The first preliminary results from Work Package 4 (WP4, Core HTA), WP5 (Adapting HTAs to new settings), and WP7 (monitoring new technologies and prioritisation of HTA) were presented on June 17 during a pre-conference workshop “EUnetHTA – transnational methodological developments” organised by EUnetHTA at the annual international HTAi conference in Barcelona.
The presentations delivered by the lead partners in the three Work were followed by the question and answers session – below you could find some of the questions and responses from the session (not verbatim!).
Q: To what extent are the stakeholders involved in the work processes in WP4 and 5?
A: Kristian Lampe (WP4; FinOHTA, Finland): The core HTA model and the first practical application of the model (the core HTA on drug eluting stents) were developed by the WP4 partners. The model and a core HTA on drug eluting stents are currently being reviewed and validated.
A: Debbie Chase (WP5; NCCHTA, UK): The adaptation toolkit is undergoing an applicability testing within the project, however, we welcome input and comments from the stakeholders. Please be aware that the document presented is still a draft and will be adjusted based on the received input.
A: Finn Børlum Kristensen (Project Leader; DACEHTA, Denmark): An Open Stakeholder Forum is being currently developed within the project which will provide a possibility for feedback on the general and specific developments within the project. Please be aware that the final results for the project will be presented at the final EUnetHTA conference on November 20, 2008 in Paris. Until then all the results publicly available are work-in-progress.
Q: INAHTA has developed a checklist for HTA reports. It also has done some work on ethical issues in HTA reports. Is this work considered when WP4 and 5 products are developed?
A: Kristian Lampe (WP4; FinOHTA, Finland): The WP4 working group on ethical domain was in contact with INAHTA. The core model includes ethics as a separate domain. In addition, the general design chapter of the core model includes key ethical principles that should be taken into account in HTA projects.
A: Debbie Chase (WP5; NCCHTA, UK): WP5 is working with existing approaches, checklists, etc, however some areas are less developed than others. WP5 have incorporated questions from the INAHTA checklist within the speedy sifting part of the toolkit and provided a link to this checklist for further information. Organisational aspects of HTA reports is a more difficult area where not so much information available and WP5 is “breaking new ground” here – any input is welcome!
Q: Please name 3 most controversial development areas in a core HTA model. Is pragmatism taken into account when the model is developed?
A: Kristian Lampe (WP4; FinOHTA, Finland): Yes, we try to be as pragmatic as possible. We rely on the work that had been completed (eg, in previous EU-supported HTA projects and national HTA methodologies), however, we aim at operationalisation of the concepts and results to a highest degree in the EUnetHTA project making them tangible and applicable in a working process of HTA. Controversial areas with ongoing discussion within the Work Package:
1) defining which elements belong to core HTA. They can be many or few.
2) How to define a Core HTA? Should all the domains be included in the report to be considered a Core HTA, or only some of the domains?
Q: How are quality issues taken into your work?
A: Kristian Lampe (WP4; FinOHTA, Finland): The description of the model will include some guidance on the quality of research. We use references to the existing resources on research methodologies and employ currently available recommendations and instruments. The model itself will make it easier to retrieve the data from the HTA reports which in turn facilitates an evaluation of the data quality and assessment of how well it fits your purpose.
A: Debbie Chase (WP5; NCCHTA, UK): When applying adaptation toolkit, it is the user who will decide how to use the information and if it fits his/her purpose.
Q: How will your instruments deal with the timeliness of an HTA report and an issue of the data being outdated?
A: Debbie Chase (WP5; NCCHTA, UK): The speedy sifting part of the adaptation toolkit will allow assessing the importance and quality of the data in the HTA report. The user of the toolkit will be judging relevance of the data with regards to his/her purposes. Whether a report is out of date will be dependent on the technology that is assessed in the report (diffusion rate, number of studies published subsequent to the report etc.).
A: Kristian Lampe (WP4; FinOHTA, Finland): Some of the HTA agencies are already putting “best before” label on their HTA reports. A core HTA model will provide a possibility to include information on the timeliness of the information regarding each assessment element and necessity for updates. Hence the final report may have several “best before” labels instead of one.
Q: How useful and transferable are your tools to the HTA agencies in the middle- or low-income countries?
A: Debbie Chase (WP5; NCCHTA, UK): Three partners in WP5 are from the middle-income countries and they find an adaptation toolkit very useful. Instead of developing their own HTA reports “from scratch” they prefer to use existing HTA reports by adapting them to their own settings and local contexts.
Q: Who are evaluating the draft prototype of the information service on emerging technologies now?
A: Claudia Wild (WP7, Strand B; LBI@HTA, Austria): WP7 partners are asked to send the draft prototype to 3 representatives of the targeted groups (health politicians, reimbursers, healthcare decision-makers). Currently it is tested internally within WP7.
Q: In developing a monitoring system are you interacting with regulatory authorities? Who is going to decide if a monitoring system is to be set up?
A: Sun Hae Lee Robin (WP7, Strand A; HAS, France): Yes we interact with the regulatory authorities. With regards to the regulation of medical devices and procedures there is a lack of standardised procedures across Europe.
Q: Is there a role for HTA in developing a fertile ground for innovation in Europe?
A: Finn Børlum Kristensen (Project Leader; DACEHTA, Denmark): HTA’s role is in informing healthcare decision-making. The HTA process should be transparent and based on research methods and aim at helping an introduction of innovative and effective health technologies.
Q: There might be a need to train personnel of HTA agencies in applying and using the WP4 and 5 tools. An impact on a small HTA agency’s resources can be significant, with a benefit of reusing and adapting HTA data coming at a later stage. Are there any considerations regarding the training needs in relation to WP4 and 5 tools?
A: Kristian Lampe (WP4; FinOHTA, Finland): Training needs have not been considered directly when a core HTA model was developed, however, through testing and validation process we are getting sense of training needs.
Q: How EUnetHTA findings, results and efforts toward standardisation of HTA methods are disseminated in Europe?
A: Finn Børlum Kristensen (Project Leader; DACEHTA, Denmark): EUnetHTA has more than 50 partners and that provides fairly good coverage of European organisations. We greatly rely on our partners in disseminating the results from the project and urge them to work closely with their national and regional health ministries to make the project and its results more visible. A lot of dissemination goes through the “on the job training”, ie, through participation in the EUnetHTA Work Packages. We are also working with the European Commission by informing, eg, the High Level Group, on the developments in the project. However, the project is underfunded and most of the scarce resources are put into the developmental work.
EUnetHTA Partners’ comments from the floor on the question:
The success of the project is also seen through the spin-off activities of closer cross-border collaboration on specific HTA projects among the European HTA agencies, eg, HPV vaccination, age-related macular degeneration.
EUnetHTA is clearly developing a more efficient ways of working in HTA projects by developing practical tools. It is very important to ensure that this work will be supported in the future beyond the project time frame. Already now it is important to encourage HTA agencies to use the developed tools. Some Nordic HTA agencies are considering applying the core HTA model approach already in 2008.