations. Although many complain, the Czech health-
care system is more or less working with respect to the
delivery of accessible care. Any change (and an introduction
of HTA would be a rather heavy change) represents a danger
for many actors. The bureaucracy would lose a part of their
power, the public health insurance companies (belonging to
the bureaucracy) would at least have more responsibility and
hence more work (at present they redistribute the premium,
while the rules are decided by the Ministry of Health).
Healthcare providers (hospitals) are afraid of a violation of a
fragile nancial balance, being accommodated to the status
quo. Also clinicians are interested above all in reimburse-
ment, when the older ones do not believe in economic
methods. However, some of the younger generation (espe-
cially from university hospitals and other facilities involved
in research) are interested in economic consequences of the
methods they propose. Patient organizations are weak in the
Czech Republic, and the existing ones are afraid of a worse
access of patients to expensive healthcare. The general
public has been frightened that any new administrative
barrier would make the current extremely liberal healthcare
system less patient-friendly putting obstacles to the acces-
sibility of some care. The current adoptive system with a low
level of transparency might also become less open to new
technologies. In reality, we have a two-tier system, hardly
permissive for new drugs on the one hand, and open but
orderless and static for non-pharmaceutical technologies on
the other. As concerns industry, the situation differs in the
pharma industry and the medical device industry. The for-
mer support the institutionalization of HTA as a way to
equalizing the conditions, the later consider HTA for another
administrative barrier, and mostly oppose it. Thus, the
political consensus to introduce HTA methods into the
Czech healthcare system at the national level is missing
(except for the existing requirements in drug reimbursement
proceedings). Let us remark that a quite different situation is
at the hospital level. The interest in the hospital-based HTA
has been growing, especially in the area of medical device
procurement and in hospital process adjustment.
On the other hand, the academic (epistemic) community
is prepared for an establishment of a national HTA system.
In our opinion, what is most important is the legal frame-
work and a general agreement on common guidelines sup-
ported by a kind of their ofcial acknowledgement. No new
super-ofce is necessary; Czech Republic can follow the
model of one or more small (light) HTA bodies. Until the
health insurance ofces manage the healthcare (and not only
distribute the collected premium money), the government
should support the newly established HTA bodies by com-
missioning some studies and by encouraging other authori-
ties to order some analyses for their own purposes. On the
other hand, it may be some disappointment that HTA studies
do not bring nal solutions, but only provide
decision-makers with further evidence; decisions are a
purely political issue and should take into account all
dimensions of the problem (which is contained in a good
HTA study, though).
6 Conclusion
The HTA landscape is not a tabula rasa in the Czech
Republic. There is a visible (academic) community sup-
porting it, and most healthcare actors are generally informed,
although they have sometimes unrealistic believes and
expectations. What is missing is a demand for HTA studies
to support decisions at the national level. Completed
Czech HTA studies have been rare if any until now; nev-
ertheless, there are numerous results of partial studies
available (and sometimes even applied in practice). The
HTA in the Czech Republic: Still Behind 103
institutionalization will probably depend on the political will
of future governments. The Czech Republic is not alone
disregarding HTA methods or results. The situation is sim-
ilar in most European post-communist countries [7]. An
introduction of a transparent HTA process would not prob-
ably bring any decrease in costs, but would support the
quality of the healthcare and its adaptation to up-to-date
medicine.
Conict of Interests The authors declare no conict of interests.
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Objectives: Health Technology Assessment (HTA) of Medical devices (MDs) and MD-based procedures can be challenging due to the unique features and particularities of this group of technologies, such as device-operator interaction. The aim of this study was to (1) clarify, and supplement earlier findings on European HTA institutions' structural, procedural and methodological characteristics with regard to the assessment of MDs and to (2) capture the institutions' perceptions regarding challenges and future trends. Methods: Semi-structured telephone interviews with 16 representatives from leading European HTA institutions were performed between April and July 2015. Summative and directed content analysis was used for the analysis, which is reported according to the COREQ checklist. Results: Findings from the analysis of the interviews were manifold and partially confirmed what has been noted in the literature (e.g. scarce evidence; identifying relevant studies challenging due to more incremental innovations). Additional themes emerged that can be important for future considerations by HTA institutions and policy-makers alike (e.g. areas for future research; need for specific tools). Conclusions: The collective opinion of 16 European HTA institutions on MD evaluation could provide ideas to ameliorate the current regulatory situation beyond the modified EU regulation and start broader, more in-depth methodological discussions around the issue. Interviewed experts seem to agree that new approaches such as coverage with evidence development as some countries already introduced could help to overcome the problem with scarce evidence.
Chapter
The next generation human-computer interaction requires, a close-to-real, virtual reality environment and a more sensitive real-time brain states monitoring to account for instantaneous human thoughts and feelings. Within this goal area, workload evaluation of human subject is extraordinary critical to both safety and security of risk-sensitive domains, including flight operations and mission success. In this paper, we present a non-intrusive workload assessment framework by real-time processing of continuous EEG signals measured from “pilots” during flight operations. Our framework has been experimented on a 2D computer screen based flight simulation platform (MATB-II, Revised Multi-Attribute Task Battery) and a virtual reality-based realistic flight simulator. This novel framework has the potential of reducing task overloads and improving performance in risk-sensitive domains.
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In the past two decades, setting up independent health technology assessment (HTA) agencies has become a popular tool to inform reimbursement decision-making in health care, spreading from Northern European countries across Western Europe but much less so to post-communist countries. Structural political science explanations leave gaps in clarifying this diffusion pattern. This paper proposes a theoretical model focusing on the influence of domestic epistemic communities mitigating policy diffusion. Based on a review of HTA institutions in the EU, it proposes a chronological taxonomy of HTA agencies in Europe (the forerunners, the mainstreamers and the non-adopters) and asks why there is such an important East-West divide. The paper discusses theoretical explanations from different literatures, finding unsatisfactory many traditional political science answers such as the degree of centralization of a country's health system, its financial organization (Bismarckian or Beveridgian), the attitude toward independent regulatory bodies in general, the influence of international actors, or lack of resources. Finally, it suggests cases for empirical testing of the domestic epistemic communities model.