With a recently finished European Commission project on Health Technology Assessment (HTA) and a Directive from the Commission that promotes greater cooperation in the field, HTA is a hot topic at the moment. However, governments have been using HTA for years, they provide the basis of decision-making processes about new health technologies. So what is HTA and why have they become the focus of so much attention?
"Health technology assessment (HTA) is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner." Danish National Board of health (Sundhedsstyrelsen).
Health Technology Assessments are carried out in order to provide a Government or competent health authority with the information they need to make safe effective and accurate judgments on technologies to be used in their health systems. Assessments of drugs and technologies are generally made on two basic criteria: clinical effectiveness and economic viability. New technologies are continually emerging in the healthcare domain. Health authorities use HTA to carry out cost-benefit analysis to ensure the financial viability of their health system and the safety, effectiveness and value for money of these new technologies.
All HTAs aim to be as robust and unbiased as possible so that the decisions that are based on their judgments can be made in a similarly unbiased way. In the UK, the National Institute for Clinical Excellence is an independent body that provides both the assessment and the approval of technologies, including medicines, for use in the UK National Health Service (NHS). Other HTAs provide advice but nothing more, they have no role as a regulator and cannot approve or disapprove technologies. The German Institute for Quality and Efficiency in Health Care (IQWiG) carries out analysis into risk-benefit and cost benefit on the medicines and medical technologies for social insurers, which then use this information to make planning decisions around whether to make certain medicines or technologies publicly available.
Why now? Why is HTA so high on the current political agenda?
With the financial crisis, Member States are under considerable pressure to cut costs and HTA is a tool that allows Member States to do just that.
HTA is a key element in health system planning as it allows national authorities to understand the cost of new technologies and predict the impact that they will have. However, if the health authority uses the HTA to not approve medicines that could save lives and use it as a tool for cost cutting with no concern for the citizens health, then the system is undoubtedly up for discussion.
in Europe there is a growing focus on healthcare sustainability. Member States are being encouraged to look to the future of their healthcare systems. Much interest is focused on what can be done to lessen the blows that will be dealt by an increased incidence of chronic disease and disability due, in part, to an ageing population. The financial sustainability of healthcare systems is the theme of a Czech Presidency Ministerial Conference in May 2009. HTA and the ability to plan that it provides is clearly a key part of the sustainability debate.
In 2004 the Commission and Council described HTA as "a political priority" and recognised "An urgent need for establishing a sustainable European network on HTA." The Commission call was answered in 2005 by a group of 35 organisations throughout Europe, led by the Danish Centre for HTA (DACEHTA) in Copenhagen.
This Project that ran from 2006-2008 called the European network for Health Technology Assessment, EUnetHTA, aimed to set up and coordinate a network of HTA throughout Europe. The network brought together all the different HTA authorities in Europe and some from beyond its borders, to share information and best practice. Although this project is now finished there have been calls from some interested parties to institutionalise it and make it permanent.
In the Summer of 2008, the European Commission released a highly [controversial).]] Directive on patients’ rights in cross-border mobility. Article 17 of this Directive calls for Member States cooperation on the development of "a network connecting the national authorities or bodies responsible for health technology assessment." This duty of cooperation called for by the Commission, effectively tries to institutionalise the EUnetHTA project.
Some HTA, such as NICE, consult stakeholders: doctors, patient groups, industry and have formal processes for doing so. NICE uses these opinions to develop policy and make decisions. Other HTA do not consult extensively with stakeholders such as the Agency for Health Technology Assessment in Poland (AHTAPol) as it may effect their impartiality.
The European Commission has recently focused heavily on the empowerment of patients and increasing patient access to information. This focus has led to speculation that there is potential for greater involvement in the stakeholder groups of HTA and in any EU network of HTA set up as a result of the patients’ rights Directive.
This has led to fierce lobbying for involvement of the various industries affected as well as civil society organisations. Several of the 1000 or so amendments submitted to the patients’ rights Directive have called for greater stakeholder involvement in the network to be set up in accordance with article 17.
But with Stakeholder involvement comes the ability to influence, should stakeholders be involved in decision making? Should industry be able to influence decisions on the approval of their drugs? Should stakeholders opinions be institutionalised as part of the approval process? Or should stakeholders be exluded from HTA completely? These are the questions that are being asked and the questions that need answers.
The network of national authorities proposed by this Directive has led many opponents to express concern over the fact that this could lead to an EU-wide HTA. This, some say, could mean that national systems would lose their individuality and ability to limit technologies entering their healthcare systems. Others argue, however, that a single EU-wide HTA would be a solution to the problem of having to carry out 27 different HTA every time a new technology or drug enters the European Common market. They argue that Member States keeping so many different HTA is just a way for Health Authorities to cut costs and that it delivers no increased benefit for patients.
Although an EU-wide HTA may seem like a simple solution, a network of this type carries many hidden agendas. Aside from the fact that Member States may lose their ability to plan effectively, a single network of HTA could allow industries easier access to the entire market through one process.
So two questions present themselves: Should there be greater involvement of stakeholders, including industry, in the HTA processes? Should there be a single EU-wide HTA? Whatever the answers, it is of paramount importance that the decisions are made for the rights reasons. The decision must be taken to make life easier, safer, cheaper and better for patients and citizens and not solely in order to allow Governments and industries to cut costs.
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