ArticlePDF Available

Identifying critical steps towards improved access to innovation in cancer care: a European CanCer Organisation position paper

Authors:

Abstract and Figures

In recent decades cancer care has seen improvements in the speed and accuracy of diagnostic procedures; the effectiveness of surgery, radiation therapy and medical treatments; the power of information technology; and the development of multidisciplinary, specialist-led approaches to care. Such innovations are essential if we are to continue improving the lives of cancer patients across Europe despite financial pressures on our healthcare systems. Investment in innovation must be balanced with the need to ensure the sustainability of healthcare budgets, and all health professionals have a responsibility to help achieve this balance. It requires scrutiny of the way care is delivered; we must be ready to discontinue practices or interventions that are inefficient, and prioritise innovations that may deliver the best outcomes possible for patients within the limits of available resources. Decisions on innovations should take into account their long-term impact on patient outcomes and costs, not just their immediate costs. Adopting a culture of innovation requires a multidisciplinary team approach, with the patient at the centre and an integral part of the team. It must take a whole-system and whole-patient perspective on cancer care and be guided by high-quality real-world data, including outcomes relevant to the patient and actual costs of care; this accurately reflects the impact of any innovation in clinical practice. The European CanCer Organisation is committed to working with its member societies, patient organisations and the cancer community at large to find sustainable ways to identify and integrate the most meaningful innovations into all aspects of cancer care.
Content may be subject to copyright.
Position Paper
Identifying critical steps towards improved access to
innovation in cancer care: a European CanCer
Organisation position paper
Matti Aapro
a,
*, Alain Astier
b
, Riccardo Audisio
c
, Ian Banks
d
,
Pierre Bedossa
e
, Etienne Brain
f
, David Cameron
g
, Paolo Casali
h
,
Arturo Chiti
i
, Leticia De Mattos-Arruda
j
, Daniel Kelly
k
,
Denis Lacombe
l
, Per J. Nilsson
m
, Martine Piccart
n
, Philip Poortmans
o
,
Katrine Riklund
p
, Gunnar Saeter
q
, Martin Schrappe
r
,
Riccardo Soffietti
s
, Luzia Travado
t
, Hein van Poppel
u
, Suzanne Wait
v
,
Peter Naredi
n,
**
a
European School of Oncology (ESO)
b
European Society of Oncology Pharmacy (ESOP)
c
European Society of Surgical Oncology (ESSO)
d
ECCO Patient Advisory Committee (PAC)
e
European Society of Pathology
f
International Society of Geriatric Oncology (SIOG)
g
Breast International Group (BIG)
h
European Society for Medical Oncology (ESMO)
i
European Association of Nuclear Medicine (EANM)
j
Flims Alumni Club (FAC)
k
European Oncology Nursing Society (EONS)
l
European Organisation for Research and Treatment of Cancer (EORTC)
m
European Society of Coloproctology (ESCP)
n
European CanCer Organisation (ECCO)
o
European Society for Radiotherapy and Oncology (ESTRO)
p
European Society of Radiology (ESR)
q
Organisation of European Cancer Institutes (OECI)
r
European Society for Paediatric Oncology (SIOPE)
s
European Association of Neuro-Oncology (EANO)
t
International Psycho-Oncology Society (IPOS)
u
European Association of Urology (EAU)
v
The Health Policy Partnership, London, UK
Received 30 March 2017; accepted 3 April 2017
Available online 7 July 2017
*Corresponding author: ECCO eThe European CanCer Organisation, Avenue E. Mounier 83, B-1200 Brussels, Belgium. Fax: þ32 2 775 02 00.
** Corresponding author: ECCO eThe European CanCer Organisation, Avenue E. Mounier 83, B-1200 Brussels, Belgium. Fax: þ32 2 775 02 00.
E-mail addresses: maapro@genolier.net (M. Aapro), pnaredi@sg.se (P. Naredi).
http://dx.doi.org/10.1016/j.ejca.2017.04.014
0959-8049/ª2017 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://
creativecommons.org/licenses/by-nc-nd/4.0/).
Available online at www.sciencedirect.com
ScienceDirect
journal homepage: www.ejcancer.com
European Journal of Cancer 82 (2017) 193e202
KEYWORDS
Cancer;
Healthcare systems;
Efficiency;
Value;
Patient-relevant
outcomes;
Innovation;
Data collection;
Clinical trial;
Reimbursement
Abstract In recent decades cancer care has seen improvements in the speed and accuracy of
diagnostic procedures; the effectiveness of surgery, radiation therapy and medical treatments;
the power of information technology; and the development of multidisciplinary, specialist-led
approaches to care. Such innovations are essential if we are to continue improving the lives of
cancer patients across Europe despite financial pressures on our healthcare systems. Invest-
ment in innovation must be balanced with the need to ensure the sustainability of healthcare
budgets, and all health professionals have a responsibility to help achieve this balance. It re-
quires scrutiny of the way care is delivered; we must be ready to discontinue practices or in-
terventions that are inefficient, and prioritise innovations that may deliver the best outcomes
possible for patients within the limits of available resources. Decisions on innovations should
take into account their long-term impact on patient outcomes and costs, not just their imme-
diate costs. Adopting a culture of innovation requires a multidisciplinary team approach, with
the patient at the centre and an integral part of the team. It must take a whole-system and
whole-patient perspective on cancer care and be guided by high-quality real-world data,
including outcomes relevant to the patient and actual costs of care; this accurately reflects
the impact of any innovation in clinical practice. The European CanCer Organisation is
committed to working with its member societies, patient organisations and the cancer commu-
nity at large to find sustainable ways to identify and integrate the most meaningful innovations
into all aspects of cancer care.
ª2017 The Authors. Published by Elsevier Ltd. This is an open access article under the CC
BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
1. Introduction
Over the last two to three decades, the field of cancer has
seen improvements in the speed and accuracy of diag-
nostic procedures [1], the effectiveness of surgery [2e4],
radiation therapy [5,6] and medical treatments [7,8] and
the power of information technology [9]. Development
of clinical support rolesdsuch as those of specialist
oncology nurses and of multidisciplinary, specialist-led
approaches to caredhave also played an important
role in improving the care offered to cancer patients.
Investment in all these innovations is critical if we are
to continue to improve the lives of cancer patients across
all age groups in years to come. However, there is
growing evidence of inequalities in, and complex barriers
to access to, many innovations in Europe, as healthcare
systems are increasingly challenging their costs, and out-
of-pocket payments for cancer care are growing [10,11].
Although much of the literature and policy debate
focuses on inequalities in access to anticancer medicines
[12,13], significant inequalities also exist for other as-
pects of cancer care. Within this context, it is critical to
balance investment in innovation with the need to
ensure the sustainability of healthcare budgets, and this
is a global concern [14e16].
In all countries, notions of innovation and value are
intrinsically linked. We need to apply more scrutiny to
the way we deliver care today, be ready to remove or
discontinue practices or interventions that are inefficient,
and be forward-thinking to prioritise innovations that
may deliver the best outcomes possible for patients with
the resources at hand. Implementation of innovations
also needs to follow a structured pathway, and practices
should be adapted to accommodate them. Greater
transparency is needed on prices and pricing policies, as
has been called for by the European Cancer Leagues
Task Force for Equal Access to Cancer Medicines. This
being said, investment decisions on innovations should
consider the long-term impact of innovations on patient
outcomes and costs, not just their immediate costs.
All health professionals have a key responsibility to
help achieve this balance. Within this context, this
article offers a multidisciplinary perspective on how we
can responsibly and sustainably encourage access to the
most meaningful innovations for cancer patients in years
to come whilst improving on existing practice and
decreasing waste and inefficiencies across all aspects of
cancer care. It was developed by the European CanCer
Organisation (ECCO) with input from its member so-
cieties and the ECCO Patient Advisory Committee and
is intended as the basis for future actions to be taken by
relevant health professionals. These actions will be
developed into an action plan in the next few months.
2. How do we define innovation in cancer care?
It may be argued that the term ‘innovation’ has been
over-used in recent years and is usually thought of
simply as ‘something new’ [18,19]. However, ‘newer’ is
not necessarily better than older alternatives, and in
reality what constitutes an innovation is more nuanced.
Innovation can take place within any aspect of cancer
care. It does not have to be complex, or expensive;
simple interventions may often have the greatest impact
on improving patient care. In addition, meaningful
progress often occurs over time, as a result of a series of
M. Aapro et al. / European Journal of Cancer 82 (2017) 193e202194
incremental changes which, if taken in isolation, may
not necessarily be transformative in their own right.
It is also critical to recognise that innovation is an
evolving concept and must keep pace with our growing
understanding of cancer and treatment expectations.
For example, drug development models need to consider
expected patterns of relapse and disease evolution to
make sure that we are providing patients with the most
appropriate course of treatment and not simply making
decisions, one treatment at a time.
