34 Eurohealth Systems and Policies

UNIVERSAL HEALTH COVERAGE

AND THE ROLE OF EVIDENCE-BASED
APPROACHES IN BENEFIT BASKET
DECISIONS
By: Juliane Winkelmann, Dimitra Panteli, Miriam Blümel and Reinhard Busse

Summary: The extension of universal health coverage along its three

dimensions – population coverage, benefit coverage and financial
protection – has dominated health policy agendas in recent years.
However, decisions on the benefits covered by publicly financed
schemes have only recently received increased attention, being
supported by evidence-based approaches such as health technology
assessment (HTA) to ensure quality and “value for money” of care.
Yet, new developments in the area of high-cost speciality medicines
have highlighted the limitations of HTA in guiding the optimal
allocation of finite resources, posing a challenge to “universality”
of coverage and requiring increased efforts towards aligned HTA
in Europe.

Keywords: Universal Health Coverage, Health Basket, Innovations, Pharmaceuticals,

Health Technology Assessment

Introduction of health coverage, encompassing a

mandatory public and a voluntary
All health care systems are confronted
private component.
with the question of which treatments
and pharmaceuticals to pay for publicly
The rationale behind covering certain
as resources for health are limited, thus
Juliane Winkelmann is Research benefits while excluding others varies
Fellow; Dimitra Panteli is Research competing with other sectors within the
between jurisdictions, reflecting both
Fellow; Miriam Blümel is Research public budget. Despite health needs and
Fellow at the Department of societal norms and system characteristics.
desires, it is not possible for a health
Health Care Management, Berlin Public benefit “baskets” or packages
system to afford to pay for all available
University of Technology, Germany. are usually defined more broadly at the
Reinhard Busse is Co-Director of health care benefits for everyone, even
legislative level with a stipulation of the
the European Observatory on Health under universal coverage aspirations.
Systems and Policies and Professor areas of care to be covered. They are
Therefore, trade-offs arise in coverage
and Head of the Department then regulated more concretely, centrally
for Health Care Management, decisions when priorities have to be set
or regionally and usually within each
Berlin University of Technology, between different benefits and cost-
Berlin, Germany. Email: juliane. area of care, resulting in more or less
sharing levels as well as the population
[email protected] explicit benefit baskets. Especially in the
groups covered. As a consequence, most
realm of coverage decisions for health
countries opt for two-tiered models

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Eurohealth Systems and Policies 35

Figure 1: The three dimensions of universal health coverage population coverage and financial
protection. While both dimensions offer
little scope for policy variation if the
fundamental values of universality and
Total health expenditure
Height: solidarity are not to be contradicted, the
What range of services covered by publicly
proportion financed schemes constitutes a playing
of the costs
is covered?
field in health policy for decision-making. 8

Indeed, there is a lot of variation in the

Other
level of explicitness and the approaches
Cost sharing countries use to define their priorities
services
and benefit packages. They range from
very detailed (positive) lists of all goods
and services available through statutory
coverage to a vaguely formulated and
Public expenditure implicit benefit package with reference to
Uninsured broad categories of services (e.g. primary
on health Depth:
care, pharmaceuticals). 4 7 9 For example,
Which benefits
are covered? UK legislation defines very broad
categories of health care services,
Breadth: Who is insured? considering services necessary within
‘reasonable limits’, while leaving providers
7
with the possibility to establish positive
Source:
lists. 6 8 At the same time, an institution
tasked with identifying necessary,
technologies, evidence-based approaches demonstrating their commitment to appropriate and cost-effective care, the
have been increasingly employed to ensure achieving health care for all. Today it is National Institute for Health and Care
quality and efficiency of care, or “value one of the most prominent global health Excellence (NICE) provides very clear
for money”, in the composition of the policies, most notably retained in the guidance on whether a new medicine
benefit package. Sustainable Development Goals (SDGs) should be made available to NHS patients
in 2015. The UHC concept encompasses who meet particular criteria. 8 Health
In recent years, benefit baskets in many three dimensions: coverage for everyone benefit baskets can also be defined
European countries have been expanded (breadth), type and number of needed negatively by excluding certain benefits.
by costly innovations in medicines health services covered (depth) and For example, Italy and Spain use positive
and devices leading to rising health the proportion of total health service and negative lists and have a structured
expenditures. In a context of already costs that are publicly funded and not and detailed minimum benefit baskets that
constrained health budgets, formal subject to cost sharing (height), also can be further adapted by regional health
structures to support evidence-based referred to as financial risk protection, authorities. 3 9 Israel is probably the only
decision-making in a multitude of and is best reflected in the UHC cube country in the world with one detailed list
countries have been established to identify (see Figure 1). The UHC cube was first of all benefits across all sectors covered
(non-) cost-effective services. At the same conceived in mid-2000 2 3 and was further under the National Health Insurance Act;
time, the fundamental values of universal developed for the framework behind the the list is updated once a year. 10
health coverage (UHC) and solidarity have European Observatory’s Health Systems
come under threat; this became evident in Transition reports. 4 It was most Over the last two decades, there has been
particularly during the economic crisis prominently used in the World Health a general trend to make positive lists more
when countries had to decide between Reports 2008 and 2010  5 6 and has since explicit, both in tax-funded countries
restricting the number of people covered become known as the coverage cube. (where benefits were previously left to the
(most visibly in Greece), the services Today, it is used worldwide to illustrate discretion of providers) as well as those
included the benefit basket (see Box 1) and UHC and supports related analyses. with Social Health Insurance (where lists
the extent of the cost to be borne privately used to be merely fee schedules), and to
for services in the benefit basket. 1 expand the range of services in the benefit
Defining the health benefit basket is
baskets. 3 7 However, the opposite can
still challenging
also be observed, in particular during
Achieving UHC along the
Despite the importance of the range the economic crisis when services were
‘coverage cube’
of benefits covered, the focus in the removed from the benefits package
In the last 20 years, UHC has substantially discussion on UHC to date has been (see Box 1).
gained importance with governments dominated by the two dimensions of

