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Value-based healthcare in Spain
Regional experimentation in a
shared governance setting
A report from The Economist Intelligence Unit
1© The Economist Intelligence Unit Limited 2015
Value-based healthcare in Spain Regional experimentation in a shared governance setting
Contents
About this report 2
Introduction 3
Chapter 1: A system with high levels of regional autonomy 4
Chapter 2: Finding more consistent ways to measure value 9
Conclusion 11
2 © The Economist Intelligence Unit Limited 2015
Value-based healthcare in Spain Regional experimentation in a shared governance setting
About this
report
Value-based healthcare in Spain: Regional experimentation in
a shared governance setting is an Economist Intelligence Unit
(EIU) report, commissioned by Gilead Sciences, which looks at
health outcomes of treatment relative to cost. In this particular
paper, The EIU looks at the structure of Spanish healthcare
delivery, the process of making healthcare more accountable in
Spain, and the growth and adoption of value-based measures.
In September-October 2015 The EIU conducted three
interviews with senior healthcare executives and academics;
the insights from these experts on value-based healthcare
in Spain appear throughout the report. The EIU would like to
thank the following interviewees (listed alphabetically) for
sharing their insight and experience:
 José Maria Argimon, director, Catalan Agency for Health
Information, Assessment and Quality (Agencia de Qualitat i
Avalució Sanitaries de Catalunya, or AQuAS)
 Rafael Bengoa, director, Health Department, Deusto
Business School, Bilbao
 Guillem López-Casasnovas, professor of public finance and
founder and director of the Centre for Research in Health and
Economics, University Pompeu Fabra, Barcelona; member of
the board of directors, Spanish Central Bank
The EIU bears sole responsibility for the content of this
report. The findings and views expressed in the report do not
necessarily reflect the views of the sponsor. Andrea Chipman
was the author of the report, and Martin Koehring was the
editor.
October 2015
3© The Economist Intelligence Unit Limited 2015
Value-based healthcare in Spain Regional experimentation in a shared governance setting
Introduction
Spain’s 1978 constitution established the
framework for the decentralisation of the
country’s National Health System from the
central government in Madrid to the regional
health services of the country’s 17 autonomous
communities and two autonomous cities.1
Rising
healthcare costs, concerns about efficiency in
healthcare provision and a desire to streamline the
process of introducing new health technologies
were the main drivers behind the introduction of
health technology assessment (HTA) in the 1980s.2
Although Spain’s Ministry of Health, Social Services
and Equality continues to co-ordinate broader
healthcare priorities and set pharmaceutical
policy—including assessment, authorisation and
pricing—it has transferred significant power over
financing, planning and management of healthcare
to the country’s regions since 1981. While the
Ministry of Health sets pharmaceutical policy, the
regions run their own health budgets, with a degree
of co-operation and sharing of best practices
and HTA between them. However, just a few of
them have taken the lead in experimenting with
initiatives in transparency, shared decision-making
between doctors and patients, and a greater role
for population management.
Meanwhile, as power has devolved from Madrid
to the ministries of health in the regional
governments, the regions have also taken on more
responsibility for the appraisal of treatments and
care pathways, and for final price negotiations with
drug manufacturers. This gradual process has seen
regional health departments take on responsibility
for between 30% and 40% of regional governments’
total annual budgets.3
Spain’s total (public and private) health
expenditure as a proportion of GDP was 8.9% in
2013, the last year for which data are available,
compared with 9.6% in 2010, according to the
World Bank,4
with just under €10bn (US$11bn) of
cuts in the healthcare budget in the four years from
2009 to 2013.5
Meanwhile, the country has made
€4.3bn in savings on pharmaceutical expenditure
since 2012.6
A key catalyst of healthcare reforms over the past
few decades has been cost containment, with four
royal decrees in two years dedicated to reducing
expenditure. However, there has been little
assessment of the value of what the health system
is buying, according to Guillem López-Casasnovas,
professor of political economy and founder of the
Centre for Research in Health and Economics at the
University Pompeu Fabra in Barcelona.
This paper will show that the process of making
healthcare more accountable in Spain is
evolving in a number of intriguing ways, yet the
growth and adoption of value-based measures
remain fragmented, in large part owing to the
decentralised administration of healthcare in the
country. While on the one hand the system enables
flexibility for innovation in the regions, on the
other hand it also makes it more difficult to roll this
out on a national level.
1
International Society
for Pharmacoeconomics
and Outcomes Research
(ISPOR), ISPOR Global
Health Care Systems Road
Map: Spain – Pharmaceuti-
cal, 2009. Available at:
https://www.ispor.org/
HTARoadMaps/Spain.asp.
2
Sampietro-Colom, L, Asua,
J et al, “History of health
technology assessment:
Spain,” International
Journal of Technology As-
sessment in Health Care,
25 Supplement 1 (2009),
p. 163.
3
Healthcare information
and Management Systems
Society (HiMSS), Strategic
Interoperability in Germany,
Spain & the UK: The Clinical
and Business Imperative for
Healthcare Organisations,
May 26th 2014, p. 7.
4
http://data.worldbank.
org/indicator/SH.XPD.
TOTL.ZS.
5
Lamata, F, “Gasto Sani-
tario Público: 10.000 mil-
lones menos en cuatro años
¿había (hay) alternativas?”,
March 15th 2015. Available
at: http://fernandolamata.
blogspot.com.es/2015/03/
gasto-sanitario-publico-
10000-millones.html
6
Ministerio de Sanidad,
Servicios Sociales e Igual-
dad, “El gasto farmacéutico
se mantiene estable en el
año 2014 y se consolida
el ahorro para el Sistema
Nacional de Salud”, Janu-
ary 30th 2015. Available
at: http://www.msssi.gob.
es/gabinete/notasPrensa.
do?id=3542
4 © The Economist Intelligence Unit Limited 2015
Value-based healthcare in Spain Regional experimentation in a shared governance setting
Chapter 1: A system with high levels
of regional autonomy1
The evolution of HTA in Spain
The history of health technology assessment
(HTA) in Spain dates back to the late 1980s,
with its introduction driven—as in many
other European countries—by the increase in
healthcare costs and worries about the efficiency
of healthcare provision and the rationalisation
of the introduction of new technologies.7
In
Spain HTA takes place at three different levels:
at the national level, to define a common benefit
package for devices and treatments excluding
pharmaceuticals; at the national level, for
pharmaceuticals; and at the regional level.8
At the national level, the Spanish Agency for
Medicines and Healthcare Products (Agencia
Española de Medicamentos y Productos
Sanitarios, or AEMPS) is responsible for the
authorisation and classification of new medicines.
Since 2013 AEMPS has prepared so-called
national therapeutic positioning reports, in
which the clinical benefits, level of innovation
and positioning in therapy of a new drug are
evaluated.9
Drugs assessment falls under the remit of the
General Directorate for Pharmacy and Medicinal
Products, which is part of the Ministry of Health
and is responsible for setting pharmaceutical
policy.10
The General Directorate also evaluates
drugs before market entry and assesses them
based on a range of criteria, including the
severity of indications, the usefulness of
medicines, patient requirements, the rationality
of costs, the existence of therapeutic options and
the degree of innovation.11
The inter-ministerial pricing committee (Comisión
Interministerial de Precios de los Medicamentos,
or CIPM)—which includes officials from the
Ministry of Health, the Ministry of Economy and
Finance and the Ministry of Industry, Tourism and
Trade—deals with reimbursement and pricing,
and sets maximum ex-factory prices for every
medicine, including generics. Since March 2012
the regions have been members of the pricing
committee, with two regional representatives
rotating every six months. Like similar bodies
in other European countries, they take cost,
efficacy, safety and need into account when
determining the coverage of “curative care” for
both outpatient and inpatient services. Unlike in
Germany and England, which are often used as
references, however, the Spanish authorities do
not consistently evaluate cost-effectiveness or
budget impacts.12
Pricing in other European countries is used as a
reference for innovative medicines. In practice,
therefore, although the national government
defines the common basket of products, the
trend in recent years has been to use the lowest
7
Sampietro-Colom et al,
History of health technology
assessment: Spain, p. 163.