A definition of innovation that transcends these
complexities is that it is any intervention within the care
pathway that makes a meaningful difference to patients.
With this definition in mind, member organisations of
ECCO have made suggestions as to what aspects of
cancer care represent the most meaningful innovations
in their view and which practices should be considered
as obsolete as they do not offer benefits to patients (see
Table 1). These suggestions will be discussed and pri-
oritised as a next step in this initiative by ECCO and its
member organisations.
3. How does one measure the value of innovation?
Defining the value of an innovation requires a compre-
hensive assessment of its impact on patient outcomes,
quality of life, quality of care and costs across the
system.
The necessary starting point to the measurement of
value of any innovation is to determine whether it offers
real benefits to patients. Over the past few years, the
European Society for Medical Oncology (ESMO),
American Society of Clinical Oncology, European So-
ciety for Radiotherapy and Oncology (ESTRO) and
other professional societies have called for a more
consistent approach in the evaluation of new treatments
and have proposed new measures aimed at capturing the
real benefit of anticancer medicines and other technol-
ogies [20e22]. For example, ESMO’s Magnitude of
Clinical Benefit Scale (ESMO-MCBS) aims to ‘help
frame the appropriate use of limited public and personal
resources to deliver cost-effective and affordable cancer
care’ [20]. The ESMO-MCBS is an important innovative
instrument but is based solely on data from clinical
trials, without consideration of costs [23]. Other scales
include costs [24], however in Europe these vary from
country to country. The ESMO-MCBS was initially
developed without input from patients [25].
These limitations point to the need to consider the
value of new interventions from the patient’s perspec-
tive, giving adequate weight to quality of life and
progression-free survival, and not only overall survival,
and with input from all stakeholders.
Real-world data (from registries, large databases and
big data initiatives) are part of the continuum of clinical
research. They are key to determining whether benefits
observed in clinical trials are also seen in unselectedpatient
populations in real-world settings and to understanding
the impact of a given innovation on patient outcomes.
Real-world data should also include the full costs of care.
Real-world data are very important for surgical tech-
niques and medical devices, for which typically the data is
much scarcer at the time of regulatory approval than for
medicines. The IDEAL collaboration (Idea, Develop-
ment, Exploration, Assessment, Long-term Follow-up,
Improving the Quality of Research in Surgery) has rec-
ommended that real-world data on the efficacy and safety
of any new surgical procedure [26] or medical device
[27,28] should be collected as soon as it is introduced into
clinical practice, to guide clinical guidelines and improve
the use of these procedures in clinical practice.
Real-world data are particularly critical in the case of
rare adult cancers and paediatric cancers, as small patient
numbers may limit the potential to gather sufficient evi-
dence within traditional clinical trial settings. They are
also a key component of ‘coverage with evidence’ schemes
increasingly being used for new anticancer medicines,
particularly ‘breakthrough innovations’ that are approved
on the basis of early-stage trial data through accelerated
approval schemes. These medicines may be granted pro-
visional reimbursement based on early clinical trial data,
on the condition that this decision is to be reviewed, and
access potentially expanded, at a later timepoint once real-
world data on the impact of this intervention are available.
4. What are barriers to the development and uptake of
innovation?
Barriers may occur at different stages: research and
clinical trials /regulatory approval (European Medi-
cines Agency [EMA] and national) /national and
regional access decisions (health technology assessment
[HTA] or pricing and reimbursement) /uptake into
local practice.
4.1. Research and clinical trials
There are numerous barriers to the development of
innovative medicines, diagnostics and technologies
during the research stage (e.g. in clinical trials), which
contribute to delaying individual patients’ access to in-
novations in areas of high unmet needs. These barriers
delay the generation of meaningful data and knowledge
from clinical research as well as the publication of
research findings, leading to delays in the time it takes
for an innovation to be adopted post-approval into
clinical practice. Barriers in research often result from
the absence of collaboration across disciplines and be-
tween different layers of healthcare provisioning (e.g.
primary care, community oncology care, hospitals and
academic centres), as well as insufficient information
provided to patients and healthcare professionals about
ongoing and completed research. Further barriers exist
M. Aapro et al. / European Journal of Cancer 82 (2017) 193e202 195
Table 1
Defining areas of innovation and obsolescence across the cancer care spectrum.
Aspect of care Areas of innovation Examples of obsolescence
Psycho-oncology
[30]
Routine psychosocial distress screening using validated self-
report measures to identify cancer patients who should be
referred to psychosocial services
Reliance solely on clinician observations or patient requests
to identify cancer patients who should be referred to
psychosocial services
Oncology nursing
[46,47]
Increasing trained oncology nursing services in all European
countries
Lack of appropriate and specific funding for trained
oncology nurses
Supportive care and
rehabilitation
Providing adequate and appropriate supportive treatments
over the entire course of care
Assessing the impact of treatment side-effects (physical,
emotional, cognitive, sexual and nutritional) and develop a
rehabilitation/survivorship plan to address and reduce those
symptoms and problems
Insufficient supportive care leading to worse patient
outcomes
Genetics [7] Improved understanding of predisposition factors and use
of these data to better characterise a tumour’s aetiology and
adapt therapy where supported by evidence
Pathology [1,7,48] Identification of molecular markers of prognostic or
predictive value using various methodologies
Quality control of pathology
Research-based ‘liquid biopsies’ for characterising and
monitoring tumours
Decision-making without use of such tools, when
adequately recognised by scientific evidence
Monitoring [49] Use of advanced imaging techniques to define disease extent
and tailor treatment
Unjustified staging examinations
Unjustified follow-up procedures
Adjuvant treatment
[5,50]
Defining the need for long-term treatment versus shorter
treatments
Development of adjuvant treatments in specific biologically
defined patient subsets
Further exploration of how neo-adjuvant treatment results
could be appropriately used to select adjuvant treatment
and therefore avoid ‘blind’ adjuvant treatments
Studies that are not based on the present understanding of
the biology of various tumour subtypes
Surgery [51e53] Optimisation and standardisation of cancer surgery with
educational programmes and quality assessment e.g.
introduction of total mesorectal excision (TME) in
colorectal cancer surgery
Technological advances: e.g. minimally invasive surgery and
interventional radiology to reduce short- and long-term
negative outcomes
When a new procedure is of proven benefit, make it
accessible and develop centre expertise to ensure its
appropriate use
Surgery performed in multiple low-volume centres with
inadequate demonstration of expertise and quality results
Radiation therapy Development of radiation therapy facilities according to
standards supported by ESTRO, with image-guided
radiation therapy, modulated and adaptive techniques and
specific particle therapy facilities
When a new procedure is of proven benefit, make it
accessible and develop centre expertise to ensure its
appropriate use
Radiation therapy performed in multiple low-volume
centres with inadequate demonstration of expertise and
quality results
Medicines [20] Development of the use of the ESMO evaluation system
(ESMO relative value scale) to prioritise medicines of
greatest benefit to patients
Use of local scoring systems to decide whether or not to
include a given medicine in a formulary
Geriatric oncology
[54]
Screening for frailty and using geriatric assessment to
stratify older populations with cancer and adjust treatment
accordingly
Using civil or chronological age as a threshold for making
strategic decisions related to a patient’s care
Paediatric oncology
[55,56]
(also valid in
adult treatment)
Accelerated and early access to innovative therapies during
their development
Novel immunotherapeutic approaches and medicines
targeting epigenetics
Novel functional and statistical tools to assess objective
response and long-term survival benefit
Standardised assessment of toxicity with emphasis where
possible on patient-reported outcomes
Transparent and obligatory patient-oriented long-term
outcomes assessment
Repeating old and toxic therapies without any attempt to
improve practice based on knowledge of molecular
pathways and their function in different cancers
Use of new therapies based on ‘single-case evidence’, as
opposed to multicentre clinical trialsdas was the case with
haematopoietic stem cell transplantation years ago
M. Aapro et al. / European Journal of Cancer 82 (2017) 193e202196
in access to clinical trials between European countries.
There is also a lack of large pan-European studies rather
than regional or local studies with insufficient power to
answer relevant clinical questions.
