framework for a societal benefits approach to HTA

Taking society into account
when planning HTA
1 November 2012
Bulgarian Parliament
My intervention will cover
• HTA in Europe – a very brief trends overview
• Why « Societal » and not only « social » issues
need to be taken into account (the Epposi
• By whom?
• The AGNSS example
Epposi’s mission and goals
Founded in 1994, Epposi is an independent, not-for-profit, partnership-based and
multi-stakeholder think tank based in Brussels, Belgium.
Our goal is to work at the "cutting edge" of European health policy-making, providing
members and the wider public with high quality independent research, capacitybuilding, knowledge exchange and dissemination with the aim of bridging the gap
between innovation and improved public health outcomes.
In order to fulfil our mission and build on our established, unique, citizen-centric and
multi-constituency approach, Epposi enables consensus-driven, equally-weighted
outcomes between the different stakeholder groups of its membership: patients'
organisations, science and industry.
Epposi is open to members from EU-facing umbrella patients' organisations,
commercial enterprises and their related trade bodies, research institutes,
professional and business federations. Associate membership is open on nomination
to NGOs representing a broad range of civil society interests, foundations and
international organisations which support the Epposi ethos and are active in human
HTA in Europe
HTA ….
“multidisciplinary field of policy analysis that
studies the medical, social, ethical, and economic
implications of development, diffusion, and use of
health technology”
Source: International Network of Agencies for Health
Technology Assessment (INAHTA)
…. In Europe today
• There is a gap between the actual focus of HTA
reports and what the HTA community wishes
them to address.
• There is no harmonised HTA model (criteria
used to assess health technologies)
• EUNetHTA (European Network for HTA) is now
entering it’s second Joint Action
– Closest to society is “social” elements
The reality is still the basics of HTA
which do not benefit society as a
whole (purely economic evaluation)
« Societal benefits »:
Moving beyond cost/ relative
effectiveness and QUALYs to a
societal benefits approach to
Models of HTA focus on cost OR
relative effectiveness (economic
Source: CRA Report 2011
Challenge for rare disease community
Can we apply HTA to treatments for rare
disorders, characterized by small patient
populations, no other or comparable treatments,
life-threatening illnesses, high per-patient costs,
and limited long-term, survival or QALY data?
Social element of EUNetHTA Core
“Domain focuses on the patients' and his or her
significant others' considerations, worries and
experiences before, during and after the health
technology has been put to use.
It describes how the technology moulds and is
moulded in diverse social arenas (hospitals,
general practitioner, everyday life, homes,
schools, and workplace), and what specific
meanings people give to the technology.”
Source: EUNetHTA core model online
Example of how social activities can be
taken into account under the
EUNetHTA model
Taking broader elements into
account to the benefit of
The Epposi framework for a
societal benefits approach to
Epposi’s Research Goals AIP-HTA
“ How can HTA agencies at national level consider societal
benefits as an integral element of HTA core model which
positively contribute not only to the realisation of better health
outcomes for EU citizens but also to a smart, sustainable
Key outputs:
• To build a framework for a societal benefits approach to HTA
• Focusing on how to effect attitudinal as well as systematic
change in HTA structures and processes which can take better
account of smaller, specific patient group across Europe, as
well as the needs of wider populations.
Definition of societal benefits ?
Societal benefit means a process that involves principles of
solidarity, transparency, equality and effectiveness, where
the various stakeholders’ involvement play a crucial role and
can be achieved by optimised use of monetary and nonmonetary resources across various policy sectors.
(Source: Epposi AIP-HTA desk research initial conclusions , November 2011)
Taxonomy key domains
Governance (solidarity, transparency, equality)
All stakeholder involvement
HTA methodologies
Patient/Stakeholder-defined outcomes
Ethical aspects
Cross-sectoral policy making
Psychological aspects (including impact of comorbidity, etc.)
Case studies
• AGNSS Initiative for the case of rare diseases –
• Continued economic activity – Sweden
• Medical devices and pharma looking at the
wider us or reuse of health data to speed up
the processes
• Conditional reimbursements linked to
participating in registries – Netherlands
HTA Planning that takes into
account « societal benefits »
for ultra rare diseases:
The AGNSS example
The Advisory Group for National
Specialised Services (AGNSS)
• AGNSS provides a single source of advice to
Ministers on:
– which services at which centres should be
nationally commissioned
– a small number of highly specialised new
drugs and technologies that are not suitable
for consideration by NICE
• Pilot run until 2012
• Now integrated into NICE in England
Key to involve All stakeholders
Chair: Professor Michael
• Patient members
• Lay members
• Local commissioners
• Health economist
• Ethicist
• General Practitioner
• Psychiatrist
• Geneticist
• Pharmacist
Public Health Physician
Regional Chief
• Regional Finance
• Regional Medical
• Health Technology
Assessment Director
AGNSS decision making framework
• Developed through
interviews & workshops
with over 80 stakeholders
• Put patient needs at
the centre
A holistic view taken accross all
assessment criteria
• Does it work?
• Does it add
value to society?
• Is it a reasonable
cost to the public
• Is it the best way
to deliver the
Conclusions & Next steps
Adopting a societal benefits approach
• Involves ALL stakeholders with patients at the
• Shares the cost burden beyond health
• Shares benefits throughout society
• Provides opportunities to better manage limited
funds in the current economy.
Next steps for Epposi
• Workshop – and policy reccomendations
– 4 February 2013, Brussels
– White paper on a framework for a societal
benefits approach to HTA
• Further work on the meaning of « value » in
For further information about Epposi’s HTA
Programme, please contact:
Jacqueline Bowman-Busato
Executive Director
[email protected]
Dr Andrea Pavlickova
Programme Manager
[email protected]
+32 2 503 1307

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