At the end of last year the European Network of Health Technology Assessment (EUnetHTA) has strengthened its position as the umbrella organisation for dozens of Health Technology assessment (HTA) bodies across Europe.
Despite forming in 2006, the network of agencies in charge of evaluating the suitability for reimbursement of medicines and all health technologies finally held its first meeting in October 2013. EUnetHTA has been endorsed by the EU directive on cross border healthcare, establishing a framework for its future aims and giving it a boost as the European scientific and technical cooperation current mechanism, at least until 2015.
But what is EUnetHTA´s role in European healthcare? Will it pave the way for a centralised HTA agency? And what are the implications for the pharmaceutical industry?
EUnetHTA’s core model is to provide a framework for HTA assessment in an efficient, structured and systematic way
Transnational HTA collaboration started as a project several years ago and it has been moving up the European health policy agenda as a means of enhancing cooperation between member states. It focuses on sharing resources and tools for evidence-based decision making on cost-effectiveness, tackling health inequalities and increasing access to new medicines and treatments.
EUnetHTA’s core model is to provide a framework for HTA assessment in an efficient, structured and systematic way and some of the most influential agencies, such as NICE have joined. Many HTA agencies in Europe are now working closely with the network on different projects and using its methodology.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has supported the creation of this network, hoping it will develop a robust, consistent, measurable and transparent approach to evaluation of new health technologies, replacing the current landscape of regionalised, fragmented and multiple reimbursement systems and payers.
This wide variety of HTA systems in the EU has impacted on the increasing gap between pricing and reimbursement of medicines and treatments, adding to the growing cost burden of funding healthcare services in Europe.
EUnetHTA represents 39 regional and national agencies from the 29 EU member states, plus Norway, with Denmark currently serving as the secretariat via its National Board of Health.
These bodies have similar agendas and can benefit hugely from using a common framework, particularly as healthcare budgets are shrinking. EUnetHTA also reaches out to research institutions and is engaging with patient groups, payers and the pharma industry. Regarding the latter, pharma is keen to see an improvement in the uptake of innovative medicines, less duplication, more information sharing for clinical trial design and early feedback on reimbursement suitability – all of which can be supported by EUnetHTA.
Pharmaceuticals, diagnostic and treatment methods, medical equipment, rehabilitation and prevention methods, organisational and support systems used to deliver healthcare are currently part of HTA, although, in the context of EUnetHTA, the areas within the purview of the network are still under discussion.
Collaborating with the EMA
EUnetHTA has recently agreed on a joint work plan with the European Medicines Agency (EMA) to increase collaboration, in a recent flush of activity. Guidance for EMA-HTA parallel scientific advice will be developed and published for public consultation in early 2014. The guidance will detail the timelines and actions whereby applicants can seek simultaneous feedback from regulators and HTA bodies on their development plans.
This plan fits into the European Commission’s 2020 strategy ‘Together for health’, which supports efficient spending on healthcare as a precondition for economic growth. It is seen as part of the solution to better funding for healthcare and improving coverage in the current financial crisis.
Martin Seychell, deputy director general at DG SANCO (EC Health and Consumers), chaired the EUnetHTA meeting in October and reiterated: “The EC is highly committed to the success of HTA cooperation in Europe. Significant investments have been made since the 1990s. The EC intends to continue to provide a high level of financial support in the next programming period of the Health Programme 2014-2020. The role of the HTA Network is crucial.” However, he acknowledged: “We are at a turning point: either we accelerate and build on results achieved so far or we may need to reconsider the entire initiative.”
This statement relates to the convoluted process of setting up such a broad network, giving it a permanent structure and defining its role, scope, and allocating funds. Unlike the EMA´s process for centralised approval, which is compulsory, EUnetHTA is a voluntary network with loose ends, spotty funding and is yet to achieve a solid legal grounding.
HTA bodies are deeply rooted and connected to the healthcare systems of each country in which they are integrated
The concept of a pan-European HTA agency or ‘Euro NICE’ has been discussed in the healthcare industry, but it is likely to be very hard to implement due to differences in patient populations, incompatible national agendas and dissimilar views on cost effectiveness. HTA bodies, like regulatory agencies, are deeply rooted and connected to the healthcare systems of each country in which they are integrated. Besides, political divisions created by the economic crisis have made some countries less enthusiastic on matters of harmonisation and taking directions from Brussels.
The current EUnetHTA activity is a step towards enhanced cooperation across Europe but it is still very premature to talk about a centralised European HTA agency, a controversial move which requires much more political commitment and unity and could have a much wider impact on stakeholders, particularly the pharma industry.
Aims of EUnetHTA:
- Supporting efficient production and use of HTA in countries across Europe
- Providing an independent and science-based platform for HTA agencies in countries across Europe to exchange and develop HTA information and methodology
- Providing an access point for communication with stakeholders to promote transparency, objectivity, independence of expertise, fairness of procedure and appropriate stakeholder consultations
- Developing alliances with contributing fields of research to support a stronger and broader evidence base for HTA while using the best available scientific competence.
Main functions of EUnetHTA are to:
- Be a contact point for the HTA community in Europe
- Maintain a shared HTA Information and Communication system
- Develop common processes for performing and reporting HTA
- Pilot processes for the collaborative production of HTA information taking into account European priorities in the healthcare field
- Facilitate adequate evidence generation
- Facilitate the establishment and continuous development of HTA institutions.
EFPIA hopes EUnetHTA will:
- Have a robust, consistent, measurable and transparent approach to evaluation of new health technologies
- Minimise duplication
- Speed up uptake and increase access to innovative therapies
- Improve information sharing for clinical trials purposes.