4.2. Regulatory approval
Processes to obtain regulatory approval for surgical pro-
cedures, radiation oncology and imaging techniques, and
their introduction into centres, vary considerably across
Europe. As mentioned previously, the evidentiary re-
quirements for these procedures are typically much lower
than for medicines, often leaving it up to individual cli-
nicians to evaluate them over time. The IDEAL frame-
work mentioned previously calls for a much more
transparent, evidence-based system whereby real-world
evidence of the impact of new procedures is collected
prospectively, with the aim of creating an up-to-date
Table 1 (continued )
Aspect of care Areas of innovation Examples of obsolescence
Big data [57,58] Facilitate the exchange of ‘big data’ among different
European countries in order to ameliorate, among other
things, the quality of overall therapy
Perpetuation of siloed, disjointed health information
systems and lack of cohesive solutions across different
settings of care
Registries [59e62] Making cancer registries an obligatory part of Europe-wide
registration of any cancer type
Use of epidemiological data to evaluate different practices
and outcomesdto drive future treatment plans towards the
most effective practices
Lack of such an approachdresulting in perpetuation of
ineffective practices that could have been identified through
appropriate data and research
Care planning
[63,64]
Shaping future services in response to national cancer
experience surveys of people living with cancer
Lack of multidisciplinary decision-making and out-of-date
uni-disciplinary attitudes
Lack of role development opportunities for the cancer
workforce. These are necessary to respond to rising demand
and patient expectations
Professional
education [45]
Knowledge transfer across all relevant disciplines to apply
novel techniques in diagnostics and treatment
Professional education programmes to extend knowledge to
all relevant specialities of:
the principles of risk assessment for acute
complications
the principles of risk assessment for long-term
outcomes and sequelae of treatment
Development of a Europe-wide qualification and
certification system in oncologyde.g. in the form of cross-
border educational programmesdwith transparent
standards for quality assessment
Extending knowledge to all health professionals involved in
cancer care that health education, physical activity and
lifestyle should be implemented to improve cancer care and
quality of life for patients
Clinical research
[43,44]
New models of clinical studies developed in cooperation
with population-based registries
New types of access platforms where single cohort patients
can be benchmarked to contemporary real-life patients
New partnerships between academia/government and
industry to allow
more ‘risky’ treatment arms in the design of registra-
tion trials (such as short exposure to a new drug)
sharing of anonymised individual patient biomarker
and efficacy data from registration trials according to
a predefined timing, thereby allowing data protection
for only a limited period
Regulatory [65] Solutions for efficiently bringing the most promising
therapeutic solutions to patients (e.g. adaptive licencing and
accelerated approval schemes)
Better coordination of European Commission directorates
(DG Sante
´, DG Research and so forth) to enable optimal
access of patients to trials and treatments
Perpetuation of distinct mechanisms and policies within the
European Commission leading to disjointed practices
between the different directorates
Lack of harmonisation of regulatory practices across
Europe, despite EMA centralised procedures, as well as
different evidentiary requirements between countries leading
to slow uptake of innovations
ESTRO ZEuropean Society for Radiotherapyand Oncology; ESMOZEuropean Societyfor Medical Oncology;EMA ZEuropean Medicines Agency.
M. Aapro et al. / European Journal of Cancer 82 (2017) 193e202 197
database to guide more rapid and appropriate evaluation
and uptake of these technologies over time [26e28].
In the field of medicines, significant strides have been
made by regulatory agencies such as the EMA in recent
years to accelerate the approval of potential in-
novations. For example, special allowances for orphan
drugs and piloting of adaptive pathways by the EMA all
allow for greater flexibility in regulatory requirements
and more rapid access to new medicines by patients. The
new EU Clinical Trial Regulation [29]dwhich aims to
reduce some of the bureaucracy in clinical development
programmes by requiring only one application via a
single portal for trials conducted in several member
statesdmay also be an important development. For
paediatric cancers, the EU Paediatric Regulation has
significantly changed the landscape for new drug
development; however, significant unmet needs remain.
4.3. Reimbursement
Reimbursement or funding decisions for different com-
ponents of cancer care are often divided among different
decision bodies, who may base decisions on very
different types of evidence. Different components of
care are also evaluated and reimbursed separately. For
example, targeted therapies, multi-target combinations
thereof, as well as their companion diagnostics or bio-
markers are often not evaluated jointly, and medicines
given in hospital may be evaluated differently from
those given in an outpatient setting. Finally, as has been
mentioned previously, the level of evidence available to
judge the value of medicines, diagnostics, imaging and
surgical techniques may differ considerably, with phy-
sicians often asked to confirm the cost-effectiveness of
medical diagnostics, for example, without necessarily
having adequate training to do so.
A key issue is also that many reimbursement decisions
focus solely on the immediate budget impact of a given
intervention, so that even promising innovations are only
looked at in terms of their immediate costs, with little
consideration for their overall impact on healthcare uti-
lisation in terms of reduced hospitalisations or long-term
care, not to mention social costs such as fewer sick days
due to a better tolerability profile or fewer complications.
This is evident in the case of psychosocial support for
patients, which is not reimbursed in many European
countries. Even in countries where it is reimbursed, pa-
tients may not be reimbursed if they need to access psy-
chosocial care outside of their local area or from private
providers if these services are not available locally [30].
Another important limitation is that patients and
their representatives are too seldom involved in HTA
and other reimbursement decisions [31]. The inclusion of
patient experience data captured during clinical trials
would represent an important step forward from what is
currently provided for HTA and other reimbursement
submissions. This would contribute to providing a more
accurate and relevant account of the impact of new
technologies on patients.
Finally, delays in reimbursement between countries
are an ongoing concern, as they cause inequalities in ac-
cess to care for patients across Europe. Looking specif-
ically at medicines: in 1989, the European Commission set
a maximum limit of 180 days [32] between the time a
reimbursement dossier is submitted to the relevant na-
tional agency and market access is granted. Yet many
countries continue to exceed this time limit, particularly
in Central Eastern European countries (2008e2010 data)
[33] and the United Kingdom. Reimbursement sub-
missions are done on a countrydand sometimes even a
regionaldlevel, with significant differences in access be-
tween and within countries as a result [9]. The recent work
of the European Network for Health Technology
Assessment (EUNetHTA) has helped in trying to increase
collaboration between agencies and harmonise the evi-
dence requirements across different HTA agencies,
hopefully contributing to closer alignment when new
medicines become available to patients in different
countries. Needless to say, similar alignment is also
needed for other aspects of cancer care.
4.4. Local uptake
There are known variations in the uptake of innovations
across different care settings, often reflecting variations
in the quality of care offered between specialised and
non-specialised centres. Lack of specialisation may also
increase the reliance on outdated or ineffective treat-
ment approaches that could be replaced by more effec-
tive ones, thereby compromising the integration of
innovative approaches into patient care.
A chosen approach in several countries has been to
create designated ‘centres of excellence’ (or specialised
centres). This centralisation may help to ensure con-
sistency of quality across designated centres and allow
for economies of scale in the purchase of imaging and
other expensive equipment. Delivery of cancer care in
specialist centres is particularly critical for rare cancers,
as the small number of cases means that it is difficult
for physicians to acquire sufficient experience and
expertise in their treatment and care. To this end, Rare
Cancers Europe has recommended that care for rare
cancers be centralised in European Reference Net-
works (ERNs), of which three cover rare cancers
(ERNs on rare adult solid tumours, blood disease and
paediatric cancers).
With the development of ERNs and other centres of
excellence, however, it will be important to make sure
that centralisation of care does not create additional
barriers to care for patients and that they work in close
networks with local practitioners as part of a multidis-
ciplinary care team adhering to the same protocols and
guidelines. This networked model of care is already
being implemented for children and adolescents with
M. Aapro et al. / European Journal of Cancer 82 (2017) 193e202198
cancer, and the European Society for Paediatric
Oncology has defined the European Standards of Care
for Children with Cancer [34].
A critical issue for centres of excellence is that they
meet clear standards or essential requirements. For
example, many hospitals that have so-called specialist
cancer services are not organised into multidisciplinary
units, as recommended by ECCO and other professional
societies [35e37]. To this end, ECCO is currently
developing essential standards to ensure a more consis-
tent level of quality within designated specialised cen-
tres, looking specifically at colorectal cancer and bone
and soft-tissue sarcomas [38,39].
An interesting example of the application of essen-
tial requirements is the designation of specialist breast
units. Essential requirements were outlined by the
European Society of Mastology in 2000 and updated in
2013 [40,41] and include a minimum caseload (>150
newly diagnosed cases per year), an audited database
of quality indicators and research, multidisciplinary
case management meetings, clear verbal and written
patient information, and defined teaching and research
plans [42].
Implementation of innovations may also be facili-
tated by the expansion of ‘coverage with evidence
development’ (CED) schemes, which should be applied
to all types of innovations, not just medicines. These
schemes should be guided by health economic simula-
tions in the early stages of research, and the availability
of health economic expertise and knowledge to help
guide implementation of CED schemes and data
collection within each institution. Close collaboration
with professional societies is also needed to ensure
acceptance of innovations within practice guidelines.
5. Improving access to innovation in cancer care: potential
solutions
Improving accessdand overcoming some of the existing
hurdles to accessdto innovation will require a combi-
nation of levers at the political, system and individual
hospital or clinic level. These are described in the
following section.
