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VALUE IN HEALTH 21 (2018) 1069–1076
Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/jval
Comparative-Effectiveness Research/HTA
Physicians’ Decision Making on Adoption of New
Technologies and Role of Coverage with Evidence Development:
A Qualitative Study
Susanne Felgner, MSc*, Patricia Ex, Dr. P.H., Cornelia Henschke, Dr. rer. oec.
Department of Health Care Management, Technische Universität Berlin, Berlin, Germany
AB STR A CT
Objectives: To foster value-based pricing and coverage with evidence
development in Germany, certain new diagnostic and treatment
methods have been subject to a benefit assessment since 2016 to
determine their reimbursement. Although this is a paradigm shift, the
German approach is limited to some few specific technologies for
which reimbursement is requested. As physicians encounter this
regulatory instrument, the aim of the study was to understand
physicians’ decision making regarding the adoption of new medical
technologies and to identify their perspectives on the evidence base
and financing with additional reimbursement systems. Methods:
From April to August 2017, semistructured interviews with chief and
senior physicians of vascular surgery and cardiology in inpatient care
in Germany were conducted (N ¼ 23). The interviews were carried out
by one researcher in one-to-one appointments or via telephone. Data
were analyzed inductively to identify factors and generate thematic
categories using qualitative content analysis. Results: We identified
52 factors in eight categories influencing physicians’ adoption of new
technologies. The evidence base for new technologies was criticized
(e.g., lack of available studies). Physicians’ knowledge of the regulation
of market approval and innovation payments varied. They recommended the utilization of new technologies in certain specialist
centers and the facilitation of observational studies. Conclusions:
Physicians saw the need for the new approach and supported its aim.
However, its design and implementation appeared to be questionable
from their medical perspective. The provision of summarized information on the benefit of technologies might be a possibility to assist
physicians’ decision making.
Keywords: adoption of technologies, coverage with evidence
development, evidence, innovation, inpatient care, physician.
Introduction
and decide, sometimes within teams, whether to adopt a new
technology or to use established alternatives. A variety of studies
have investigated factors influencing physicians’ decision making. Several quantitative studies have evaluated the influence of
hospital characteristics [6,7], external factors (e.g., financing
systems and reimbursement) [8,9], and technology-related factors of particular technologies [10,11]. Qualitative studies have
highlighted that adoption decisions are based on financial and
social pressures, while evidence is often limited [12,13]. Different
dimensions to categorize factors influencing decision making
have been developed, broadly differentiating among adopterspecific, technology-related, and external factors [14–18]. However, most of these studies used previously developed categories
and fill the existing ones, which may undermine relevant aspects
that do not fit into the model used.
In particular, the trade-off between time of adoption and
evidence base is highly relevant for physicians with regard to
When new medical technologies enter the market, their time of
adoption is a key point in patient care, as evidence and experience regarding their utilization often differ in their extent [1].
With the aim of maximizing patient benefit and reducing risks
[2], many new technologies can lead to better outcomes in
patients’ treatment and diagnosis; however, there might be
uncertainty regarding their effectiveness and risks because at
the time of market approval only little or no evidence may be
available [3,4]. Thus, the adoption and utilization of new technologies is necessary to gather knowledge and real-world evidence. This is the case for medical devices, especially in the
European Union, where requirements to obtain market approval
are generally lower than, for instance, in the United States [5].
Regarding new technologies used in inpatient care, the primary adopters are physicians, as they assess treatment options
Copyright & 2018, ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc.
The study was realized by using a 1st shared authorship of Susanne Felgner and Patricia Ex.
* Address correspondence to: Susanne Felgner, Department of Health Care Management, Technische Universität Berlin, Straße des 17.
Juni 135, H80, 10623 Berlin, Germany.
E-mail: susanne.felgner@tu-berlin.de
1098-3015$36.00 – see front matter Copyright & 2018, ISPOR–The Professional Society for Health Economics and Outcomes Research.
