A short Curriculum Vitae of
the author Dr. Zikopoulos Athanasios |
Comments on the published paper |
Dr. Zikopoulos Athanasios
The author discloses
that there were no sources of funding used to assist in the preparation of the
manuscript apart from his personal involvement.
Dr. Athanasios
Zikopoulos is General Manager of the Mundipharma Medical Company,
To investigate
the knowledge and usage of economic evaluations in different groups of
decision-makers, and to compare the results from Switzerland with the overall
European results of the European Network on Methodology and Application of
Economic Evaluation Techniques (EUROMET) project a survey with hospital
pharmacists, regulators and members of health insurance companies in
Switzerland (n=50) was conducted.
71% of
the decision-makers responded to the survey. They generally are very positive
to economic evaluations and 9 out of 10 respondents want the influence of
cost/economic aspects on the medical practice to be bigger than it is at the
moment. A higher proportion of the Swiss respondents in comparison with other
European countries received further education or training in health economics
and had made use of an economic evaluation study in decision processes. The
problem of sponsorship bias turned out to be the major barrier to the use of
economic evaluation studies in
The very
positive attitude of the Swiss decision-makers towards economic evaluations
could be encouraged by further education or training in health economics and by
methodological improvements to increase the reliability of economic evaluation
studies.
In the
light of cost-containment efforts in the Swiss healthcare system, the pressure
to base decision-making for reimbursement or purchasing of pharmaceutical
products on systematic and thorough evaluation is increasing.
Reimbursement
is the dominant component of the success or failure of a marketed
pharmaceutical and therefore the requirement for pharmacoeconomic data in order
to attain reimbursement constitutes an additional barrier to product launch. Pharmacoeconomics relates to the determination
of a drug's cost effectiveness in addition to clinical effectiveness. It is
often described as a 4th hurdle to the extent that cost effectiveness is used
as an explicit criterion for a drug's admission to the market in addition to
safety, efficacy, and quality.
The
Medical Technology Unit of the Federal Social Insurance Office Switzerland
(ELK) is providing informal guidelines for the economic evaluation of medical
services to determine reimbursement: (i) costs and consequential costs should
be calculated on patient basis, (ii) if available always refer to the gold
standard and (iii) give an estimate of the impact on Switzerland (7), (8).
There exist no precise specifications in terms of methodology to be used. The
Drug Commission Unit of the Federal Social Insurance Office Switzerland (EAK)
does not provide written recommendations for a drug application but refers to
the guidelines of the Medical Technology Unit.
Given the
growing activity in the field of health economics and the encouragement of
decision-makers to consider the results of those studies, very little is known
about the influence of economic evaluation studies on health care
decision-making (9). Only two studies, both in the UK, have surveyed
decision-makers rather than health economic researchers: Drummond et al. (10)
sent a postal questionnaire survey to pharmacists and directors of public
health services; and Duthie et al. (11) used interviews on the relevance of a
number of diverse health economic measures. Their general conclusion was that
the impact of economic studies was limited. However, little was known about
other European countries other than the
In an
attempt to provide some answers to these questions some initiatives have been
developed by 9 European countries that are part of the EU (
For the survey the standard
questionnaire of eight questions that was developed by the EUROMET project
group (13) translated into German and French was used. Questions include issues
about participation in health economic courses, knowledge of economic
evaluation techniques and where the participants obtained information about the
costs and effectiveness of health care interventions. They were also asked
about the extent to which economic considerations should apply and the ethical
consequences as well as barriers and incentives in the use of health economic
studies. Questions on the professional background of the participants and 2
other questions (“What do you personally understand under health economic
studies?” “Should the influence of economic and cost aspects be bigger, smaller
or stay as it is?”) were added to the
standard questionnaire. In the question of the potential barriers for the use
of economic evaluations the factor “Economic studies are not needed nor
required in my country” was replaced by the factor “The prices of innovative
drugs are so high in the meantime that also health economic studies can hardly
justify these prices”. In the question, which deals with factors that might
encourage the use of health economic studies a supplemental factor “Construction
and content of the studies must correspond with accepted guidelines” was
added to be assessed by the respondents.
In February 2003, questionnaires
were sent out to 72 decision-makers in
A total of 51 decision-makers
responded to the survey (response rate 71%). The questionnaire was filled in
fairly completely by all decision-makers.
2.2.1 Professional background and
activities
All participants had an academic
education and most of them had a degree in pharmacy (78%). More than half of
the respondents (30, 59%) were members of a hospital-pharmacy-commission, 7
(14%) were additionally members of the Swiss Pharmaceutical Commission (EAK)
and 5 (10%) were members of a health insurance company. Nine decision-makers
did not specify their professional activity or did not respond to the question.
57% were active in a public, 22% in a private and 10% in a charitable
institution/organization (1 non-respondent).