5.1. Greater involvement of patients and caregivers in
defining and assessing the value of innovation
Comprehensive assessment of the impact of innovations on
patients’ quality of life, risk/benefit balance and overall
experience of care must be an integral part of the evaluation
of any innovation, by using validated patient-reported
outcomes and experience measures.
Patients and their representatives should be involved early
in the planning and conduct of research, as well as regu-
latory and HTA discussions related to innovation, to ensure
that their perspectives guide the development and evalua-
tion of innovations.
Patient organisations should be supported to develop
accessible information materials to inform the patient
community about upcoming innovations with close
collaboration from clinical specialists. They may act as
powerful advocates for the integration of innovations into
clinical practice and acceptability in the broad patient
population.
5.2. A whole-system, whole-patient approach to guide
investment in innovation
Despite the continual focus on cost containment in
healthcare, national governments should foster an innova-
tion agenda by adopting a system-wide strategy for in-
vestment in innovation.
This strategy should
be guided by identified patient needs, as measured by
patient-relevant outcomes, with more research needed in
close partnership with patient organisations to better
understand unmet patient needs (clinical but also psy-
chosocial and emotional), relevance and priorities in
different cancers and where the need for innovation is
greatest;
take a ‘whole-system’ as well as a ‘whole-patient’
approach, looking at what innovations may have the
most impact across the entire care pathway, and moving
away from siloed decisions on different types of care (e.g.
medicines, medical devices, equipment, radiology and
surgery).
5.3. More efficient and harmonised evaluation of
innovation
The evaluation of all innovations should be centralised and
harmonised at a national or regional level, with a credible
multidisciplinary group of stakeholders guiding decisions.
This should ideally free individual hospitals or departments
from having to make decisions about the value of in-
novations and create a more transparent evidence base on
which investment in innovations may be made across
different settings of care.
Greater transparency in the evidence required for HTA and
reimbursement decisions for all types of diagnostic pro-
cedures and care is also needed, including
closer alignment between these decisions and regulatory
bodies to avoid unnecessary delays in access to patients;
where possible, greater alignment between countries in
terms of HTA and reimbursement decisions, making
greater use of EUNetHTA or similar entities for a coor-
dinated approach between HTA agencies.
5.4. Investment in real-world data to guide investment in
innovation
Investment in well-designed registries, big data and other
real-world data collection is key to assess the potential
impact of innovations in clinical practice. Harmonisation of
data sets both within and between countries is needed for us
to be able to pool data from different sources. Real-world
data may be used to guide:
reimbursement decisions, looking at the impact on costs
and outcomes across the entire care pathway, and thereby
M. Aapro et al. / European Journal of Cancer 82 (2017) 193e202 199
avoiding decisions based on immediate budget impact
alone. Ideally, this process should be reviewed regularly,
based on new data emerging over time;
investment and integration of innovations into clinical
practice;
updating of clinical guidelines to reflect why a given
intervention has not been integrated into the guideline
based on evolving data on its effectiveness.
Efforts to improve the potential for sharing of registry data
across different countries are also needed; an example is the
EMA project which is looking at making better use of
existing patient registries and supporting the set-up of new
ones on the basis of common protocols, scientific methods,
structures, data sharing and transparency [43,44].
5.5. Promotion of an innovation culture within the delivery
of cancer care
The implementation of multidisciplinary teams (MDTs)
across cancer care may compel individual specialists to look
beyond their own area of expertise and take a whole-system
approach to innovation, focussing on innovations that may
make the greatest difference to patients, and adapt care
pathways to integrate them into practice, and, together,
ask: ‘How can we do things better?’ [35]
MDTs may also provide an opportunity to continuously
review clinical practice and stop wasting resources on things
that have become inferior compared to updated standards
and could be replaced by more efficient, innovative prac-
tices [35].
New models of cancer care integrating primary care and
secondary care need to be established to improve the
quality of care, starting with an effective diagnosis.
Continued educational efforts are also needed to dissemi-
nate existing guidelines to physicians and encourage their
implementation, with specialist centres taking the lead in
educational activities, on-site training, webinars or other
information-sharing activities to keep everyone up-to-date
on advances in care. European reference documents such as
the European Guide on Quality National Cancer Control
Plans [45] should also be considered.
5.6. A pan-European vision on innovation (a vision and a
will)
Finally, European cancer agencies may help build political
will across different countries to embrace innovations. They
may contribution to Europe-wide researchdin true
collaboration between the various Directorates of the Eu-
ropean Commissiondlooking at how different healthcare
systems may foster and evaluate innovations using common
approaches and measures.
These recommendations should be embedded in revised
National Cancer Control Plans, which should be reviewed
on a regular basis to take account of the continuously
evolving care and treatment landscape.
6. Conclusions
Innovation requires investment, and this investment is
needed if we are to continuously improve the lives and
hopes of cancer patients across Europe despite the
financial pressures on our healthcare systems. Adopting
a culture of innovation requires a multidisciplinary team
approach, with the patient at the centre and an integral
part of the team. It must take a whole-system and
whole-patient perspective on cancer care, address unmet
patient needs and be guided by high-quality real-world
data, including patient-relevant outcomes and actual
costs of care; these factors reflect the impact of any
innovation in clinical practice. Similarly, patient orga-
nisations need to be actively engaged with other key
stakeholders in the planning and evaluation of all as-
pects of cancer care.
This article is intended as a starting point to engage
all relevant professionals involved in cancer care, as well
as the patient and care community, in finding sustain-
able solutions to foster innovation within current and
future cancer care. ECCO is committed to working with
its member societies, patient organisations and the
cancer community at large, to help identify sustainable
ways to identify and integrate the most meaningful in-
novations into all aspects of cancer care. It is also
committed to working with, and building on, profes-
sional educational efforts already being made by the
European School of Oncology, ESTRO, European So-
ciety of Surgical Oncology and others to build multi-
disciplinary excellence in cancer care. It is our hope that
this article may contribute to those efforts and be
developed into a concrete action plan that ECCO and its
member societies may follow to help contribute to sus-
tainable, innovative cancer care for patients in years to
come.
Conflict of interest statement
Dr. Suzanne Wait from the Health Policy Partnership
provided support in drafting the article and was offered
an honorarium from ECCO to do so. No other funding
sources were used for the development of this article,
and the other authors declare no conflicts of interest.
Acknowledgements
This position paper has been produced by the Euro-
pean CanCer Organisation (ECCO), a federation of 24
professional societies in oncology, in collaboration with
the ECCO Patient Advisory Committee (PAC).
Through its 24 Member Societiesdrepresenting over
80,000 professionalsdECCO is the only multidisci-
plinary organisation that connects and responds to all
stakeholders in oncology Europe wide. ECCO is a not-
for-profit federation that exists to uphold the right of all
European cancer patients to the best possible treatment
and care, promoting interaction between all organisa-
tions involved in cancer at European level. It does this
by creating awareness of patients’ needs and wishes,
M. Aapro et al. / European Journal of Cancer 82 (2017) 193e202200
encouraging progressive thinking in cancer policy,
training and education and promoting European cancer
research, prevention, diagnosis, treatment and quality
care through the organisation of international multi-
disciplinary meetings. ECCO would like to acknowledge
the contribution of Professor Dirk Arnold (ESMO) to
the development of this article, and thank all member
Societies and the ECCO Patient Advisory Committee
for their input. ECCO would also like to thank the
European School of Oncology Innovation and Obso-
lescence Task Force [17] which has addressed many of
the areas developed herein.
References
[1] Glunde K, Penet M-F, Jiang L, Jacobs MA, Bhujwalla ZM. Choline
metabolism-based molecular diagnosis of cancer: an update. Expert
Rev Mol Diagn 2015;15(6):735e47. http:
//dx.doi.org/10.1586/14737159.2015.1039515.
[2] Hartwig W, Werner J, Ja
¨ger D, Debus J, Buechler MW.
Improvement of surgical results for pancreatic cancer. Lancet
Oncol 2013;14(11):e476e85. http://dx.doi.org/10.1016/S1470-
2045(13)70172-4.
[3] Hashizume M, Tsugawa K. Robotic surgery and cancer: the
present state, problems and future vision. Jpn J Clin Oncol 2004;
34(5):227e37 [published Online First: 2004/07/03].
[4] MacFarlane JK, Ryall RD, RJ H. Mesorectal excision for rectal
cancer. Lancet 1993;341:457e60.
[5] Gupta V, McGunigal M, Prasad-Hayes M, Kalir T, Liu J.
Adjuvant radiation therapy is associated with improved overall
survival in high-intermediate risk stage I endometrial cancer: a
national cancer data base analysis. Gynecol Oncol 2016. http:
//dx.doi.org/10.1016/j.ygyno.2016.10.028.