8
ISPOR Global Health Care
Systems Road Map: Spain
– Pharmaceutical, 2009.
Available at: https://www.
ispor.org/HTARoadMaps/
Spain.asp.
9
Quintiles, HTA Uncovered,
Issue No. 1, May 2013.
Available at: http://www.
quintiles.com/~/media/li-
brary/fact%20sheets/hta-
uncovered-may-2013-final.
pdf
10
Pharmaceutical Health
Information System, PHIS
Pharma Profile Spain 2010.
Available at: http://whocc.
goeg.at/Literaturliste/Do-
kumente/CountryInforma-
tionReports/Spain_PHIS_
PharmaProfile_2010.pdf
11
Ibid.
12
Garrido, MV, Kristensen,
FB et al, Health Technol-
ogy Assessment and Health
Policy-Making in Europe:
Current status, challenges
and potential, European
Observatory on Health
Systems and Policies,
Observatory Studies Series
No 14, 2008, p. 74. Avail-
able at: http://www.euro.
who.int/__data/assets/
pdf_file/0003/90426/
E91922.pdf?ua=1.
5© The Economist Intelligence Unit Limited 2015
Value-based healthcare in Spain Regional experimentation in a shared governance setting
European price as a reference. The decision on
price and reimbursement of a new drug must be
taken within 180-270 days in Spain; however, in
practice it has taken longer in recent years—the
process of setting prices took 431 days on average
in 2013, for example.13
For drugs used in hospital settings, funding
of medicines is covered by regional/hospital
budgets, and the Ministry of Health decides on an
official maximum price to be reimbursed by the
National Health Service. Regions may apply for
specific reimbursement conditions
But while this structure provides an initial
pricing framework, regional health services and
hospitals may negotiate lower unit prices or risk-
sharing agreements, as in the case of Catalonia
and Valencia, for example. It is this degree of
flexibility that has given the regions an especially
powerful role in recent years.14
“European reference pricing is something that is
looked at on the national level,” says Professor
López-Casasnovas. “There is an inter-ministerial
committee on prices, but it doesn’t guarantee
what unit price pharma will get; regions are able
to negotiate volumes according to discounts
because they can decide on prescription levels.”
In practice, therefore, although the national
government defines the common basket of
products the Spanish National Health Service
will cover, the regions have significant leeway to
add services and products. Moreover, the process
of HTA itself further illustrates some of the
fragmentation within the Spanish system.
Fragmentation
The number of agencies having some
responsibility for HTA in Spain is extensive, in
some cases contributing to an overlapping of
responsibilities and a sense of fragmentation.
The Spanish Agency for HTA (Agencia de
Evaluación de Tecnologias Sanitarias, or AETS),
which was established in 1994, primarily
evaluates equipment, devices, surgical and
medical procedures and issues HTA reports
commissioned by the government or government-
related agencies. Assessment criteria include
social, economic and ethical dimensions of the
technology or procedure.
Despite the existence of separate healthcare
infrastructures in all autonomous regions,
only seven—Madrid, Andalusia, the Basque
Country, Catalonia, Galicia, the Canary Islands
and Aragon—have set up their own regional HTA
agencies. Other regions have units for planning
and advice on decision-making, which in some
cases includes a degree of HTA evaluation. An
overview of the regional HTA agencies is given
below.
Aragon’s Institute of Health Sciences (Instituto
Aragonés de Ciencias de la Salud, or IACS) does
not carry out formal evaluation activities, but it
does conduct some HTA-related projects, and its
new government has announced plans to create a
dedicated HTA agency.
13
Pinyol, C, Valmaseda, A et
al, “Duración del proceso de
financiación en España de los
fármacos innovadores aprobados
por la Agencia Europea del Me-
dicamento. 2008-2013”, Revista
Española de Salud Pública, Vol. 89
No. 2, March/April 2015, pp. 89-
200. Available at: http://scielo.
isciii.es/scielo.php?pid=S1135-
57272015000200007&script=sci_
arttext&tlng=es#bajo
14
Pharmaceutical Health
Information System, PHIS
Pharma Profile Spain 2010.
Region Regional HTA agency Launch
Catalonia Catalan Agency for Health Information, Assessment and Quality (Agencia de
Qualitat i Avalució Sanitaries de Catalunya, or AQuAS), formerly the Catalan
Agency for Health Technology Assessment and Research
1991
Basque Country Basque Office for Health Technology Assessment (OSTEBA) 1992
Canary Islands HTA Unit of the Canary Islands (Servicio Canario de Salud, or SESCS) 1993
Andalusia Andalusian Agency for Health Technology Assessment (Agencia de Evaluación
de Tecnologias Sanitarias de Andalucía, or AETSA)
1996
Galicia Galician Agency for Health Technology Assessment (Axencia de Avaliación de
Tecnoloxías Sanitarias de Galicia, or AVALIA-T)
1999
Madrid Unit for Health Technology Assessment (Unidad de Evaluación de Tecnologias
Sanitarias (UETS)
2003
6 © The Economist Intelligence Unit Limited 2015
Value-based healthcare in Spain Regional experimentation in a shared governance setting
The regional agencies, like their national
equivalents, primarily evaluate equipment,
devices and surgical or medical procedures,
although some are involved in drugs evaluation,
notably AQuAS, which co-ordinates the
Committee for the Assessment of Hospital Use of
Drugs. Some of the regional agencies—including
AETSA, OSTEBA, and AVALIA-T—also produce
clinical practice guidelines. In the case of OSTEBA,
AETS, AETSA and AVALIA-T, the agencies also
undertake some horizon-scanning of emerging
technologies.15
A virtual network of the Spanish Agency for HTA
and the six regional agencies, known as AuNETS,
was formed in 2007 to provide high levels of
co-ordination and specialisation and support the
trend for the devolution of HTA from government-
linked agencies to hospital-based HTA. However,
the system still operates largely in an advisory
capacity and could play a stronger role as an
independent body, according to Rafael Bengoa,
director of the health department at Deusto
Business School in Bilbao and a former minister
of health and consumer affairs in the Basque
regional government.
“In the past three to four years those units have
begun to get together as a network, dividing the
work among themselves and providing advice to
ministers,” Dr Bengoa says, adding: “I can’t yet
say that the Spanish system has teeth.”
José Maria Argimon, director of AQuAS, also
observes that although the network’s advice
runs the gamut from what type of medicines are
covered to what types of patients will be treated—
and includes devices, processes, diagnoses and
clinical practices—its recommendations are not
binding at the national level.
Public hospitals, meanwhile, have their own
annual budgets set by the health department in
each region, which can be used to “rationalise
the introduction and diffusion of technologies”.16
Hospitals also have pharmaco-therapeutic
commissions, with those in teaching and high-
technology hospitals especially likely to be in
charge of advising on the purchase of big-ticket
drugs. They also assess the added value of
innovative drugs approved by the Spanish Agency
for Medicines and Healthcare Products after a
review of the evidence regarding safety, efficacy
and cost.17
On top of these agencies, every region
has a regional drug committee.
