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and the personalization of the patient’s entire experience. Trends in healthcare tech-
nology are pointing towards a future in which it will be possible to have a hub-and-
spoke design, whereby a central hub will be the anchor point for a number of
different surgical procedures that can then be performed at nearby or faraway hos-
pitals. It is possible that the same might occur for abdominal wall surgery. A highly
specialized, interdisciplinary team could operate out of a command center, with
monitors and equipment capable of providing real-time imaging and vital signs; this
command unit could then guide other teams who, in turn, have prepared their
patients, and who will be able to request specic support as their own surgical pro-
cedure unfolds.
Thirdly, the evolution mentioned above is part of another trend towards patient
care networks, which in many countries is regulated by PDTA (Diagnostic and
Therapeutic Healthcare Protocols). These protocols organize patient care and
healthcare services into networks. Except for emergencies caused by physical
trauma or other unpredictable events, the effectiveness and appropriateness of oper-
ations—including abdominal wall surgery—depend on the logical organization of
the following phases:
• Ability to anticipate needs (very early or early diagnosis phase);
• Scheduling of operations with adequate preparation of patients, in a way that
considers the complexity of the health situation and the availability of the best
materials to use;
• Performance of the surgical procedure;
• Establishment of a postoperative care program that includes follow-up visits and
lifestyle recommendations which facilitate a quick recovery and prevent compli-
cations and/or recurrences.
Needless to say, these phases necessarily involve various facilities and profes-
sionals, who all must be coordinated. And, that coordination depends on access to
complete information all along the chain, which is why it makes sense to work as a
network.
Fourthly, this evolution in healthcare models towards PDTA, patient care net-
works and hub-and-spoke networks means that funding systems for healthcare pro-
viders must be revised as well. Indeed, DRG-type systems focus on individual
procedures and services (in this case, surgery) with the goal of improving efciency
and productivity, reducing the costs of individual services, and possibly stimulating
constructive competition among providers. Nonetheless, when the focus shifts from
the service/procedure to a coordinated chain of events, optimizing the efciency and
costs of each individual phase in the process does not mean that the efciency and
costs of the process as a whole will be optimized; the same goes for patient out-
comes, which must be the main priority. For example, suppose that the DRG of a
complex abdominal wall procedure for incisional hernias calls for a reimbursement
of about 5000 euros, which means that the latest generation of meshes cannot be
used because they cost too much; and suppose that not using those meshes leads to
recurrences or complications in 30% of cases, each of which results in an additional
E. Borgonovi and D. P. Greco
233
cost of about 2000 euros (hypothesis of 4days of hospitalization for complications
with an average cost of 500 euros a day); the total cost for the healthcare system in
this case would be 5600 euros (5000+2000×0.30). Thus, if there were a funding/
reimbursement system in place that was connected to the entire process and lower
than 5600 euros, and which reduced recurrences/complications, it would not only
be more cost effective, but also more satisfactory for those 30% of patients and
caregiver who would no longer have additional health problems. This means mov-
ing from current funding models—which operate as if they were in silos or “pipe
organs”, with no communication between them—to a comprehensive funding sys-
tem connected to the process, the outcomes (pay for performance) and the value
generated (value-based funding).
Fifthly, evolutions in technology, healthcare models and funding models mean
that the relationship between sustainability and personalization/Taylorization of
healthcare needs to be re-examined. There is no doubt that personalized, precision
healthcare in general, and surgery in particular, would become economically unsus-
tainable if the overall approach towards patients was not re-examined. Indeed, the
benets of standardization in terms of productivity and unit costs are lost in person-
alization/Taylorization. The experience is generally the same in all industries:
bringing the service to the customer and personalizing it are ways of charging higher
prices. Technically speaking, it is said that personalization/Taylorization increases
real or perceived value in the eyes of the customer, who is then willing to pay a
higher price. However, a national health service is rooted in principles of universal-
ity, solidarity and equity, meaning that any increase in “health value” that may
derive from the personalization/Taylorization of care cannot lead to a higher price
for the patient. After all, there is no price when the system is funded through taxes.
Therefore, an increase in value for patients must be achieved by reorganizing the
entire healthcare system in a way that reduces overall costs. And, that cost reduction
must be the result of the savings obtained by greater appropriateness in care, elimi-
nating complications and recurrences, and, as mentioned above, organizing health-
care within a network so as to eliminate phases that do not generate value for the
patient. Indeed, an organizational change is needed, but it can be achieved by chang-
ing the culture of doctors, nurses, other healthcare professionals, managers and
those in charge of funding on a regional and national level. The goal of achieving a
sustainable healthcare system will have to be pursued within a more general welfare
system that—contrary to the past—will no longer be able to rely on an increase in
resources, but rather on the best use of stable or diminishing resources.
For what concerns the future sustainability of the healthcare system, it must be
underlined that people affected by diseases need to receive effective treatments and
therapies that give them the best opportunity for health. However, the resources
available may be limited and must be appropriately allocated based on the princi-
ples of cost-effectiveness. This requires a revision and an update of the health tech-
nology assessment (HTA) process, which was initiated about 40 years ago in
response to the uncontrolled diffusion of expensive healthcare technologies. It
started out as a multidisciplinary evaluation process, with the aim of establishing
itself as a tool to support cost-effective decision-making when allocating economic
21 Ferrying totheFuture
234
resources. The process is indeed multifaceted because the impact of technology
should be evaluated from clinical, economic, ethical, social and organizational
points of view.