[6] Purdy JA. 3D treatment planning and intensity-modulated radi-
ation therapy. Oncology (Williston Park, NY) 1999;13(10 Suppl
5):155e68 [published Online First: 1999/11/07].
[7] Gonzalez de Castro D, Clarke PA, Al-Lazikani B, Workman P.
Personalized cancer medicine: molecular diagnostics, predictive
biomarkers, and drug resistance. Clin Pharmacol Ther 2013;93(3):
252e9. http://dx.doi.org/10.1038/clpt.2012.237.
[8] Gerber DE. Targeted therapies: a new generation of cancer
treatments. Am Fam Phys 2008;77(3):311e9.
[9] Miriovsky BJ, Shulman LN, Abernethy AP. Importance of health
information technology, electronic health records, and continu-
ously aggregating data to comparative effectiveness research and
learning health care. J Clin Oncol 2012;30(34):4243e8. http:
//dx.doi.org/10.1200/jco.2012.42.8011.
[10] Cherny N, S R, Torode J, Saar M, Eniu A. ESMO European
Consortium Study on the availability, out-of-pocket costs and
accessibility of antineoplastic medicines in Europe. Ann Oncol
2016;27:1423e43.
[11] Jo
¨nsson B, Hofmarcher T, Lindgren P, Wilking N. Comparator
report on patient access to cancer medicines in Europe revisited.
IHE Report. Lund: IHE; 2016.
[12] Directorate General for Internal policies. EU options for
improving access to medicines. Study for the ENVI Committee:
European Parliament Policy department Economic and Scientific
Policy A. 2016.
[13] Lawler M, Apostolidis K, Banks I, Florindi F, Militaru M,
Price R, on Behalf of the Europe of Disparities in Cancer
Working Group. Challenging the Europe of Disparities in Cancer
ea framework for improving survival and better quality of life
for European cancer patients. On behalf of the Europe of Dis-
parities in Cancer Working Group; 2015.
[14] Sullivan R, Peppercorn J, Sikora K, Zalcberg J, Meropol NJ,
Amir E, et al. Delivering affordable cancer care in high-income
countries. Lancet Oncol 2011;12(10):933e80. http:
//dx.doi.org/10.1016/S1470-2045(11)70141-3.
[15] Thomas R, Callahan R, Bartlett R, Geissler J. Delivering afford-
able cancer care: a value challenge to health systems. In: World
Innovation Summit for Health, editor. WISH Highlights. Institute
of Global Health Innovation, Imperial College London; 2015.
[16] Cavalli F. Tackling cancer: time for a global response. Lancet
2016;387:e13e4.
[17] Wagstaff A. Five steps to putting innovation at the heart of
cancer care. Cancer World 2014. Available from: http://www.
cancerworld.org/pdf/3437_pagina_25_33_Systems_Services.pdf
[Accessed 7 April 2016].
[18] Merriam-Webster Dictionary Online. Innovation.
[19] Oxford Dictionaries Online. Innovation.
[20] Cherny N, Sullivan R, Dafni U, Kerst JM, Sobrero A,
Zielinski C, et al. A standardised, generic, validated approach to
stratify the magnitude of clinical benefit that can be anticipated
from anti-cancer therapies: the European Society for Medical
Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).
Ann Oncol 2015;26:1547e73.
[21] Schnipper LE, Davidson NE, Wollins DS, Blayney DW, Dicker AP,
Ganz PA, et al. Updating the American Society of Clinical Oncology
value framework: revisions and reflections in response to comments
received. J Clin Oncol 2016;34(24):2925e34. http:
//dx.doi.org/10.1200/JCO.2016.68.2518.
[22] Institute for Clinical and Economic Review. ICER value assess-
ment framework. 2016. Available from: https://icer-review.org/
methodology/icers-methods/icer-value-assessment-framework/
[Accessed 27 October 2016].
[23] Schnipper L, B A. New frameworks to assess value of cancer care:
strengths and limitations. Oncologist 2016;21:654e8.
[24] Network. NCC. Available at: http://www.nccn.org/evidenceblocks/
pdf. [Accessed 20 May 2016].
[25] Schilsky RL. Moving from evaluation to value in cancer care. Clin
Cancer Res 2015;21(5):947e9. http://dx.doi.org/10.1158/1078-
0432.ccr-14-2533 [published Online First: 2014/10/23].
[26] McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P,
Marshall JC, et al. No surgical innovation without evaluation: the
IDEAL recommendations. Lancet 2009;374(9695):1105e12. http:
//dx.doi.org/10.1016/s0140-6736(09)61116-8 [published Online
First: 2009/09/29].
[27] Pennell CP, Hirst A, Sedrakyan A, McCulloch PG. Adapting the
IDEAL Framework and Recommendations for medical device
evaluation: a modified Delphi survey. Int J Surg 2016;28:141e8.
http://dx.doi.org/10.1016/j.ijsu.2016.01.082 [published Online
First: 2016/02/16].
[28] Sedrakyan A, Campbell B, Merino JG, Kuntz R, Hirst A,
McCulloch P. IDEAL-D: a rational framework for evaluating and
regulating the use of medical devices. BMJ 2016;353:i2372. http:
//dx.doi.org/10.1136/bmj.i2372 [published Online First:
2016/06/11].
[29] European Parliament. Regulation (EU) No 536/2014 of the Eu-
ropean Parliament and of the Council of 16 April 2014 on clinical
trials on medicinal products for human use, and repealing
Directive 2001/20/EC. In: Union CotE, editor; 2014.
[30] Travado L, Reis JC, Watson M, Borras J. Psychosocial oncology
care resources in Europe: a study under the European Partnership
for Action Against Cancer (EPAAC). Psychooncology 2015. http:
//dx.doi.org/10.1002/pon.4044.
[31] European Patients’ Forum. Patient involvement in health tech-
nology assessment in Europe ean interim report on EPF survey
with HTA agencies. EPF Survey. 2013.
[32] European Commission. Council directive relating to the trans-
parency of measures regulating the pricing of medicinal products
for human use and their inclusion in the scope of national health
insurance systems. In: Commission E, editor; 1989. 89/105/EEC.
M. Aapro et al. / European Journal of Cancer 82 (2017) 193e202 201
[33] European Federation of Pharmaceutical Industries and Associa-
tions. Patients’ W.A.I.T. Indicator. Market Access Delays. 2010.
[34] KowalczykJ, Samardakiewicz M, Pritchard-Jones K, Ladenstein R,
Essiaf S, Fitzgerald E, et al. European survey on standards of care in
paediatric oncology centres. Eur J Cancer 2016;61(11e19).
[35] European Partnership Action Against Cancer consensus group,
Borras JM, Albreht T, Audisio R, Briers E, Casali P, Esperou H,
et al. Policy statementon multidisciplinary cancercare. Eur J Cancer
2014;50(3):475e80. http://dx.doi.org/10.1016/j.ejca.2013.11.012.
[36] Epstein NE. Multidisciplinary in-hospital teams improve patient
outcomes: a review. Surg Neurol Int 2014;5(Suppl 7):S295e303.
http://dx.doi.org/10.4103/2152-7806.139612.
[37] Prades J, Remue E, van Hoof E, Borras JM. Is it worth reor-
ganising cancer services on the basis of multidisciplinary teams
(MDTs)? A systematic review of the objectives and organisation
of MDTs and their impact on patient outcomes. Health Policy
2015;119(4):464e74. http:
//dx.doi.org/10.1016/j.healthpol.2014.09.006.
[38] Andritsch E, Beishon M, Bielack S, Bonvalot S, Casali P, Crul M,
et al. ECCO essential requirements for quality cancer care: soft
tissue sarcoma in adults and bone sarcoma. A critical review. Crit
Rev Oncol Hematol 2017;110:94e105.
[39] Beets G, Sebag-Montefiore D, Andritsch E, Arnold D,
Beishon M, Crul M, et al. ECCO essential requirements for
quality cancer care: colorectal cancer. A critical review. Crit Rev
Oncol Hematol 2017;110:81e93.
[40] Blamey R, Cataliotti L. The requirements of a specialist breast
unit. Eur J Cancer 2000;36:2288e93.
[41] Wilson AR, Marotti L, Bianchi S, Biganzoli L, Claassen S,
Decker T, et al. The requirements of a specialist Breast Centre.
Eur J Cancer 2013;49(17):3579e87. http://dx.doi.org/10.1016/-
j.ejca.2013.07.017 [published Online First: 2013/08/24].
[42] European CanCer Organisation. European breast units manifesto
2016. 2016 [updated 11 March 2016; cited 2016 27 October].
Available from: http://www.ecco-org.eu/Events/EBCC10/
European-Breast-Units-Manifesto [Accessed 27 October 2016].
[43] European Medicines Agency. Collecting high-quality information
on medicines through patient registries. Initiative aims to support
use of existing registries to collect information on medicines in
clinical use and support benefit-risk evaluation. 2015.