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36 Eurohealth Systems and Policies

(most commonly following an application to existing alternatives. 16 17 However, they

for inclusion in the benefit basket by the do require evaluation and investment of
Box 1: UHC and the economic crisis manufacturer or a request by relevant HTA-related resources.
decision-makers), scientific evidence
In response to budget pressures
is collected and evaluated (evidence New medicines based on novel
during the economic crisis, many
assessment) and subsequently appraised mechanisms, such as gene and cell
countries redefined benefit baskets
in context (evidence appraisal). therapies, have started entering the
and some tried to remove non-cost-
market with extremely high price
effective services from coverage.
These formal assessment mechanisms tags (e.g. Novartis´ immunocellular
In a study jointly carried out by the
are most frequently in place for therapy against leukaemia was priced
European Observatory and the WHO
pharmaceuticals. In Europe, at $475 000 per infusion for the US
Regional Office for Europe in 2014,
pharmaceuticals have historically market). Viewed against a backdrop of
15 European Union countries
represented one of the largest expenditure a per capita pharmaceutical expenditure
reported trying to restrict or redefine
items in health care spending with of US$ PPP 553 (OECD country average
the publicly financed benefit basket
costs predominantly being covered in 2015 14 ), it becomes clear that health
between 2008 and 2013. Of these,
by statutory funds. 14 To bring a new systems will be unable to bear such costs
only four countries incorporated
medicine to market, demonstration of in a routine manner as part of the benefit
HTA in decision-making while eleven
safety and clinical “efficacy” are usually package. A new discussion on the effect
countries restricted benefits on an
sufficient. These are demonstrated within of these medicines on the “universality”
ad hoc basis. Disinvestment mostly
randomised controlled trials, with selected of coverage in European health systems is
involved medicines, followed by cash
patients (e.g. excluding multimorbid warranted. Indeed, the Dutch Presidency
benefits for temporary sickness leave
ones) and using placebo as control. It of the European Council in 2016 placed
and dental care, but also primary
is the role of the subsequent HTA to the spotlight on the imbalances in the
care visits (e.g. a cap was introduced
determine whether – at least in principle current system of development, pricing
on the number of general practice
– the therapeutic benefit is meaningful to and reimbursement of medicines and
visits covered in Romania) and
patients compared to alternatives in real raised questions about its sustainability
preventive services (the Netherlands
world conditions – and therefore whether, for Europe and Europeans.
and Bulgaria). 1 11 12
to what extent and/or at what price new
medicines will be covered publicly. To
Looking forward
ensure that they are subsequently used
The importance of HTA for coverage appropriately is mainly the domain of Decision-makers are increasingly
decisions has grown clinical guidelines. 15 confronted with difficult coverage
decisions due to budget constraints and
Tools supporting evidence-based decision-
new and costly health technologies.
making are increasingly incorporated Expensive innovations have big
Over the last two decades numerous
in formal decision-making structures, implications for coverage decisions
techniques have been applied to guide
as mentioned above, especially in the
New developments in the output portfolio the decision-making process and to direct
realm of coverage decisions for health
of the pharmaceutical industry have the optimal allocation of finite resources.
technologies (i.e. pharmaceuticals, medical
highlighted the limitations of traditional The desire to maximise the value for
devices, procedures or interventions).
HTA-based systems in guiding the optimal money of health services and to ensure
The concept of technology assessment as
allocation of finite resources. The market the long-term sustainability of access to
a policy-informing tool to guide decision-
entry of breakthrough therapies with technologies, have been met by increased
making for coverage in health care was
large target populations and steep price use of evidence-based approaches. In
first introduced in the United States
tags (such as the pharmaceuticals against this context, the application of HTA has
in 1975. The evaluation model of the
Hepatitis C in 2014) served as a wake- received increased attention in health
Office of Technology Assessment (OTA)
up call for policymakers, who were policy in most European countries and
included elements of safety, effectiveness
suddenly confronted with unmanageable will continue to play an important role,
and cost, as well as socioeconomic and
budget impacts and a lack of suitable thus requiring enhanced collaboration
ethical implications of adopting (new)
management levers. The number of and knowledge exchange. Indeed, the
technologies in health care. It was
new high-cost specialty medicines and European Commission has been promoting
subsequently adapted by national health
so-called “niche-busters” (aimed at very related research and collaborative activities
technology assessment programmes in a
narrowly defined patient sub-populations) for more than 15 years, culminating in
number of European countries. 13