Recent efforts to refine this process include the
establishment by the Spanish Society of Hospital
Pharmacies of GENESIS (Grupo de Evaluación de
Novedades, Estandarización e Investigación en
Selección de Medicamentos), a working group
which aims to standardise a methodology for
evaluating the added value of hospital drug
innovations approved by the Spanish Agency for
Medicines and Healthcare Products. GENESIS
includes hospitals from 11 autonomous regions,
and there is a similar initiative to assess and
control the added value of innovative drugs at
the primary-care level. This project, known as the
mixed committee for the evaluation of new drugs,
is co-ordinated among five regions: Aragon,
Andalusia, Catalonia, Navarra and the Basque
Country.
In the case of pharmaceutical products, Spain
looks especially to the UK’s National Institute
for Health and Care Excellence (NICE) as a model
for its assessment decisions, according to those
interviewed for this report. However, unlike
NICE, which assesses cost-effective medicines
and treatments as those that cost no more than
£20,000-30,000 (US$31,000-46,000) per quality-
adjusted life-year (QALY), Spain stops short of
establishing a formal cut-off point for measuring
cost-effectiveness.
Regional differences and
experimentation
As mentioned above, six of Spain’s 17 regions
have taken the lead in setting up their own health
assessment units and taking more decisions on
healthcare planning and policy at the regional
level. Yet even within this self-selected group
there is a significant degree of difference in policy
outcomes, whether as a result of the dominant
16
Sampietro-Colom et al,
History of health technology
assessment: Spain, p. 165.
17
Ibid.
15
Garrido et al, Health
Technology Assessment and
Health Policy-Making in
Europe, p. 94.
7© The Economist Intelligence Unit Limited 2015
Value-based healthcare in Spain Regional experimentation in a shared governance setting
political party in the regional government or
because regional health authorities take into
account the leverage of industry in the region.
These considerations are becoming increasingly
important in price negotiations between
pharmaceutical companies and the regions.
“At the final step, after prescription levels are
assessed by the regional authorities, there is a
process that means strong bargaining between
the authorities and pharma on a regional
basis over rebates,” explains Professor López-
Casasnovas.
This process for setting prices can lead to a
number of anomalies, including the fact that
while there may be transparency over price at the
national level, the determination of unit cost of a
given drug depends on the regional authorities,
including the extent to which the medicine is used
in hospitals and what volumes will be required.
“Authorisation and pricing at the national level
were formerly more important, but they are
not really so important these days,” Professor
López-Casasnovas adds. “Whatever you are
doing in volume, prescription and appraisal
in reimbursement is more important.” In
this respect, he says, four regional health
authorities—Catalonia, Madrid/Valencia,
Andalusia and the Basque Country—are most
influential, with the other regions largely
following their lead. “Whatever the national
government sets, it is not the final price,” he
explains.
Ironically, Professor López-Casasnovas notes,
Spain’s decentralised system can be beneficial to
both sides of the negotiations: taxpayers benefit
because manufacturers can no longer determine a
final price by lobbying the Ministry of Health, but
must instead negotiate individually with at least
the largest regions.
But the system also holds advantages for
pharmaceutical companies, he observes. “They
might go for a regional authority that sees
things closer to the way they do,” he points out,
noting that the most pioneering regions, such as
Catalonia, investigate the degree of therapeutic
innovation and efficacy, with the potential for
drug makers to increase prices by as much as
15% for the most innovative products. “If they
can prove that the drug works the way they
say it does, they may show the regions why the
treatment should be a standard.”
This leads to a wide degree of flexibility in the way
regional governments deal with pharmaceutical
suppliers, with some negotiating risk-sharing
agreements and others preferring to base their
own discussions on unit pricing on agreements
reached by neighbouring regional governments.
Catalonia currently has nearly 16 risk-sharing
agreements in place, according to Dr Argimon of
AQuAS.
In addition to enhancing local decision-making
on the adoption of innovative treatments, the
devolution of healthcare funding and policy has
led to a significant degree of experimentation to
try to enhance medical outcomes and value.
This is most notable in Catalonia, which has
Spain’s oldest regional HTA agency. In 2012
AQuAS introduced a number of programmes aimed
at making it easier for Catalan health officials to
measure outcomes, the first of which is designed
to try to reduce overdiagnosis and overtreatment
within the healthcare system.
“Today, there is enough evidence to show that,
within clinical practice, there are procedures that
do not add value,” explains Dr Argimon. Taking
the example of patients who receive X-rays or
magnetic resonance imaging (MRI) scans for pain
despite having no neurological symptoms, he
notes that there are some 40,000 such procedures
carried out in Catalonia every year, costing a
total of €700,000. Eliminating those that are
unnecessary “can free up resources to fund a
primary-care team or 280 knee replacements,” he
adds. AQuAS operates the project in collaboration
with scientific societies and healthcare providers,
so all recommendations are evidence-based and
quantifiable.
8 © The Economist Intelligence Unit Limited 2015
Value-based healthcare in Spain Regional experimentation in a shared governance setting
One example of an area in which new guidelines
have helped to reduce unnecessary expenditure
is AQuAS’s decision to recommend that doctors
should no longer prescribe bisphosphonates to
post-menopausal women with a low risk of bone
fractures. In the year after the guideline was
changed the number of women over 50 treated
with bisphosphonates for more than five years fell
by 28%, equivalent to savings of €8m, according
to Dr Argimon.
Also since 2012, AQuAS has been publishing the
results of 90 indicators relating to outcomes,
including mortality, nosocomial (hospital-
acquired) infections, surgical complications
and patient satisfaction in an effort to make the
Catalan region’s healthcare system as transparent
as possible. The project, known as the Outcomes
Report (Central de Resultats) of the Catalan
healthcare system, will introduce patients’ views
as an additional indicator later this year, Dr
Argimon says. In previous reports patients had
suggested that indicators related to services
received, such as waiting-room comfort or
information on waiting times, were of the greatest
interest. The project is now hoping to ask citizens
about other indicators they are likely to find most
useful.
“For policymakers and health managers, the
mortality rate or the number of nosocomial
infections are good indicators of the quality of the
health system; however, these indicators may not
be useful for patients,” he adds.
The information appears on the region’s website
in an open-data format, meaning that patients
in Santander can access information to compare
their hospitals with those in Barcelona. “The idea
is that benchmarking is the best way of improving
our healthcare,” Dr Argimon explains, adding
that although it is too soon to expect changes in
patient behaviour, the Outcomes Report is likely
to increase transparency and strengthen citizen
participation.
The project does not just involve publication
of data, but also meetings between different
hospitals, in which specialists in areas such as
cardiovascular medicine or cancer can evaluate
and refine the indicators, as well as having
the opportunity to adopt different methods of
patient management for replication in their own
institution. It also identifies care models that are
shared between healthcare-system stakeholders
through an open innovation collaboration
platform.
“One hospital may say it’s not necessary to do a
pre-surgical visit for anaesthesia because there is
a lot of information coming from clinical records,”
Dr Argimon says. “If a small hospital in Catalonia
puts it in the platform, others are copying the idea
and allowing a sharing of best practices.”
The More Value to the Health Information in
Catalonia Project (VISC+) is another initiative
introduced with the goal of making better use of
data. VISC+ collects all the information gathered
by the Catalan healthcare system in one database,
anonymously and securely, in order to improve
the quality of research, accelerate innovation and
increase the quality of healthcare. “The amount
of data digitally collected is vast, and I think the
data will change the way healthcare services are
provided,” Dr Argimon comments.
A third project, launched earlier this year and
building on a similar programme pioneered in the
Canary Islands region, is designed to encourage
patients to share in decision-making about their
own treatment with physicians by providing them
with the tools and knowledge to make their own
decisions.