[44] European Medicines Agency. Initiative for patient registries: strat-
egy and pilot phase. In: Inspections and Human Medicines Phar-
macovigilance Division, editor; 2015. London, United Kingdom.
[45] Albreht T, Martin-Moreno JM, Jelenc M, Gorgojo L, Harris M.
European guide for quality national cancer control programmes.
National Institute of Public Health; 2015.
[46] Macmillan Cancer Support. Cancer clinical nurse specialists.
Impact briefs. 2014.
[47] European Oncology Nursing Society (EONS). EONS position state-
ment: the role of nurses in cancer care. Available from: http://www.
cancernurse.eu/advocacy/positionstatementcancercare.html2016.
[48] Tot T, Viale G, Rutgers E, Bergsten-Nordstrom E, Costa A.
Optimal breast cancer pathology manifesto. Eur J Cancer 2015;
51(16):2285e8. http://dx.doi.org/10.1016/j.ejca.2015.06.127
[published Online First: 2015/08/19].
[49] Jain KK. Personalised medicine for cancer: from drug develop-
ment into clinical practice. Expert Opin Pharmacother 2005;6(9):
1463e76. http://dx.doi.org/10.1517/14656566.6.9.1463.
[50] Moran MS, Schnitt SJ, Giuliano AE, Harris JR, Khan SA, Horton J,
et al. Society of Surgical OncologyeAmerican Society for Radiation
Oncology Consensus Guideline on margins for breast-conserving
surgery with whole-breast irradiation in stages I and II invasive
breast cancer. Int J Radiat Oncol Biol Phys 2014;88(3):553e64. http:
//dx.doi.org/10.1016/j.ijrobp.2013.11.012.
[51] Ferna
´ndez-Hevia M, Delgado S, Castells A, Tasende M,
Momblan D, Dı
´az del Gobbo G, et al. Transanal total mesorectal
excision in rectal cancer: short-term outcomes in comparison with
laparoscopic surgery. Ann Surg 2015;261(2):221e7. http:
//dx.doi.org/10.1097/sla.0000000000000865.
[52] Heald R, Husband E, Ryall R. The mesorectum in rectal cancer
surgerydtheclue to pelvic recurrence? Br J Surg 1982;69(10):613e6.
[53] Marshall JL, Cartwright TH, Berry CA, Stowell S, Miller SC. Imple-
mentation of a pperformance improvement initiative in colorectal
cancer care. J Oncol Pract 2012;8(5):309e14. http:
//dx.doi.org/10.1200/JOP.2011.000461.
[54] Owusu C, Berger NA. Comprehensive geriatric assessment in the
older cancer patient: coming of age in clinical cancer care. Clin
Pract 2014;11(6):749e62. http://dx.doi.org/10.2217/cpr.14.72.
[55] Vassal G, Rousseau R, Blanc P, Moreno L, Bode G, Schwoch S.
Creating a unique, multi-stakeholder Paediatric Oncology Plat-
form to improve drug development for children and adolescents
with cancer. Eur J Cancer 2015;51:218e24.
[56] Vassal G, Fitzgerald E, Schrappe M, Arnold F, Kowalczyk J,
Walker D. Challenges for children and adolescents with cancer in
Europe: the SIOP-Europe agenda. Pediatr Blood Cancer 2014;61:
1551e7.
[57] Salas-Vega S, Haimann A, Mossialos E. Big data and health care:
challenges and opportunities for coordinated policy development
in the EU. Health Syst Reform 2015;1(4):285e300. http:
//dx.doi.org/10.1080/23288604.2015.1091538.
[58] Garrison LP, Neumann PJ, Erickson P, Marshall D, Mullins CD.
Using real-world data for coverage and payment decisions: the
ISPOR real-world data task force report. Value Health 2007;
10(5):326e35. http://dx.doi.org/10.1111/j.1524-4733.2007.00186.x.
[59] Larsen MB, Jensen H, Hansen RP, Olesen F, Vedsted P. Identi-
fication of patients with incident cancers using administrative
registry data. Dan Med J 2014;61.
[60] Christensen KG, Fenger-Gron M, Flarup KR, Vedsted P. Use of
general practice, diagnostic investigations and hospital services
before and after cancer diagnosis-a population-based nationwide
registry study of 127,000 incident adult cancer patients. BMC
Health Serv Res 2012;12. http://dx.doi.org/10.1186/1472-6963-12-
224.
[61] Coleman MP, Forman D, Bryant H, Butler J, Rachet B,
Maringe C, et al. Cancer survival in Australia, Canada, Denmark,
Norway, Sweden, and the UK, 1995e2007 (the International
Cancer Benchmarking Partnership): an analysis of population-
based cancer registry data. Lancet 2011;377. http:
//dx.doi.org/10.1016/s0140-6736(10)62231-3.
[62] Gjerstorff ML. The Danish cancer registry. Scand J Public Health
2011;39. http://dx.doi.org/10.1177/1403494810393562.
[63] El Turabi A, Abel GA, Roland M, Lyratzopoulos G. Variation in
reported experience of involvement in cancer treatment decision
making: evidence from the National Cancer Patient Experience
Survey. Br J cancer 2013;109(3):780e7.
[64] Coulter A, Locock L, Ziebland S, Calabrese J. Collecting data
on patient experience is not enough: they must be used to
improve care. BMJ 2014;348:g2225. http://dx.doi.org/10.
1136/bmj.g2225.
[65] Schulthess D, Baird LG, Trusheim M, Unger TF, Lumpkin M,
Hoos A, et al. Medicines adaptive pathways to patients (MAPPs):
a story of international collaboration leading to implementation.
Ther Innov Regul Sci 2015. http://dx.doi.org/10.1177/
2168479015618697.
M. Aapro et al. / European Journal of Cancer 82 (2017) 193e202202
... Some innovations represent major changes with the potential to impact outcome in a stepswise fashion, think of new dose fractionation schedules, new radiotherapy-drug combinations or technologies with distinct biological, physical or imaging properties such as particle therapy or MR-guided radiotherapy. As in other aspects of cancer, innovation may however not be seen as a major breakthrough at onset, yet present itself as a series of smaller, incremental, changes of which the real impact gradually becomes evident over time [11,12]. Examples of the latter could be new immobilisation devices or computer planning algorithms. ...
... Innovation is taking place in all aspects of cancer care -often with shorthening life cycles -which, along with the increasing incidence and burden of cancer, has resulted in an unprecedented growth of cancer care expenditure over the past decades [13,14]. In view of the need for financial sustainability, healthcare systems should focus on the introduction of those new cancer care interventions that are high-quality, efficient and equitable, by using dedicated health technology assessment (HTA), reimbursement and policy decisions [12,15]. Moreover, acknowledging that innovations should make a meaningful difference to patients, greater involvement of patients and caregivers in defining and assessing their value is needed. ...
... Moreover, acknowledging that innovations should make a meaningful difference to patients, greater involvement of patients and caregivers in defining and assessing their value is needed. [12]. ...
Article
Full-text available
Radiotherapy interventions are rapidly evolving and improving, holding promise for better patient outcomes, yet at the possible detriment of higher societal costs. The ESTRO-HERO value-based radiotherapy project aims to develop a framework defining and assessing the value of radiotherapy innovations, to support clinical implementation and equitable access, within a sustainable healthcare system.
... The OECI has 38 quality standards on patient involvement and empowerment which accredited cancer centres should comply with, ranging from co-creation of services, to shared decision-making [108]. Patient involvement, engagement and empowerment are ethical imperatives and an evidence-based choice, resulting in better psychosocial and economic Table 3 Research and Innovation which is improving cancer practice (from references [92][93][94][95][96][97][98][99][100][101][102][103][104]. ...
... 1. Advances in understanding the cell and molecular biology of cancer and cancer genetics which characterise the hallmarks of cancer, underpin advances in cancer pharmacology and drug development, immunology and microbiology, immunotherapy and vaccines [92,93,94]. 2. Precision oncology allows clinicians and patients to choose the right treatment at the right time [95]. ...
... Research brings benefits to patients both through the implementation of its results and its influence on the quality of clinical cancer care. We have summarised those areas of research which are currently improving or likely to improve cancer practice in the foreseeable future in Table 3 [92][93][94][95][96][97][98][99][100][101][102][103]. While patients must be absolutely free to choose whether they wish to be individually involved or continue to be involved in research, it is essential that they have the right to be informed about research options and the research activities of their cancer care teams. ...