In Europe, the rst institutions dedicated to the evaluation of healthcare tech-
nologies were established in France and Spain in the early 1980s and in Sweden in
1987. During the following decade, HTA programs were established in almost all
European countries. Since the second half of the 1980s, European and international
networks have been developed to share and compare results and experiences
between countries. Starting from the late 1990s, there have been signicant changes
especially in terms of efforts to coordinate the activities related to HTA among the
various European Union member countries. The international drive to harmonize
methods for assessing healthcare technologies derived from the goal to guarantee
greater transparency and stability in evaluation systems.
At the beginning of 2018, the European Commission presented a proposal to
promote cooperation between the EU member states on health technology assess-
ment. The proposal for a regulation—which would cover new drugs and medical
devices—lays the foundation for permanent and sustainable cooperation at the EU
level on joint clinical evaluations in these sectors. Member states will be able to use
common tools, methodologies and procedures for health technology assessment
across the EU. In particular, considering the context of abdominal wall surgery,
member states will be in a position to perform joint clinical assessments focusing on
the most innovative materials and surgical techniques with the most signicant
impact on patients, in order to choose the most appropriate technology for the indi-
vidual patient according to a “tailored surgery” approach. The responsibility for the
assessment of non-clinical (e.g. economic, social and ethical) aspects of health tech-
nologies and of pricing and reimbursement decisions will continue to be referred to
individual EU countries. The proposal will now be discussed in the European
Parliament and the Council of Ministers. The Commission expects that, once it has
been adopted and entered into force, it will be applicable after three years. From the
date of application, a further three-year period is foreseen to allow member states to
adapt gradually to the new system.
While the European Commission is promoting the cooperation of EU members
on HTA activities, on the other hand there is the need to produce clinical and eco-
nomic data to sustain these activities. Evidence on the effectiveness of drugs or
medical devices to inform HTA submissions has conventionally been derived from
randomized controlled trials. However, due to patient randomization and inclusion
and exclusion criteria, extrapolating efcacy to effectiveness in clinical practice is
very challenging. Real-world data (RWD), dened as data gathered outside the con-
text of randomized controlled trials, may be another opportunity to inform cost-
effectiveness estimates of new or existing drugs or medical devices in clinical
practice. RWD can be derived from numerous sources, including registries, obser-
vational studies and case report forms. RWD, which in general consider non-
randomized treatment allocation, longer patient follow-ups and broader patient
populations, may provide a more generalizable representation of treatment effects
in clinical practice. As regards abdominal wall surgery, outcome data on all patients
E. Borgonovi and D. P. Greco
235
undergoing hernia surgery procedures should be collected in a prospective manner
through registries/databases consistent with patient privacy and condentiality reg-
ulations. This process has a twofold aim: to perform cost-effectiveness and budget
impact analyses using economic data at a local level, and to evaluate surgeons and
centers according to the pre-specied criteria for abdominal wall surgery certica-
tion. The certication of surgeons and clinical centers is of great importance to
guarantee high quality in surgery. This is particularly important for hernia surgery,
which is one of the most commonly performed surgical procedures in the world,
because improvements in materials (prostheses, and xation materials) and surgical
techniques mean that the decisions to be made in the management of every single
patient are more complex. At present, only Germany has a detailed program in place
for the certication of hernia centers, while other countries have no uniform way of
classifying hernia surgery units. All centers performing hernia surgery should face
up to this challenge and become certied. To this end, hernia societies worldwide
should implement certication programs to ensure high-quality standards in
surgery.
Essentially, good quality care in abdominal wall surgery requires safe and appro-
priate: surgical procedures, materials and waiting time. The correct choice of the
biocompatible material can prevent recurrences or other complications such as neu-
ralgia or sinus tract. However, appropriateness alone does not mean that the patient
will perceive the care as necessary or preferred. High-quality medical care should
ensure that every procedure or treatment also meets the patient’s objectives for care.
It is so very important to involve patients in what becomes a shared decision- making
process. In the future, reforms should focus on the improvement of medical care
while also taking into account the preferences of patients.
Last but not least, some key questions must be answered: is it possible to design
and decide on three- or four-year plans in an environment that is continuously and
rapidly changing? Indeed, “Moore’s law” implies that every eighteen months the
innovation process doubles in potential or halves costs. Once again, the answer is
that “disruptive innovation” can be faced with a “disruptive cultural approach”. In
the past, three-to-ve-year plans were dened with the intention of implementing
them. Nowadays, and in the future, three-to-ve-year plans should be designed with
the certainty that they will not be respected or implemented. On the contrary, they
should be designed with the goal of imagining possible scenarios in a way that bet-
ter prepares all involved to adopt solutions day by day, week by week and month by
month in response to a given technological, organizational, social, political, institu-
tional and economic context.
21 Ferrying totheFuture