“We launched this project with patient
associations, with clinical teams giving patients
information and trying to make them reflect
on different possible treatments, including
personal preferences, side effects and so forth,”
Dr Argimon explains. The project has focused on
diseases where there are several potential courses
of action, including prostate cancer and kidney
disease, and is expected to extend to breast
cancer and hip replacements by the end of the
year, he adds.
9© The Economist Intelligence Unit Limited 2015
Value-based healthcare in Spain Regional experimentation in a shared governance setting
While Spain’s regions have begun to pioneer ways
of extracting greater value from their healthcare
investments and are sharing best practices
accordingly, some of those interviewed say the
system needs to develop better measures of value
and learn how this can be best delivered.
In the Basque Country, policy experts are
increasingly looking abroad for models that
can help them create such a system, according
to Dr Bengoa, who is also an adviser to the
Socialist Party ahead of the general election in
December 2015. As a former health minister,
he says he designed a programme for treating
chronic diseases that involved much more
integrated delivery of care. He adds that he and
his colleagues were particularly interested in
the evolution of accountable care organisations
(ACOs), which emphasise greater integration of
healthcare provision as part of a co-ordinated
approach to healthcare and are increasingly
gaining traction in the US.
In his region, Dr Bengoa points out, policymakers
see the value of using HTA to review not
only healthcare itself, but also population
management, in which preventative care
is a crucial element of overall healthcare
management. “We are moving towards local
integrated care organisations,” he adds. “Once
they are organised and you have primary care
connected to hospital care, you have an area for
responsibility for the health—and not only the
healthcare—of the population.”
Dr Bengoa notes that reforming the Spanish
system could include lessons from the Triple Aim
Initiative for optimising healthcare, developed
in the US by the Institute for Healthcare
Improvement (IHI) in Cambridge, Massachusetts.
The initiative consists of improving the patient
experience of care, improving the health of
populations, and reducing the per-capita cost of
healthcare.18
Stronger focus on value
“The interesting thing about value-based
healthcare is that commissioners are beginning
to be interested in this,” says Dr Bengoa. “Before,
commissioners were buying traditional services
and activities, and now they are realising that
they don’t know what they are getting. They want
value from providers.”
Looking more closely at the HTA agenda, he
adds, it becomes clear that if it remains within
the existing framework—with fragmented care,
delivery and financing—the triple aim will be
impossible to achieve. “The change is radical at
both the financing and the delivery level, but we
have to be able to get the delivery model going,”
he points out.
Chapter 2: Finding more consistent
ways to measure value2
18
Institute for Healthcare
Improvement, IHI Triple
Aim Initiative. Available at:
http://www.ihi.org/en-
gage/initiatives/TripleAim/
Pages/default.aspx.
10 © The Economist Intelligence Unit Limited 2015
Value-based healthcare in Spain Regional experimentation in a shared governance setting
Spain already has some of the tools it needs
to implement such a system, Dr Bengoa says,
including the ability to stratify populations,
electronic medical records, electronic
prescriptions and use of telemedicine. A recent
report by Accenture, a consultancy, found
that Spain was among the top scorers of eight
countries on its Connected Health Maturity
Index, with one of the highest rates of healthcare
IT adoption and health information exchange for
both primary and secondary care.19
Moreover, a white paper on interoperability by
the Healthcare Information and Management
Systems Society (HiMSS), a global non-profit
organisation, found that more than 93% of
Spanish hospitals had interoperable systems,
with 89% interoperable across multiple
locations and 62% interoperable with other
organisations. This is due to that fact that around
95% of IT budgets are in the hands of regional
authorities.20
Opportunities in greater transparency
and consistency
Models of how more consistent healthcare
delivery might look can be found in the
approaches that have been adopted in a
comprehensive way at the national level. In
the case of Hepatitis C, Spain has a detailed
national plan that co-ordinates the collection
of epidemiological data about the disease and
patient outcomes, provides for the sharing of
information between regions, and explicitly
spells out how different patient populations
should be treated.21
Finding a way of creating greater consistency
in the appraisal and pricing of pharmaceutical
products at the regional level could also be
an advantage, according to Professor López-
Casasnovas. He says, however, that even at the
regional level “very few agencies go for their
own evaluation in terms of cost-effectiveness,”
although some agencies do some meta-analyses
of drug performance or look at evidence sets
from external bodies such as the Cochrane
Collaboration.22
Both Dr Bengoa and Dr Argimon say that the
lack of transparency about how decisions are
made and the unwillingness to acknowledge
where difficult choices are being made remain a
key problem. “We need to make these decisions
like NICE does, available to the public, so tough
decisions can be made,” Dr Argimon emphasises.
Spain also has an opportunity to increase its use
of generic or biosimilar drugs, with a generic
penetration rate of just 38% measured in
volume,23
compared with 67% in the UK.24
“We
need to identify a new delivery system that is
sustainable in economic terms and improves
quality,” Dr Bengoa says. “The decentralised
system makes it easier, because I don’t think it is
going to happen at the national level.”
Developing a more independent HTA system
would also help, although it is likely to face
opposition from entrenched political interests,
according to Professor López-Casasnovas.
“Politicians do not want to be subjected to these
recommendations; so far, their policies have been
fully discretionary, and they don’t want to lose
that.” He notes, however, that the uncertainty
surrounding the upcoming general election in
Spain creates a window of opportunity for those
looking to establish a system similar to the
UK’s NICE or Germany’s Institute for Quality and
Efficiency in Healthcare (IQWIG) at the regional
or the national level, “because they need some
sort of formal proceeding for cost-effectiveness
priority-setting to weaken the otherwise costly
political battle over healthcare.”
19
Accenture, Making the
case for Connected Health:
Accenture study explore the
future of integrated health-
care delivery, February
2012, p. 6.
20
HiMSS, Strategic Interop-
erability in Germany, Spain
& the UK; p. 7.
21
Ministry of Health, Social
Services and Equality, Stra-
tegic Plan to Tackle Hepatitis
C in the National Health
System, May 21st 2015.
22
Cochrane, About us,
Who we are. Available
at: http://community.
cochrane.org/about-us
23
Spanish Generic Medi-
cines Association (AESEG),
“The Value of Generic
Medicines”. Available at:
http://www.aeseg.es/
en/the-value-of-generic-
medicines#
24
British Generic Manu-
facturers Association
(BGMA), “British Generic
Manufacturers Association
Overview”. Available at:
http://www.britishgener-
ics.co.uk/
11© The Economist Intelligence Unit Limited 2015
Value-based healthcare in Spain Regional experimentation in a shared governance setting
point, because it means that policymakers are not
deciding based on evidence.”
There are some encouraging signs that change
is on the cards. Spanish regional experiments
suggest that a willingness to re-evaluate
ineffective treatments, involve patients in
decision-making and commit to a greater
integration of healthcare provision are just some
of the ways in which the country could help to
enhance value.
The experts interviewed for this paper agree
that, looking ahead, mounting health costs and
a greater emphasis on value measures in other
developed economies will lead to increased
pressure for Spanish health authorities to
measure value as a proportion of cost more
widely. These trends, they say, are likely to drive
the development of a home-grown, centralised
national body with the authority to make difficult
funding choices in a more transparent and
consistent way.
Spain’s decentralised health and HTA system
has allowed for significant innovation and the
sharing of best practices, but the level of regional
autonomy has contributed to both a lack of
consistency and an absence of transparency.
And although the system enables flexibility
for innovation in regions, it also makes it more
complicated to roll this out on a national level
and regional equity access is crucial.
Moreover, while Spanish agencies look at patient
experiences and efficacy when assessing medical
treatments, devices and care pathways, decisions
have largely been framed by cost-containment
pressures, with little effort so far to measure
cost-effectiveness.