Article
Full-text available
There are considerable disparities between the quality of cancer care and clinical outcomes for cancer patients in different European countries, regions, hospitals and communities. These have persisted despite the introduction of many European and National Cancer Plans, an extensive portfolio of clinical guidelines and the existence of evidence based guidelines for the good practice in planning cancer healthcare systems. We describe the European Code of Cancer Practice which is a citizen and patient-centred accessible widely disseminated statement of the core requirements for good clinical cancer practice. The Code sets out 10 key overarching Rights of what a patient should expect from their healthcare system each supported by a plain language explanation. The Rights highlight the importance of equal access to affordable and optimal cancer care, good quality information about an individual patient’s disease and treatment and about the quality and outcomes of the cancer service they will use. Specialised multidisciplinary cancer care teams, shared decision-making, research and innovation, a focus on quality of life, the integration of supportive and palliative care within oncology are all emphasised. There is a need for a systematic approach to supporting cancer survivors with a survivorship care plan including their rehabilitation, reintegration into society and return to work where appropriate without discrimination. The Code has been co-produced by a team of cancer patients, patient advocates and cancer professionals to bridge the gap between clinical guidelines, healthcare policies and patients’ everyday experience. It is robustly evidence-based and supported by a comprehensive review of the medical literature and evidence for good clinical practice. The Code is strongly endorsed by Europe’s professional and patient cancer organisations and the European Commission.
... 9 Patient's delay occurs due partly to the patient's lack of financial resources, fear, and lack of information, 10 among other reasons, while treatment delay is due to the characteristics of the health systems, including referral mechanisms, high volume of patients, longer distance to the clinic, 10 and problems related to the untimely acquisition of cancer treatment drugs. 11 Mexico is currently undergoing a major health system reform, with the replacement of the Seguro Popular with the National Institute of Health for Welfare (Insabi, Spanish acronym). 12 Therefore, an analysis of the key determinants of survival becomes relevant to guide the decisions of policy makers. ...
Article
Full-text available
Objective: To assess whether the Catastrophic Health Expenditures Fund (FPGC, Spanish acronym) was associated with delays in seeking medical care and in starting treatment. Materials and methods: We conducted a before and after cross-sectional study. We included 266 women with breast cancer (BC) diagnosis treated during the last three years before the hospitals received the FPGC and 309 wo-men treated in the following three years after the fund was received by the accredited hospitals. Results: After adjusting for potential confounders, we found no association between the FPGC and delay in seeking medical care or between the FPGC and the treatment delay. Conclusions: The FPGC initiative reduced neither the delay in seeking breast cancer medical care for breast cancer nor the treatment delay.
... Besides the incessant development and use of novel and expensive systemic agents, similar evolution has taken place in cancer surgery and radiation oncology, resulting in a broad portfolio of new devices and treatment approaches [8,9]. The decision which innovative interventions to reimburse, when and how, has become increasingly difficult and relevant, as reimbursement is considered a key barrier to the adoption of innovations offering meaningful improvements in cancer outcomes [2,10]. Developing reimbursement systems that are able to capture the continuous evolution in cancer care and correctly cover for the cost of evidencebased interventions, thus supporting sustainable -yet equitable -availability and access, has never been more crucial [2]. ...
Article
Full-text available
Background and purpose: Complex surgery and radiotherapy are the central pillars of loco-regional oncology treatment. This paper describes the reimbursement schemes used in radiation and complex surgical oncology, reports on literature and policy reviews. Material and methods A systematic review of the literature of the reimbursement models has been carried out separately for radiotherapy and complex cancer surgery based on PRISMA guidelines. Using searches of PubMed and grey literature, we identified articles from scientific journals and reports published since 2000 on provider payment or reimbursement systems currently used in radiation oncology and complex cancer surgery, also including policy models. Results Most European health systems reimburse radiotherapy using a budget-based, fee-for-service or fraction-based system; while few reimburse services according to an episode-based model. Also, the reimbursement models for cancer surgery are mostly restricted to differences embedded in the DRG system and adjustments applied to the fees, based on the complexity of each surgical procedure. There is an enormous variability in reimbursement across countries, resulting in different incentives and different amounts paid for the same therapeutic strategy. Conclusion A reimbursement policy, based on the episode of care as the basic payment unit, is advocated for. Innovation should be tackled in a two-tier approach: one defining the common criteria for reimbursement of proven evidence-based interventions; another for financing emerging innovation with uncertain definitive value. Relevant clinical and economic data, also collected real-life, should support reimbursement systems that mirror the actual cost of evidence-based practice.
... The pace of introducing innovative interventions in clinical cancer practice has accelerated in recent years and deserves specific consideration. Besides the incessant development and use of novel and expensive systemic agents, similar evolution has taken place in cancer surgery and radiation oncology, resulting in a broad portfolio of new devices and treatment approaches [8,9] become increasingly difficult and relevant, as reimbursement is considered a key barrier to the adoption of innovations offering meaningful improvements in cancer outcomes [2,10]. Developing reimbursement systems that are able to capture the continuous evolution in cancer care and correctly cover for the cost of evidence-based interventions, thus supporting sustainable -yet equitable -availability and access, has never been more crucial [2]. ...
Article
Full-text available
Background and purpose Complex surgery and radiotherapy are the central pillars of loco-regional oncology treatment. This paper describes the reimbursement schemes used in radiation and complex surgical oncology, reports on literature and policy reviews. Material and methods A systematic review of the literature of the reimbursement models has been carried out separately for radiotherapy and complex cancer surgery based on PRISMA guidelines. Using searches of PubMed and grey literature, we identified articles from scientific journals and reports published since 2000 on provider payment or reimbursement systems currently used in radiation oncology and complex cancer surgery, also including policy models. Results Most European health systems reimburse radiotherapy using a budget-based, fee-for-service or fraction-based system; while few reimburse services according to an episode-based model. Also, the reimbursement models for cancer surgery are mostly restricted to differences embedded in the DRG system and adjustments applied to the fees, based on the complexity of each surgical procedure. There is an enormous variability in reimbursement across countries, resulting in different incentives and different amounts paid for the same therapeutic strategy. Conclusion A reimbursement policy, based on the episode of care as the basic payment unit, is advocated for. Innovation should be tackled in a two-tier approach: one defining the common criteria for reimbursement of proven evidence-based interventions; another for financing emerging innovation with uncertain definitive value. Relevant clinical and economic data, also collected real-life, should support reimbursement systems that mirror the actual cost of evidence-based practice.
... 3 Innovation is an evolving concept with different aspects, both disruptive and incremental. We agree with Aapro et al. 4 in considering innovation as "any intervention within the care pathway that makes a meaningful difference to patients." ...
Article
Oncology is going through the fastest innovation period in the history of medicine and a growing number of patients improve or experience increased chances of survival. The declining death rate, starting from 1991, resulted in 2.9 million deaths avoided in the United States so far. A growing prevalence of patients is observed in all Western countries. New cancer drug approvals between 2000 and 2016, linked to other diagnostic, surgical, and health care improvements, were significantly associated with death reduction for the most common cancers. Alongside many positive aspects, other effects of innovations in oncology also deserve attention, especially challenges associated with the substantial increase of knowledge volume, the sharp growth of prevalence, and a concomitant or consequent increase in clinical, social, and organizational complexity. We analyse some of the consequences of oncology innovation on healthcare systems and professionals and present some suggestions on how these could be addressed by healthcare systems.
... In the future, important strides will come from de-escalation of treatment intensity, the neoadjuvant model (as a development accelerator), addressing better and more adequately the underserved patient populations and expectations of patients with cancer themselves (22). ...
Article
Full-text available
In early 2020, the book "Breast cancer: Global Quality Care" was published by Oxford University Press. In the year since then, publications, interviews (by ecancer), presentations, webinars, and virtual congress have been organized to disseminate further the main message of the project: "A call for Fairer Breast Cancer Care for all Women in a Globalized World." Special attention is paid to increasing the "value-based healthcare" putting the patient in the center of the care pathway and sharing information on high-quality integrated breast cancer care. Specific recommendations are made considering the local resource facilities. The multidisciplinary breast conference is considered "the jewel in the crown" of the integrated practice unit, connecting multiple specializations and functions concerned with patients with breast cancer. Management and coordination of medical expertise, facilities, and their interfaces are highly recommended. The participation of two world-leading cancer research programs, the CONCORD program and Breast Health Global Initiative, in this project has been particularly important. The project is continuously under review with feedback from the faculty. The future plan is to arrive at an openaccess publication that is freely available to all interested people. This project is designed to help ease the burden and suffering of women with breast cancer across the globe.
Article
Full-text available
Purpose: This study examined what support cancer patients and their close ones need and how this support should be organized when developing cancer care pathways. The study focused on the opinions of professionals of the Cancer Society of Finland (CSF), who play a central role in presenting the third sector’s perspective on care pathways. Method: Six semi-structured group interviews were carried out with counselling nurses (n = 12) and managers (n = 9) of the CSF during summer 2017. The results were analysed using content analysis. Results: Both patients and their close ones need more information, psychosocial support and financial counselling after diagnosis, during rehabilitation and follow-up, at relapse and during the palliative care phase; additionally, close ones require support after the patient’s death. Participants emphasized close collaboration between public healthcare and the CSF to meet the needs of patients and their close ones. Conclusion: Psychosocial support can—and should—be provided as part of the care pathway. This support can be provided by organizations in the third sector, such as the CSF, which have resources in this area.