Published by Elsevier Inc.
https://doi.org/10.1016/j.jval.2018.03.006
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VALUE IN HEALTH 21 (2018) 1069–1076
technology adoption decisions but also for health care systems. In
light of limited resources and high health expenditures, a large
share of which is spent on technologies, health care systems and
payers are under pressure to control their expenditures [19]. Many
countries therefore have introduced schemes to reimburse only
those new technologies that have shown benefit. The main idea is
to link the coverage decision and price setting for a technology to
its value [4]. Owing to the often low level of available evidence on
the effectiveness of new technologies, the approach of coverage with
evidence development (CED) has been developed, in which a technology is covered by health insurers while further post-market evidence
is obligatorily generated. This approach was originally implemented
for Medicare in the United States [20] and has been adapted in France
[21], Germany [22], Sweden, and the Netherlands [23], among other
countries. Although these CED approaches exhibit common elements (e.g., clear legal foundation and preference for high-quality
study designs), their specific features depend on the underlying
health system in each country. Differences exist with regard to the
types of technologies being assessed (i.e., drugs, procedures, or
medical devices) [22]. Compared to those in other countries, the
German approach, introduced in 2016, is based on an early benefit
assessment (§137h in combination with §137e Social Code Book V
[SGB V]) of a particular group of medical devices. Furthermore, the
approach has been linked to the concept of inpatient innovation
payments (see Methods for detailed information), and is a further
step in a paradigm shift for the medical device industry, patient care,
and inpatient physicians adopting these technologies.
As no international literature is available on the German health
policy reform and its relevance for clinical practice, we aimed to fill
this gap. Accordingly, the term “new technologies” in this article
refers to medical devices as well as diagnostic and treatment
methods, but excludes pharmaceuticals. The aim of this study was,
first, to describe the German CED scheme to gain a more in-depth
insight into the decision making of physicians adopting new technologies, and, second, to explore physicians’ perspectives on the
trade-off between evidence base and reimbursement of new technologies. Our research has been led by two research questions:
I. How do physicians describe their decision criteria for adopting a new technology in patient care?
II. What experiences and constructive remarks do physicians
have regarding the evidence base and financing of new
technologies?
Methods
Brief Overview of 2016 German CED Reform
The aim of this study and, consequently, the development of the
interview questionnaire focused on the German health policy
reform of the CED; thus, the approach will be introduced in this
section, clarifying why the reform especially affects physicians
(e.g., responsibility to provide further information on a medical
device or its exclusion from reimbursement).
Before 2016, approved new technologies could generally be used
in German inpatient care without a prior external assessment
(§137c SGB V). In 2012, the CED was first introduced for diagnostic
and therapeutic methods (§137e SGB V), for which the German
Federal Joint Committee (G-BA) had passed a directive for
the conduction of clinical trials to gather additional data on
effectiveness and safety [22]. The reform of 2016 focuses on new
diagnostic and therapeutic methods whose technical application
is based essentially on a medical device of high-risk class
(i.e., “high-risk medical device”). According to the SGB V,
“high-risk medical devices” are (1) medical devices of risk class IIb
or III in line with the Directive 93/42/EEC or active implantable
medical devices in line with the Directive 90/385/EEC,1 whose (2)
application possesses a highly invasive character. “New diagnostic
and therapeutic methods” are thereby defined as medical procedures using a new theoretical and scientific concept. The term
“method” involves procedures in terms of a “physician-led treatment concept” characterized by a certain degree of complexity.
These are thus different from other medical devices, such as
medical instruments or appliances, that are used for one-step
procedures [24]. The underlying new theoretical and scientific
concept of the method has to differentiate it from others [24]; that
is, according to §137h SGB V, the new method’s mode of action or
its field of application needs to differ substantially from systematic
approaches already used in inpatient care. An example of a method
that was considered for assessment so far is coronary lithoplasty for
the treatment of coronary heart disease (CHD). This is different
from, for example, rotablation, which is utilized in the treatment of
CHD using another mode of action for coronary plaque ablation [25].
Figure 1 provides a schematic overview of the new CED approach
[26]. The starting point of an early benefit assessment is the
hospitals’ first application on innovation payments for new
technologies, so-called New Diagnostic and Treatment Methods.
Innovation payments are separate from the system of diagnosisrelated groups (DRGs) in that they involve additional funding
(i.e., are paid on a fee-for-service basis) and are negotiated locally
[27,28]. The benefit assessment of a method leads to one of the
following results: (1) sufficient proof of benefit, (2) no sufficient proof
but potential of benefit, or (3) no sufficient proof of benefit. According to the Institute for Quality and Efficiency in Health Care (IQWiG),
“benefit” is defined as valid positive effects of methods concerning
patient-related end points (e.g., mortality, morbidity, or patient’s
quality of life) compared to placebo or comparator interventions [29].