As Dr Bengoa explains: “Although we have
the infrastructure to do fairly sophisticated
assessments of both drugs and new technologies,
and those units produce important results
that are even being used internationally, the
connection between that advice and the policy
decision being taken is not well made. It’s a big
Conclusion
While every effort has been taken to verify the
accuracy of this information, The Economist
Intelligence Unit Ltd. cannot accept any
responsibility or liability for reliance by any person
on this report or any of the information, opinions
or conclusions set out in this report.
LONDON
20 Cabot Square
London
E14 4QW
United Kingdom
Tel: (44.20) 7576 8000
Fax: (44.20) 7576 8500
E-mail: london@eiu.com
NEW YORK
750 Third Avenue
5th Floor
New York, NY 10017
United States
Tel: (1.212) 554 0600
Fax: (1.212) 586 1181/2
E-mail: newyork@eiu.com
HONG KONG
1301 Cityplaza Four
12 Taikoo Wan Road,
Taikoo Shing
Hong Kong
Tel: (852) 2585 3888
Fax: (852) 2802 7638
E-mail: hongkong@eiu.com
GENEVA
Rue de l’Athénée 32
1206 Geneva
Switzerland
Tel: (41) 22 566 2470
Fax: (41) 22 346 93 47
E-mail: geneva@eiu.com

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Value-based healthcare in Spain

  • 1. SPONSORED BY: Value-based healthcare in Spain Regional experimentation in a shared governance setting A report from The Economist Intelligence Unit
  • 2. 1© The Economist Intelligence Unit Limited 2015 Value-based healthcare in Spain Regional experimentation in a shared governance setting Contents About this report 2 Introduction 3 Chapter 1: A system with high levels of regional autonomy 4 Chapter 2: Finding more consistent ways to measure value 9 Conclusion 11
  • 3. 2 © The Economist Intelligence Unit Limited 2015 Value-based healthcare in Spain Regional experimentation in a shared governance setting About this report Value-based healthcare in Spain: Regional experimentation in a shared governance setting is an Economist Intelligence Unit (EIU) report, commissioned by Gilead Sciences, which looks at health outcomes of treatment relative to cost. In this particular paper, The EIU looks at the structure of Spanish healthcare delivery, the process of making healthcare more accountable in Spain, and the growth and adoption of value-based measures. In September-October 2015 The EIU conducted three interviews with senior healthcare executives and academics; the insights from these experts on value-based healthcare in Spain appear throughout the report. The EIU would like to thank the following interviewees (listed alphabetically) for sharing their insight and experience:  José Maria Argimon, director, Catalan Agency for Health Information, Assessment and Quality (Agencia de Qualitat i Avalució Sanitaries de Catalunya, or AQuAS)  Rafael Bengoa, director, Health Department, Deusto Business School, Bilbao  Guillem López-Casasnovas, professor of public finance and founder and director of the Centre for Research in Health and Economics, University Pompeu Fabra, Barcelona; member of the board of directors, Spanish Central Bank The EIU bears sole responsibility for the content of this report. The findings and views expressed in the report do not necessarily reflect the views of the sponsor. Andrea Chipman was the author of the report, and Martin Koehring was the editor. October 2015
  • 4. 3© The Economist Intelligence Unit Limited 2015 Value-based healthcare in Spain Regional experimentation in a shared governance setting Introduction Spain’s 1978 constitution established the framework for the decentralisation of the country’s National Health System from the central government in Madrid to the regional health services of the country’s 17 autonomous communities and two autonomous cities.1 Rising healthcare costs, concerns about efficiency in healthcare provision and a desire to streamline the process of introducing new health technologies were the main drivers behind the introduction of health technology assessment (HTA) in the 1980s.2 Although Spain’s Ministry of Health, Social Services and Equality continues to co-ordinate broader healthcare priorities and set pharmaceutical policy—including assessment, authorisation and pricing—it has transferred significant power over financing, planning and management of healthcare to the country’s regions since 1981. While the Ministry of Health sets pharmaceutical policy, the regions run their own health budgets, with a degree of co-operation and sharing of best practices and HTA between them. However, just a few of them have taken the lead in experimenting with initiatives in transparency, shared decision-making between doctors and patients, and a greater role for population management. Meanwhile, as power has devolved from Madrid to the ministries of health in the regional governments, the regions have also taken on more responsibility for the appraisal of treatments and care pathways, and for final price negotiations with drug manufacturers. This gradual process has seen regional health departments take on responsibility for between 30% and 40% of regional governments’ total annual budgets.3 Spain’s total (public and private) health expenditure as a proportion of GDP was 8.9% in 2013, the last year for which data are available, compared with 9.6% in 2010, according to the World Bank,4 with just under €10bn (US$11bn) of cuts in the healthcare budget in the four years from 2009 to 2013.5 Meanwhile, the country has made €4.3bn in savings on pharmaceutical expenditure since 2012.6 A key catalyst of healthcare reforms over the past few decades has been cost containment, with four royal decrees in two years dedicated to reducing expenditure. However, there has been little assessment of the value of what the health system is buying, according to Guillem López-Casasnovas, professor of political economy and founder of the Centre for Research in Health and Economics at the University Pompeu Fabra in Barcelona. This paper will show that the process of making healthcare more accountable in Spain is evolving in a number of intriguing ways, yet the growth and adoption of value-based measures remain fragmented, in large part owing to the decentralised administration of healthcare in the country. While on the one hand the system enables flexibility for innovation in the regions, on the other hand it also makes it more difficult to roll this out on a national level. 1 International Society for Pharmacoeconomics and Outcomes Research (ISPOR), ISPOR Global Health Care Systems Road Map: Spain – Pharmaceuti- cal, 2009. Available at: https://www.ispor.org/ HTARoadMaps/Spain.asp. 2 Sampietro-Colom, L, Asua, J et al, “History of health technology assessment: Spain,” International Journal of Technology As- sessment in Health Care, 25 Supplement 1 (2009), p. 163. 3 Healthcare information and Management Systems Society (HiMSS), Strategic Interoperability in Germany, Spain & the UK: The Clinical and Business Imperative for Healthcare Organisations, May 26th 2014, p. 7. 4 http://data.worldbank. org/indicator/SH.XPD. TOTL.ZS. 5 Lamata, F, “Gasto Sani- tario Público: 10.000 mil- lones menos en cuatro años ¿había (hay) alternativas?”, March 15th 2015. Available at: http://fernandolamata. blogspot.com.es/2015/03/ gasto-sanitario-publico- 10000-millones.html 6 Ministerio de Sanidad, Servicios Sociales e Igual- dad, “El gasto farmacéutico se mantiene estable en el año 2014 y se consolida el ahorro para el Sistema Nacional de Salud”, Janu- ary 30th 2015. Available at: http://www.msssi.gob. es/gabinete/notasPrensa. do?id=3542
  • 5. 4 © The Economist Intelligence Unit Limited 2015 Value-based healthcare in Spain Regional experimentation in a shared governance setting Chapter 1: A system with high levels of regional autonomy1 The evolution of HTA in Spain The history of health technology assessment (HTA) in Spain dates back to the late 1980s, with its introduction driven—as in many other European countries—by the increase in healthcare costs and worries about the efficiency of healthcare provision and the rationalisation of the introduction of new technologies.7 In Spain HTA takes place at three different levels: at the national level, to define a common benefit package for devices and treatments excluding pharmaceuticals; at the national level, for pharmaceuticals; and at the regional level.8 At the national level, the Spanish Agency for Medicines and Healthcare Products (Agencia Española de Medicamentos y Productos Sanitarios, or AEMPS) is responsible for the authorisation and classification of new medicines. Since 2013 AEMPS has prepared so-called national therapeutic positioning reports, in which the clinical benefits, level of innovation and positioning in therapy of a new drug are evaluated.9 Drugs assessment falls under the remit of the General Directorate for Pharmacy and Medicinal Products, which is part of the Ministry of Health and is responsible for setting pharmaceutical policy.10 The General Directorate also evaluates drugs before market entry and assesses them based on a range of criteria, including the severity of indications, the usefulness of medicines, patient requirements, the rationality of costs, the existence of therapeutic options and the degree of innovation.11 The inter-ministerial pricing committee (Comisión Interministerial de Precios de los Medicamentos, or CIPM)—which includes officials from the Ministry of Health, the Ministry of Economy and Finance and the Ministry of Industry, Tourism and Trade—deals with reimbursement and pricing, and sets maximum ex-factory prices for every medicine, including generics. Since March 2012 the regions have been members of the pricing committee, with two regional representatives rotating every six months. Like similar bodies in other European countries, they take cost, efficacy, safety and need into account when determining the coverage of “curative care” for both outpatient and inpatient services. Unlike in Germany and England, which are often used as references, however, the Spanish authorities do not consistently evaluate cost-effectiveness or budget impacts.12 Pricing in other European countries is used as a reference for innovative medicines. In practice, therefore, although the national government defines the common basket of products, the trend in recent years has been to use the lowest 7 Sampietro-Colom et al, History of health technology assessment: Spain, p. 163. 8 ISPOR Global Health Care Systems Road Map: Spain – Pharmaceutical, 2009. Available at: https://www. ispor.org/HTARoadMaps/ Spain.asp. 9 Quintiles, HTA Uncovered, Issue No. 1, May 2013. Available at: http://www. quintiles.com/~/media/li- brary/fact%20sheets/hta- uncovered-may-2013-final. pdf 10 Pharmaceutical Health Information System, PHIS Pharma Profile Spain 2010. Available at: http://whocc. goeg.at/Literaturliste/Do- kumente/CountryInforma- tionReports/Spain_PHIS_ PharmaProfile_2010.pdf 11 Ibid. 12 Garrido, MV, Kristensen, FB et al, Health Technol- ogy Assessment and Health Policy-Making in Europe: Current status, challenges and potential, European Observatory on Health Systems and Policies, Observatory Studies Series No 14, 2008, p. 74. Avail- able at: http://www.euro. who.int/__data/assets/ pdf_file/0003/90426/ E91922.pdf?ua=1.