36 respondents (71%) received further education or training in
health economics. Only 5 attended a course with a formal degree. Most of them
(27) received further education on the job.
All members of health insurance
companies and 86% of the members of the EAK indicated receiving further education
or training in health economics compared with 67% of the members of
hospital-pharmacy-commissions.
The results of the question “How
good are you acquainted with the following methods of health economic
evaluation?” are listed in table 1. Respondents were asked to rate their
knowledge on a four-point scale, on which the far left option was labelled “not
at all” (value= 1) and the far right option was labelled “very good” (value=
4).
28% of the participants indicated to
have very good knowledge of cost-benefit-analysis, whereas only 14% and 10%
indicated this for cost-effectiveness-analysis and cost-utility-analysis,
respectively. Decision-makers with further education or training in health
economics clearly indicated to have better knowledge of all of the methods,
being most obvious regarding cost-utility-analysis.
2.2.3 Actual use of economic
evaluations
The participants were asked if
they had ever made use of the results of a cost-benefit, a cost-effectiveness
or a cost-utility analysis in order to take decisions regarding the launch, the
use or the financing of a drug or therapy. 33 respondents (65%) indicated yes.
This group consisted of 26 participants with further (in total 36, 72%) and 7
participants with no further education or training in health economics (in
total 15, 47%).
Most of the studies have been taken
from the literature (61%), others from the provider of the therapy (15%) or
have been carried out by the respondent himself (9%).
2.2.4 Attitudes toward economic
evaluations
The questionnaire included the
question “What do you personally understand under health economic studies?”.
The answers are listed in table 2:
The respondents were also asked if
economic aspects should influence the medical practice. All of them gave a
favourable opinion. 75% of the participants with further education and 60% of
the participants with no further education in health economics indicated this
influence should be strong or very strong. 90% wanted the influence to be
bigger than it is at the moment.
Ethical considerations and conflicts
have been addressed with the question “Are you of the opinion, that it is
ethically defensible, to renounce the launch or financing of a new drug or a
new therapy on the basis of economic arguments?”. 57% of the decision-makers
considered it to some extent and 29% ethical without restriction, whereas 8%
felt that it is unethical.
2.2.5 Potential barriers and
incentives for the use of economic evaluations
All participants were asked to
fill in two figures in which potential barriers and potential incentives
respectively for the use of economic evaluations were listed. Respondents were
asked to rate the importance of these barriers and incentives on a five-point
scale, on which the far-left option was labelled “not at all” (value=1) and the
far-right option was labelled “very important” (value=5). The graded responses
were scored from 1 to 5 and the mean response for all individuals calculated.
These were then ranked. Participants could also add other barriers/incentives
they felt were missing in the list. The results of the questions are listed in table
3
There were no evident differences
between the responses of the hospital pharmacists, the regulators and the
members of health insurance companies in
The questionnaire contained one
group of questions designed mainly to investigate the participants’ knowledge
of pharmacoeconomics, and another group that was concerned mainly with
attitudes.
In
The knowledge of the methods of
health economic evaluation is higher in
As in other European countries it
seems typical to get information from several sources: both scientific journals
and reports/working papers are the most important source of information. Articles
from general medical scientific journals (e.g. BMJ, Lancet,
Krankenhauspharmazie, Prescrire) are mentioned as well as specialist journals
(e.g. Pharmacoeconomics).
Many more Swiss respondents (65%)
than the European average had ever made use of an economic evaluation in
decision processes. This even exceeded the percentages in
The expression “health economic
studies” was expected to be familiar to the respondents due to its use in
various documents and in everyday context. However, the expression is not
always used in a precise and consistent manner, and by asking the respondents
what they associated with the term, their understanding and knowledge of the
expression could be tested. Not unexpectedly, a rather large percentage of the
decision-makers associated health economic studies with methods for
cost-containment in the health service (35%), an understanding not
corresponding to the theoretical basis of socioeconomic evaluation of
pharmaceuticals.
The decision-makers in
29% of the participants think it is
ethical to refuse to adopt or to finance a new treatment on economic grounds.
The majority of the British and Spanish decision-makers and a quarter of the
German decision-makers also do not see ethical conflicts whereas only 2% of the
Portuguese physicians take this view (Hoffmann and Schulenburg, 2000). Most of
the Swiss decision-makers (57%) do not want to adopt a clear attitude and state
that the refusing on economic grounds is only acceptable in some cases.
The five most important obstacles in
the better use of health economic study results are on the whole the same in
The Swiss decision-makers ranked the
newly added factor that “the prices of innovative drugs are so high in the
meantime that also health economic studies can hardly justify these prices”
second.
