Allira Attwill

Rotaviruses are the most common cause of severe diarrhoeal disease in young children throughout the
world. Rotavirus results in significant costs to society and health systems in terms of human life; lost
productivity while parents stay home and care for their sick child; and health system expenditure
(Rheingans et al., 2009)
Belgium was the first country in the European Union (EU) to introduce a universal rotavirus vaccination
programme. This programme partly subsidizes the available vaccines (Rotarix and RotaTeq) though still
requires an out of pocket payment of €11.60 per dose (KCE, 2007a).
The Belgian Healthcare Knowledge Centre (KCE), conducted a Health Technology Assessment (HTA) to
determine the cost-effectiveness of the current subsidized programme compared to a fully funded
universal vaccination programme. The HTA found that partial reimbursement is less cost-effective than
fully funded universal vaccination (KCE, 2007a).
The logical policy response from a societal perspective may seem clear: introduce fully funded universal
rotavirus vaccination. However, the KCE findings were not implemented in Belgium. Using the Belgian
experience as a case study, this article seeks to explore barriers to uptake and implementation of HTA
recommendations.
Rotavirus vaccination
Rotaviruses are the most common cause of severe diarrhoeal disease in young children throughout the
world. According to WHO 2004 estimates, 527 000 children aged <5 years die each year from vaccinepreventable
rotavirus infections; most of these children live in low-income countries (World Health
Organisation, 2010).
Two oral, live, attenuated rotavirus vaccines, Rotarix and RotaTeq, are available internationally: Rotarix
requires two doses, and RotaTeq requires three doses. Both vaccines are considered safe and effective
in preventing gastrointestinal disease (World Health Organisation, 2010).
WHO recommends that rotavirus vaccine for infants should be included in all national immunization
programmes. In countries where diarrhoeal deaths account for ≥10% of mortality among children aged
<5 years, the introduction of the vaccine is strongly recommended (World Health Organisation, 2010).
WHO recommends that the first dose of either RotaTeq or Rotarix be administered at age 6–15 weeks.
The maximum age for administering the last dose of either vaccine should be 32 weeks (World Health
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Organisation, 2010). WHO explicates that rotavirus vaccines are an important measure that can be used
to reduce severe rotavirus-associated diarrhoea and child mortality.
The Gasthuisberg University Hospital has monitored the incidence of rotavirus gastroenteritis since 1986
(Zeller et al., 2010). The average percentage of rotavirus positive cases out of all hospitalized gastroenteritis
cases tested (>95% of these cases are younger than 5 years old) at the GUH between 1986 and
2006 was 19.0%. This percentage dropped to 12.4%, 9.6% and 6.4% in the three seasons post vaccine
introduction (2006–2009), which is a decline of 34.7%, 49.4% and 66.3% respectively. In addition the
rotavirus season was found to be shortened and delayed (Zeller et al., 2010).
Belgium was the first country in the European Union (EU) to introduce a universal rotavirus vaccine
programme. Access to the partially reimbursed vaccine requires an out of pocket payment of €11.60 per
prescribed dose, with the remainder (€59.60 and €40.10 for Rotarix and RotaTeq respectively) being
paid by National Health Insurance.
Healthcare decision-making in the Belgian health system is complex due to its decentralised nature and
consequent number of stakeholders. The federal level is responsible for health insurance and the public
health budget. Responsibilities for health policy are divided between the federal level and the federated
entities (regions and communities). The federal level is responsible for regulating and financing
compulsory health insurance; accreditation and minimum standards; the financing of hospital budgets
and market access, pricing and reimbursement of pharmaceuticals (Gerkens & Merkur, 2010).
Federated entities (regions and communities), have responsibility for health promotion and prevention;
maternity and child health services; different aspects of elderly care; the implementation of
accreditation standards; and the financing of hospital investment (Gerkens & Merkur, 2010).
The cost-effectiveness of rotavirus vaccination depends largely on the value policy makers place on the
prevention of mild disease and their willingness to pay (KCE, 2007a). In Belgium, rotavirus vaccination
would prevent short-lived mild disease in virtually all children, and thus represent a potential saving to
society and healthcare payers. The majority of these savings are in the form of QALYs and indirect cost
savings, largely attributable to lost productivity averted due to parents staying home (KCE, 2007a).

The financial sustainability of publicly funded universal access health systems in Europe is currently
endangered by the combined forces of among other things population ageing, technological progress
and limited financial resources (Pammolli, Riccaboni & Magazzini, 2012), with chronic and noncommunicable
disease driving a significant proportion of costs (Busse et al., 2010). These developments
raise increased demands on the effectiveness and cost-effectiveness of EU health systems, which must
respond to both increasing health challenges and a more restricted budgetary context(EC, 2010).
In the Tallin Charter, adopted at the WHO European Ministerial Conference on Health and Health
Systems in 2008, member states of the World Health Organization Regional Office for Europe
(WHO/Europe) committed to improving population health by strengthening health systems and
addressing major health challenges in the context of epidemiological and demographic change,
widening socioeconomic disparity, limited resources, technological development and rising expectations
(WHO, 2008). In the 2013 follow-up meeting, Health systems for Health and Wealth in the Context of
Health 2020, member states commitment to the Charter was reaffirmed (WHO, 2013).
The RAHEE project aims to outline a future research agenda for the EU on health economic evaluation,
based on both gaps in the available evidence and the application of health economic evidence in
practice. The main objectives are 1) to prepare an overview of the state of health economic evidence for
a selection of high burden conditions in the European Union, based on a systematic assessment of the
scientific literature, complemented by cross-cutting observations on methodological or other
weaknesses that reduce the applicability of health economic evidence in practice; and 2) to identify
difficulties in the translation of existing evidence on preventive public health interventions based on
case studies in selected countries. A High Level Expert Panel consisting of public health officials, health
economists and policymakers will formulate research recommendations for the EU based on this
research.
The present report outlines the health economic evidence base for the 10 highest burden conditions in
the EU. Chapter 1 outlines the methodology employed for the identification of health economic
evidence, how it is mapped to the clinical reality, and how relevant experts have been identified for
consultation. It briefly outlines the limitations of the approach described, and gives an overview of the
search that was implemented. The subsequent chapters, 2 to 16, each report the search results for
individual conditions and for preventive studies for selected conditions with significant modifiable risk
factors. For ease of reference, separate bibliographies are included for all chapters.