  • 6. 5© The Economist Intelligence Unit Limited 2015 Value-based healthcare in Spain Regional experimentation in a shared governance setting European price as a reference. The decision on price and reimbursement of a new drug must be taken within 180-270 days in Spain; however, in practice it has taken longer in recent years—the process of setting prices took 431 days on average in 2013, for example.13 For drugs used in hospital settings, funding of medicines is covered by regional/hospital budgets, and the Ministry of Health decides on an official maximum price to be reimbursed by the National Health Service. Regions may apply for specific reimbursement conditions But while this structure provides an initial pricing framework, regional health services and hospitals may negotiate lower unit prices or risk- sharing agreements, as in the case of Catalonia and Valencia, for example. It is this degree of flexibility that has given the regions an especially powerful role in recent years.14 “European reference pricing is something that is looked at on the national level,” says Professor López-Casasnovas. “There is an inter-ministerial committee on prices, but it doesn’t guarantee what unit price pharma will get; regions are able to negotiate volumes according to discounts because they can decide on prescription levels.” In practice, therefore, although the national government defines the common basket of products the Spanish National Health Service will cover, the regions have significant leeway to add services and products. Moreover, the process of HTA itself further illustrates some of the fragmentation within the Spanish system. Fragmentation The number of agencies having some responsibility for HTA in Spain is extensive, in some cases contributing to an overlapping of responsibilities and a sense of fragmentation. The Spanish Agency for HTA (Agencia de Evaluación de Tecnologias Sanitarias, or AETS), which was established in 1994, primarily evaluates equipment, devices, surgical and medical procedures and issues HTA reports commissioned by the government or government- related agencies. Assessment criteria include social, economic and ethical dimensions of the technology or procedure. Despite the existence of separate healthcare infrastructures in all autonomous regions, only seven—Madrid, Andalusia, the Basque Country, Catalonia, Galicia, the Canary Islands and Aragon—have set up their own regional HTA agencies. Other regions have units for planning and advice on decision-making, which in some cases includes a degree of HTA evaluation. An overview of the regional HTA agencies is given below. Aragon’s Institute of Health Sciences (Instituto Aragonés de Ciencias de la Salud, or IACS) does not carry out formal evaluation activities, but it does conduct some HTA-related projects, and its new government has announced plans to create a dedicated HTA agency. 13 Pinyol, C, Valmaseda, A et al, “Duración del proceso de financiación en España de los fármacos innovadores aprobados por la Agencia Europea del Me- dicamento. 2008-2013”, Revista Española de Salud Pública, Vol. 89 No. 2, March/April 2015, pp. 89- 200. Available at: http://scielo. isciii.es/scielo.php?pid=S1135- 57272015000200007&script=sci_ arttext&tlng=es#bajo 14 Pharmaceutical Health Information System, PHIS Pharma Profile Spain 2010. Region Regional HTA agency Launch Catalonia Catalan Agency for Health Information, Assessment and Quality (Agencia de Qualitat i Avalució Sanitaries de Catalunya, or AQuAS), formerly the Catalan Agency for Health Technology Assessment and Research 1991 Basque Country Basque Office for Health Technology Assessment (OSTEBA) 1992 Canary Islands HTA Unit of the Canary Islands (Servicio Canario de Salud, or SESCS) 1993 Andalusia Andalusian Agency for Health Technology Assessment (Agencia de Evaluación de Tecnologias Sanitarias de Andalucía, or AETSA) 1996 Galicia Galician Agency for Health Technology Assessment (Axencia de Avaliación de Tecnoloxías Sanitarias de Galicia, or AVALIA-T) 1999 Madrid Unit for Health Technology Assessment (Unidad de Evaluación de Tecnologias Sanitarias (UETS) 2003
  • 7. 6 © The Economist Intelligence Unit Limited 2015 Value-based healthcare in Spain Regional experimentation in a shared governance setting The regional agencies, like their national equivalents, primarily evaluate equipment, devices and surgical or medical procedures, although some are involved in drugs evaluation, notably AQuAS, which co-ordinates the Committee for the Assessment of Hospital Use of Drugs. Some of the regional agencies—including AETSA, OSTEBA, and AVALIA-T—also produce clinical practice guidelines. In the case of OSTEBA, AETS, AETSA and AVALIA-T, the agencies also undertake some horizon-scanning of emerging technologies.15 A virtual network of the Spanish Agency for HTA and the six regional agencies, known as AuNETS, was formed in 2007 to provide high levels of co-ordination and specialisation and support the trend for the devolution of HTA from government- linked agencies to hospital-based HTA. However, the system still operates largely in an advisory capacity and could play a stronger role as an independent body, according to Rafael Bengoa, director of the health department at Deusto Business School in Bilbao and a former minister of health and consumer affairs in the Basque regional government. “In the past three to four years those units have begun to get together as a network, dividing the work among themselves and providing advice to ministers,” Dr Bengoa says, adding: “I can’t yet say that the Spanish system has teeth.” José Maria Argimon, director of AQuAS, also observes that although the network’s advice runs the gamut from what type of medicines are covered to what types of patients will be treated— and includes devices, processes, diagnoses and clinical practices—its recommendations are not binding at the national level. Public hospitals, meanwhile, have their own annual budgets set by the health department in each region, which can be used to “rationalise the introduction and diffusion of technologies”.16 Hospitals also have pharmaco-therapeutic commissions, with those in teaching and high- technology hospitals especially likely to be in charge of advising on the purchase of big-ticket drugs. They also assess the added value of innovative drugs approved by the Spanish Agency for Medicines and Healthcare Products after a review of the evidence regarding safety, efficacy and cost.17 On top of these agencies, every region has a regional drug committee. Recent efforts to refine this process include the establishment by the Spanish Society of Hospital Pharmacies of GENESIS (Grupo de Evaluación de Novedades, Estandarización e Investigación en Selección de Medicamentos), a working group which aims to standardise a methodology for evaluating the added value of hospital drug innovations approved by the Spanish Agency for Medicines and Healthcare Products. GENESIS includes hospitals from 11 autonomous regions, and there is a similar initiative to assess and control the added value of innovative drugs at the primary-care level. This project, known as the mixed committee for the evaluation of new drugs, is co-ordinated among five regions: Aragon, Andalusia, Catalonia, Navarra and the Basque Country. In the case of pharmaceutical products, Spain looks especially to the UK’s National Institute for Health and Care Excellence (NICE) as a model for its assessment decisions, according to those interviewed for this report. However, unlike NICE, which assesses cost-effective medicines and treatments as those that cost no more than £20,000-30,000 (US$31,000-46,000) per quality- adjusted life-year (QALY), Spain stops short of establishing a formal cut-off point for measuring cost-effectiveness. Regional differences and experimentation As mentioned above, six of Spain’s 17 regions have taken the lead in setting up their own health assessment units and taking more decisions on healthcare planning and policy at the regional level. Yet even within this self-selected group there is a significant degree of difference in policy outcomes, whether as a result of the dominant 16 Sampietro-Colom et al, History of health technology assessment: Spain, p. 165. 17 Ibid. 15 Garrido et al, Health Technology Assessment and Health Policy-Making in Europe, p. 94.
