How do European HTA processes add new value over existing formal assessment procedures for medicine and medical devices?
HTA is a broader approach to evaluating diagnostics, pharmaceuticals, medical devices, procedures and other interventions than many existing, formal assessment processes. In addition to clinical evaluation, health technology assessment includes a broad health economic evaluation as well as assessment of organisational, social and ethical matters. HTA aim at informing decision making processes and can also address decisions on the clinical use of health technologies. That is: HTA can inform policy and decision-making from the clinic to the national level.
What is the difference between assessment and appraisal, and which actors are responsible for undertaking which processes?
HTA informs policy but does not define policies. It is therefore crucial to clarify locally where HTA stops and policy-making takes over (or where the interface is). To make this distinction clear assessment refers to the systematic, research-based activities undertaken in an HTA (such as the Core HTA model) whereas appraisal refers to processes in which HTAs and other information (such as local values or available resources) are integrated into processes leading to formulation of policies and to decisions. Although the words assessment and appraisal mean the same thing in daily language the terms should be applied as described to distinguish between informing and making decisions and policies.
The actors responsible for conducting assessment and appraisal vary considerably depending on the national and regional context as decision making processes are different among European Member States. Assessments undertaken in EUnetHTA relates to production of generalized information and leaves decision making and policy formulation to the national and regional level. EUnetHTA thus aims at undertaking activities which can be of general interest for those producing health technology assessments. The added value of the collaboration is the fact sets of quality assured general information that has been produced in a common process can contribute to HTA reports in many national, regional or local settings.
How/where can formal appeal processes add value to HTA processes?
Several stakeholders from the industry have demanded that formal appeal processes be implemented in relation to work in EUnetHTA and to reimbursement decisions as well. EUnetHTA acknowledge that appeal processes may be a way to ensure stakeholder involvement in decision making processes. Formal appeal processes may however be more suitable to incorporate at the national level where full HTA reports are produced and policy decisions are made rather than at the European level where information sharing and methodological development are in focus, and no decisions are made.
How can EUnetHTA support countries with limited HTA capacity?
It is an explicit aim for EUnetHTA to support continuous development of HTA institutions across Europe in countries with limited experience in HTA as well as in countries with established HTA units. Through the developmental work obtained within the collaboration, EUnetHTA can provide models of good HTA practice for the methods and processes supporting HTA. EUnetHTA could e.g. develop training courses in HTA methods, and establish a database of experts who will take on consulting for HTA agencies which ask for guidance in developing a new or existing HTA agency. Through such possible activities EUnetHTA wish to support countries in the development of HTA institutions.
How bound are national HTA agencies by methodological developments obtained within EUnetHTA?
The EUnetHTA Collaboration aims to function at multiple levels. General networking and information sharing comprises all partners. More specific activities related to functions and products frequently involve groups of partners according to topic and interest. The more specific the level of collaboration is the more commitment is required. The framework is that collaboration should be flexible, transparent and allow for variation in commitment and responsibility to specific undertakings. The use of published EUnetHTA information, distributed tools and other products is voluntary for each partner organisation. However, having been part of the development of methods and tools is assumed to motivate partners to utilize the results of EUnetHTA. The level of collaboration chosen by partners in EUnetHTA is optional and gives room for development and changes in the collaboration that may occur over time.
How is stakeholder influence on EUnetHTA activities assured?
EUnetHTA acknowledge the interests of stakeholders in general issues related to HTA processes as well as in specific HTA reports at national or regional level. The focus of EUnetHTA’s work is on methodological development, information collection and analysis of specific health technologies with the aim of presenting information that may be used at national or regional level for their production of context specific HTA. EUnetHTA has an interest in communicating and collaborating with stakeholders on general HTA processes and issues, but the EUnetHTA does not play a role in stakeholder involvement at national or regional level. EUnetHTA has identified a range of stakeholder organisations:
• Policymakers at regional level,
• Policymakers at institutional level,
• Patient organisations,
• Healthcare professionals and
• Industry.
EUnetHTA has chosen to focus on collaboration with umbrella organisations operating at the European level.