Chapter
Breast cancer is the most common cancer and the main cause of death from cancer among women in Europe and worldwide. The third cycle of the CONCORD programme found wide global differences in five-year net survival for women with breast cancer, both between countries and over time. Survival from breast cancer is higher for more affluent women than more deprived women. Patient and tumour characteristics, factors related to the healthcare system and to the wider social environment may explain some of these socioeconomic differences.
Chapter
Pancreatic cancer is the deadliest cancer we know and only a very few surviving patients have a possibility to be active in patients’ advocacy groups. The knowledge about pancreatic cancer, the symptoms of the disease and possible curative or palliative treatments is also very bad among the general population. These are two reasons why pancreatic cancer has not had the rightful attention by politicians and other decision makers. Lately this has changed and there are now several initiatives by patient advocacy groups, health professional organisations and governmental bodies to strengthen awareness, research and funding about pancreatic cancer. In the US the Recalcitrant Cancer Research Act improved the framework for scientific research. In Europe the EU iPAAC Joint Action specifically addresses pancreatic cancer as one of the neglected cancers and with focus on cancer by the EU Commissioner for Research, Science and Innovation, the EU Commissioner for Health and Food safety, and by Europe’s beating cancer plan there is hope that necessary actions will be taken to improve research resources and care for patients with pancreatic cancer.
Article
Full-text available
ECCO essential requirements for quality cancer care (ERQCC) are checklists and explanations of organisation and actions that are necessary to give high-quality care to patients who have a specific tumour type. They are written by European experts representing all disciplines involved in cancer care.
Article
Full-text available
Background: ECCO essential requirements for quality cancer care (ERQCC) are checklists and explanations of organisation and actions that are necessary to give high-quality care to patients who have a specific tumour type. They are written by European experts representing all disciplines involved in cancer care. ERQCC papers give oncology teams, patients, policymakers and managers an overview of the elements needed in any healthcare system to provide high quality of care throughout the patient journey. References are made to clinical guidelines and other resources where appropriate, and the focus is on care in Europe. Colorectal cancer: essential requirements for quality care • Colorectal cancer (CRC) is the second most common cause of cancer death in Europe and has wide variation in outcomes among countries. Increasing numbers of older people are contracting the disease, and treatments for advanced stages are becoming more complex. A growing number of survivors also require specialist support. • High-quality care can only be a carried out in specialised CRC units or centres which have both a core multidisciplinary team and an extended team of allied professionals, and which are subject to quality and audit procedures. Such units or centres are far from universal in all European countries. • It is essential that, to meet European aspirations for comprehensive cancer control, healthcare organisations implement the essential requirements in this paper, paying particular attention to multidisciplinarity and patient-centred pathways from diagnosis, to treatment, to survivorship. Conclusion: Taken together, the information presented in this paper provides a comprehensive description of the essential requirements for establishing a high-quality CRC service. The ECCO expert group is aware that it is not possible to propose a ‘one size fits all’ system for all countries, but urges that access to multidisciplinary units or centres must be guaranteed for all those with CRC.
Article
Full-text available
Background The management of cancer is predicated on the availability and affordability of anticancer therapies, which may be either curative or noncurative. Aim The primary aims of the study were to evaluate (i) the formulary availability of licensed antineoplastic medicines across Europe; (ii) patient out-of-pocket costs for the medications and (iii) the actual availability of the medication for a patient with a valid prescription. Materials and methods The survey tool was based on the previous ESMO studies that addressed the availability and accessibility of opioids for the management of cancer pain. A total of 185 field reporters from 49 countries were invited to participate. The preliminary set of data was posted on the ESMO website for open peer-review, and amendments have been incorporated into the final report. Results There are substantial differences in the formulary availability, out-of-pocket costs and actual availability for many anticancer medicines. The most profound lack of availability is in countries with lower levels of economic development, particularly in Eastern Europe, and these are largely related to the cost of targeted agents approved in the last 10 years. Discrepancies are less profound among medications on the WHO model essential medicines list (EML) for cancer and in curative settings. However, medicine shortages also affect WHO EML medicines, with relevant therapeutic implications for many patients. Conclusions The cost and affordability of anticancer treatments with recent market approval is the major factor contributing to inequity of access to anticancer medications. This is especially true with regards to new medications used in the management of EGFR- or ALK-mutated non-small-cell lung cancer, metastatic melanoma, metastatic renal cell cancer, RAS/RAF wild-type metastatic colorectal cancer, HER2 overexpressed breast cancer and castration-resistant metastatic prostate cancer.
Book
Full-text available
A key output of the European Partnership Action Against Cancer (EPAAC), this report summarises the technical components of an effective and high-qual- ity National Cancer Control Programmes (NCCPs). The report is directed towards policymakers and health system administrators who wish to develop, implement or improve their NCCP, taking into consideration the main verti- cal and horizontal areas for policy action. Three parts (Cancer prevention, In- tegrated care, and Supportive functions within the health system), are divided into 10 chapters, covering the following topics: ...
Article
Purpose: Adjuvant radiation therapy (RT) was shown to improve local control in patients with high-intermediate risk (HIR) stage I endometrial cancer (EC) in randomized trials. Overall survival (OS) was not significantly different with adjuvant RT in these trials or subsequent meta-analyses; however, they were underpowered to assess OS. We used the National Cancer Data Base (NCDB) to examine the impact of adjuvant RT on OS in HIR EC patients. Methods: The NCDB was queried for patients diagnosed with FIGO (2009) Stage I endometrioid adenocarcinoma from 1998 to 2012 who underwent surgery±adjuvant RT. Per ASTRO guidelines, HIR risk was defined as stage IB and/or grade 3. Patients were excluded if: non-surgical primary therapy, RT>180days after surgery, unknown stage/grade/RT status, or RT to targets outside pelvis/vagina. Kaplan-Meier plots and Cox proportional hazards regression were used. Results: 33,600 patients met criteria. 18,070 patients (53.8%) received surgery alone, 15,530 patients (46.2%) received surgery+adjuvant RT. Of patients who received adjuvant RT, 42.2% received external beam RT, 44.7% brachytherapy, and 13.1% received both. 5-year OS was 79.2% for the surgery alone group and 83.3% for the surgery+adjuvant RT (p<0.0001). On multivariate analysis, adjuvant RT was independently associated with improved OS vs. surgery alone (HR 0.7; 95% CI 0.8-0.9, p<0.0001). Conclusions: Our results show that surgery+adjuvant RT was associated with a statistically significant 4.1% improvement in 5-year OS vs. surgery alone in stage I HIR EC. This data along suggests that the improvement in local control with adjuvant RT leads to improved OS.
Article
High profile device failures have highlighted the inadequacies of current regulation. Art Sedrakyan and colleagues call for a move to a graduated model of approval and suggest a framework to achieve this goal Implantable devices such as pacemakers and hip implants have transformed many lives, but there have also been high profile instances of harm.1 2 3 4 5 Unlike the system for drugs, marketing approval for devices in the European Union and the United States has historically focused on proof of safety as a minimum requirement, and approval could be granted based on preclinical evidence alone, with no randomised clinical trials (fig 1⇓). In both jurisdictions, recent years have seen some tightening of requirements. In the US, more invasive devices now generally require a rigorous “pivotal” clinical trial either through the FDA’s pre-market approval (PMA) pathway or within the 510k pathway. In the EU, the CE mark requirements are being moved in a similar direction by the evolving medical device reform (MDR) programme. Fig 1 Simplified flowcharts showing approval process for invasive medical devices in the European Union and United States Despite these improvements, both systems dichotomise device status as either pre-market (not yet approved) or post-market (approved), so removing incentives for fuller evaluation and reporting at both early and later stages in the evolution of the device. A system in which data requirements for device approval and surveillance can be matched to the device’s stage of development, known as total product life cycle evaluation,6 would encourage better evidence development and reporting both before and after a pivotal trial, in much the same way that the Kefauver-Harris Amendment 1962 did for medicines after thalidomide.7 While the total product life cycle idea is attractive in principle, there has been little guidance on implementation. The IDEAL (Idea, …
Article
Confronted with the different clinical impacts of different treatments, the rising cost of cancer care, and the financial burden of high drug prices, several influential professional organizations have developed models with which to assess the clinical benefit and value of cancer treatment regimens. The goal is a system of valuing patient therapies that is aligned with the beneficial impact to the patient and society and that moves away from a fixed cost regardless of clinical circumstances.