  • 8. 7© The Economist Intelligence Unit Limited 2015 Value-based healthcare in Spain Regional experimentation in a shared governance setting political party in the regional government or because regional health authorities take into account the leverage of industry in the region. These considerations are becoming increasingly important in price negotiations between pharmaceutical companies and the regions. “At the final step, after prescription levels are assessed by the regional authorities, there is a process that means strong bargaining between the authorities and pharma on a regional basis over rebates,” explains Professor López- Casasnovas. This process for setting prices can lead to a number of anomalies, including the fact that while there may be transparency over price at the national level, the determination of unit cost of a given drug depends on the regional authorities, including the extent to which the medicine is used in hospitals and what volumes will be required. “Authorisation and pricing at the national level were formerly more important, but they are not really so important these days,” Professor López-Casasnovas adds. “Whatever you are doing in volume, prescription and appraisal in reimbursement is more important.” In this respect, he says, four regional health authorities—Catalonia, Madrid/Valencia, Andalusia and the Basque Country—are most influential, with the other regions largely following their lead. “Whatever the national government sets, it is not the final price,” he explains. Ironically, Professor López-Casasnovas notes, Spain’s decentralised system can be beneficial to both sides of the negotiations: taxpayers benefit because manufacturers can no longer determine a final price by lobbying the Ministry of Health, but must instead negotiate individually with at least the largest regions. But the system also holds advantages for pharmaceutical companies, he observes. “They might go for a regional authority that sees things closer to the way they do,” he points out, noting that the most pioneering regions, such as Catalonia, investigate the degree of therapeutic innovation and efficacy, with the potential for drug makers to increase prices by as much as 15% for the most innovative products. “If they can prove that the drug works the way they say it does, they may show the regions why the treatment should be a standard.” This leads to a wide degree of flexibility in the way regional governments deal with pharmaceutical suppliers, with some negotiating risk-sharing agreements and others preferring to base their own discussions on unit pricing on agreements reached by neighbouring regional governments. Catalonia currently has nearly 16 risk-sharing agreements in place, according to Dr Argimon of AQuAS. In addition to enhancing local decision-making on the adoption of innovative treatments, the devolution of healthcare funding and policy has led to a significant degree of experimentation to try to enhance medical outcomes and value. This is most notable in Catalonia, which has Spain’s oldest regional HTA agency. In 2012 AQuAS introduced a number of programmes aimed at making it easier for Catalan health officials to measure outcomes, the first of which is designed to try to reduce overdiagnosis and overtreatment within the healthcare system. “Today, there is enough evidence to show that, within clinical practice, there are procedures that do not add value,” explains Dr Argimon. Taking the example of patients who receive X-rays or magnetic resonance imaging (MRI) scans for pain despite having no neurological symptoms, he notes that there are some 40,000 such procedures carried out in Catalonia every year, costing a total of €700,000. Eliminating those that are unnecessary “can free up resources to fund a primary-care team or 280 knee replacements,” he adds. AQuAS operates the project in collaboration with scientific societies and healthcare providers, so all recommendations are evidence-based and quantifiable.
  • 9. 8 © The Economist Intelligence Unit Limited 2015 Value-based healthcare in Spain Regional experimentation in a shared governance setting One example of an area in which new guidelines have helped to reduce unnecessary expenditure is AQuAS’s decision to recommend that doctors should no longer prescribe bisphosphonates to post-menopausal women with a low risk of bone fractures. In the year after the guideline was changed the number of women over 50 treated with bisphosphonates for more than five years fell by 28%, equivalent to savings of €8m, according to Dr Argimon. Also since 2012, AQuAS has been publishing the results of 90 indicators relating to outcomes, including mortality, nosocomial (hospital- acquired) infections, surgical complications and patient satisfaction in an effort to make the Catalan region’s healthcare system as transparent as possible. The project, known as the Outcomes Report (Central de Resultats) of the Catalan healthcare system, will introduce patients’ views as an additional indicator later this year, Dr Argimon says. In previous reports patients had suggested that indicators related to services received, such as waiting-room comfort or information on waiting times, were of the greatest interest. The project is now hoping to ask citizens about other indicators they are likely to find most useful. “For policymakers and health managers, the mortality rate or the number of nosocomial infections are good indicators of the quality of the health system; however, these indicators may not be useful for patients,” he adds. The information appears on the region’s website in an open-data format, meaning that patients in Santander can access information to compare their hospitals with those in Barcelona. “The idea is that benchmarking is the best way of improving our healthcare,” Dr Argimon explains, adding that although it is too soon to expect changes in patient behaviour, the Outcomes Report is likely to increase transparency and strengthen citizen participation. The project does not just involve publication of data, but also meetings between different hospitals, in which specialists in areas such as cardiovascular medicine or cancer can evaluate and refine the indicators, as well as having the opportunity to adopt different methods of patient management for replication in their own institution. It also identifies care models that are shared between healthcare-system stakeholders through an open innovation collaboration platform. “One hospital may say it’s not necessary to do a pre-surgical visit for anaesthesia because there is a lot of information coming from clinical records,” Dr Argimon says. “If a small hospital in Catalonia puts it in the platform, others are copying the idea and allowing a sharing of best practices.” The More Value to the Health Information in Catalonia Project (VISC+) is another initiative introduced with the goal of making better use of data. VISC+ collects all the information gathered by the Catalan healthcare system in one database, anonymously and securely, in order to improve the quality of research, accelerate innovation and increase the quality of healthcare. “The amount of data digitally collected is vast, and I think the data will change the way healthcare services are provided,” Dr Argimon comments. A third project, launched earlier this year and building on a similar programme pioneered in the Canary Islands region, is designed to encourage patients to share in decision-making about their own treatment with physicians by providing them with the tools and knowledge to make their own decisions. “We launched this project with patient associations, with clinical teams giving patients information and trying to make them reflect on different possible treatments, including personal preferences, side effects and so forth,” Dr Argimon explains. The project has focused on diseases where there are several potential courses of action, including prostate cancer and kidney disease, and is expected to extend to breast cancer and hip replacements by the end of the year, he adds.