Study Design and Participants
As the complexity of adoption processes is well known [17], we
applied qualitative content analysis to adequately examine this
organizational phenomenon [30]. This study was approved by the
ethical committee of the Technische Universität Berlin via a fast
track procedure. We collected data using in-depth semistructured
interviews, enabling us to ask additional context-driven questions [31]. The questionnaire covered the following subject areas:
(I) factors influencing physicians’ decisions to adopt new technologies, (IIa) physicians’ assessment of the evidence base, and
(IIb) physicians’ assessment of the concept of innovation payments in clinical practice. With the aim of testing the comprehensibility and appropriateness of the questions, a pilot test was
conducted with two physicians [32]. The interviews of the pilot
study were not included in the analysis.
To identify medical disciplines where a variety of new and
higher priced technologies compared to standard technologies are
used, the lists of requested innovation payments in Germany
(2011–2015) were screened. As a result, we conducted all interviews in the disciplines of vascular surgery and cardiology or other
designated areas, also carrying out interventions in those fields,
for example, internal medicine. We identified all relevant inpatient hospitals in the city of Berlin and the federal state of
Brandenburg, limiting the regional area for the following reasons:
(1) keeping the area of investigation at a small size permits having
all physicians interviewed by the same researcher, preventing bias
resulting from different researchers [33]; (2) Berlin, as a populous
city with a high hospital density, and Brandenburg, consisting of
suburban and rural regions, offer a variety in hospital sizes and
1
As of May 25, 2017 the new Medical Device Regulation (MDR)
came into force. Regulation (EU) 2017/745 will replace the directives concerning medical devices and active implantable devices
after a transitional period of 3 years.
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VALUE IN HEALTH 21 (2018) 1069–1076
Deadline 31 October
2 weeks
4 weeks
12 weeks
1. Evidence provides sufficient
proof of benefit
G-BA
All requirements for benefit assessment
need to be fulfilled:
Hospital request on
innovation payments
regarding the new
method¹ to the InEK and
transfer of information²
to the G-BA.
Public call for
• Innovation payment is requested for the first time.
• Method is largely based on the utilisation of a ‘high-risk MD‘
Risk class IIb or
risk class III or
active implantable
and
highly
invasive
character.
Yes
• hospitals intending
to use the method
and
No
• manufacturers
Legend:
Decision of the G-BA
Optional involvement of the IQWiG
Request/ decision
Information
¹ first-time request of ‘high-risk MD‘
² on the best available scientific knowledge and use
Assessment of the
method’s benefit, harm
and potential.
to deliver further
information² on MD.
Method is authorised for
utilisation.
•
Agreement on innovation
payments within 12 weeks.
•
Quality requirements necessary?
2. Evidence does not provide
sufficient proof of benefit, but
shows potential
•
Decision on coverage with
evidence development
(§137e Social Code Book V).
•
Hospitals intending to use the
method are required to
participate in the study.
IQWiG
• and has a new theoretical and scientific concept.
Return to standard procedure of innovation payments: negotiate
payment with sickness funds if InEK determines that it is not
yet covered by DRGs (Status 1).
G-BA
•
Notification of the InEK
until 31 January which
methods qualify for
innovation payments.
3. Evidence does not provide
sufficient proof of benefit
•
Method is excluded from the
benefit basket.
Acronyms:
DRG – Diagnosis Related Group
G-BA – Federal Joint Committee
InEK – Institute for the Hospital Remuneration System
IQWiG – Institute for Quality and Efficiency in Health Care
MD – Medical device
Fig. 1 – Benefit assessment of methods with ‘high-risk medical devices’ in German inpatient care [26]; IQWiG, Institute for
Quality and Efficiency in Health Care; MD, medical device.
provider types [34,35]. The recruitment process took place from
March to July 2017, and 170 physicians were contacted. The overall
response rate was about 20% (N ¼ 33). However, 10 physicians
declined the invitation because of lack of time or interest.
The semistructured interviews were conducted in one-to-one
appointments or via telephone from April to August 2017 and
were audiotaped. After the 23 interviews were conducted, no
fundamentally new information or arguments emerged. This
indicated that the point of saturation had been reached [36];
thus, no further physicians were recruited.
