Taking society into account when planning HTA 1 November 2012 Bulgarian Parliament.

Taking society into account when planning HTA

1 November 2012Bulgarian 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 framework)

• By whom?• The AGNSS example

Epposi’s mission and goalsFounded 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, capacity-building, 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 healthcare.

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)

Source:

« Societal benefits »:Moving beyond cost/ relative

effectiveness and QUALYs to a societal benefits approach to

HTA

Models of HTA focus on cost OR relative effectiveness (economic values)

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 Model

“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

society:The Epposi framework for a

societal benefits approach to HTA

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 economy?”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 non-

monetary 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• Assessment• HTA methodologies• Patient/Stakeholder-defined outcomes• Workability• Ethical aspects• Value• Cross-sectoral policy making• Psychological aspects (including impact of co-

morbidity, etc.)

Case studies

• AGNSS Initiative for the case of rare diseases – UK

• 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

AGNSS decision making framework

• Developed through interviews & workshops with over 80 stakeholders

• Put patient needs atthe 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 service?

Conclusions & Next steps

Adopting a societal benefits approach

• Involves ALL stakeholders with patients at the centre

• Shares the cost burden beyond health authorities

• 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 2013.

For further information about Epposi’s HTA Programme, please contact:

Jacqueline Bowman-BusatoExecutive Director

[email protected]

Dr Andrea Pavlickova Programme Manager

[email protected]

+32 2 503 1307 www.epposi.org