  • 10. 9© The Economist Intelligence Unit Limited 2015 Value-based healthcare in Spain Regional experimentation in a shared governance setting While Spain’s regions have begun to pioneer ways of extracting greater value from their healthcare investments and are sharing best practices accordingly, some of those interviewed say the system needs to develop better measures of value and learn how this can be best delivered. In the Basque Country, policy experts are increasingly looking abroad for models that can help them create such a system, according to Dr Bengoa, who is also an adviser to the Socialist Party ahead of the general election in December 2015. As a former health minister, he says he designed a programme for treating chronic diseases that involved much more integrated delivery of care. He adds that he and his colleagues were particularly interested in the evolution of accountable care organisations (ACOs), which emphasise greater integration of healthcare provision as part of a co-ordinated approach to healthcare and are increasingly gaining traction in the US. In his region, Dr Bengoa points out, policymakers see the value of using HTA to review not only healthcare itself, but also population management, in which preventative care is a crucial element of overall healthcare management. “We are moving towards local integrated care organisations,” he adds. “Once they are organised and you have primary care connected to hospital care, you have an area for responsibility for the health—and not only the healthcare—of the population.” Dr Bengoa notes that reforming the Spanish system could include lessons from the Triple Aim Initiative for optimising healthcare, developed in the US by the Institute for Healthcare Improvement (IHI) in Cambridge, Massachusetts. The initiative consists of improving the patient experience of care, improving the health of populations, and reducing the per-capita cost of healthcare.18 Stronger focus on value “The interesting thing about value-based healthcare is that commissioners are beginning to be interested in this,” says Dr Bengoa. “Before, commissioners were buying traditional services and activities, and now they are realising that they don’t know what they are getting. They want value from providers.” Looking more closely at the HTA agenda, he adds, it becomes clear that if it remains within the existing framework—with fragmented care, delivery and financing—the triple aim will be impossible to achieve. “The change is radical at both the financing and the delivery level, but we have to be able to get the delivery model going,” he points out. Chapter 2: Finding more consistent ways to measure value2 18 Institute for Healthcare Improvement, IHI Triple Aim Initiative. Available at: http://www.ihi.org/en- gage/initiatives/TripleAim/ Pages/default.aspx.
  • 11. 10 © The Economist Intelligence Unit Limited 2015 Value-based healthcare in Spain Regional experimentation in a shared governance setting Spain already has some of the tools it needs to implement such a system, Dr Bengoa says, including the ability to stratify populations, electronic medical records, electronic prescriptions and use of telemedicine. A recent report by Accenture, a consultancy, found that Spain was among the top scorers of eight countries on its Connected Health Maturity Index, with one of the highest rates of healthcare IT adoption and health information exchange for both primary and secondary care.19 Moreover, a white paper on interoperability by the Healthcare Information and Management Systems Society (HiMSS), a global non-profit organisation, found that more than 93% of Spanish hospitals had interoperable systems, with 89% interoperable across multiple locations and 62% interoperable with other organisations. This is due to that fact that around 95% of IT budgets are in the hands of regional authorities.20 Opportunities in greater transparency and consistency Models of how more consistent healthcare delivery might look can be found in the approaches that have been adopted in a comprehensive way at the national level. In the case of Hepatitis C, Spain has a detailed national plan that co-ordinates the collection of epidemiological data about the disease and patient outcomes, provides for the sharing of information between regions, and explicitly spells out how different patient populations should be treated.21 Finding a way of creating greater consistency in the appraisal and pricing of pharmaceutical products at the regional level could also be an advantage, according to Professor López- Casasnovas. He says, however, that even at the regional level “very few agencies go for their own evaluation in terms of cost-effectiveness,” although some agencies do some meta-analyses of drug performance or look at evidence sets from external bodies such as the Cochrane Collaboration.22 Both Dr Bengoa and Dr Argimon say that the lack of transparency about how decisions are made and the unwillingness to acknowledge where difficult choices are being made remain a key problem. “We need to make these decisions like NICE does, available to the public, so tough decisions can be made,” Dr Argimon emphasises. Spain also has an opportunity to increase its use of generic or biosimilar drugs, with a generic penetration rate of just 38% measured in volume,23 compared with 67% in the UK.24 “We need to identify a new delivery system that is sustainable in economic terms and improves quality,” Dr Bengoa says. “The decentralised system makes it easier, because I don’t think it is going to happen at the national level.” Developing a more independent HTA system would also help, although it is likely to face opposition from entrenched political interests, according to Professor López-Casasnovas. “Politicians do not want to be subjected to these recommendations; so far, their policies have been fully discretionary, and they don’t want to lose that.” He notes, however, that the uncertainty surrounding the upcoming general election in Spain creates a window of opportunity for those looking to establish a system similar to the UK’s NICE or Germany’s Institute for Quality and Efficiency in Healthcare (IQWIG) at the regional or the national level, “because they need some sort of formal proceeding for cost-effectiveness priority-setting to weaken the otherwise costly political battle over healthcare.” 19 Accenture, Making the case for Connected Health: Accenture study explore the future of integrated health- care delivery, February 2012, p. 6. 20 HiMSS, Strategic Interop- erability in Germany, Spain & the UK; p. 7. 21 Ministry of Health, Social Services and Equality, Stra- tegic Plan to Tackle Hepatitis C in the National Health System, May 21st 2015. 22 Cochrane, About us, Who we are. Available at: http://community. cochrane.org/about-us 23 Spanish Generic Medi- cines Association (AESEG), “The Value of Generic Medicines”. Available at: http://www.aeseg.es/ en/the-value-of-generic- medicines# 24 British Generic Manu- facturers Association (BGMA), “British Generic Manufacturers Association Overview”. Available at: http://www.britishgener- ics.co.uk/
  • 12. 11© The Economist Intelligence Unit Limited 2015 Value-based healthcare in Spain Regional experimentation in a shared governance setting point, because it means that policymakers are not deciding based on evidence.” There are some encouraging signs that change is on the cards. Spanish regional experiments suggest that a willingness to re-evaluate ineffective treatments, involve patients in decision-making and commit to a greater integration of healthcare provision are just some of the ways in which the country could help to enhance value. The experts interviewed for this paper agree that, looking ahead, mounting health costs and a greater emphasis on value measures in other developed economies will lead to increased pressure for Spanish health authorities to measure value as a proportion of cost more widely. These trends, they say, are likely to drive the development of a home-grown, centralised national body with the authority to make difficult funding choices in a more transparent and consistent way. Spain’s decentralised health and HTA system has allowed for significant innovation and the sharing of best practices, but the level of regional autonomy has contributed to both a lack of consistency and an absence of transparency. And although the system enables flexibility for innovation in regions, it also makes it more complicated to roll this out on a national level and regional equity access is crucial. Moreover, while Spanish agencies look at patient experiences and efficacy when assessing medical treatments, devices and care pathways, decisions have largely been framed by cost-containment pressures, with little effort so far to measure cost-effectiveness. As Dr Bengoa explains: “Although we have the infrastructure to do fairly sophisticated assessments of both drugs and new technologies, and those units produce important results that are even being used internationally, the connection between that advice and the policy decision being taken is not well made. It’s a big Conclusion
  • 13. While every effort has been taken to verify the accuracy of this information, The Economist Intelligence Unit Ltd. cannot accept any responsibility or liability for reliance by any person on this report or any of the information, opinions or conclusions set out in this report.
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