11.4. Health Technology Assessment

 

The development of research-based innovations provides health care with a multitude of effective technologies and contributes to the improvement of the health of European citizens. The range of health technologies spans from prevention to diagnostic procedures, pharmacological and non-pharmacological interventions and therapies, surgery and rehabilitation. Even the systems within which health is protected and maintained - including health informatics - can be seen as technologies.

 

A few examples of technologies are e.g.

·         Diagnostics such as computer tomography in mild head injury

·         Pharmaceuticals and biological medicines e.g. monoclonal antibody (Trastuzumab) in early HER2-positive breast cancer

·         Complex organisational and clinical interventions e.g. acute inpatient care and early rehabilitation in stroke

·         Population based screening programmes to reduce the risk of cervical cancer

·         Recent vaccines against Human Papilloma Virus (HPV) to reduce the risk of cervical cancer

·         Laparoscopic bariatric surgery in severe obesity.

 

Effective health technologies do not by themselves find their way into health systems through some kind of passive diffusion. Often implementation is scattered leading to uneven application, sometimes involving overuse and underuse within the same system. Successful implementation depends on many factors. The following text describes a research-based multidisciplinary facilitator to improve the implementation of new technologies in health systems: the Health Technology Assessment.

 

The role of Health Technology Assessment (HTA) is to inform the development of healthcare policies of given health systems. Technology assessment in healthcare is defined as a multidisciplinary field of policy analysis. It studies the medical, social, ethical and economic implications of development, diffusion and use of health technology (INAHTA). HTA is described as a multidisciplinary process that summarises information on the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused and seek to achieve best value. Despite its policy goals, HTA must always be firmly rooted in research and the scientific method (EUnetHTA).

 

The role of HTA has been compared with that of a bridge between research and decision-making. Figure 11.7 depicts how HTA projects ideally make their starting point in questions from the policy world and base their work processes on methods and information from the research world. The reporting is fed back to the policy world to inform specific policies.

 

Figure 11.7. Relations between research and decision-making process.

 

 

 

 

 

HTA is one source among other sources of information for policy. Policy-makers also make use of expert opinion, scientific advice, health statistics and information, public hearings, lobbyists, etc. HTA should be seen as information into - but separate from - policy-making and decision-making. Often, many issues play a role in the actual definition of policies that cannot all be covered by HTA (Figure 11.8).

 

Figure 11.8. HTA as an input to priority-setting and decision-making.

 

 

 

 

From the 1980’s onwards, HTA has been institutionalised at national and regional levels in most EU member states. By 2007 there were national agencies in 15 member states, and national focal points for HTA in most other member states (www.eunethta.eu). Countries such as Spain and Italy have several regional HTA agencies. A global network for HTA agencies, INAHTA, has existed since 1993 (www.inahta.org), and there is an international society for HTA (HTAi) (www.htai.org) and a scientific journal, International Journal for Technology Assessment in Health Care.

 

Irrespective of national variations, that may reflect the specific policy setting that HTA is informing into, the process of HTA can normatively be described as depicted in Figure 11.9. The key point that HTA is multidimensional and multidisciplinary is reflected in the several dimensions that should be considered for inclusion in an HTA project (Busse et al., 2002). The EU funded ECHTA/ECAHI project listed the following sciences and research methodologies that contribute to HTA:

 

Safety, efficacy, effectiveness aspects

·         Interventional clinical research, mainly randomised controlled trials

·         Clinical epidemiology and statistics

·         Population-based epidemiology

·         Systematic review of published evidence

·         Research in biotechnology

·         Medico-technical research

 

Psychological, social, ethical aspects

·         Psychology (personality as well as social psychology)

·         Anthropology

·         Sociology

·         Academic ethics

 

Organisational, professional aspects

·         Health services research

·         Organisational research

·         Systems science

·         Occupational and organisational psychology

·         Sociology of organisations

·         Informatics research

 

Economic aspects

 

General economic theory

·         Macroeconomics

·         Microeconomics

·         Health economic methods such as

·         Modelling cost-effectiveness ratios using quality-adjusted life years (QALY)

 

The incorporation of population and patient preferences in health economic analysis

Information and data for HTA comes primarily from two sources:

 

·         Published research, be it clinical, epidemiological, psychological, economic or other relevant research

·         Health information including economic information from population or healthcare registers, surveys, epidemiologic studies etc.

 

Figure 11.9. Conduction of an assessment

 

 

Source: Busse et al (2002)

 

 

The reporting of HTA varies from, say, large reports that cover a range of technologies for specific diseases, such as Diabetes type-2 or low back pain, to alerts on single technologies and reports on single interventional procedures. Transparency in HTA processes and reporting is important for the credibility of the products, and most institutions involve external peer-review in their quality assurance procedures. Pressures to provide timely HTA information to policy processes which can sometimes be very rapid with a lot of public attention has lead to HTA products such as “Rapid HTAs” and “Alerts”.

 

The practice of HTA varies considerably across national settings. HTA informs policy- and decision-making, which is done in a specific political, economical, and institutional context. For the sake of utility, HTA designs its processes and output to fit the relevant context. However, there is a considerable duplication of efforts in European HTA – including elements in the process of HTA that can be shared. One obvious example is the results of systematic search and review of published evidence on the efficacy and effectiveness of interventions. However, unnecessary duplication of methodologies and procedures in the processes of planning, making and publishing HTAs on specific technologies is also prevalent. Considerable resources may be restricted if definable and agreed best practices are not applied in HTA across Europe. When the same information seemingly is leading to varying conclusions and subsequent recommendations, the duplication of HTA on the same topic may even lead to controversy over the scientific soundness of HTA, as was the case with HTA in positron emission tomography (PET) some years ago.

 

The current EU funded European Network for Health Technology Assessment, EUnetHTA project aims at reducing duplication of efforts through practical tools and methodologies that can work trans-nationally. See www.eunethta.eu for more information.

 

HTA is increasingly used in formal policy processes across Europe. As previously underlined, HTA informs policy and does not define policies nor make decisions. There is a clear distinction in England between assessment (a scientific process and the role of the HTA Programme) and appraisal (the role of policymakers, such as the National Institute for Health and Clinical Excellence (NICE) (Walley, 2007) .

 

The HTA Programme supports all NICE technology appraisals by commissioning independent assessments of the evidence, accompanied by economic evaluation and a review of manufacturers’ submissions. These are provided to NICE’s appraisal committees to inform its decisions, and are made publicly available once NICE has reached its preliminary decisions. The assessment does not make any recommendations.

 

The EU Commission and the Council of Health Ministers have stressed the need for a sustainable network for HTA in Europe. The Commission has expressed that “Health technology assessment is a good example, where it is more efficient for everyone to collaborate on assessing new health technologies rather than duplicating assessments across the Member States”. Thus, EU member states and the Commission should be able to agree on mechanisms to bring a sustainable network for HTA in place by the end of the current EUnetHTA project (2006-08).

 

 

During 2008 the EUnetHTA project partners continued to create an organisation that could  ensure the transition from a project to a permanent collaboration in a sustainable network for HTA. This work involved HTA agencies, Ministries of health in Member States and the EU Commission. A public consultation was carried out on a draft proposal for European HTA Collaboration years 2009+ in November 2007 – January 2008 (www.eunethta.eu) which encouraged the efforts and gave valuable information for making the final proposal.