Data Editing and Analysis
The recordings were transcribed verbatim by an external office and
the transcripts were anonymized by two researchers. With the aim
to prevent information processing bias and ensure a systematic
analysis of qualitative data, we used the analytical software tool
Atlas.ti (version 8.0) for coding [37]. All relevant text passages were
coded separately by two researchers who directly derived code titles
from the text data [38]. Two rounds of analysis were conducted. A
first set of codes was developed based on a discussion with the
option of adding or amending codes for further analysis. To
harmonize the analysis, the final results were compared after the
second round to reach consensus [39]. In case of disagreement, a
neutral researcher was consulted and the codes were discussed. To
answer the first research question, all codes representing factors
influencing physicians’ decision making were pooled in thematic
categories using the bottom-up-approach [40]. To answer the
second research question, codes were systematically ordered.
Results
The data set consisted of 23 in-depth semistructured interviews
with chief and senior physicians of vascular surgery and cardiology in inpatient care that lasted between 11 and 33 minutes. The
interviewed physicians had practiced for an average of 24.7 years
and 8.6 years in their current position. Their departments had a
mean of 50.5 beds. Table 1 provides an overview of physicians’
characteristics, departments, and hospitals.
Factors Influencing Physicians’ Decisions to Adopt New
Technologies
In the interviews, we identified a total of 52 individual factors that
physicians described as influencing their decision to adopt a new
technology. We grouped these influencing factors into eight thematic
categories: 1) technology, 2) evidence base, 3) state of medical care, 4)
manufacturer, 5) regulation, 6) hospital (including its institutional
characteristics and strategy), 7) individual, and 8) patient. Figure 2
displays these categories including the influencing factors.
Technology-related factors included the handling of a medical
device by physicians, its durability and extent of improvement,
and whether it reduced the invasiveness of a treatment. Owing to
the diversity of technologies, the comparison of a single characteristic was not possible, forcing physicians to make an overall
assessment considering a variety of aspects. Physicians also
assessed the evidence base when deciding whether or not to adopt
a technology. They were aware of a limited evidence base for
medical devices after their market authorization, in particular in
the European Union. However, physicians viewed this as an
opportunity to carefully adopt a technology in a hospital setting.
They also reported that this might nevertheless lead to an
excessive proliferation of new technologies. Physicians criticized
that available studies were often based on a very small patient
cohort and were biased by manufacturer interests.
Furthermore, physicians’ decision to use new technologies
was influenced by the state of medical care. Interviewees assessed
the level of care in their discipline as excellent with regard to the
quality and availability of options. Thus, they set high standards
for new technologies to compete against established methods. On
the contrary, if few or no alternatives existed for an indication,
such as rare diseases, physicians were willing to utilize certain
new technologies despite lacking evidence. Nonetheless, overall,
they mentioned guidelines as an important point of reference.
Manufacturer-related aspects were identified as a further factor
influencing physicians’ decisions to adopt new technologies. They
described the influence of manufacturers’ sales activities, ranging
from no interaction to using interactions as basically the only source
of information, and criticized the focus on marketing activities.
Furthermore, physicians considered the service provided by manufacturers in their decision making. Another factor mentioned was
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VALUE IN HEALTH 21 (2018) 1069–1076
Table 1 – Characteristics of 23 interviewed physicians (n=21 hospitals).
Variable
Physician level
Position
Years in practice
Years in position
Sex
Department level
Medical discipline
Number of beds in department
Patients’ financial situation*
Hospital level
Number of hospitals†
From which
University hospitals‡
Specialist centers‡
Specification
N
%
Chief physician
Senior physician
≤20
21–30
430
≤5
6–10
410
Not specified
Female
Male
Cardiology
Vascular surgery
≤30
31–60
460
Not specified
Rather poor
Average
Well off
—
15
8
7
11
5
10
4
8
1
0
23
13
10
6
8
8
1
6
13
4
21
65
35
30
48
22
43
17
35
4
0
100
57
43
26
35
35
4
26
57
17
100
1
2
5
10
—
—
* Description of patients by physicians.
†
There were two physicians interviewed from the same hospital but different departments.
‡
One physician was interviewed from each of the institutions.
the manufacturer price and cost–benefit ratio, that is, the manufacturer’s pricing strategy for a technology in relation to the expected
benefits. They observed that prices decreased after the initial market
launch, and some reported waiting until prices declined.