Methodological issues seem to play a
major role in decision-makers objection to health economic studies. One
decision-maker added that economics is a “soft science“. Mainly participants
with further education or training stressed the fact that “economic studies are
based on too many assumptions”. Just as relevant turned out to be the factor
“the savings traced in economic studies describe expectations, but are no
realistic values”. A respondent had the opinion that the evaluation studies are
often not enough differentiated.
Less frequently mentioned barriers
relate to the problems of implementing study results because of inflexibilities
in health care budgets, i.e. “it is difficult to transfer financial resources
from one sector (budgets) into others” and “budgets are allocated so scarcely
that no resources for the admission of new treatment methods can be provided”,
the first being more frequently mentioned by participants with and the latter
by participants without further education or training. These factors turned out
to be much more relevant in other European countries.
For decision-makers with no further
education or training in health economics, the factor “economic studies are
complicated and difficult to understand” is a very important barrier for the
use of economic evaluations.
It is encouraging to find that the
idea that “cost containment is more important than cost-effectiveness” is not
perceived as a major barrier (ranked 8th). Interestingly, more
participants with further education or training in health economics were of
this opinion.
The opinion about factors
encouraging a greater use of economic evaluation study results was much more
homogenous. The factor “improved comparability of studies (e.g. through the
employment of standardized measures)” has scored highest on the list. This is
in line with the high importance of the added incentive factor “construction
and content of the studies must correspond with accepted guidelines”. This
factor was also considered important by Austrian and German decision-makers who
gave this factor rank three on the list of possible incentives (9).
The respondents strongly wished to
have easier access to studies (e.g. through publications in renowned
magazines). Moreover, the results show that the decision-makers interviewed
acknowledged their knowledge gap in economic evaluation techniques and
consequently, factors which might improve their methodological abilities were
given high priority: “more training in health economics” and “more extensive
explanations of the practical relevance of the results of the studies (e.g.
actual cost savings)” turned up on ranks three and four. There was very little
difference regarding these factors between participants with or without further
education or training in health economics.
Not as relevant as in other European
countries (e.g.
“Legal regulations for the use of
economic evaluation” and “the direct usefulness for my department or me” are
not considered to be important incentives in
One participant added that a clear
social debate on the ethical choices and their economic consequences could
favour a greater use of economic evaluation study results.
The
relative value of the different elements of a pharmaceutical - efficacy,
scientific validity and credibility of studies, unit cost, results of economic
analysis etc, - in the decision process of listing or not listing have, is not
systematically known. But a new study from
Decision-makers in
Some barriers to the use of
pharmacoeconomic information may be attenuated over time. Although quite a high
proportion of the Swiss decision-makers received further education or training
in health economics, there exists a potential to strengthen the discipline by
further education. Many decision-makers in
Journal editors, as well as managed
care executives, pharmacy directors and members of Pharmacy and Therapeutics
Committees, consistently report concerns over the potential for bias arising
from industry-sponsored research (17). These concerns, whether accurate or not,
manifestly also exist in
1.
Drummond, M., Cooke, J. and Walley, T. Economic
evaluation under managed competition: evidence from the
2. Bradley, K. Cost-effective
healthcare solutions: The strategic impact of pharmacoeconomics in key markets.
3.
McDaid,
D., Cookson, R., and the ASTEC team. Evaluation activity in
4. Cookson, R. The role of industry in
evaluation of health interventions. In: Maynard, A., Cookson, R., McDaid, D.,
Sassi, F. Sheldon, T. and the ASTEC group. Analysis of Scientific and Technical
Evaluation of Health Interventions in the European Union. Final Summary Report.
London/Brussels: 2000, 1-20.
5. Glasziou, P.P., and
Mitchell, A.S. Use of pharmacoeconomic data by regulatory authorities. In: Spilker,
B., editor, Quality of life and pharmacoeconomics in clinical trials, 2nd
edition, Philadelphia (PA): Lippincott-Raven Publishers, 1996: 1141-1147.
6. MacArthur, D. Handbook of
pharmaceutical pricing and reimbursement. Western Europe 2000,
7. Bundesamt für
Sozialversicherung Handbuch zur Standardisierung der medizinischen und
wirtschaftlichen Bewertung medizinischer Leistungen, 2000. (Data Source)
8. Bundesamt für
Sozialversicherung. Supplement Kostenfolgen einer neuen Leistung zum Handbuch
zur Standardisierung der medizinischen und wirtschaftlichen Bewertung
medizinischer Leistungen, Oktober 2002.
9. Hoffmann, C., and
Schulenburg, J.-M. Graf v.d. The use of economic evaluation studies in health
care decision-making – Summary report. In: Schulenburg,
J.-M. Graf v.d., editor. The influence of economic evaluation studies on health
care decision-making. A European survey.
10.