EUnetHTA suggests that in a future EUnetHTA Collaboration the involvement of stakeholders in EUnetHTA activities mainly happens through an advisory council. EUnetHTA also suggest that it be accepted that content specific experts, say, in specific methodologies, may participate as individuals in EUnetHTA working groups under Standing Committees to be established. Experts cannot represent their stakeholder organisation or company but can contribute with their personal expertise.
What do stakeholders gain from involvement in EUnetHTA activities?
EUnetHTA can provide a platform for meetings and discussions between institutions involved in HTA production and stakeholders on issues on HTA. The stakeholders are policymakers at national and regional level, healthcare professionals, patient organisations and industry, and the health media. The platform can be used to discuss issues in relation to HTA methodology. Important issues to discuss are e.g. what constitutes value in relation to health technologies and how to measure value, how to perceive evidence and which evidence is required in HTAs, and how to time HTA production while balancing regards for rapid access to technological innovations against needs for patient safety and keeping within healthcare budgets. Stakeholder umbrella organisations can be represented in an advisory council as the forum to bring up such discussions.
How can EUnetHTA’s relations to external actors at national, European and international level be characterised?
National political units making coverage decisions
With regard to national/regional decision makers EUnetHTA aim at facilitating efficient use of HTA in decision making processes, but will not directly deliver input to national/regional policy making. However, tools, data and information produced among partners in EUnetHTA can be contextualised and used by national or regional HTA institutions to inform policy-making. EUnetHTA aims further at facilitating continuous organisational development and capacity building of HTA institutions in European Union Members States. EUnetHTA supports national and regional processes through the work undertaken in collaboration at European level.
The European Commission
The EUnetHTA project has been encouraged and co-financed by the European Commission in the three year project period (2006-2008). The Commission’s Proposal for a Directive on the application of patients in cross border healthcare mentions Health Technology Assessment and encourages the establishment of a sustainable network: “The Directive provides for establishment of the Community network on health technology assessment (Article 17), which should support cooperation between responsible national authorities, support provision of objective, reliable, timely, transparent and transferable information on the short- and long-term effectiveness of health technologies, enable an effective exchange of this information within the network and to provide support to policy decisions by Member States”. Mechanisms for funding of a sustainable EUnetHTA Collaboration are currently being explored by member states and the Commission.
The Proposal for a Directive on the application of patients in cross border healthcare is available here.
International networks operating in the HTA field
In the international HTA community a number of global organisations are natural collaborators for EUnetHTA. Such organisations include among others the International Network of Agencies for HTA (INATHA), HTA International (HTAi), EUROSCAN, Guidelines International Network (GIN), International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and the Cochrane Collaboration. EUnetHTA distinguishes itself from these by focussing specifically at HTA in Europe and at responding to an explicit political need for HTA in Europe. It is an explicit aim for EUnetHTA to reduce duplication of work in the HTA field. Therefore in relation to these global organisations, EUnetHTA will seek to share information and coordinate efforts while maintaining that “added value” should be a guiding principle for involvement in existing field of activity.
How will the quality of EUnetHTA outputs guaranteed?
It is fundamental for the EUnetHTA Collaboration that work in the network builds on best available evidence, common methodological and process standards and common review processes. In addition to these quality assurance criteria EUnetHTA will further explore mechanisms to enable public hearing processes of EUnetHTA products and thus give stakeholders an opportunity to comment on them. Hereby EUnetHTA seek to ensure that high quality products are developed.
How does EUnetHTA ensure transparency of its work?
EUnetHTA consider the question of transparency relevant in relation to at least three fields:
• transparency in stakeholder influence
• transparency in financing
• transparency in working methods.
EUnetHTA find it crucial to ensure, that stakeholder views are obtained to advice on the work of EUnetHTA in a transparent manner. Therefore EUnetHTA seek to develop clear and transparent involvement processes through clear stakeholder policies. The Draft Stakeholder Policy is available here.
EUnetHTA protects its integrity and independence by requiring transparency in all financial support. More specifically EUnetHTA will accept financial contributions from EU, governments, publicly funded statutory health insurance organisations, non-for profit organisations and partners. Other sources of funding may be accepted but will need approval from the EUnetHTA Steering Committee. In all cases, conflicts of interests will be recorded.
Finally, transparency in working methods will be ensured by thorough review and hearing processes.