In the context of regulation, relationships between different
factors of adoption played a significant role: reimbursement
decisions and price developments were relevant in physicians’
decisions to adopt new technologies. Some physicians mentioned the possibility of using a technology even if they had to
cross-finance it from other DRGs.
Technology
Durability, Extent of improvement,
Handling, Invasiveness,
Overall assessment,
Product generations, Product type
State of medical care
Guidelines, Pre-/ post care,
Status quo, Treatment alternatives
Regulation
Liability, Possibility of reimbursement,
Reimbursement requests at health insurance,
Utilization without reimbursement
Regarding hospital-related factors influencing the adoption decision of new technologies, physicians distinguished between characteristics of the institution, such as size and type of provider, and
strategic decision making of hospitals. Interviewed physicians of
non-university hospitals mentioned that university hospitals and
specialist centers might have more possibilities of refinancing and
thus should adopt new technologies first. They also reported not
having sufficient patient numbers in a certain indication to utilize
new technologies. Strategic aspects of hospitals included internal
processes regarding central purchasing, logistical efforts, and coor-
Evidence base
Benefit and harm, Biased data,
Plausibility, Quality of data,
Study requirements
Physicians’ decision
Patient
Expectations,
Medical compatibility,
Overall health and age
Hospital:
Institutional aspects
Experienced staff, General vs. specialist care,
Hospital size, Number of patients in indication,
Provider, Structural conditions, University status
Strategic aspects
Central purchasing, Debate with CEO/ controlling,
Division of locations, Freedom of choice,
Hospital competition, Increase patient numbers,
Instructions of supervisor, Logistical efforts,
Pressure to be the first, Product portfolio,
Reputation
Manufacturer
Market mechanisms,
Price, Sales activities,
Services
Individual
Familiarity with other technologies,
Medical experiences,
Medical school of thought, Peer group,
Personality and interest, Product type,
Research and career
Note: Size and order of circles as of factors and determinants do not imply a weighting.
Fig. 2 – Factors influencing technologies adoption decision of physicians.
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VALUE IN HEALTH 21 (2018) 1069–1076
Table 2 – Physicians’ statements on factors influencing technologies’ adoption decision (selection of factors
and statements).
Category
Physician
decision
Factor
Evidence base
Quality of data
Hospital
Structural conditions
(institutional aspects)
Individual
Increasing patient numbers
(strategic aspects)
Personality and interest
Manufacturer
Price
Patient
Overall health and age
Regulation
Possibility of
reimbursement
State of medical care
Treatment alternatives
Technology
Handling
Statement
“The experience teaches that many medical devices in the first generation
obviously sound great, include a basic innovation, but the benefit of this
new system is eaten up, not only by the exorbitant costs, but also by
complications, which then question the benefit again.” (no. 2)
“…the larger the hospital, the more responsive the hospital is with regard to
new technologies. However, there are hospitals of public ownership
exhibiting a dormant status. Not that much happens there…” (no. 14)
“…With this product, we will acquire new patients and improve the
physicians’ work. This is of course a good argument…” (no. 17)
“…Well, a positive consequence for me is that I receive more patients and
more interesting patients. Because I have a service mission for about 90
percent, these are the basic care treatments, I always call it the ‘breadand-butter-business’. But 10 percent are issues that are interesting, they
are fun, they bring color into life. And I want more of these…” (no. 18)
“…If an existing technology has the same therapeutic effect and the new
technology is considerably more expensive, then you have to weigh in
how far the new technology really has an added value justifying the
price…” (no. 23)
“…If I can spare someone a surgery with a certain new device, then this is
something I would not do with a 30-year old person, but I would do it with
a really old patient, whose life expectancy is by far more limited and
whose risks for surgery are much higher…” (no. 3)
“…DRGs are a quasi-downward spiral as they are constantly revised. There
is only one direction, namely the downward direction. This makes it more
difficult for all involved actors […] leading to enormous cost pressures for
hospitals. […] This is far away from medical treatment, medical ethos,
and patient care. It leads to the fact that the provision of patient
treatment is only a secondary product of earning money…” (no. 9)
“Well, in the field of cardiology, treatment alternatives that we can use these
days are good, in any way. And we do not have the need, from my
perspective, to urgently take a risk because standard therapy would not be
satisfying. There is no thought about that at any point.” (no. 5)
“…when the handling is impractical. That is one factor, when you would not
want to use the product…” (no. 6)
Note: Number of interviewee is added at the end of each quotation in brackets.
dination with administrative colleagues. In addition, strategic
hospital decisions such as increasing patient numbers and quality
in patient care played a role in physicians’ decisions to adopt
new technologies, as well as reputation and patient satisfaction.