Drummond, M., Cooke, J. and Walley, T. Economic
evaluation under managed competition: evidence from the
11. Duthie, T., Trueman, P., Chancellor,
J. et al. Research into the use of health economics in decision making in the
12.
Zwart-van
Rijkom, J.E.F., et al. Differences
in attitudes, knowledge and use of economic evaluations in decision-making in
the Netherlands. Pharmacoeconomics 2000; 18(2): 149-160.
13. Schulenburg, J.-M. Graf v.d., ed. The influence of economic evaluation
studies on health care decision-making. A European survey.
14. Pausjenssen, A.M., Singer, P.A., and
Detsky, A.S. Ontario’s Formulary Committee How Recommendations Are Made.
Pharmacoeconomics 2003; 21(4): 285-294.
15. Hoffmann, C., et al. Do Health-Care
Decision Makers Find Economic Evaluations Useful? The Findings of Focus Group
Research in
16. Rorvik, E.M., Toverud, E.L., and
Walloe, L. The introduction of pharmacoeconomic analysis in
17. Lyles, A. Decision-makers’ use of
pharmacoeconomics: what does the research tell us? Expert Rev.
Pharmacoeconomics Outcomes Res 2001; 1(2): 133-144.
18. Armstrong, E.P., Abarca, J. and
Grizzle A.J. The role of Pharmacoeconomic Information from the Pharmaceutical
Industry Perspective. Drug Benefit Trends 2001, 13(3), 39-45.
Table
1: How good are you acquainted with the following
methods of health economic evaluation? (Mean scores on a four-point scale)
|
Further education or training in
health economics |
|||||
yes |
No |
total |
||||
|
Mean |
Valid N |
Mean |
Valid N |
Mean |
Valid N |
CEA |
2.8 |
36 |
1.9 |
15 |
2.6 |
51 |
CBA |
3.2 |
36 |
2.3 |
15 |
3.0 |
51 |
CUA |
2.7 |
36 |
1.6 |
15 |
2.4 |
51 |
Table 2: What
do you personally understand under health economic studies?
(multiple responses)
|
Count |
Column Responses % (Base: Count) |
Responses |
Column Responses % (Base: Responses) |
Equivalent estimation of costs, effectiveness and
results |
38 |
74.5% |
38 |
26.4% |
Comparison of therapy alternatives under cost point
of view |
35 |
68.6% |
35 |
24.3% |
Calculation of the impact of new therapies on
expenditures |
28 |
54.9% |
28 |
19.4% |
Demonstration of savings potentials with existing
therapies |
24 |
47.1% |
24 |
16.7% |
Methods for cost-containment in the health service |
18 |
35.3% |
18 |
12.5% |
other |
1 |
2.0% |
1 |
0.7% |
Total |
51 |
282.4% |
144 |
100.0% |
Table
3: Potential barriers and incentives for the use
of economic evaluations by further education or training in health economics
(mean scores on a five-point scale)
|
Further education or training in health
economics |
||
Yes |
No |
Total |
|
Barriers
|
|
||
The sponsoring of economic studies (e.g. through the
industry) distorts the results |
3.5 |
3.4 |
3.5 |
The prices of innovative drugs are so high in the
meantime that also health economic studies can hardly justify these prices |
3.0 |
2.9 |
3.0 |
Economic studies are based on too many assumptions |
3.0 |
2.4 |
2.8 |
The savings traced in economic studies describe
expectations, but are no realistic values |
2.9 |
2.7 |
2.8 |
It is difficult to transfer financial resources from
one sector (budgets) into others |
2.7 |
2.2 |
2.5 |
Economic studies are complicated and difficult to
understand |
2.2 |
2.9 |
2.4 |
Budgets are allocated so scarcely that no resources
for the admission of new treatment methods can be provided |
1.7 |
2.6 |
2.0 |
Cost containment is more important than cost
effectiveness |
1.6 |
1.1 |
1.4 |
Incentives
|
|
||
Improved comparability of studies (e.g. through the
employment of standardized measures) |
3.3 |
3.5 |
3.3 |
Easier access to studies (e.g. through publications
in renowned magazines) |
3.3 |
3.3 |
3.3 |
More training in health economics |
3.2 |
3.3 |
3.3 |
More extensive explanations of the practical relevance
of the results of the studies (e.g. actual cost savings) |
3.2 |
3.1 |
3.2 |
Construction and content of the studies must
correspond with accepted guidelines |
3.2 |
3.1 |
3.1 |
Assessment of studies through a trustworthy expert |
2.8 |
3.1 |
2.9 |
More flexibility with budgets in the health sector
(e.g. transfer of funds from one budget to another one) |
2.7 |
2.1 |
2.5 |
Legal regulations for the use of economic evaluation |
2.5 |
2.1 |
2.4 |
The direct usefulness for myself or my department |
2.3 |
2.2 |
2.2 |
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