has increased substantially over the last the establishment of an HTA network in
two decades. At the same time, evidence Directive 2011/24/EU. The scientific and
The exact scope and configuration of HTA
suggests that a substantial majority of technical cooperation of the network has
are country-specific and heterogeneous.
these new pharmaceuticals do not provide been the responsibility of the EUnet HTA
However, HTA is generally applied
substantial patient benefit gains compared Joint Actions.
following marketing authorisation. After
selection of the technologies to evaluate

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 Eurohealth Systems and Policies 37

A further promising step towards 3

Schreyögg J, Stargardt T, Velasco-Garrido M, 11
Thomson S, Evetovits E, Kluge H. Universal
aligned and centralised HTA in the EU Busse R. Defining the “Health Benefit Basket” in nine health coverage and the economic crisis in Europe.
European countries. Evidence from the European Eurohealth 2016;22(2):18 – 22.
was made on 31 January 2018 when
Union Health BASKET Project. European Journal
the European Commission issued a Health Economics 2005;6(Suppl. 1):2–10.
12
Thomson S. Changes to health coverage. In
proposal for regulation building on the Thomson S, Figueras J, Evetovits T, et al. (eds.)
4
Rechel B, Thomson S, van Ginneken E. Health Economic Crisis, Health Systems and Health
exeprience of EU Member States in the
Systems in Transition: template for authors. in Europe. Impact and implications for policy.
area of HTA and related collaboration Copenhagen: WHO Regional Office for Europe, Maidenhead: Open University Press, 2015.
and mandating joint assessments of on behalf of the European Observatory on Health 13
Velasco-Garrido M, Børlum Kristensen F,
clinical elements (effectiveness and Systems and Policies, 2010.
Palmhøj Nielsen C, Busse R (eds.) Health technology
safety) of new medicines and certain new 5
World Health Organization. World Health Report: assessment and health policy-making in Europe –
medical devices. Although the proposal primary health care – no more than ever. Geneva: Current status, challenges and potential. Copenhagen:
has been criticised for various reasons World Health Organization, 2008. WHO Regional Office for Europe on behalf of the
(e.g. manufacturers are not mandated to 6
World Health Organization. World Health Report:
European Observatory on Health Systems and
Policies, 2008.
provide full trial data but are afforded health systems financing: the path to universal
the possibility to comment on assessment coverage. Geneva: World Health Organization, 2010. 14
OECD. Health at a Glance 2017. OECD Indicators.
drafts and specify which information is 7
Busse R, Schlette S. Focus on Prevention, Health
Paris: OECD Publishing, 2017. Available at: http://
dx.doi.org/10.1787/health_glance-2017-en
not to be made publicly available), more and Ageing and Human Resources. Gütersloh: Verlag
collaboration in the evaluation of new Bertelsmann Stiftung, 2007. 15
Legido-Quigley H, Panteli D, Car J, McKee M,
medicines is a welcome concept on the 8
Smith P, Chalkidou K. Should Countries Set an
Busse R. Clinical guidelines for chronic conditions
in the European Union. Copenhagen: World Health
path to ensuring that new technologies Explicit Health Benefits Package? The Case of the
Organization, on behalf of the European Observatory
with true patient benefit are identified English National Health Service. Value in Health
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early and evaluated for inclusion in the 2017;20(1):60 – 6.
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Salas-Vega S, Iliopoulos O,
benefit basket at affordable costs. 9
Auraaen A, Fujisawa R, de Lagasnerie G, Paris V,
Mossialos E. Assessment of overall survival, quality
et al. How OECD health systems define the range
of life, and safety benefits associated with new cancer
of good and services to be financed collectively.
medicines. JAMA Oncology 2017;3(3):382 – 90.
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Related Observatory publications:

Economic crisis, health systems Clinical guidelines for chronic Health technology assessment and health
and health in Europe: impact and conditions in the European Union (2013) policy-making in Europe – Current
implications for policy (2014) https://goo.gl/Fh4kCj status, challenges and potential (2008)
https://goo.gl/vB5Wp8 https://goo.gl/zNu1gj

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