Physicians also mentioned that they did not feel under pressure to
be the first to adopt a new technology. Instead, they would wait for
other clinicians to utilize the technology first, so as to adopt it at a
later stage when more experience had been acquired.
Regarding individual-related factors, physicians reported their
interest in something new and extraordinary as a driver to utilize
new technologies, which was closely related to their personalities.
Their careers and urge to publish articles, however, also constituted
motivations that physicians assessed as a dominating incentive at
times. On the other hand, being familiar with a certain product
could set a barrier to using new technologies.
Regarding patient-related factors affecting the decision to adopt
new technologies, physicians mentioned patients’ overall health
and the compatibility of the new technology with individual
patients. Whereas some physicians stated that they utilized new
technologies primarily with young patients, others reported the
opposite. Besides, some physicians were also willing to consider
patient preferences for a certain technology, even in the context of
implantable devices, while others were not willing to do so. A
selection of physicians’ statements on the determinants of the
decision to adopt new technologies is listed in Table 2.
Physicians’ Experiences and Remarks Regarding Evidence
Base and Financing of New Technologies
With regard to the second research question, physicians overall
mentioned a trade-off between early adoption and the possibility
to utilize innovative technologies, in particular in the case of new
technologies without treatment alternatives. They criticized the
fact that the evidence base at the point of market entry was scarce.
Therefore, they sometimes preferred to wait for additional evidence. Physicians complained that some new technologies were
financed too early through innovation payments. Moreover, they
reported that the process of requesting and receiving an innovation payment was too complicated and inflexible. Table 3 provides
an overview of physicians’ experiences and remarks. Statements
about the evidence base at the time of adoption were divided into
comments regarding market authorization, utilization, and study
situation. Physicians’ experiences and expectations about innovation payments were divided into issues regarding the new technology, process of requesting and negotiating additional
payments, and effects of this financing system.
Discussion
This study provides detailed information on factors determining
the adoption of new technologies from clinicians’ point of view.
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Table 3 – Overview of physicians’ experiences and remarks.
Variable
Remark/ criticism
Evidence base at the time of adoption
Market
Ensuring product variety
authorization
Suggestion of diversified
approval
Requirements for approval
Adoption and
utilisation
Broad diffusion despite lack
of evidence
No treatment alternatives
Long-term effects
Study situation
Study availability
Study design
Generating further evidence
Risk information letter
Innovation payments
Technology
Insufficient evidence and
outdated technologies
Process of
applying and
negotiating
Effects of
financing
Complicated and inflexible
Nontransparent
reimbursement criteria
Negotiations differ
regionally
No sufficient coverage of
additional expenses
Wrong economic incentives
Statement
“I experienced many developments and saw the USA at the same time. I saw that due to
the faster implementation of evolutionary steps, we always had much nicer and better
designed products, while the Americans, even worse the Japanese, had to use those old
things, which we had not used in the last eight, nine years.” (no. 3)
“What I think is missing in the field of innovative medical devices in Germany is a tiered
system of the approval. The initial barrier of new devices that do not have market
approval is too high. That is why we lose these companies and therefore benefits for
the German market.” (no. 14)
“It’s different here than for example the regulation in the United States through the FDA.
There, you first have to show that your new product is better than existing alternatives,
before being allowed to use it.” (no. 13)
“The [procedure] was a sensation [...] but the results were based on small pilot studies
only, so the evidence was limited. Several colleagues used the procedure that was easy
to perform and, without a doubt, might have had a certain placebo effect on people. But
finally, the long-term study could not show any proven benefit.” (no. 2)
“Regarding technologies for rare indications, where no evidence exists due to the low
number of diagnoses or illnesses… This probably exists more often than we would like.
But I still believe that this technology is the best we have, even if I cannot prove it.”
(no. 18)
“It usually takes a long time until you know for sure what a specific medical device is able
to accomplish.” (no. 14)
“We experience that a manufacturer publishes three main results, e.g. “somewhat
superior regarding mortality”, and it can take a long time until the entire study is
available […] I think that’s really bad.” (no. 5)
“Some of the conducted studies really leave much to be desired. Sometimes it is just not
acceptable. There are medical devices with participants of 20, 30, 50, 60 people. How
can you possibly assess whether it really makes sense or not. That’s challenging.”
(no. 10)
“University hospitals should utilise more technologies within trials, to clarify whether
that’s really suitable for the patient. […] And these hurdles of post-market control. […]
It should be designed in a way that if an innovative product comes to the market, one
would have to do a respective observational study in the next phase.” (no. 10)
“Something important such a ‘red hand letter’ does not exist from my knowledge for
medical devices. There have been a few safety alerts, but a comprehensive system, as it
is the case for pharmaceuticals, does not exist.” (no. 2)
“Funny system. It’s outdated and once something is reimbursed, even if it’s nonsense,
they just continue paying it. In cardiology, I still see innovation payments for
technologies where everyone knows that they are worthless. But, no one is doing
anything.” (no. 3)
“You can only request innovation payments until 31st of October, but you cannot say
‘well, I apply for it in January for the running year.’ […] I think that’s impractical.” (no. 6)
“The procedure, in particular the selection criteria, which diagnostic and treatment
procedures might be reimbursed and which not, is not-transparently I have to say.”
(no. 7)
“There are different forms of negotiating an innovation payment. Here in province 1, it is
completely different from my previous experiences in province 2.” (no. 9)
“The approved requests for innovation payments are in few cases really revenuerelevant. The procedure is overall good, but its implementation is deficient.” (no. 13)
“One should really control that it is impossible for hospitals with an urgent need for
financial means that they take this chance to improve their financial situation.” (no. 7)
Note: Number of interviewee is added at the end of each quotation in brackets.
The lack of evidence of individual values and attitudes of local
innovators was previously highlighted by Varabyova [18]. In
addition, Hatz et al. [17] concluded in their analysis of adoption
decisions that the behavior of physicians differed according to
the length of time that a cardiovascular medical device had been
on the market; they thus differentiated between “new” and “old”
medical technologies. We contributed to the research on adoption of new technologies by addressing these differences and the
research gap, and in addition investigated the role of innovation
payments in combination with the introduction of a new regulatory approach for high-risk medical devices in Germany.
Our in-depth analysis of physicians’ decision making in relation to the adoption of new technologies generated eight thematic
categories. These categories are similar to the categories of
influencing factors in German inpatient care identified in previous
studies [14–18]. The category regulation can be seen to refer to
VALUE IN HEALTH 21 (2018) 1069–1076
previously defined structural, contextual, and environmental factors [14–18]. Organizational factors described in the literature
[14,16–18] are presented in our study as hospital-related factors,
split into institutional and strategic factors. A particularity in health
care is the structure of demand, as physicians use technologies in
patient care but the patient is actually the end user. Thus, we
decided to split adopter-specific factors into (1) the individual
category, including factors of the physicians themselves, and (2)
the patient category, covering patient-relevant adoption factors.
Lastly, our results comprise typical technology-related factors.
Moreover, new thematic categories were identified. Further
categories need to be defined supplementing the existing dimensions based on previous research. First, for the physicians in our
study, the state of medical care played an important role in adopting
decisions, that is, availability of alternative treatments, existence
of different technology generations, availability of a follow-up
treatment for certain technologies, and so forth. Most previous
studies did not consider these factors. The same holds true for
activities of the manufacturer, which have been described in the
present study, but rarely in previous studies examining physicians’ adoption behavior. Hatz et al. [17] showed that perceived
support from the manufacturer was associated with a higher
probability of adoption for the group of “new” technologies [17].
Our results show that physicians expected a high service availability, while taking a critical view on studies because of possible
influences of manufacturers. High service availability might
improve device–operator interactions, as it generates learning
curve effects by increasing operators’ experience in the utilization
of technologies. Learning curve effects might affect the technologies’ effectiveness [41], as shown by Varabyova et al. [42] for
endovascular aneurysm repair (EVAR), a minimally invasive treatment method for abdominal aortic aneurysms. This emphasizes
the need for training in the use of medical devices. In addition,
physicians discussed the available evidence extensively. Hatz
et al. [17] did not identify perceived medical evidence as a major
driver of adoption. However, our results showed that the evidence
base, depending on the availability of treatment alternatives, was
a factor influencing adoption decisions. The interviewed physicians assessed studies and its evidence independently. However,
they also stated that the manufacturer served as the basis for
decision making. As evidence base did not fit properly into any of
the defined categories, we established it as an extra category.
Indeed, physicians considered available evidence as an important issue influencing their decision. Our results indicated that
physicians perceived the evidence base at the time of market
entry to be scarce. In this context, the interviewed physicians
criticized the overall lack of studies, the small number of patients
in approval studies, and the supposed influence of manufacturers
on studies. Furthermore, they noted a lack of studies investigating the effectiveness of new technologies compared to their
alternatives, highlighting that such studies are not required for
medical devices in the European Union. They viewed additional
benefits as a relevant indicator, as in their experience, many
technologies provided some minor improvements while generating several complications and overall uncertainty. Regarding the
financing of new technologies, the interviewed physicians had
the power within the hospital to choose the product and manufacturer they preferred, even if it was more expensive than the
calculated costs in the reimbursed rates. Nonetheless, physicians
felt a personal responsibility to support the economic well-being
of the hospital or the goal of breaking even. Therefore, clinicians
tried to act within the scope of the DRGs. This supports the
notion that the diffusion of new technologies is steered by their
reimbursement.
Owing to scarce evidence and the requirement of additional
reimbursement, the physicians supported the aim and objectives
of the health policy reform. However, the design of the approach
1075
and its implementation were criticized. With regard to medical
decision making based on effectiveness evidence, this regulatory
instrument will fall short. Additional evidence may be gathered
only for a small group of technologies with the following
prerequisites: (1) hospitals’ first request for innovation payment,
(2) defined as “high-risk medical device”, (3) with an underlying
“new theoretical and scientific concept,” and (4) status of “potential.” Many technologies do not fall under this approach as it is
currently designed (e.g., high-risk technologies without requests
for innovation payments).
Although this study allowed a unique insight into physicians’
perspectives using a qualitative approach, some limitations need
to be acknowledged [43]. Besides the researchers’ individual
conclusions of the analysis, our study results might not be
representative of all physicians [44,45]. In addition, conducting
telephone interviews has disadvantages compared to an appointment in person (e.g., lack of interaction between interviewer and
participant) [46]. Carrying out telephone interviews, however, has
also shown some advantages (e.g., high response rate, low costs)
[47]. Furthermore, we interviewed chief and senior physicians
only, who were professionals with a certain hierarchical and thus
experience level. As years of medical practice were found to be
negatively associated with the adoption of new technologies
[48,49], clinicians in other positions should also be considered
in further research. Overall, as the present analysis was based on
23 interviews to identify a wide range of factors influencing
physicians’ adoption decisions, further quantitative studies are
necessary to investigate factors according to their relevance in
adoption decisions and their relations.
Conclusions
This study provides an in-depth understanding of factors influencing the decision of clinicians to adopt new technologies. We
identified 52 factors grouped in eight thematic categories, depicting the overall trade-off that physicians have to manage in
adoption decisions. The interviewed physicians supported the
general notion of conducting benefit assessments and, if necessary, generating additional evidence. However, they criticized the
design and implementation of the German CED approach. They
appreciated improvements in receiving summarized information.
Therefore, a further step and challenge for policymakers and
payers could be to bring together country-specific evidence on the
effectiveness of new technologies at the European level to build a
transnational overarching database. The central provision of
summarized evidence might assist physicians in their decision
to use new technologies. Overall, the results of the 23 interviews
based on qualitative content analysis should be verified via
quantitative studies in future research to investigate factors
according to their relevance in adoption decisions and their
relations in more detail.
Acknowledgments
We are grateful to the clinicians who took part in the interviews
free at charge. We appreciate their time and valuable answers.
This study was funded through the Berlin Centre for Health
Economics Research by the German Federal Ministry of Education
and Research (grant no. 01EH1604A). P Ex holds a Cusanuswerk
scholarship to conduct research for her doctorate.
Supplemental Materials
Supplementary data associated with this article can be found in
the online version at https://doi.org/10.1016/j.jval.2018.03.006.
1076
VALUE IN HEALTH 21 (2018) 1069–1076
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